Gilead takes a hit af­ter a close­ly-watched Covid-19 tri­al of remde­sivir is qui­et­ly ter­mi­nat­ed, rais­ing fresh doubts

Shares of Gilead took a 3% hit $GILD Wednesday after researchers noted that they had suspended one of the closely-watched Covid-19 studies for remdesivir in China.

Initially highlighted in a note from RBC Capital, an update on clinicaltrials.gov today stated that the Phase III for mild to moderate patients had to be terminated due to a lack of patients to enroll. The sponsor is Capital Medical University with the Chinese Academy of Medical Sciences listed as a collaborator.

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Ugur Sahin, BioNTech CEO (Frank Rumpenhorst/dpa via AP Images)

New stud­ies in­di­cate mR­NA vac­cines pro­vide lim­it­ed pro­tec­tion against Omi­cron, but boost­ers and new shots may be cru­cial

The first substantial evidence for how mRNA vaccines will hold up against the new Omicron variant was released Tuesday night from scientists in South Africa.

The study, conducted by mixing sera from vaccinated individuals with live Omicron virus, showed that the variant could largely — but not entirely — dodge antibodies elicited by the Pfizer-BioNTech vaccine.

The result suggests that the vaccines will be less effective at preventing infection by Omicron. But because many antibodies do still bind to the virus, experts say, boosters should help stem the decline. And efficacy will likely hold up against the most important metric for vaccines: preventing severe disease.

Members of the public disembark a train at King Cross Station in London, on the day that extra measures are put in place to fight the spread of the Omicron variant of Covid-19. Since Nov. 30, it's been mandatory for people in England to wear face coverings in shops and on public transport. (Ben Cawthra/Sipa USA/Sipa via AP Images)

Omi­cron is a test for the next pan­dem­ic. Will the world keep mak­ing the same mis­takes?

Like hundreds of other virologists and epidemiologists, Benjamin tenOever’s Thanksgiving weekend was interrupted with emails about an emergency Omicron meeting.

But when he logged onto a WHO conference call 9 a.m. Monday morning, officials had a surprisingly upbeat spin on the little-understood variant that had already prompted leaders around the world, fearful the strain could evade vaccines, to close their borders to broad swaths of Southern Africa.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Video: Hear from End­points' 2021 Women in Bio­phar­ma R&D hon­orees and lis­ten in on our pan­el dis­cus­sion on break­ing the glass ceil­ing

Each year, we aim to highlight 20 extraordinary women who are leaving their mark on drug R&D — and this year’s group was no exception.

Our list, while by no means exhaustive, includes scientists, CEOs, researchers and professors who are supercharging the discovery and development of new therapies worldwide. Our team of writers spent time with each honoree (with a few exceptions), learning their stories and sketching profiles, which you’ll find in our special report.

For the second time, we brought the celebration to a live virtual audience, featuring an award presentation followed by a panel on what it takes to break the glass ceiling in biopharma with Kojin Therapeutics CEO Luba Greenwood, AskBio CEO Sheila Mikhail, and Silverback Therapeutics CEO Laura Shawver. Our panelists had a lively discussion on how the industry’s culture has changed, how to handle sexual harassment, the progress we’ve made and the challenges that still hold women back today.

We applaud each of our honorees for scaling the heights of biopharma R&D. You got to meet most of them via brief recordings we played during our live event. Below, you’ll find bonus videos offering a longer glimpse into those interviews. And if you didn’t get a chance to tune in to our main event live, you can replay the entire show.

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FDA ad­comm votes unan­i­mous­ly against Reata's po­ten­tial Al­port syn­drome treat­ment

The US FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday voted 13-0 that the agency should not approve Reata Pharmaceuticals’ bardoxolone methyl capsules as a treatment to slow the progression of chronic kidney disease in those with the rare Alport syndrome.

The lopsided vote follows similar comments from FDA on Monday, which painted an overwhelmingly negative opinion on Reata’s $RETA potential drug, according to briefing documents released ahead of today’s meeting.

Of­fer­ing a long-await­ed op­tion for the un­vac­ci­nat­ed, FDA au­tho­rizes As­traZeneca's long-act­ing pre­ven­ta­tive an­ti­body

The FDA authorized AstraZeneca’s long-acting monoclonal antibody cocktail to prevent Covid-19 in patients who are immunocomprised, providing the first level of additional protection for people who may not be adequately protected by vaccines.

Although it will only be for a small subset of the population, the EUA marks another pandemic milestone. Many people with conditions or on treatments that severely weaken their immune systems, such as cancer or multiple sclerosis, have found themselves left behind as much of the the country reopened last year.

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Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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No­var­tis drafts artist No­ma Bar's bold vi­su­als to ex­plain com­plex MDS blood can­cer

Myelodysplastic syndrome is not only hard to say, it’s also hard to explain. So Novartis hired Noma Bar, an artist and illustrator well-known for his simple and striking imagery to create a video that explains the rare blood cancer.

The 2-minute video uses bold colors and seamless graphics that morph from image to image. A white blood cell, for instance, turns into a Pacman-like character gobbling infection, while a drop of blood turns into a dial pointer and then an exclamation point.

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FDA+ roundup: Re­pub­li­cans will be key for Rob Calif­f's con­fir­ma­tion; Janet Wood­cock and Mar­garet Ham­burg talk FDA and the pan­dem­ic

President Biden’s nominee to be the next FDA commissioner officially has his Senate confirmation hearing set for next Tuesday. Rob Califf, who’s prepping for his second run as FDA commish, will be peppered with questions by senators ahead of an up or down vote that will likely go Califf’s way.

At least four Democrats, including Bernie Sanders and West Virginia’s Joe Manchin, have already said they won’t vote for Califf, as they did during Califf’s first confirmation (89-4 was the final vote on that one). While Califf’s industry ties and views on the pandemic will likely be the focus of the hearing, all eyes will be on the Republicans (given the tight R-D split in the Senate), and whether they’re willing to back a Biden nominee.

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