Recon: EU states can offer early access to Pfizer’s COVID pill; Biogen to submit final designs for Aduhelm postmarketing study in March
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Biogen plans to submit final design of Aduhelm confirmatory trial to FDA in March (Reuters)
- As Aduhelm faces doubts, Biogen plans another pivotal trial for 2022 (STAT)
- Uncoordinated and redundant: FDA's Pazdur slams checkpoint inhibitor developers for creating a 'Wild West’ (Endpoints)
- A C.D.C. panel is meeting on a blood clot risk linked to J.&J.’s vaccine. (NYTimes) (Reuters)
- 'Quite hopeful': Abortion pill decision could reshape reproductive health war (Politico)
- Closing arguments are set to begin in the trial of Elizabeth Holmes. (NYTimes)
- Japan approves Moderna COVID vaccine as booster, Novavax files for 1st approval (Reuters)
- EU regulator approves manufacturing capacity hike for Janssen, Moderna, Pfizer shots (Reuters) (EMA)
- EU regulator builds Omicron defences with approvals of GSK-Vir, Sobi drugs (Reuters) (EMA 1 , 2)
- EU states can use Pfizer's anti-COVID pill-regulator (Reuters) (EMA)
- Valneva says its booster works as a follow up to its own COVID-19 shot (Reuters)
- Congo declares end of Ebola outbreak that killed six people (Reuters)
- AstraZeneca therapy works against Omicron; results mixed for Regeneron (Reuters)
- US sanctions Chinese drugmakers amid addiction epidemic (The Guardian)
- Citing omicron, advocates and Democrats press Biden to push faster on efforts to vaccinate the world (Washington Post)
- COVID-19 test makers, labs warned demand could soon double or even triple: report (The Hill)
- Brazil health regulator approves Pfizer COVID-19 shot for ages 5 to 11 (Reuters)
- Refugees lack COVID shots because drugmakers fear lawsuits – documents (Reuters)
- Denmark approves Merck's COVID-19 pill for at-risk patients (Reuters)
- C.D.C. Virus Tests Were Contaminated and Poorly Designed, Agency Says (NYTimes)
- Op-ed: 5 unsettled issues a Califf-run FDA will need to tackle in 2022 and beyond (Endpoints)
- As part of $800M investment, Pfizer opens gene therapy facility in NC for early-stage production (Fierce)
- Idera Pharmaceuticals' stock tanks after AbbVie cuts enrollment early in a PhIb trial (Endpoints)
- Flush with cash, large drugmakers turn to share buybacks, deals (BioPharmaDive)
- US blacklists Chinese research institutes over 'brain control' efforts as investor frets roil biotech stocks (Endpoints)
- Calliditas nabs accelerated OK for rare kidney disease, beating two competitors to the punch (Endpoints) (FDA)
- IN8bio's 'off-the-shelf' gamma delta T cells stave off relapse for high-risk leukemia patients in very early data cut (Endpoints)
- Horizon hits the gas pedal on renewed early-stage R&D, enlisting a Mitch Gold biotech in a $1.5B+ deal (Endpoints)
- IVDR Amending Proposal And New Transition Provisions Due To Be Formally Adopted On 21 December (MedtechInsight)
- AbbVie's $550M Medical Device Deal Moving Ahead (Law360)
- FDA seeks FTC action after rejecting petition to block first generics for decades-old vasopressin (Endpoints)
- Centene Hits Gilead With HIV Generic Antitrust Suit (Law360)
- Medical Equipment Company Owners Sentenced to More Than 12 Years for $27 Million Fraud Scheme (DOJ)
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