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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%).
American children under the age of five may not be vaccinated until mid-2022, as Pfizer said Friday that it’s going to now test a third dose of its Covid-19 vaccine in the trial.
The decision comes as Pfizer announced non-inferiority was not met for children between the ages of two and five when compared to older teenagers in the current trial.
Pfizer previously said it might apply for an EUA in this youngest population by the end of December or early next year, but now says that if the three-dose study proves successful, Pfizer and BioNTech expect to submit data to regulators to support an EUA ‘in the first half of 2022.’
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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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.
Remember the sandwich generation? That’s the group of middle-aged people who are caring for both children and aging parents.
It’s a group that pharma companies often market to directly as parents who are making decisions about vaccinations, routine visits or rare conditions, but less often in their roles as caregivers who are making healthcare decisions for older family members.
But maybe they should.
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Usama Malik, ex-Immunomedics CFO
A couple weeks after facing insider trading allegations, former Immunomedics CFO Usama Malik responded to the charges in a vaguely worded LinkedIn post reflecting on the moment when his ‘world was upended.’
Malik was charged on Dec. 2 over allegations that he tipped off his then-girlfriend and four others that a Phase III study for Immunomedics’ breast cancer drug Trodelvy would be stopped early, the Department of Justice said in a complaint. Those individuals went on to purchase more than 9,000 Immunomedics shares, with one of them selling those shares right after the news broke and the biotech’s stock price doubled.
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The European Medicines Agency announced Friday it recommended the European Commission reject Aduhelm, dealing a new — albeit expected — blow to Biogen’s hopes of finding a widespread market for its struggling Alzheimer’s drug.
The EMA recommendation had been expected for a month, since the EMA’s human medicines committee gave Biogen ‘a negative trend vote’ after an oral presentation from the company. As such Biogen’s stock, which has lost all the stratospheric value it gained after Aduhelm’s approval in June, only ticked down 3% pre-market Friday, from $235.52 to $235.
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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.
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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https://endpts.com/its-beginning-to-look-a-lot-like-m-aduhelm-runs-into-more-resistance-eli-lilly-bristol-myers-get-in-early-on-cancer-efforts-and-more/
