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GSK's new RSV data, a depression failure, & a BeiGene exec mind-boggled

 

The Readout

Hiya, it's Meghana. Today we've got an update on that neck-and-neck RSV race, and a report that China's refusal of mRNA vaccines is considered by a top BeiGene exec to be "mind-boggling." Oh, and looks like your new Pfizer booster is protective against Omicron, so, win. 

GSK's RSV shot may have shot to the head of the pack

Competition just got even more fierce in the RSV race: GSK’s vaccine for respiratory syncytial virus was 82.6% effective in older adults, Reuters writes. The trial enrolled about 25,000 adults older than 60, and also demonstrated that the shot was 94.1% effective against severe lower respiratory tract disease. “These are truly exceptional results given that today RSV remains one of the major infectious diseases without a vaccine, despite over 60 years of research,” GSK’s chief scientific officer said in a statement. If it’s approved, Jefferies analysts project global RSV sales could hit $2.5 billion.

Pfizer, too, recently had positive results for its own RSV vaccine: Its efficacy against RSV-associated lower respiratory tract illness with two or more symptoms was 66.7%, and efficacy against severe disease was 85.7%. Morgan Stanley analysts said a direct comparison between GSK and Pfizer’s inoculations was difficult, however, given the different endpoints in the trials. “That said, the GSK data do look strong relative to that presented by Pfizer,” they said. Johnson & Johnson has experimental RSV vaccines with late-stage trials underway as well.

 

Top BeiGene exec shocked Beijing hasn’t imported mRNA vaccines

It boggles BeiGene’s research chief’s mind that China hasn’t imported or approved mRNA-based Covid vaccines from either Moderna or BioNTech/Pfizer. China is the only major economy that still has restrictive quarantines in place for international travelers, and lockdowns to curb Covid outbreaks. It’s stunted the country’s economic growth, and disrupted global supply chains — in part because of less-effective homegrown vaccines.

“It’s mind-boggling. I don’t fully understand why they are doing that,” Wang Lai, BeiGene’s global head of R&D, told the Financial Times, adding that he thought Chinese authorities wanted to “somewhat protect some of the China vaccines . . . which is unfortunate.”

What’s going on at biotech’s lobbying organization?

Where does mRNA go from here? And what happens when startups close down?

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. STAT Washington correspondent Rachel Cohrs joins us to explain the abrupt departure of the CEO of BIO, the lobbying group representing biotech on Capitol Hill, and its wider implications. We also discuss the latest news in the life sciences, including the future of mRNA, a promising startup closing its doors, and Biogen’s search for a new CEO.

Listen here.

Relmada’s drug fails Phase 3, shares plummet

An experimental depression pill from Relmada Therapeutics failed in a late-stage trial. It’s a heavy blow for the company, given that it’s Relmada’s only medicine in clinical development. Shares dropped 85% on the news. Relmada has two other Phase 3 trials for REL-1017 underway, so the company is still hoping the others turn out positive and offer enough data for a marketing submission.

Relmada described the results as “disappointing” and “paradoxical,” because at some sites where the study was conducted, participants in the placebo arm dramatically outperformed those taking REL-1017. Clinical trials in major depressive disorder are exceptionally difficult, which is why drugmakers tend to run several late-stage trials concurrently. That way, the odds increase to achieve a favorable result.

Read more.

More reads

  • Early human data validates effectiveness of Pfizer-BioNTech Omicron booster, BioSpace
  • Inotrem’s phase 2 data spark hope for septic shock treatment, FierceBiotech

Thanks for reading! Until next week,

@megkesh
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Friday, October 14, 2022

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