| 01.24.22 | Merck cough med nixed by FDA, clearing path for rivals; What next-gen COVID-19 vaccines need

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This week's sponsor is Ajinomoto Bio-Pharma Services.

Today's Rundown

Merck's chronic cough med gets a nay from FDA, potentially clearing first-to-market path for Bellus Does the world need more COVID-19 vaccines? These companies think there's still room for improvement New clinical trial organization launches with promise to conduct randomized trials at fraction of the cost 1b, or not 1b: FDA hits Viking with clinical hold over mix-up in phase of rare disease trial MaaT wraps up cancer microbiome trial early to power into phase 2/3 this year In biopharma VC world, what does it mean to take a 'leap'? For Leaps by Bayer, it's 'fewer, but maybe bigger bets' Gilead's Veklury expands FDA nod to patients outside the hospital as oral version heads to trial Casana lands $30M to take its heart-scanning smart toilet seat to the FDA The eviction moratorium in New York has ended. Here's how one practice is prepared to serve affected patients You say Trintellix, I say Brintellix: Why a drug name in the US won't always translate across the pond Global digital health funding skyrockets to $57.2B with record cash for mental health, telehealth

Featured Story

Merck's chronic cough med gets a nay from FDA, potentially clearing first-to-market path for Bellus

By Kyle LaHucik

The FDA rejected Merck's chronic cough treatment, potentially setting up more breathing room for competitor Bellus Health in a first-to-market battle.

This week's sponsor is Eurofins BioPharma Product Testing.

Does the world need more COVID-19 vaccines? These companies think there's still room for improvement

By Annalee Armstrong,Kyle LaHucik

The ultimate COVID-19 vaccine will be able to tackle all emerging coronavirus strains, easy to store and quick to manufacture. And yes, there's still time for the stragglers who were beaten to the punch by Pfizer, BioNTech and Moderna—at least according to the companies still trying to get in line.

New clinical trial organization launches with promise to conduct randomized trials at fraction of the cost

By Annalee Armstrong

After quickly identifying an existing medication would be an effective COVID-19 treatment using a large randomized clinical trial design, a leading epidemiologist has formed a new not-for-profit organization out of the U.K. to apply the same approach to other conditions.

1b, or not 1b: FDA hits Viking with clinical hold over mix-up in phase of rare disease trial

By Nick Paul Taylor

Viking Therapeutics thought it was running a phase 1b clinical trial. The FDA thought otherwise, leading it to slap a clinical hold on the metabolic disorder study while Viking does the preclinical work needed to enter phase 2.

MaaT wraps up cancer microbiome trial early to power into phase 2/3 this year

By Nick Paul Taylor

MaaT Pharma is racing its microbiome therapy into a late-phase cancer clinical trial. Rather than take the current phase 1b to its planned conclusion, MaaT is wrapping the trial up early to accelerate its push into a larger study of acute myeloid leukemia patients.

In biopharma VC world, what does it mean to take a 'leap'? For Leaps by Bayer, it's 'fewer, but maybe bigger bets'

By Kyle LaHucik

Sparking innovation at a Big Pharma with a 150-year history can be difficult, so sometimes it takes some outside perspective to get the ball rolling. That's where Leaps by Bayer comes in.

Gilead's Veklury expands FDA nod to patients outside the hospital as oral version heads to trial

By Angus Liu

Gilead Sciences’ Veklury has extended its reach to outpatients at a time when effective COVID-19 therapies against omicron are in high demand. To overcome the inconvenience factor—Veklury is injectable, compared with newer oral antivirals— the company has started clinical trials with an oral version.