Pascal Prigent, Genfit CEO
Somebody believes in elafibranor after all.
The drug, which had been considered a bright prospect in the failure-prone but highly lucrative race to treat non-alcoholic steatohepatitis, imploded after it failed a closely watched trial, forcing its developer, Genfit, to throw in the towel. But after a lonely year steering past the wreckage — chopping nearly half of its workforce in a painful restructuring — Genfit has found a trusting partner in fellow French drugmaker Ipsen.
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Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
Richard Pazdur (via AACR)
There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.
‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.
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Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)
Since the pandemic began, the FDA has allowed women to access the abortion drug mifepristone via the mail, making it easier for them and ensuring that they don’t have to go to a clinic to receive the pills.
The FDA’s temporary change became permanent on Thursday afternoon, with the FDA announcing that the REMS on mifepristone (brand name Mifeprex) and its generic versions must be modified by removing this in-person dispensing requirement.
Justin Klee (L) and Joshua Cohen (Amylyx)
The biotech that has gone all-in on ALS on its way to earning one of the highest neuroscience financing rounds in the last five years is now ready to take the Nasdaq leap.
Amylyx Pharmaceuticals filed its S-1 with the SEC late Thursday, penciling in a $100 million raise estimate to help bring its only product candidate to market. The move comes about five months after Amylyx pulled in $135 million in a Series C.
The CDC has officially recommended that Americans receive one of the mRNA vaccines over J&J’s single-dose vaccine due to renewed concerns about rare but sometimes fatal blood clots.
The decision followed a unanimous vote by the Advisory Committee on Immunization Practices (ACIP) to recommend against taking J&J’s shot, if either the Pfizer/BioNTech or Moderna shot is available. J&J’s vaccine will still be available to those who are unable or unwilling to get an mRNA vaccine.
Stigma around lung cancer likely isn’t going away — the ‘you did it to yourself’ critics continue no matter the statistics or circumstances presented. So instead Novartis is encouraging people with lung cancer to self-advocate and have meaningful conversations where it matters.
Its ‘Sound Up for Lung Cancer’ campaign focuses on the power patients do have. In videos that center on patients’ voices, for instance, people talk about how they felt blamed or isolated after diagnosis and how they dealt with it. As one woman says, ‘Connecting with other people going through it and focusing on what’s important. That’s what helped me find my normal again.’
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The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Robert Califf (Graeme Sloan/Sipa via AP Images)
As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.
The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.
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Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)
Well, see you in January 2023.
In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.
The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.
https://endpts.com/ipsen-fronts-136m-to-bag-genfits-once-failed-nash-drug-betting-on-its-potential-in-rare-liver-condition/
