#pharma manufacturer in california

[invapharm]

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[uboat53]

California is going to start producing insulin itself and… guys, this is huge.

For those who don't know, the guys who invented insulin sold the patent for $1 hoping that it would allow widespread production of this lifesaving drug at an affordable price. It still only costs about $10 to produce a dose of insulin, but those among us who use it know that the cost to the user is much, much higher.

Effectively, even though the patent is freely available and the per-unit production cost is so low, the costs associated with startup and obtaining FDA approval are so high and the time it takes is so long that it's effectively allowed about three companies to take control of the market and squeeze massive profits by hiking the price of a drug that people will (and do) literally die without.

California's plan to produce the drug and sell it at cost is an attack on the notion that the market for insulin is truly "free".

Look, the standard line is that patent and privatization is important in order to encourage and reward the kind of innovation that improves products and technology for the next generation, but what about a product that hasn't changed in 100 years? That's right, the insulin available today is basically the same as the insulin that Banting, Collip, Macleod, and Best discovered in 1921, can we really say that we're protecting innovation if there hasn't been any for over a century?

Instead, a virtual cartel of insulin producers is protected by making slight changes to their injectors that "justify" re-patenting them every time the patent is about to run out, the fact that it would take hundreds of millions of dollars and nearly a decade to start up a competing line of insulin, and the fact that any potential competitor knows that, should they actually go through the process and start up a line, these companies could simply lower their own prices until the new company is driven out of business before raising them again.

Unlike a competing company, however, the state doesn't have to make a profit. In fact, California's plan is to sell at cost, meaning that the companies can't simply drive them out of business by lowering their prices for a time. If this works it's likely that other drugs will be next in line and Washington and Maine are already looking at doing something similar.

There are far too many industries where massive profits and a complete lack of innovation are allowed to exist largley due to systemic and regulatory issues. I say it's great that people are starting to get creative about breaking up those kinds of things which serve only to drain otherwise useful resources out of the rest of society.

If you're interested in the details of what's in the pipeline, this piece does a great job explaining it.

[mariacallous]

Once upon a time, a very long time ago, about two years ago, companies—like the beloved children’s character Winnie the Pooh—lived, if not all by themselves, then at least far from geopolitics.

How rapidly the world has changed since then. Last year, a staggering 93 percent of multinationals reported losses linked to political instability, up from 35 percent in 2020, a new survey from WTW and Oxford Analytica found. Companies should brace themselves for even more turbulence this year. And next year. And the year after that. Businesses, which have for decades operated in a world where they could float above any squabbling among countries, are discovering that charmed era has ended.

Weeks after Russia invaded Ukraine, BP decided to let go of its 19.75-percent stake in the Russian oil and gas giant Rosneft and two joint ventures in Russia—which meant it had to write down more than $20 billion in the first quarter of 2022. The German DIY chain Obi Baumarkt sold its Russian stores to local staff for 10 euros. The Italian bank UniCredit has lost $1.3 billion, ExxonMobil has lost more than $3 billion, and H&M has lost nearly $200 million. Indeed, every company leaving the country (and hundreds have made announcements to that effect) is incurring substantial losses—if they manage to leave.

Companies wishing to depart need the approval of Russian authorities, and as of March this year, they also have to make a “mandatory donation” to the Russian government. Meanwhile, companies operating in China, or exporting to the country, know that they risk becoming a target if their home governments say or do something that displeases Beijing; this has happened to companies as diverse as Ericsson and Taiwanese pineapple farms. And when President Tsai Ing-wen of Taiwan met U.S. Speaker of the House Kevin McCarthy in California earlier this month, Beijing responded by dispatching an “inspection flotilla” to the Taiwan Strait, where its threat of inspections was certain to wreak havoc on shipping companies and their customers in one of the world’s busiest waterways. This time, the flotilla didn’t carry out any inspections, but global shipping companies and manufacturers rightly concluded there will be more such outings.

Such events have delivered a brutal awakening to companies, which until just a couple of years ago persisted in believing that they could keep operating in a largely peaceful sphere. The 2023 political risk survey conducted by Oxford Analytica for the insurance broker WTW, published on April 18, delivers sobering figures. Last year, 68 percent of companies bought political risk insurance, which provides cover for war, civil wars, coups, government expropriations, and similar misfortunes, up from 25 percent in 2019.

Even compared to last year, the fear of geopolitics has skyrocketed. In the 2022 survey, 16 percent of the executives interviewed predicted deglobalization would significantly strengthen; in this year’s report, 48 percent do (and another 38 percent believe it will simply strengthen). Last year, 12 percent of the executives predicted decoupling from China would significantly increase; now 42 percent do. Beijing has been all too happy to oblige. The Financial Times reported that between mid-February and mid-April this year, China imposed sanctions on the U.S. defense contractors Lockheed Martin and Raytheon; launched an investigation into U.S. chipmaker Micron; and harassed the U.S. due diligence firm Mintz, Japan’s Astellas Pharma group, and the Big Four consultancy Deloitte.

A sizable majority of executives have lost faith in globalization. “It’s a sea change in companies’ attitudes about geopolitical risk,” Sam Wilkin, WTW’s director of political analysis, told me. “There has been a huge change in perception, mostly as a result of the conflict in Ukraine and, for U.S. companies, the confrontation with China. Companies have started taking wars and conflicts seriously.” (Full disclosure: I serve as an occasional advisor to another division of WTW.)

Companies are taking wars and conflicts seriously because they’re being affected by both—including conflicts of the less visible kind. Twenty percent of the companies surveyed have sustained political risk-related losses in Russia or Ukraine, and 48 percent have done so in the BRICS countries—Brazil, Russia, India, China, and South Africa. “Political uncertainty manifested in the war in Ukraine and the growing uncertainty around China and a potential war in the Pacific over Taiwan: Link this to continued uncertainty over rogue states like North Korea and Iran, and it’s no surprise that political uncertainty and the impact it has on international business is growing,” said Simon Bergman, the CEO of M&C Saatchi World Services. “The West’s inability to accurately predict large state actors’ behavior has been manifest over the past 12 months, and this will continue into 2024 and beyond.”

Political risk insurance cover was created years ago with the backing of several Western governments to allow companies to operate in riskier countries. Today, though, simply operating in the globalized economy is so risky that nearly 7 in 10 companies are buying this insurance. “Companies’ ability to do business in Russia and China will continue to deteriorate,” Bergman said. “When, and it’s when, China acts on Taiwan, the international reaction will significantly impact global businesses, and many of them depend on China for commercial products. The impact will be significant if not crisis-bringing.”

Nearly two-thirds of the executives surveyed by Oxford Analytica are concerned about state-backed cyber aggression, and nearly 60 percent worry about sanctions targeting individuals and companies. More than 50 percent worry about state-backed manipulation of financial markets, and more than 40 percent are concerned about state-backed intellectual-property theft.

So dire is the situation for the corporates surveyed that Russia and China now account for the largest political risk losses, followed by India, Brazil, and (thanks to Brexit) the United Kingdom. In 2020, companies sustained their largest political risk losses in Iran, Venezuela, Zimbabwe, Angola, and Libya—a much more predictable bunch of countries, and much more manageable losses because most companies had smaller operations there than in Russia or China. China taking the place of the Angolas and Libyas of the world, measured in business risk, is a dramatic turn of events.

“The risk the business community is most worried about is the West vs. China, because Western countries are showing that they’re willing to treat China as a systemic competitor,” Wilkin said. “And now it’s possible to imagine a major economy leaving the globalized economy. In 2020, we still had some of the usual suspects ranking as the world’s riskiest. Back then, you could operate in politically risky countries because you had diversified operations including many countries with no or little political risk. Now political risk has shifted major world economies that used to be major investment destinations. Companies are worrying about going out of business as a result of political risk.”

It has come to this: Businesses are worried about going bust not as a result of misunderstanding the market or making foolish investments—but as a result of geopolitics. Western companies in particular are extremely vulnerable now that globalization’s ultimate prize, China, is not just battling the United States over global power but also battling its own private sector, lest it become uncomfortably powerful. So severe was Beijing’s recent crackdown of China’s most successful tech giants that the companies’ shares plummeted when President Xi Jinping was reelected to a third term last fall.

“If the rate of change on the outside exceeds the rate of change on the inside, the end is near,” GE’s legendary CEO Jack Welch said. It’s not looking good for the companies that have done precisely what they were supposed to do and spent the past three decades integrating themselves into the globalized economy.

[work-at-home-mania]

Engineer II, Validation

Life Technologies (Thermo Fisher Scientific). United States – California, Remote Industry: Biotechnology / Pharma Work Schedule Standard (Mon-Fri)Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume,… Date posted: 11/09/2024 12:32 AM

[news365timesindia]

[ad_1] Quantiphi, a global AI-first digital engineering company and DDReg, a global leader in regulatory expertise today announced a partnership that will address regulatory challenges that pharmaceutical companies, biotechnology firms, medical device and cosmetics manufacturers face by bringing innovations to market more quickly through AI.DDReg Pharma partners with Quantiphi to use power of Artificial Intelligence to datamine Regulatory Intelligence for efficient submissions, faster approvals and enhance complianceNeeti Pant - DDReg Managing Director, said, "DDReg & Quantiphi collaboration harnesses DDReg's unparalleled regulatory knowledge and Quantiphi's innovative technology, along with a deep understanding of artificial intelligence, to revolutionize regulatory processes. Together, we are transforming how the life sciences sector navigates some of its most pressing regulatory challenges, ensuring compliance, enhancing safety, and accelerating the time to market for new therapies. This collaboration will not only address current regulatory demands but also anticipate future needs, providing a solid framework for sustainable growth and innovation. By combining our strengths, we are paving the way for a more streamlined, effective, proactive & cost-efficient approach to regulatory affairs in the life sciences industry."Quantiphi Global Head of Healthcare and Life Sciences, Barinder Marhok said the partnership marries DDReg's expertise in global regulatory process management and securing and renewing government approvals for healthcare interventions with Quantiphi's expertise in AI-managed processes and documents."As the life sciences industry grapples with the ever-evolving regulation landscape, Quantiphi and DDReg have come together to help deliver cutting-edge solutions that streamline regulatory processes across both the drug development and commercialization lifecycle, ultimately helping improve more lives," Marhok said. "Leveraging cloud, data and AI technologies, our joint efforts aim to accelerate approvals, enhance compliance and optimize Life Cycle Management (LCM), ensuring a faster and more efficient path to market."About DDRegDDReg is a global Pharmaceutical Regulatory Services and Pharmacovigilance services provider company with offices in Gurgaon (India), Delaware, California (USA), Cologne (Germany), and Singapore. It is an ISO 9001:2015 & ISO 27001 TV SD certified organization that is involved in a wide variety of regulatory consulting and pharmacovigilance assignments. DDReg services span across global markets and include, European Union, the USA, UK & Australia among developed markets to Asia, Africa, Middle East & GCC, CIS, and LATAM among the emerging markets- driven by WHO.DDReg has supported its clients in ensuring compliance with worldwide regulations for a wide range of products including generics, new drug products, biologics, biosimilars, medical devices & combination products, cosmetics, and consumer products. The team has deep subject matter expertise and a knowledge base of over 120 regulatory bodies for regulatory compliance. DDReg's expansion strategy focuses on leveraging emerging technologies and expanding further into key international markets, especially those that have complex and/or ambiguous regulatory frameworks and growth of the pharmaceutical industry.Follow us on LinkedIn, X, formerly Twitter and Facebook. [ad_2] Source link

[news365times]

[ad_1] Quantiphi, a global AI-first digital engineering company and DDReg, a global leader in regulatory expertise today announced a partnership that will address regulatory challenges that pharmaceutical companies, biotechnology firms, medical device and cosmetics manufacturers face by bringing innovations to market more quickly through AI.DDReg Pharma partners with Quantiphi to use power of Artificial Intelligence to datamine Regulatory Intelligence for efficient submissions, faster approvals and enhance complianceNeeti Pant - DDReg Managing Director, said, "DDReg & Quantiphi collaboration harnesses DDReg's unparalleled regulatory knowledge and Quantiphi's innovative technology, along with a deep understanding of artificial intelligence, to revolutionize regulatory processes. Together, we are transforming how the life sciences sector navigates some of its most pressing regulatory challenges, ensuring compliance, enhancing safety, and accelerating the time to market for new therapies. This collaboration will not only address current regulatory demands but also anticipate future needs, providing a solid framework for sustainable growth and innovation. By combining our strengths, we are paving the way for a more streamlined, effective, proactive & cost-efficient approach to regulatory affairs in the life sciences industry."Quantiphi Global Head of Healthcare and Life Sciences, Barinder Marhok said the partnership marries DDReg's expertise in global regulatory process management and securing and renewing government approvals for healthcare interventions with Quantiphi's expertise in AI-managed processes and documents."As the life sciences industry grapples with the ever-evolving regulation landscape, Quantiphi and DDReg have come together to help deliver cutting-edge solutions that streamline regulatory processes across both the drug development and commercialization lifecycle, ultimately helping improve more lives," Marhok said. "Leveraging cloud, data and AI technologies, our joint efforts aim to accelerate approvals, enhance compliance and optimize Life Cycle Management (LCM), ensuring a faster and more efficient path to market."About DDRegDDReg is a global Pharmaceutical Regulatory Services and Pharmacovigilance services provider company with offices in Gurgaon (India), Delaware, California (USA), Cologne (Germany), and Singapore. It is an ISO 9001:2015 & ISO 27001 TV SD certified organization that is involved in a wide variety of regulatory consulting and pharmacovigilance assignments. DDReg services span across global markets and include, European Union, the USA, UK & Australia among developed markets to Asia, Africa, Middle East & GCC, CIS, and LATAM among the emerging markets- driven by WHO.DDReg has supported its clients in ensuring compliance with worldwide regulations for a wide range of products including generics, new drug products, biologics, biosimilars, medical devices & combination products, cosmetics, and consumer products. The team has deep subject matter expertise and a knowledge base of over 120 regulatory bodies for regulatory compliance. DDReg's expansion strategy focuses on leveraging emerging technologies and expanding further into key international markets, especially those that have complex and/or ambiguous regulatory frameworks and growth of the pharmaceutical industry.Follow us on LinkedIn, X, formerly Twitter and Facebook. [ad_2] Source link

[ashwetu]

Global Pharmaceutical Contract Development and Manufacturing Market to Reach $261.57 Billion by 2031, Driven by Advancements in Biologics and Generic Drug Demand

[Redding, California] – Meticulous Research®, a leading global market research firm, has unveiled its latest comprehensive analysis titled “Pharmaceutical Contract Development & Manufacturing Market Size, Share, Forecast, & Trends Analysis by Service(Manufacturing [API, FDF {Parenteral, Injectable, Tablet, Capsule, Oral Liquid, Biologics}], Drug Development) End User - Global Forecast to 2031.” According to the report, the pharmaceutical contract development and manufacturing market is poised to reach a significant milestone of $261.57 billion by 2031, registering a compound annual growth rate (CAGR) of 7.4% from 2024 to 2031.

1. Market Growth Catalysts

The growth trajectory of the pharmaceutical contract development and manufacturing market is primarily fueled by the pharmaceutical industry's increasing complexity, alongside a growing reliance on cutting-edge manufacturing technologies. The surge in pharmaceutical R&D investments, the expiration of critical patents, and the escalating demand for generic medicines and biologics are additional key drivers. However, challenges such as supply chain disruptions and stringent regulatory frameworks are creating headwinds for the market.

Download Sample Report Here : https://www.meticulousresearch.com/download-samplereport/cp_id=5171

2. Emerging Opportunities and Challenges

As the market evolves, it presents notable opportunities, particularly in the burgeoning sectors of cell therapies, gene therapies, and personalized medicine. The growth in high-potency active pharmaceutical ingredients (HPAPI) and antibody-drug conjugates (ADC) markets further underscores the potential for expansion. However, the market also faces significant challenges, including intellectual property risks and a shortage of skilled professionals required to navigate the complexities of pharmaceutical manufacturing.

3. Key Industry Players

The pharmaceutical contract development and manufacturing landscape is dominated by several key players, including:

•        Lonza Group Ltd. (Switzerland)

•        Catalent Inc. (U.S.)

•        Patheon (a subsidiary of Thermo Fisher Scientific Inc., U.S.)

•        Recipharm AB (Sweden)

•        C.H. Boehringer Sohn AG & CO. KG. (Germany)

•        Aurobindo Pharma Ltd. (India)

•        Jubilant Pharmova Limited (India)

•        Fareva SA (Luxembourg)

•        Vetter Pharma International GmbH (Germany)

•        Aenova Group (Germany)

•        WuXi Biologics Inc. (China)

•        Piramal Enterprises Limited (India)

•        Almac Group (U.K.)

•        Fabbrica Italiana Sintetici S.p.A. (F.I.S., Italy)

•        Samsung Biologics Co., Ltd. (South Korea)

•        Cambrex Corporation (U.S.)

•        Siegfried Holdings AG (Switzerland)

•        FUJIFILM Diosynth Biotechnologies (Japan)

•        Curia Global, Inc. (U.S.)

 Quick Buy: https://www.meticulousresearch.com/Checkout/67156803          

4. Market Segmentation and Future Outlook

The report categorizes the pharmaceutical contract development and manufacturing market by type, end user, and geography. Notably, the biologics manufacturing services segment is expected to experience a higher CAGR of 11.1% during the forecast period. This segment is further subdivided into finished dosage form (FDF) manufacturing services and active pharmaceutical ingredient (API) manufacturing services. The FDF category, driven by the rising importance of biologics and their intricate manufacturing processes, is anticipated to lead the growth.

Among end users, large pharmaceutical companies are projected to dominate the market, accounting for 42.3% of the market share by 2024. The increasing complexity of drug research and the high costs associated with facility maintenance have made contract manufacturers indispensable to large biotech and pharmaceutical companies. Additionally, with the expiration of many drug patents, these companies increasingly rely on contract development firms to bring generic versions of their drugs to market.

5 Regional Insights

Geographically, North America is poised to maintain its leadership in the pharmaceutical contract development and manufacturing market, with an estimated 44.3% market share by 2024. This dominance is supported by a diversified product pipeline, emerging therapies, shifting customer demands, and an increasing focus on biologics and generic drugs. North America also benefits from a large production base for APIs, advanced manufacturing capabilities, and the presence of major pharmaceutical companies.

Request Sample Report Here: https://www.meticulousresearch.com/request-samplereport/cp_id=5171

Key Questions Addressed in the Report

•        What are the high-growth market segments by type, end user, and region/country?

•        What are the historical market sizes and forecasts for 2024–2031?

•        What are the primary drivers, restraints, opportunities, and challenges in the market?

•        Who are the major players and market leaders?

•        What recent developments and strategies have shaped the competitive landscape?

•        Which regions/countries are experiencing the highest growth?

Contact Information

Meticulous Research®

Email: sales@meticulousresearch.com

Phone: +1-646-781-8004

LinkedIn: Connect with us on LinkedIn

[douxlen]

There’s Now a Nasal Spray for Dangerous Allergic Reactions

New Post has been published on https://douxle.com/2024/08/14/theres-now-a-nasal-spray-for-dangerous-allergic-reactions/

There’s Now a Nasal Spray for Dangerous Allergic Reactions

U.S. health officials on Friday approved a nasal spray to treat severe allergic reactions, the first needle-free alternative to shots like EpiPen.

The Food and Drug Administration said it approved the spray from drugmaker ARS Pharmaceuticals Inc. as an emergency treatment for adults and older children experiencing life-threatening allergic reactions known as anaphylaxis.

Anaphylaxis occurs when the body’s immune system develops a sudden, unexpected reaction to a foreign substance, such as food, insect stings or medications. Common symptoms include hives, swelling, itching, vomiting and difficulty breathing.

The device, marketed as Neffy, could upend treatment for the 33 million to 45 million Americans with severe allergies to food and other triggers. Anaphylaxis sends more than 30,000 people to emergency rooms and results in more than 2,000 hospitalizations and more than 230 deaths in the U.S. each year.

Read More: Your High Cholesterol Might Be Genetic

Of the 6 million prescriptions written for auto-injectors each year, more than 40% are never filled, Dr. Thomas Casale, an allergist at the University of South Florida, told an FDA advisory panel last year. Even when they are available to caregivers, many auto-injectors are used incorrectly, he said.

“There’s a real unmet medical need for a large portion of the population,” he said.

Neffy is intended for people who weigh at least 66 pounds. It is given in a single dose sprayed into one nostril. A second dose can be given if the person’s symptoms don’t improve.

The new treatment could be life-changing for people with severe food allergies, said Dr. Kelly Cleary, a pediatrician and director with the Food Allergy Research & Education, a nonprofit advocacy group.

“I have seen the look of worry or fear,” said Cleary, whose 11-year-old son has multiple food allergies. “I worry about what happens if someone hesitates.”

Requiring an injection in an emergency is as scary to some children as the allergic reaction itself. Some parents have had to restrain thrashing children to inject them, sometimes causing cuts that require stitches. About 3,500 caregivers a year are injured when they accidentally inject themselves in the hands, ARS said.

Priscilla Hernandez, of Pasadena, California said her 12-year-old son, Zacky, who is allergic to sesame, peanuts, tree nuts, avocado and other foods, was traumatized when he had a reaction at school about six years ago and a nurse treated him with an auto-injector.

“Having to do a shot creates this whole different level of anxiety,” she said.

She said, “we are over the moon” about the FDA’s approval of the spray, which Zacky will start carrying when it becomes available.

First marketed in 1901, epinephrine predates the FDA itself. Products like the EpiPen auto-injector, approved in 1987, were authorized based on chemistry and manufacturing data and were not required to prove safety and efficacy.

Clinical trials of people experiencing potentially deadly reactions are difficult for ethical and pragmatic reasons. Instead, ARS officials compared the effect of the nasal spray on biological markers to existing epinephrine treatments.

Results showed Neffy worked about as well as injected epinephrine to boost heart rate and blood pressure, which counter severe reactions. The drug is combined with a patented agent that allows it to be easily absorbed through nasal membranes.

Other needle-free epinephrine devices are being developed to treat allergic reactions. In the pipeline are nasal sprays from Bryn Pharma, of North Carolina, and Nausus Pharma, of Israel; a needle-free auto-injector from Crossject of France; and an epinephrine film that is administered under the tongue from Aquestive Therapeutics, of New Jersey.

Neffy is designed to be easy to carry and easy to use, especially for children, said Richard Lowenthal, president and chief executive of San Diego-based ARS.

“We don’t want fear. There’s no needle, there’s no pain with this product,” he said. “It’s basically like spraying saline into your nose.”

ARS didn’t immediately disclose a list price, but said it would make the spray available through certain discount programs for about $200 per two-pack. Insurance plans must still decide whether to cover the product and at what price.

[sa7abnews]

There’s Now a Nasal Spray for Dangerous Allergic Reactions

New Post has been published on https://sa7ab.info/2024/08/13/theres-now-a-nasal-spray-for-dangerous-allergic-reactions/

There’s Now a Nasal Spray for Dangerous Allergic Reactions

U.S. health officials on Friday approved a nasal spray to treat severe allergic reactions, the first needle-free alternative to shots like EpiPen.

The Food and Drug Administration said it approved the spray from drugmaker ARS Pharmaceuticals Inc. as an emergency treatment for adults and older children experiencing life-threatening allergic reactions known as anaphylaxis.

Anaphylaxis occurs when the body’s immune system develops a sudden, unexpected reaction to a foreign substance, such as food, insect stings or medications. Common symptoms include hives, swelling, itching, vomiting and difficulty breathing.

The device, marketed as Neffy, could upend treatment for the 33 million to 45 million Americans with severe allergies to food and other triggers. Anaphylaxis sends more than 30,000 people to emergency rooms and results in more than 2,000 hospitalizations and more than 230 deaths in the U.S. each year.

Read More: Your High Cholesterol Might Be Genetic

Of the 6 million prescriptions written for auto-injectors each year, more than 40% are never filled, Dr. Thomas Casale, an allergist at the University of South Florida, told an FDA advisory panel last year. Even when they are available to caregivers, many auto-injectors are used incorrectly, he said.

“There’s a real unmet medical need for a large portion of the population,” he said.

Neffy is intended for people who weigh at least 66 pounds. It is given in a single dose sprayed into one nostril. A second dose can be given if the person’s symptoms don’t improve.

The new treatment could be life-changing for people with severe food allergies, said Dr. Kelly Cleary, a pediatrician and director with the Food Allergy Research & Education, a nonprofit advocacy group.

“I have seen the look of worry or fear,” said Cleary, whose 11-year-old son has multiple food allergies. “I worry about what happens if someone hesitates.”

Requiring an injection in an emergency is as scary to some children as the allergic reaction itself. Some parents have had to restrain thrashing children to inject them, sometimes causing cuts that require stitches. About 3,500 caregivers a year are injured when they accidentally inject themselves in the hands, ARS said.

Priscilla Hernandez, of Pasadena, California said her 12-year-old son, Zacky, who is allergic to sesame, peanuts, tree nuts, avocado and other foods, was traumatized when he had a reaction at school about six years ago and a nurse treated him with an auto-injector.

“Having to do a shot creates this whole different level of anxiety,” she said.

She said, “we are over the moon” about the FDA’s approval of the spray, which Zacky will start carrying when it becomes available.

First marketed in 1901, epinephrine predates the FDA itself. Products like the EpiPen auto-injector, approved in 1987, were authorized based on chemistry and manufacturing data and were not required to prove safety and efficacy.

Clinical trials of people experiencing potentially deadly reactions are difficult for ethical and pragmatic reasons. Instead, ARS officials compared the effect of the nasal spray on biological markers to existing epinephrine treatments.

Results showed Neffy worked about as well as injected epinephrine to boost heart rate and blood pressure, which counter severe reactions. The drug is combined with a patented agent that allows it to be easily absorbed through nasal membranes.

Other needle-free epinephrine devices are being developed to treat allergic reactions. In the pipeline are nasal sprays from Bryn Pharma, of North Carolina, and Nausus Pharma, of Israel; a needle-free auto-injector from Crossject of France; and an epinephrine film that is administered under the tongue from Aquestive Therapeutics, of New Jersey.

Neffy is designed to be easy to carry and easy to use, especially for children, said Richard Lowenthal, president and chief executive of San Diego-based ARS.

“We don’t want fear. There’s no needle, there’s no pain with this product,” he said. “It’s basically like spraying saline into your nose.”

ARS didn’t immediately disclose a list price, but said it would make the spray available through certain discount programs for about $200 per two-pack. Insurance plans must still decide whether to cover the product and at what price.

[spookysaladchaos]

Global Top 15 Companies Accounted for 58% of total Oral Dissolving Film market (QYResearch, 2021)

Oral Dissolving Film that employs a water dissolving polymer which allows the dosage form to quickly hydrate by saliva, adhere to mucosa, and disintegrate within a few seconds, dissolve and releases medication for oromucosal absorption when placed on the tongue or oral cavity.

According to the new market research report “Global Oral Dissolving Film Market Report 2023-2029”, published by QYResearch, the global Oral Dissolving Film market size is projected to reach USD 0.75 billion by 2029, at a CAGR of 7.8% during the forecast period.

Figure.   Global Oral Dissolving Film Market Size (US$ Million), 2018-2029

Figure.   Global Oral Dissolving Film Top 15 Players Ranking and Market Share (Ranking is based on the revenue of 2022, continually updated)

The global key manufacturers of Oral Dissolving Film include Kyukyu Pharmaceutical, Aquestive Therapeutics, BioDelivery(BDSI), Tapemark, Shilpa Therapeutics, CL Pharm, Adhex Pharma, Lubrizol Life Science, Aavishkar, DK Livkon, etc. In 2021, the global top 10 players had a share approximately 58.0% in terms of revenue.

About QYResearch

QYResearch founded in California, USA in 2007.It is a leading global market research and consulting company. With over 16 years’ experience and professional research team in various cities over the world QY Research focuses on management consulting, database and seminar services, IPO consulting, industry chain research and customized research to help our clients in providing non-linear revenue model and make them successful. We are globally recognized for our expansive portfolio of services, good corporate citizenship, and our strong commitment to sustainability. Up to now, we have cooperated with more than 60,000 clients across five continents. Let’s work closely with you and build a bold and better future.

QYResearch is a world-renowned large-scale consulting company. The industry covers various high-tech industry chain market segments, spanning the semiconductor industry chain (semiconductor equipment and parts, semiconductor materials, ICs, Foundry, packaging and testing, discrete devices, sensors, optoelectronic devices), photovoltaic industry chain (equipment, cells, modules, auxiliary material brackets, inverters, power station terminals), new energy automobile industry chain (batteries and materials, auto parts, batteries, motors, electronic control, automotive semiconductors, etc.), communication industry chain (communication system equipment, terminal equipment, electronic components, RF front-end, optical modules, 4G/5G/6G, broadband, IoT, digital economy, AI), advanced materials industry Chain (metal materials, polymer materials, ceramic materials, nano materials, etc.), machinery manufacturing industry chain (CNC machine tools, construction machinery, electrical machinery, 3C automation, industrial robots, lasers, industrial control, drones), food, beverages and pharmaceuticals, medical equipment, agriculture, etc.

[invapharm]

Invapharm: Elevating Health with High-Quality Dietary Supplements

Invapharm stands tall as a renowned Best quality supplement manufacturers, making waves in the industry. As a distinguished Best pharma manufacturer in USA, they have carved a niche for themselves by consistently producing the best supplements. Headquartered in California, their dedication to quality has earned them the reputation of being the pharma manufacturer in california.

Invapharm's commitment to excellence extends to being a high quality supplement supplier. They specialise in manufacturer supplements that meet the highest standards, ensuring optimal health benefits. As a leading tablet manufacturer, their cutting-edge facilities and expertise enable them to produce pharma-grade supplements.

Partnering with Invapharm as a contract manufacturer supplements ensures brands receive premium formulations. Their expertise in health supplement manufacturer places them at the forefront of the industry. Choose Invapharm and embark on a journey to elevate health with a top-tier health supplement manufacturer.

For more info visit : https://invapharm.com/

[work-at-home-mania]

Engineer II, Field Service

Life Technologies (Thermo Fisher Scientific). United States – California, Remote Industry: Biotechnology / Pharma Work Schedule Standard (Mon-Fri)Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume,… Date posted: 11/07/2024 12:31 AM

[laxmipharma]

Automatic Vial Sticker Labelling Machine in United States

Company Overview: Laxmi Pharma Equipment is a prominent Manufacturer, Supplier, and Exporter of Automatic Vial Sticker Labelling Machine in United States. Laxmi Pharma Equipment, established in 1985, operates from Phase III, Vatva, Ahmedabad, Gujarat, India. It is a prominent Manufacturer, Exporter, and Supplier specializing in pharmaceutical machinery. The company offers a wide range of pharmaceutical machinery, including Washing Machines, Filling Machines, Stoppering Machines, Capping Machines, Labelling Machines, Packaging Machines, Process Equipment, and more. Features: This machine automates the process of affixing labels onto vials, ensuring speed, efficiency, and accuracy. No change parts are required for switching between vial sizes. Features synchronized speed of label dispensing, conveyor, and pressing device. Easy adjustment for label application height and self-protection against voltage fluctuations. Suitable for various labeling types including partial, full wrap-around, and overlap labeling. High production speed of up to 250 vials per minute. PLC-based system with touch screen HMI for user-friendly operation. Conveyor and servo speed synchronized and controlled from HMI. Includes in-built speed indicator & counter and requires no oil or grease for maintenance. Option for online rejection system if needed. Laxmi Pharma Equipment is Exporter of Automatic Vial Sticker Labelling Machine  in United States Including Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. For more details, we invite you to engage in a professional conversation with our team. Read the full article

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Achieve Extraordinary Muscle Gains with RAD-140 by German Pharma

Are you ready to elevate your strength, maximize muscle growth, and sculpt a lean, defined physique? RAD-140 by German Pharma is here to transform your fitness journey. This powerful selective androgen receptor modulator (SARM) is meticulously formulated to enhance muscle development, increase strength, and support effective fat loss. Discover why RAD-140 is the ultimate choice for athletes and fitness enthusiasts serious about reaching their peak potential.

The Science Behind RAD-140

RAD-140 by German Pharma stands out in the supplement market due to its potent and scientifically backed formula. At its core, RAD-140 contains Testolone, a SARM known for its ability to promote muscle growth, increase strength, and support fat loss.

Testolone (RAD-140): Testolone is a SARM that selectively binds to androgen receptors in muscle and bone tissues. This selective binding enhances protein synthesis and muscle growth without the unwanted side effects often associated with traditional anabolic steroids. Testolone is renowned for its ability to promote lean muscle mass, improve strength, and support overall physical performance.

Maximizing Muscle Growth and Strength

The effectiveness of RAD-140 lies in its ability to support significant muscle gains and enhance physical performance. The supplement’s unique formula works synergistically to promote muscle growth, increase strength, and improve overall body composition. Whether you're a bodybuilder, an athlete, or someone looking to achieve a more muscular physique, RAD-140 provides the support you need to reach your goals.

Promoting Muscle Growth: By enhancing protein synthesis, RAD-140 promotes significant muscle growth and helps you achieve a more muscular and defined physique. Users report noticeable increases in muscle size and density within weeks of starting the supplement.

Increasing Strength: RAD-140 helps increase strength by promoting lean muscle mass and improving muscle recovery. This allows you to lift heavier weights and push through plateaus, leading to continuous progress in your fitness journey.

Supporting Fat Loss: RAD-140’s anabolic properties also support fat loss by increasing metabolic rate and promoting the utilization of stored fat for energy. This results in a leaner, more defined physique.

Comprehensive Benefits for Your Fitness Journey

While RAD-140 is renowned for its muscle-building and strength-enhancing capabilities, the benefits extend far beyond that. Users report improved energy levels, enhanced recovery, and better overall well-being. The supplement’s potent formula ensures that you can achieve your fitness goals without the risk of unwanted side effects.

Quality and Safety You Can Trust

German Pharma is committed to delivering products that meet the highest standards of quality and efficacy. RAD-140 is manufactured in a state-of-the-art facility, adhering to strict quality control standards. This ensures you’re getting a safe, effective, and reliable product every time.

Real Results from Real People

RAD-140 has garnered praise from countless users who have experienced significant results. John, a fitness enthusiast from California, shares his experience: “RAD-140 has been a game-changer for me. The muscle gains and strength improvements are incredible. I’ve seen dramatic changes in my physique and overall performance.”

How to Use RAD-140

To maximize the benefits of RAD-140, follow the recommended usage guidelines. Take one capsule daily with a meal to ensure optimal absorption and effectiveness. Pair the supplement with a balanced diet and regular exercise to achieve the best results. Remember to stay hydrated and consult with a healthcare professional before starting any new supplement regimen.

Transform Your Fitness Journey Today

There’s no better time to take control of your health and fitness journey than today. With RAD-140 by German Pharma, you have the tools you need to succeed. Whether you’re looking to increase muscle mass, boost your strength, or enhance your overall physical performance, RAD-140 is your ultimate solution.

In the words of one satisfied customer, "RAD-140 helped me achieve my fitness goals faster than I ever thought possible. It's a must-have for anyone serious about their health." Don’t wait—achieve extraordinary muscle gains with RAD-140 and experience the transformative power for yourself.

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[ashwetu]

Global Pharmaceutical Contract Development and Manufacturing Market to Reach $261.57 Billion by 2031, Driven by Advancements in Biologics and Generic Drug Demand

[Redding, California] – Meticulous Research®, a leading global market research firm, has unveiled its latest comprehensive analysis titled “Pharmaceutical Contract Development & Manufacturing Market Size, Share, Forecast, & Trends Analysis by Service(Manufacturing [API, FDF {Parenteral, Injectable, Tablet, Capsule, Oral Liquid, Biologics}], Drug Development) End User - Global Forecast to 2031.” According to the report, the pharmaceutical contract development and manufacturing market is poised to reach a significant milestone of $261.57 billion by 2031, registering a compound annual growth rate (CAGR) of 7.4% from 2024 to 2031.

1. Market Growth Catalysts

The growth trajectory of the pharmaceutical contract development and manufacturing market is primarily fueled by the pharmaceutical industry's increasing complexity, alongside a growing reliance on cutting-edge manufacturing technologies. The surge in pharmaceutical R&D investments, the expiration of critical patents, and the escalating demand for generic medicines and biologics are additional key drivers. However, challenges such as supply chain disruptions and stringent regulatory frameworks are creating headwinds for the market.

Download Sample Report Here : https://www.meticulousresearch.com/download-samplereport/cp_id=5171

2. Emerging Opportunities and Challenges

As the market evolves, it presents notable opportunities, particularly in the burgeoning sectors of cell therapies, gene therapies, and personalized medicine. The growth in high-potency active pharmaceutical ingredients (HPAPI) and antibody-drug conjugates (ADC) markets further underscores the potential for expansion. However, the market also faces significant challenges, including intellectual property risks and a shortage of skilled professionals required to navigate the complexities of pharmaceutical manufacturing.

3. Key Industry Players

The pharmaceutical contract development and manufacturing landscape is dominated by several key players, including:

•        Lonza Group Ltd. (Switzerland)

•        Catalent Inc. (U.S.)

•        Patheon (a subsidiary of Thermo Fisher Scientific Inc., U.S.)

•        Recipharm AB (Sweden)

•        C.H. Boehringer Sohn AG & CO. KG. (Germany)

•        Aurobindo Pharma Ltd. (India)

•        Jubilant Pharmova Limited (India)

•        Fareva SA (Luxembourg)

•        Vetter Pharma International GmbH (Germany)

•        Aenova Group (Germany)

•        WuXi Biologics Inc. (China)

•        Piramal Enterprises Limited (India)

•        Almac Group (U.K.)

•        Fabbrica Italiana Sintetici S.p.A. (F.I.S., Italy)

•        Samsung Biologics Co., Ltd. (South Korea)

•        Cambrex Corporation (U.S.)

•        Siegfried Holdings AG (Switzerland)

•        FUJIFILM Diosynth Biotechnologies (Japan)

•        Curia Global, Inc. (U.S.)

 Quick Buy: https://www.meticulousresearch.com/Checkout/67156803          

4. Market Segmentation and Future Outlook

The report categorizes the pharmaceutical contract development and manufacturing market by type, end user, and geography. Notably, the biologics manufacturing services segment is expected to experience a higher CAGR of 11.1% during the forecast period. This segment is further subdivided into finished dosage form (FDF) manufacturing services and active pharmaceutical ingredient (API) manufacturing services. The FDF category, driven by the rising importance of biologics and their intricate manufacturing processes, is anticipated to lead the growth.

Among end users, large pharmaceutical companies are projected to dominate the market, accounting for 42.3% of the market share by 2024. The increasing complexity of drug research and the high costs associated with facility maintenance have made contract manufacturers indispensable to large biotech and pharmaceutical companies. Additionally, with the expiration of many drug patents, these companies increasingly rely on contract development firms to bring generic versions of their drugs to market.

5 Regional Insights

Geographically, North America is poised to maintain its leadership in the pharmaceutical contract development and manufacturing market, with an estimated 44.3% market share by 2024. This dominance is supported by a diversified product pipeline, emerging therapies, shifting customer demands, and an increasing focus on biologics and generic drugs. North America also benefits from a large production base for APIs, advanced manufacturing capabilities, and the presence of major pharmaceutical companies.

Request Sample Report Here: https://www.meticulousresearch.com/request-samplereport/cp_id=5171

Key Questions Addressed in the Report

•        What are the high-growth market segments by type, end user, and region/country?

•        What are the historical market sizes and forecasts for 2024–2031?

•        What are the primary drivers, restraints, opportunities, and challenges in the market?

•        Who are the major players and market leaders?

•        What recent developments and strategies have shaped the competitive landscape?

•        Which regions/countries are experiencing the highest growth?

Contact Information

Meticulous Research®

Email: sales@meticulousresearch.com

Phone: +1-646-781-8004

LinkedIn: Connect with us on LinkedIn

[self-carepracticeforindividuals]

Achieve Unmatched Muscle Gains with LGD ULTRA 4033 by German Pharma

Are you ready to elevate your strength, maximize muscle growth, and achieve a lean, sculpted physique? LGD ULTRA 4033 by German Pharma is here to transform your fitness journey. This powerful selective androgen receptor modulator (SARM) is meticulously formulated to enhance muscle development, increase strength, and support effective fat loss. Discover why LGD ULTRA 4033 is the go-to choice for athletes and fitness enthusiasts serious about reaching their peak potential.

The Science Behind LGD ULTRA 4033

LGD ULTRA 4033 by German Pharma stands out in the supplement market due to its potent and scientifically backed formula. At its core, LGD ULTRA 4033 contains Ligandrol (LGD-4033), a SARM known for its ability to promote muscle growth, increase strength, and support fat loss.

Ligandrol (LGD-4033): Ligandrol is a SARM that selectively binds to androgen receptors in muscle and bone tissues. This selective binding enhances protein synthesis and muscle growth without the unwanted side effects often associated with traditional anabolic steroids. Ligandrol is renowned for its ability to promote lean muscle mass, improve strength, and support overall physical performance.

Maximizing Muscle Growth and Strength

The effectiveness of LGD ULTRA 4033 lies in its ability to support significant muscle gains and enhance physical performance. The supplement’s unique formula works synergistically to promote muscle growth, increase strength, and improve overall body composition. Whether you're a bodybuilder, an athlete, or someone looking to achieve a more muscular physique, LGD ULTRA 4033 provides the support you need to reach your goals.

Promoting Muscle Growth: By enhancing protein synthesis, LGD ULTRA 4033 promotes significant muscle growth and helps you achieve a more muscular and defined physique. Users report noticeable increases in muscle size and density within weeks of starting the supplement.

Increasing Strength: LGD ULTRA 4033 helps increase strength by promoting lean muscle mass and improving muscle recovery. This allows you to lift heavier weights and push through plateaus, leading to continuous progress in your fitness journey.

Supporting Fat Loss: LGD ULTRA 4033’s anabolic properties also support fat loss by increasing metabolic rate and promoting the utilization of stored fat for energy. This results in a leaner, more defined physique.

Comprehensive Benefits for Your Fitness Journey

While LGD ULTRA 4033 is renowned for its muscle-building and strength-enhancing capabilities, the benefits extend far beyond that. Users report improved energy levels, enhanced recovery, and better overall well-being. The supplement’s potent formula ensures that you can achieve your fitness goals without the risk of unwanted side effects.

Quality and Safety You Can Trust

German Pharma is committed to delivering products that meet the highest standards of quality and efficacy. LGD ULTRA 4033 is manufactured in a state-of-the-art facility, adhering to strict quality control standards. This ensures you’re getting a safe, effective, and reliable product every time.

Real Results from Real People

LGD ULTRA 4033 has garnered praise from countless users who have experienced significant results. John, a fitness enthusiast from California, shares his experience: “LGD ULTRA 4033 has been a game-changer for me. The muscle gains and strength improvements are incredible. I’ve seen dramatic changes in my physique and overall performance.”

How to Use LGD ULTRA 4033

To maximize the benefits of LGD ULTRA 4033, follow the recommended usage guidelines. Take one capsule daily with a meal to ensure optimal absorption and effectiveness. Pair the supplement with a balanced diet and regular exercise to achieve the best results. Remember to stay hydrated and consult with a healthcare professional before starting any new supplement regimen.

Transform Your Fitness Journey Today

There’s no better time to take control of your health and fitness journey than today. With LGD ULTRA 4033 by German Pharma, you have the tools you need to succeed. Whether you’re looking to increase muscle mass, boost your strength, or enhance your overall physical performance, LGD ULTRA 4033 is your ultimate solution.

In the words of one satisfied customer, "LGD ULTRA 4033 helped me achieve my fitness goals faster than I ever thought possible. It's a must-have for anyone serious about their health." Don’t wait—achieve unmatched muscle gains with LGD ULTRA 4033 and experience the transformative power for yourself.

"For additional case studies and success stories, head over to our website."