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authorlaurawinter · 2 years

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word find tag

Tagged by @emelkae !! thank you! my words are Right, Cute, Answer, Quiet, and Alive.

Taken from my prequel that is just a few edits away from being done!!

Right (Tybost’s POV, Brela age 3)

“Are you hurt anywhere else?” he asked, trying desperately to soften his features. It seemed to work as the girl loosened and let out a noise that was as close to a no as they were going to get. “Good.”

“Baby, can you remember what happened?” Lilla asked, the girl immediately making the same noise and burying her head into Lilla’s chest.

Tybost reached out carefully, resting a warm palm on the girl’s arm. “Don’t worry, dear. It’s not important.” Except it was, because whatever had happened to turn a trained fire wielder into slop could still be a danger, but he shoved down that part of his curiosity. He didn’t need to be the Veil Scholar right now. “How old are you?”

Cute Sweet (Elias’s POV, Brela age 19)

She raised a brow, perhaps in surprise, before turning to the group. “Never have I gotten a sex related injury.”

Tristan choked on his breath, eyes wide as he stared at Brela, then lifted the tankard to his lips again. A few others tried to discreetly take sips of their drinks, cheeks red. Elias didn’t flinch as her pale blue eyes flashed to him, waiting.

He only shrugged. “Sorry, sweetheart.”

Answer (Elias’s POV, Brela age 19)

Brela had given him a dare, and yet here he was, no closer to an answer to what this woman had wanted when she stole his money and bought enough herbs to satisfy a small army. Had she underestimated his intelligence, or had he overestimated his skills? Or was she taunting him, knowing he’d never figure it out? Was she hiding in one of these trees laughing to herself at how stupid he was?

Why was that thought somehow worse than being duped by her in the first place?

Quiet (Tybost’s POV, Brela age 7)

Quietly, Ramiele leaned closer. “Have you ever considered that maybe they have a reason to look at her like that?”

He had. So many times, he’d wondered if there was something more to this little girl who had a Veil shard burned into her skin and an extinct magic flowing through her veins. The strongest shadow magic they’d ever encountered.

Tybost closed his eyes and shook his head. “I can’t do that to her. They’d test her and put too much pressure on her to be something great, and she’s not ready for that. She might never be, considering our limited knowledge of shadow magic. It’s not fair to ask that of a seven-year-old.”

Alive (Brela’s POV, Brela age 16)

But, to her misfortune, it wasn’t Emril who had attracted the swirling sands. He still hadn’t noticed the wind and sand picking up around her, lost in some story she didn’t bother listening to.

Brela stilled her breath, focusing on the grains as they grazed her skin. Alive, the sand was alive. That was the best she could describe the feeling settling around her, like it was trying to study her.

She very quickly realized how wrong they had been about which scent they’d pick up. She knew what came next.

Ha! The fact that both a 69K and 220K manuscript came back with no results for cute definitely says something about the dark shit I write in these books. Though, it did give me some ideas for some sarcastic Brela responses using the word...

Tagging anyone who likes the following words: best, only, thought, challenge, sand.

#word find tag #writeblr #wip: shadows

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macgyvermedical · 4 years

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I was wandering about a character being drugged and also poisoned... I know drugs are damaging on their own, but actually mixing one with a poison? Any suggestion about possibilities/consequences to consider in this type of scenario? Thanks.

There’s a fine line between drug and poison a lot of the time.

Generally a drug is a chemical that at some dose has a therapeutic use, meaning it does something beneficial like bring high blood pressure into normal range, kill infectious bacteria, or alleviate a symptom like pain or nausea.

A poison is a chemical that either has no therapeutic dose and is really only harmful (say, cyanide) or is a drug at a dose so high that it does significantly more harm than good (say, a fentanyl overdose).

Some drugs interact with each other, and when taken together the outcome is different than if they were taken separately. Sometimes this can be good (the medication Tybost “boosts” the effect of certain HIV medications by blocking a metabolic pathway that breaks the medications down, meaning a person can take a lower, less toxic (or less side effect inducing) dose of their medication while having the same effect on the virus). But sometimes two medications or foods that wouldn’t be toxic taken separately are toxic when taken together (for example, taking the supplement St John’s Wort with most types of antidepressants can cause a reaction called serotonin syndrome, which can be life threatening).

Its very possible to have a character be intentionally poisoned but with a dose that usually wouldn’t be enough to kill them, but because they were taking a medication that interacted with it (or because they drank a lot of grapefruit juice that morning*) it might be more dangerous or even lethal.

Another possibility is that a medication (such as one that decreases nausea) might mask or change symptoms of a poison so it isn’t identified until it’s too late to do anything about.

Yet another is just a straight up drug reaction- a med is given to a character who has already taken a non-compatible medication.

*grapefruit juice interacts with many, many medications, recreational substances, and poisons by interfering with their metabolism, similar to Tybost. If you have a specific drug or poison in mind, google “does ______ interact with grapefruit?”

#whump reference #writing reference #drugs #poisons #drug interactions

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itswallstreetpr · 4 years

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The Coronavirus Coping Portfolio (QDEL, GILD, QBIO, CYDY)

The COVID-19 pandemic has forced a dramatic realignment of social, cultural, and economic agendas because, in all cases, the healthcare issue has priority. It’s not a genuine public debate – if you don’t solve the healthcare crisis, you can’t solve any of the other crises that have been boiling over in the public discourse. That puts a ton of pressure on the vaccine race. But an effective vaccine will take at least another 4-6 months, and probably longer than that. Which brings us to the coping tools: Therapeutics and diagnostics. For investors, the coping theme is a treasure trove. Companies able to offer real resources to help manage the situation until a viable vaccine candidate is available will reap huge rewards. We profile several stocks on this interesting playing board here: Quidel Corporation (NASDAQ:QDEL), Gilead Sciences, Inc. (NASDAQ:GILD), Q BioMed Inc. (OTCMKTS:QBIO), and CytoDyn Inc (OTCMKTS:CYDY). Quidel Corporation (NASDAQ:QDEL) leapt onto the stage in spectacular form on Monday after news spread that the FDA approved its antigen testing method following the close of trading last Friday. An effective antigen test is a superior option to the PCR RNA testing we have been leveraging thus far in our fight against the new coronavirus. The QDEL antigen test is expected to change the game for testing for COVID-19, with results in minutes rather than days. That’s a key part of an effective “test and trace” approach to tracking and defeating this enemy. The stock exploded higher in response to the news, but there may still be room to run. Quidel Corporation (NASDAQ:QDEL) frames itself as a company that develops, manufactures, and markets diagnostic testing solutions for applications in infectious diseases, cardiology, thyroid, women's and general health, eye health, gastrointestinal diseases, and toxicology worldwide. It offers Sofia and Sofia 2 fluorescent immunoassay systems; QuickVue, a lateral flow immunoassay products; and InflammaDry and AdenoPlus, a point-of-care products for the detection of infectious and inflammatory diseases and conditions of the eye. The company also provides Triage MeterPro, a portable testing platform that enables physicians to promote enhanced health outcomes, as well as the detection of certain drugs of abuse; Triage BNP test for use on Beckman Coulter lab analyzers; and Triage TOX drug screen, which provides results for the determination of the presence of drug and/or the major metabolites in urine. In addition, the company offers traditional cell lines, specimen collection devices, media, and controls for use in laboratories that culture and test for various human viruses, including respiratory and herpes family viruses; and cell-based products comprising tubes, shell vials, and multi-well plates. The stock has been ripping over recent days, up something like 50% in that time. Quidel Corporation (NASDAQ:QDEL) pulled in sales of $174.7M in its last reported quarterly financials, representing top line growth of 18%. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($108.8M against $136.2M, respectively). Gilead Sciences, Inc. (NASDAQ:GILD) is the leading player in the treatment, or therapeutic, domain when it comes to the pandemic. It’s ebola anti-viral asset, remdesivir, has shown legitimate promise as a weapon against COVID-19, especially when administered early in the disease progression. That said, the results suggest this isn’t a “silver bullet” drug, and it has to be administered at a hospital, where few “early” patients ever are. But it does work, and evidence mounts that it represents a key part of our response puzzle. Gilead Sciences, Inc. (NASDAQ:GILD) promulgates itself as a biopharmaceutical company that discovers, develops, and commercializes therapeutics in the areas of unmet medical needs in the United States, Europe, and internationally. The company's products include Biktarvy, Descovy, Odefsey, Genvoya, Stribild, Complera/Eviplera, Atripla, Truvada, Viread, Emtriva, and Tybost for the treatment of human immunodeficiency virus (HIV) infection in adults; and Vosevi, Vemlidy, Epclusa, Harvoni, Sovaldi, Viread, and Hepsera products for treating liver diseases. It also provides Yescarta, a chimeric antigen receptor T cell therapy for adult patients with relapsed or refractory large B-cell lymphoma; Zydelig, a PI3K delta inhibitor for certain blood cancers; Letairis, an oral formulation of an endothelin receptor antagonist for pulmonary arterial hypertension; Ranexa, a tablet to treat chronic angina; and Lexiscan, an injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging. In addition, the company offers Cayston, an inhaled antibiotic for the treatment of respiratory systems in cystic fibrosis patients; Tamiflu, an oral antiviral capsule for the treatment and prevention of influenza A and B; AmBisome, an antifungal agent to treat serious invasive fungal infections; and Macugen, an anti-angiogenic oligonucleotide to treat neovascular age-related macular degeneration. It will be interesting to see if the stock can break out of its recent sideways action. Over the past week, the stock is net flat, and looking for something new to spark continuation to the upside. Gilead Sciences, Inc. (NASDAQ:GILD) generated sales of $5.5B, according to information released in the company's most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate of -5.6% on the top line. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($21B against $8.9B). Q BioMed Inc. (OTCMKTS:QBIO) is a biomedical acceleration and development company that focuses on licensing, acquiring, and providing resources to life sciences and healthcare companies. The company’s ace offering is Strontium Chloride SR89, a radiopharmaceutical therapeutic for the treatment of bone cancer pain therapies. Q BioMed Inc. has a research partnership with Mannin Research Inc. for the development of therapeutics to treat a variety of vascular diseases, including the new coronavirus. In addition, the company is working on adjunct treatments for complications stemming from COVID-19. The main asset under development (rapid path) through the company’s partner, Mannin, is targeting the stabilization of 'leaky vessels' that play a critical part in organ injury, a major determinant of negative outcomes in patients affected by several infectious diseases, including influenza and the current COVID-19 pandemic. Q BioMed Inc. is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need‏. The company focuses exclusively in the biotechnology and healthcare sectors, targeting a broad spectrum of biomedical products and healthcare solutions. Q’s expertise is in business & product development and the capital formation required for phased advancement of products. Q BioMed’s team assists companies by utilizing its strategic partners and network of experts to provide public market access for private company assets. 80% of biomedical start-ups lack capital and resources to transition from incubation to development and beyond. Q BioMed Inc. (OTCMKTS:QBIO) expects to maximize risk-adjusted returns by focusing on value-driven assets from early stage to near-revenue businesses where the technical, regulatory, and commercial risks have been mitigated or where major valuation inflections are imminent. CytoDyn Inc (OTCMKTS:CYDY) is another treatment play. The company is currently testing the efficacy of its HIV drug, leronlimab. So far, CYDY is actually riding a wave of positive momentum in terms of the direction of this narrative. As a result, shares of the stock are up as much as 900% in the past 3-4 months. CytoDyn Inc (OTCMKTS:CYDY) promulgates itself as a late-stage biotechnology company that focuses on the clinical development and commercialization of humanized monoclonal antibodies to treat human immunodeficiency virus (HIV) infection. Its lead product is PRO 140, a therapeutic anti-viral agent, which is in Phase IIb extension study for HIV as monotherapy, rollover study for HIV as a combination therapy, Phase IIb/III investigative trial for HIV, Phase Ib/II trial for triple-negative breast cancer, and Phase II trial for graft-versus-host disease. CytoDyn Inc. has strategic agreement with Samsung BioLogics Co. Ltd. for the clinical and commercial manufacturing of leronlimab. The company was formerly known as RexRay Corporation. CytoDyn Inc. was incorporated in 2002 and is based in Vancouver, Washington. And the stock has been acting well over recent days, up something like 12% in that time. CytoDyn Inc (OTCMKTS:CYDY) had no reported sales in its last quarterly financial data. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($7.1M against $41M, respectively). Read the full article

#CovidStocks #COVID-19 #COVID-19pandemic #CytoDynInc(CYDY)#GileadSciences #QBiomed #QuidelCorp #Stocks

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pharmaffiliatesanalytics · 4 years

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Cobicistat and Its Impurities - Pharmaffiliates

Cobicistat is used to increase the amounts of atazanavir or darunavir in the blood when these medications are used to treat human immunodeficiency virus. Cobicistat, with trade name Tybost. Reference standards of Cobicistat API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are available at Pharmaffiliates.

#Cobicistat and Its Impurities #pharmacopeial impurities #non pharmacopeial impurities #Stable Isotopes

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dinafbrownil · 5 years

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FDA Keeps Brand-Name Drugs On A Fast Path To Market ― Despite Manufacturing Concerns

After unanimously voting to recommend a miraculous hepatitis C drug for approval in 2013, a panel of experts advising the Food and Drug Administration gushed about what they’d accomplished.

“I voted ‘yes’ because, quite simply, this is a game changer,” National Institutes of Health hepatologist Dr. Marc Ghany said of Sovaldi, Gilead Science’s new pill designed to cure most cases of hepatitis C within 12 weeks.

Dr. Lawrence Friedman, a professor at Harvard Medical School, called it his “favorite vote” as an FDA reviewer, according to the transcript.

What the panelists didn’t know was that the FDA’s drug quality inspectors had recommended against approval.

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They issued a scathing 15-item disciplinary report after finding multiple violations at Gilead’s main U.S. drug testing laboratory, down the road from its headquarters in Foster City, Calif. Their findings criticized aspects of the quality control process from start to finish: Samples were improperly stored and catalogued; failures were not adequately reviewed; and results were vulnerable to tampering that could hide problems.

Gilead Foster City doesn’t manufacture drugs. Its job is to test samples from drug batches to ensure the pills don’t crumble or contain mold, glass or bacteria, or have too little of an active antiviral ingredient.

Recent news reports have focused public attention on poor quality control and contamination in the manufacturing of cheap generic drugs, particularly those made overseas. But even some of the newest, most expensive brand-name medicines have been plagued by quality and safety concerns during production, a Kaiser Health News analysis shows.

More disturbing, even when FDA inspectors flagged the potential danger and raised red flags internally, those problems were resolved with the agency in secret ― without a follow-up inspection ― and the drugs were approved for sale.

Erin Fox, who purchases medicines for University of Utah Health hospitals, said she was shocked to hear from KHN about manufacturing problems uncovered by authorities at the facilities that make brand-name products. “Either you’re following the rules or you’re not following the rules,” Fox said. “Maybe it’s just as bad for branded drugs.”

The pressure to get innovative drugs like Sovaldi into use is considerable, both because they offer new treatments for desperate patients and because the medicines are highly profitable.

Against that backdrop, the FDA has repeatedly found a way to approve brand-name drugs despite safety concerns at manufacturing facilities that had prompted inspectors to push to reject those drugs’ approval, an ongoing KHN investigation shows. This happened in 2018 with drugs for cancer, migraines, HIV and a rare disease, and 10 other times in recent years, federal records show. In such cases, how these issues were discussed, negotiated and ultimately resolved is not public record.

For example, inspectors found that facilities making immunotherapies and migraine treatments didn’t follow up when drug products showed evidence of bacteria, glass or other contaminants. At a Chinese plant making the new HIV drug Trogarzo, employees dismissed “black residue” found to be “non-dissolvable metal oxides,” assuming it “did not pose a significant risk,” federal records show.

Without a follow-up inspection to confirm drugmakers corrected the problems inspectors found, these medicines eventually were approved for sale, and at list prices as high as $189,000 a month for an average patient, according to health data firm Connecture. The cancer drug Lutathera was initially rejected over manufacturing problems at three plants but was approved a year later without a fresh inspection and was priced at $57,000 per vial.

John Avellanet, a consultant on FDA compliance, said data integrity problems, like those at Gilead’s lab in Foster City, should have sparked further investigation, because they raise the possibility of “deeper issues.”

Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said an inspector’s recommendation to withhold approval can be “dealt with” without a follow-up. Woodcock said the agency can’t comment on specifics, and companies are reluctant to discuss them because the details of the resolution are protected as a corporate trade secret.

“That doesn’t mean that there’s anything wrong with the drug,” Woodcock said.

Dinesh Thakur, a former drug-quality employee turned whistleblower, called the secrecy a “red flag.” A follow-up inspection is critical, he said: “I’ve seen many times paper commitments are made but never followed through.”

What worries Fox is that a faulty drug could get through and nobody would know.

“In general, very few people suspect that their medicine is the problem or their medicine is not working,” Fox said. “Unless you see black shavings or something horrible in the product itself, the drug is almost the last thing that would be suspect.”

The Market Beckons

If the FDA finds problems at preapproval inspections for generics, the agency is likely to deny approval and delay the drug’s launch until the next year’s review cycle, according to industry and agency experts.

In fact, just 12% of generics were approved the first time their sponsors submitted applications from 2015 through 2017.

The calculus appears different for heralded new therapies like Sovaldi. In 2018, 95% of novel drugs ― the newest of the new ― were approved on the first try, the FDA said.

Woodcock said the agency has “the same standards for all drugs,” but she emphasized that many of the manufacturing issues “are somewhat subjective.”

For new brand-name drugs, she said, the FDA “will work very closely with the company to … bring the manufacturing up to snuff.”

The manufacturer submits written responses and commits to resolve quality concerns, but the details are kept confidential.

An estimated 2.4 million Americans have hepatitis C and, before Sovaldi, treatment came with miserable side effects and a strong chance it wouldn’t work. Sovaldi promised up to a 90% cure rate, though it came with an eye-popping $84,000 price tag for a 12-week course, putting it out of reach for most patients and health care systems.

But corporate pressure to get such therapies into the marketplace is also considerable.

Pharmaceutical firms pay hefty fees for FDA review and lobby the agency to speed products to market. For Gilead, time lost is money.

“If approval of sofosbuvir were delayed, our anticipated revenues and our stock price would be adversely affected,” Gilead wrote in an SEC document filed Oct. 31, 2013, using the generic name for Sovaldi.

Since its debut in 2013, Sovaldi has been widely criticized for its price but recognized as a medical breakthrough. Gilead has never recalled it.

However, hundreds of patients who have taken the drug have voluntarily reported cancer or other complications to the FDA’s “adverse event” reporting database, including concerns that the treatment doesn’t always work. One in 5 Sovaldi patients and health care professionals who reported serious problems to federal regulators said the drug didn’t cure the patients’ hepatitis C.

“The FDA approved these products after a rigorous inspection process, and we are confident in the quality/compliance of these products,” Gilead spokeswoman Sonia Choi said.

Problems at Foster City

Gilead’s Foster City facility has been cited for an array of problems over the years. In 2012, FDA inspectors said the facility had failed to properly review how the HIV drugs Truvada and Atripla became contaminated with “blue glass” particles; some of that tainted batch was distributed. The company “made no attempt to recover” the contaminated drugs, according to FDA inspection records.

Gilead had just filed its application for Sovaldi’s approval when FDA inspectors arrived at Foster City for an unrelated inspection in April 2013. Inspectors slapped the facility with nine violations in what’s called a 483 document and said that the reliability of the site’s methods for testing things like purity were unproven and that its records were incomplete and disorganized, according to FDA inspection documents.

As a result, the FDA initially rejected two HIV drugs, Vitekta and Tybost. Gilead had to resubmit those applications, and it would take 18 months before the FDA approved them in late 2014.

On Sept. 19, 2013, FDA officials met to discuss Sovaldi with Woodcock, agency records show. Meeting minutes show inspectors recommended hitting Gilead Foster City with a formal warning letter based on the April inspection. (A warning letter is a disciplinary action from the FDA that typically includes a threat to withhold new approvals or place a foreign facility on import alert and refuse to accept its products for sale in the U.S.)

At the same meeting, FDA inspectors said their recommendation to approve Sovaldi would be “based on” removing an unnamed drug ingredient manufacturer from the application and “a determination that Gilead Foster City has an acceptable cGMP [current good manufacturing practices] status.”

Records show the FDA didn’t issue a warning letter or otherwise delay the approval process when Foster City failed its inspection.

Instead, the Sovaldi preapproval inspection started four days later and lasted two weeks. At the end, inspectors issued Foster City another 483, this time with 15 violations, formally outlining problems and requiring a written plan to fix them. Inspectors said they couldn’t recommend Sovaldi’s approval.

FDA officials gave Gilead two options during an Oct. 29 teleconference: Remove Foster City, a “major testing site” for Sovaldi, from the application, and use a third-party contractor instead; or use Foster City but hire another firm to monitor the site and sign off on its testing work.

Gilead was optimistic. “Based on recent communications with the FDA, we do not expect these [inspection] observations to delay approval of sofosbuvir,” the company said in its Oct. 31 SEC filing.

Gilead chose to replace the Foster City plant with a contract testing site, federal records show. By December, Sovaldi was approved for distribution, and the company soon announced its $1,000-per-pill price tag.

Not Just Generics

Recent media reports, and the ongoing recall of the widely used blood pressure medicine valsartan, have led consumers ― and members of Congress ― to question whether generics are manufactured safely. Valsartan pills made in China and India were found to contain cancer-causing impurities.

Branded-drug quality, in large part, has been spared from congressional scrutiny. But many factories ― overseas and in the U.S. ― make branded and generic drugs.

In January 2018, FDA inspectors hit a Korean manufacturing plant that makes Ajovy, a migraine drug, with a warning letter. With the problems still unresolved in April, an agency reviewer recommended withholding approval. When they returned in July, inspectors wanted to give the plant the worst possible classification: “Official Actions Indicated.” Among other problems, inspectors found that glass vials sometimes broke during the manufacturing process and that the facility lacked protocols to prevent the particles from getting into drug products. The FDA’s Office of Manufacturing Quality eventually downgraded the inspection to just “Voluntary Actions Indicated.”

The drug was approved in September 2018 and priced at $690 a month. FDA records indicate no further disciplinary action was taken. Teva, the maker of Ajovy, did not respond to requests for comment.

Similarly, when FDA inspectors visited a contract manufacturing facility in Indiana used to make Revcovi, which treats an autoimmune disease, they noted that a redacted drug lot had failed a sterility test because the vials tested positive for a bacterium called Delftia acidovorans, which can be detrimental even in people with healthy immune systems, studies show. But the drug-filling machine stayed in use after the contaminant was discovered, the FDA determined. Inspectors recommended withholding approval.

The drug was approved in October 2018 even after another inspection turned up problems, with a list price of $95,000 to $189,000 per month for an average patient, according to health care data firm Connecture.

Revcovi’s manufacturer, Leadiant Biosciences, said through an outside public relations firm that its contract manufacturer’s written responses to the FDA observations were considered “adequate” by two FDA offices, adding, “We do not have any more information to share with you at this time as pharmaceutical manufacturing processes are confidential.”

Problems with drugs can take years to discover ― and then only after patients are injured. So, many health researchers say, more caution is warranted.

“They’re doing so few of these [FDA] inspections pre-market,” said Diana Zuckerman, president of the nonprofit National Center for Health Research. “The least they can do is listen to the ones they’re doing.”

from Updates By Dina https://khn.org/news/fda-keeps-brand-name-drugs-on-a-fast-path-to-market-%e2%80%95-despite-manufacturing-concerns/

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hivaidsupdates · 5 years

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Tybost Plus Darunavir Approved to Treat HIV-1 Pediatric Patients#HIV #ResearchMatters #BioTech #Virologyhttps://t.co/MwsdFSM5NW via @eMPR

— HIV & AIDS Updates U=U (@HIVAIDSupdates) October 4, 2019

from Twitter https://twitter.com/HIVAIDSupdates October 04, 2019 at 09:30PM

#HIV #PLHIV #endHIVstigma #Twitter

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traderspro · 5 years

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GILD’s value proposition is too good to pass up – isn’t it?

How To Retire In 18 Months with $2.4 Million!

Progress on the trade front has given the market a new set of momentum over the past couple of weeks – enough that the major indices are nearing the all-time highs they set at the end of July. Even so, the unpredictability associated with tariff news and the trade war itself has resulted in a lot of volatility that has kept a lot of stocks at or near historical lows; it also pushed a lot of stocks that had been star performers for a big part of the year to near-bear-market correction levels in August.

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As I’ve watched the market’s activity over the last year, and most particularly over the last few months, I’ve been intrigued by the Healthcare sector. That’s because it is a sector that I think could be in better position than most to remain strong, not only for the time being but also for the next few years. I think that could be true even when the economy, and therefore the market, does finally turn bearish. Strength in this sector, I believe is likely to be driven primarily by the fact that the demand for all types of healthcare remains pretty constant, no matter what the state of the economy is.

Last week I reviewed a number of stocks in the Healthcare Equipment industry that I think look like they could present some interesting opportunities; however if you’re looking for a stock that you could clearly call a value stock, that isn’t really the industry to focus on. Biotechnology and pharmaceutical stocks, however present some of the most interesting, value-oriented opportunities available in the market right now, and so I think if you want to consider long-term possibilities that are worth paying attention to, these are the areas of the Healthcare sector that are the most worthwhile.

That leads me to the stock I’m focusing on today. Gilead Sciences Inc. (GILD) is a large-cap biopharmeceutical stock with a major presence in some of the most cutting-edge areas of bioscience. The stock is more than -26% off of the high it reached at the beginning of 2018, and is in a long-term downward trend from that point; but it also looks like that trend has flattened significantly, with very strong support only a few dollars below the stock’s current price. The stock has some interesting elements showing a significant level of strength, however, including a very strong balance sheet. Does the stock’s relatively low current price, and fundamental strength create a compelling value? I think it could.

Fundamental and Value Profile

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes medicines in areas of unmet medical need. The Company’s portfolio of products and pipeline of investigational drugs includes treatments for Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS), liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions. Its products for HIV/AIDS patients include Descovy, Odefsey, Genvoya, Stribild, Complera/Eviplera, Truvada, Emtriva, Tybost and Vitekta. Its products for patients with liver diseases include Vemlidy, Epclusa, Harvoni, Sovaldi, Viread and Hepsera. It offers Zydelig to patients with hematology/oncology diseases. Its products for patients with various cardiovascular diseases include Letairis, Ranexa and Lexiscan. Its products for various inflammation/respiratory diseases include Cayston and Tamiflu. It had operations in more than 30 countries, as of December 31, 2016. GILD has a current market cap of $84 billion.

Earnings and Sales Growth: Over the past year, earnings declined -1.71%, while sales were flat, but positive at 0.66%. In the last quarter, earnings increased just 3%, while sales improved by 7.65%. GILD’s unimpressive earnings pattern is offset by a very healthy operating profile that is strengthening; in the last twelve months, Net Income was more than 26% of Revenues, while in the last quarter that number increased to just over 33%.

Free Cash Flow: GILD’s Free Cash Flow is generally healthy, at about $7.7 billion. On a Free Cash Flow Yield basis, that translates to 8.99%. It should be noted that this number has declined steadily since the beginning of 2016, when Free Cash Flow peaked at $19.5 billion, but it has also improved over the last two quarters from about $6.6 billion. That improvement looks like it could be a sign the company is reversing the longer trend of free cash flow deterioration, which is a positive.

Debt to Equity: GILD has a debt/equity ratio of 1.13, which is a bit higher than I prefer to see; but by itself this number doesn’t really tell the whole story. Their balance sheet shows $27.1 billion in cash against $25.6 billion in long-term debt. Along with their very strong margin profile, this is a good indication that the company has plenty of financial flexibility, not only to service their debt, but also keep funding the strategy they’ve been following for a while, which is to grow earnings via acquisition, and returning value to shareholders via stock buybacks and dividend payouts..

Dividend: GILD pays a dividend of $2.52 per share, which translates to an annual yield of about 3.79% at the stock’s current price.

Price/Book Ratio: there are a lot of ways to measure how much a stock should be worth; but one of the simplest methods that I like uses the stock’s Book Value, which for GILD is $17.96 per share. That translates to a Price/Book ratio of 3.69, versus a historical Price/Book ratio of 6.32, which actually means GILD is currently trading at a discount of about 71% from par with that average. That’s pretty compelling, and could make GILD a very interesting stock to watch, even under current market conditions.

Current Price Action/Trends and Pivots: GILD’s downward slide from January 2018 to December of last year is easy to see. From that trend low at around $60, the stock rallied to about $70 by the beginning of February, but then dropped back again. Since the beginning of March, the stock has defined a clear consolidation range, with top-end resistance between $67 and $69 and support around $62. A break above $69 could mark an early indication that the downward trend could be reversing back to the upside, with room to run to the 38.2% Fibonacci retracement line shown at around $71.50 in the near term.

Near-term Keys: Given current market conditions, it may seem a little odd to suggest that a bearish, short-term trade on GILD Is a low-probability risk right now; but the fact is that unless the stock breaks its multi-year low around $60, its downward trend is unlikely to extend much further. That doesn’t mean that it won’t break that level; that is always a possibility. However, the longer the stock’s consolidation range holds, the more likely the stock becomes to break out of that range to the upside – especially when the company’s fundamental strengths are taken into consideration. Even so, the best signal for a bullish short-term trade on the stock won’t be seen unless the stock breaks above $69 per share; if that happens, you should take it as a good signal to buy the stock, or to work with call options with a near-term exit price somewhere between $71.50 and $75. What about the stock’s long-term prospects? The value proposition is very intriguing; and if you aren’t afraid of a fair amount of volatility, both from the stock and the broad market right now, this is a stock that offers an impressive dividend yield for those who are willing to be patient and hold on for the ride.

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pozmagazine · 6 years

Link

The Food and Drug Administration (FDA) has approved Janssen’s single-tablet regimen for the treatment of HIV in adults, Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide). The tablet is approved for people who are starting antiretroviral (ARV) treatment for the first time as well as certain people who are switching from another HIV regimen and have a fully suppressed virus.

#chronic kidney disease #fracture #Gilead Sciences #Janssen Therapeutics #bone mineral density #HIV #Symtuza #antiretrovirals #treatment #Norvir #Prezista #TAF #TDF #Tybost

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azveille · 6 years

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La commission de la transparence opposée au remboursement de l'anti-VIH Symtuza*, selon un avis provisoire

La commission de la transparence a estimé que l'anti-VIH Symtuza* (ténofovir alafénamide + darunavir + cobicistat + emtricitabine, Janssen, groupe J&J) présentait un service médical rendu (SMR) insuffisant, synonyme de non-inscription au remboursement, selon un avis provisoire dont APMnews a eu connaissance.

Symtuza* a obtenu une autorisation de mise sur le marché (AMM) européenne centralisée en septembre 2017 dans le traitement de l’infection par le VIH-1 chez les adultes et les adolescents (âgés de 12 ans et plus, pesant au moins 40 kg).

La CT a examiné le dossier du médicament lors de sa séance du 21 février.

Janssen revendiquait un SMR important et une amélioration du SMR de niveau V, soulignant que Symtuza* "constitue la première association fixe à base d’un inhibiteur de protéase, en une prise par jour. Il répond ainsi aux besoins de nouveaux antirétroviraux efficaces, limitant l’émergence de mutations de résistance, bien tolérés et permettant la simplification des traitements, tels que identifiés dans les recommandations de prise en charge françaises et européennes", selon le compte rendu de la séance.

Un projet d'avis a été adopté lors de la séance du 7 mars.

Interrogée lundi par APMnews, la HAS a indiqué que Janssen avait sollicité auprès de la CT une audition, qui devrait se tenir d'ici la fin du mois.

Contacté mardi par APMnews, le laboratoire n'a pas souhaité faire de commentaire.

Dans l'avis du 7 mars, dont APMnews a eu connaissance, la CT a estimé que Symtuza* n'avait pas de place dans la stratégie thérapeutique.

"L'intérêt de l'utilisation de Symtuza*, en une prise par jour, par rapport aux trithérapies actuellement recommandées en première ligne, en particulier en alternative au darunavir/ritonavir + 2 INTI [inhibiteur nucléosidique de la transcriptase inverse], n'est pas établi", juge la CT.

"Cette spécialité n'a pas démontré apporter un bénéfice en termes d'efficacité, de tolérance ou d'observance par rapport aux comparateurs cliniquement pertinents et expose à un risque important d'interaction médicamenteuse, notamment en raison de la présence de cobicistat comme potentialisateur du darunavir, alors que l'association darunavir/ritonavir + 2 INTI a bien démontré son efficacité et sa bonne tolérance", ajoute la commission.

Inquiétude des prescripteurs

Dans un communiqué publié fin mai, la Société française de lutte contre le sida (SFLS) s'est inquiétée de l'éventualité d'un refus de remboursement de Symtuza*.

Rappelant que deux autres spécialités anti-VIH (Tybost*, cobicistat, Gilead, et Rezolsta*, darunavir + cobicistat, Janssen) avaient déjà reçu des avis défavorables par la CT, la société savante "s'interroge sur la justification de ce refus de mise à disposition de telles combinaisons d'antirétroviraux avec un argumentaire et une expertise qui semblent assez loin de la réalité clinique et des recommandations".

La SFLS estime que cela "va à l'encontre des enjeux et du concept des traitements adaptés aux personnes en matière d'infection VIH chronique".

"Ce refus de remboursement sous-entendrait que le traitement du VIH serait désormais 'réglé' avec les molécules et les combinaisons disponibles" et "ne prend nullement en compte la demande des patients d'avoir des traitements plus simples à prendre", souligne-t-elle. Elle demande à ce que des experts du VIH "plus proches des réalités de terrain" soient présents lors des instructions des antirétroviraux et antiviraux directs.

En outre, les spécialistes des maladies infectieuses Christophe Rioux (hôpital Bichat, AP-HP) et Marie-Aude Khuong (hôpital Delafontaine, Saint-Denis, Seine-Saint-Denis) ont exprimé leur "extrême surprise" dans une lettre datée du 25 mai adressée à la HAS et à la ministre des solidarités et de la santé, Agnès Buzyn (ancienne présidente du collège de la HAS), dont APMnews a eu connaissance.

"Nous ne comprenons pas la décision de refuser une association fixe acceptée dans d'autres pays, ayant une AMM européenne", écrivent-ils. "Certes la stratégie des laboratoires pharmaceutiques de promouvoir de nouvelles associations au moment où le traitement non combiné va tomber dans le domaine public est une réalité que l'on peut vouloir combattre, mais ce sont finalement les patients qui sont lésés."

"En tant que professionnels de santé, sans aucun conflit d'intérêts, prenant en charge les personnes vivant avec le VIH, nous pouvons vous assurer que toute simplification des traitements est vécue comme une avancée pour les patients -et pour les médecins," affirment-ils. Comme la SFLS, ils plaident pour que "la position des spécialistes de terrain soit prise en compte dans la décision de la HAS".

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healthcare-research-report-blog · 6 years

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Antiviral Booster Drugs Market to Record an Exponential CAGR by 2026

Antiviral drugs are a specific class of drugs used in the treatment of infections caused by viruses. Most of the antiviral drugs are used in the treatment of infections caused by a specific virus; however, broad spectrum antiviral drugs are effective against a wide range of viral infections. Most of the antimicrobial drugs such as antivirals and antibiotics only prevent the growth or development of microorganism and not destroy the target. Most of the antiviral drugs are considered comparatively harmless to the host and can be used to treat infections. These antiviral drugs are different from viricides. Viricides are not medicines; however, these are able to destroy or neutralize the virus particles in both the inside and outside of the body. There are also some natural antiviral drugs available derived from plants such as eucalyptus.

Antiviral boosters are drugs used in combination with other specific antiviral drugs to increase or enhance the effect. For instance, Norvir and Tybost are antiviral booster drugs. Norvir is an antiviral drug used in the prevention of HIV (human immunodeficiency virus) virus infection to multiply and increase its number in the body. Norvir is used in combination with other antiviral drugs as antiviral booster to treat HIV, the virus that can cause AIDS (against acquired immunodeficiency syndrome). Tybost is another antiviral booster drug used in combination with other antiviral drugs. It contains an active ingredient cobicistat, which reduces the enzymatic activity in the liver which breaks specific antiviral drug. Tybost makes antiviral drugs more effective and safe in lower dose. It is given in combination with prezista (Darunavir) or reyataz (Atazanavir) for the treatment of HIV. Tybost itself is not an antiviral agent. It is used only as antiviral boosting agent against viral infection.

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Increase in incidence rate of viral infectious diseases such as respiratory syncytial virus, influenza, human immunodeficiency virus, and epidemic viral infection across the globe drive the global Antiviral Booster Drugs Market. Novel and advanced antiviral drug formulations, strong R&D, and increased R&D expense by the global players also propel the market. However, high cost of R&D and significant risk of failure are the major factors that restrain the market.

The global antiviral booster drugs market can be segmented based on application, end-user, distribution channel, and region. In terms of application, the global market can be classified into HIV antivirals, influenza, herpes virus, hepatitis-B antivirals, hepatitis-C antivirals, and others. Based on end user, the global antiviral booster drugs market can be categorized into ambulatory surgical centers, clinics, and hospitals. In terms of distribution channel, the global market can be divided into hospital pharmacies, online pharmacies, and retail pharmacies.

The global antiviral booster drugs market can be segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is expected to dominate the global antiviral booster drugs market due to availability of advanced medications. Awareness among the people about diseases is also a major factor boosting the market in the region. The antiviral booster drugs market in Asia Pacific is anticipated to grow at a rapid pace due to increase in prevalence of HIV. Lack of awareness about the disease and unavailability of advanced medication and treatment in underdeveloped countries such as Lebanon, Syria, Cyprus, Turkey, and Iraq is likely to propel the antiviral booster drugs market in Middle East & Africa.

Key players in the global antiviral booster drugs market include AbbVie, Inc., Gilead Sciences, Inc., Bristol-Myers Squibb Company, and Abbott.

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authorlaurawinter · 3 years

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word find tag

tagged by @thegreatobsesso with forgive, remember, consider and discover as my words. (ps, thank you for tagging me, i love these games)

forgive (flashback scene, Brela’s POV)

Brela clutched at her collarbone and the Veil shard burned into her skin and bone. Her heart had never felt so broken. She’d never felt so weak, not even when Lilla and Tybost had found her at the wall, bleeding with the obsidian pressed into her skin.

Tybost and Lilla didn’t believe she was anything but a liability to them. Maybe they’d always seen her as such. Maybe they regretted saving her. Keeping her. A burden to their status as Veil Scholars.

She leaned up to the door. “I hate you,” she whispered, then snarled and spat, “I will never forgive you.”

remember (Farrah’s POV)

Farrah’s excitement was gone in an instant. “Wait, you can’t be serious.”

“I’m very serious,” Brela replied.

“I’ve only thrown three knives!” Farrah blurted.

“So?”

“What if I hit you?”

“I won’t hold it against you.”

“Brela,” Farrah grumbled.

She shrugged. “Throw the knife.”

Farrah willed her hand to stop shaking, narrowing her focus on the loaf and trying to forget that one wrong move could send the knife in her hand sinking into Brela’s face or chest. She was about to give up when she remembered that Brela was a trained assassin. Of course she wouldn’t be afraid to stand across from an untrained knife thrower. She could just move away from the blade before it hit her.

consider (Brela’s POV)

“Shame. I like this version of you better,” Emril hummed. “That crown prince must be one hell of a lay.”

Brela punched his shoulder as hard as she could. “Disgusting. I’m not fucking Oni.”

“Oni?” he said through a laugh, rubbing his shoulder. “On a first name basis with the Crown Prince of the Sand Sprites? Lenni will get a kick out of this.”

She gagged. “Oh, gods. You’re trying to figure out how to do it with her, aren’t you?”

“Please, as if she’d consider sleeping with something that wasn’t female.”

Brela shuddered. “Gods, stop this conversation right now.”

Emril pouted. “But think of the stories you could tell!”

“Four hells, Emril. Has it really been that long since you’ve been in a woman’s bed?”

“There aren’t many options out here in the desert, Brela,” he said, then very obviously let his eyes trail her body.

She flipped him off. “In your dreams.”

“Yes,” he said with a wicked smirk. “Many times.”

discover (I had to use ‘find’, no discover, but i think it’s worth it) (Brela’s POV)

Brela stepped back and wiggled her brows. “And I still think Galiena is a better kisser than you.”

Ovir’s teeth flashed in a smile. “I bet I could change your mind real quick.”

She pressed a hand on his chest, doing her best to ignore his rapid-beating heart. “Ovir, I find it very disturbing that you’re turned on after watching two old men fuck before killing them.”

“As if you’ve never felt a little bit turned on after a kill.”

He had a point.

“Why are you here? Shouldn’t you get Trellis to fix your leg?” she asked, trying desperately to change the subject before she made a bad decision and let him continue walking her to the bed.

I like leaving tags open for anyone because we all need an excuse to play some games every once in a while. Have fun, my friends. Your words are crush, piece, afternoon, dare.

#word tag game #writeblr #wip: shadows

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davidrussellschilling · 7 years

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How Do Hiv Drugs Work

C O N T E N T S:

KEY TOPICS

This new therapy is the first aimed at destroying HIV in every part of the body, and it works by combining a drug that reactivates these dormant HIV cells with a vaccine designed to help the immune system find and kill them.(More…)

Cobicistat (Tybost) is a drug that helps atazanavir and darunavir work better, but it can cause life-threatening kidney problems if you…

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#CDC #GSK #HIV #UNAIDS #United States #WHO

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itswallstreetpr · 4 years

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The Coronavirus Coping Portfolio (QDEL, GILD, QBIO, CYDY)

#CovidStocks #COVID-19 #COVID-19pandemic #CytoDynInc(CYDY)#GileadSciences #QBiomed #QuidelCorp #Stocks

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itswallstreetpr · 4 years

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The Coronavirus Coping Portfolio (QDEL, GILD, QBIO, CYDY)

#CovidStocks #COVID-19 #COVID-19pandemic #CytoDynInc(CYDY)#GileadSciences #QBiomed #QuidelCorp #Stocks

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