Recon: EU says Russia delayed EMA Sputnik V inspections; FDA approves ChemoCentryx's Tavneos for rare autoimmune disease
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Biden's biomedical research agency dropped from social spending bill (Politico)
- ChemoCentryx's drug gets US FDA nod for treating rare autoimmune disease (Reuters)
- FDA's antimicrobial adcomm unanimously backs Takeda's drug for post-transplant cytomegalovirus (Endpoints)
- Newly revealed texts from ex-FDA leader Stephen Hahn offer behind-the-scene glimpse into Trump’s Covid scare (Endpoints) (Pink Sheet)
- AbbVie loses a lawsuit over Humira trade secrets it claimed were stolen (STAT)
- Sanofi, GSK can't escape Zantac proposed class actions, judge rules (Reuters)
- Relay Therapeutics touts data on bile cancer drug (STAT)
- Mix and Match COVID Boosters: Time Crunch For Data Review May Mean No Advisory Committee Vote (Pink Sheet)
- EU envoy says Russia delays EMA Sputnik V vaccine inspections – media (Reuters)
- WHO says 'near' to solving issues on Russia's Sputnik V vaccine (Reuters)
- Merck drug less effective against moderate COVID -India regulatory source (Reuters)
- Brazil in talks to buy up to 150 mln Pfizer COVID-19 vaccines for 2022 (Reuters)
- Two Indian drugmakers seek to end trials of Merck's antiviral drug for moderate COVID-19 (Reuters)
- Europe’s largest clinical trial sponsors are getting better at reporting results (STAT)
‘Naively ambitious’: How COVAX failed on its promise to vaccinate the world (STAT) - Africans Welcome New Malaria Vaccine. But Is It a ‘Game Changer'? (NYTimes)
- Highlights of Management Board – October 2021 meeting (EMA)
- Where Biden’s vaccine mandate will hit and miss (Politico)
- Malaysia approves Pfizer-BioNTech vaccine for booster dose (Reuters)
- Schrödinger teams up with MD Anderson on WEE1 inhibitor program; Amid JAK safety concerns, AbbVie touts new data for Rinvoq (Endpoints)
- US FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary (Pink Sheet)
- Samsung Biologics partners with Enzolytics Inc for antibody therapies (Pharmafile)
- Pfizer, Bayer-backed Pyxis ups IPO price as biotech's public run continues unabated (Fierce)
- EU’s New Health Crisis Response Body ‘Won’t Duplicate’ Work Of EMA And ECDC (Pink Sheet)
- BioCina completes takeover of Pfizer-owned Australia plant; Cambrex adds space at NC site for small molecules (Endpoints)
- New England-based distributor HPNE looks to double its workforce to keep up with demand (Endpoints)
- Allogene hit with FDA clinical hold after a patient experiences 'abnormality' in CAR-T cells — shares hammered (Endpoints) (STAT)
- Relay unrolls early data for anti-FGFR drug it thinks stand alone in terms of safety profile (Endpoints)
- UPDATED: Another three biotechs are set to debut on Nasdaq as combined industry raise tops $14B (Endpoints)
- Flagship turns to Novartis HR guru in latest addition; David Grainger saddles up to new position at Centessa while Pfizer's Rod MacKenzie prepares to ride into the sunset (Endpoints)
- Pierre Fabre Fights Off Rivals For Rights To Atara's Off-The-Shelf T-Cell Therapy (Scrip)
- LabCorp, PerkinElmer latest to target COVID-flu combo test market (MedtechDive)
- Hearing Aid Maker Eargo Target Of US DOJ Investigation (MedtechInsight)
- DreaMed Diabetes' 'digital endocrinologist' AI expands to Type 2 diabetes with FDA green light (Fierce)
- Teva Says GSK Skinny Label Win Will Have 'Seismic' Impact (Law360)
- HHS Accused Of Overstepping Role In Drug Discount Program (Law360)
- Drug Cos. Can't Nix Monitoring Class In Zantac MDL (Law360)
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