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The Readout Damian Garde & Meghana Keshavan

AstraZeneca’s Phase 3 vaccine for Covid-19 put on clinical hold

A large, late-stage Covid-19 vaccine trial led by AstraZeneca and the University of Oxford trial has been put on hold, STAT reports exclusively, due to a suspected severe adverse reaction in a U.K. volunteer. 

Clinical holds are not uncommon, and a source familiar with the matter said it’s being placed “out of an abundance of caution.” Another told STAT, however, that this reaction is already impacting other AstraZeneca vaccine trials — as well as trials conducted by other vaccine makers. Researchers are now combing their databases, looking for similar adverse events in other patients.

We still don’t know what sort of adverse reaction prompted the hold, but the trial participant is expected to recover. A phase 1/2 study published in July showed that about 60% of the 1,000 participants given the vaccine had some sort of side effect — though the majority were deemed mild or moderate. 

Read more.

Time is cruel to Corbus Pharmaceuticals

Yesterday morning brought the failure of Corbus’ lead drug, called lenabasum, in a Phase 3 clinical trial involving patients with a chronic, connective tissue disease. The drug maker spent four years planning and conducting the study, so it’s inglorious end — no difference whatsoever between lenabasum and its matching placebo — wasn’t the post-Labor Day kickoff the company hoped for. 

Corbus’ stock price plunged 76%, erasing $600 million in market value. Investors are not only disappointed in the failure of this study, but they’re looking ahead to the readouts from two additional lenabasum Phase 3 studies and not feeling very confident.

Teaching hospitals are paid richly by biopharma

Teaching hospitals may be particularly susceptible to biopharmaceutical dollars — and influence, a new Health Affairs study shows. In 2018 alone, 91% of teaching hospitals across the country received $832 million in payments — spent on continuing education, royalties, consulting and speaking fees, space rentals, gifts and food. 

Conflict of interest issues are particularly fraught because these hospitals play several roles: They treat patients, train new physicians, and conduct research. The Sunshine Act has helped elucidate the financial relationships between physicians and the pharmaceutical industry. However, this is the first time the ties between industry and teaching hospitals have been closely examined, STAT’s Ed Silverman writes. 

Read more.

Merck’s lukewarm cough drug results

Merck’s experimental chronic cough medicine has showed some efficacy in Phase 3 trials — but the benefit was marginal, and most patients were unhappy that the drug, gefapixant, altered their sense of taste. This mixed data — and the fact that many patients discontinued the medication — suggests that rivals like Bayer, Shionogi, and Bellus may be able to gain ground in the chronic cough space. 

“I’d imagine that Merck is disappointed,” one ENT expert told STAT’s Adam Feuerstein. “While results look good in a vacuum, they’re barely better than placebo when compared to this control group.” 

However, he added that “the spin, I think, is that the class of drugs is promising,” and that there’s potential to evolve in this space. 

Read more.

More reads

  • CRO market to recover, using 'hybrid trials,' with revenue hitting $64B by 2024. (FierceBiotech)
  • Pfizer/BioNTech Covid-19 vaccine could be ready by mid-October, but there are still 'unknowns'. (CNN
  • Mylan to pay equivalent of $757 million to buy Aspen's Europe thrombosis business. (MarketWatch)

Thanks for reading! More tomorrow,


Wednesday, September 9, 2020


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