Recon: Pfizer COVID vaccine nabs FDA priority review; GSK plans $550M UK expansion
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Pfizer Vaccine Granted Priority Review for Full US Approval (Bloomberg) (CNN) (Axios) (Reuters)
- Pfizer agrees to pay $345 mln to resolve EpiPen pricing lawsuit (Reuters) (Law360)
- Biogen Alzheimer's drug hits roadblocks with some hospitals, insurers (Reuters)
- Expert panel votes unanimously that Biogen Alzheimer’s drug doesn’t offer patient benefits (STAT)
- Vaccine vial maker Stevanato raises $672 million in U.S. IPO (Reuters)
- DaVita, former CEO indicted on labor market collusion charges (Reuters)
- Moderna to join S&P 500, shares jump after hours (Reuters)
- Merck details an immunotherapy 'milestone' in early breast cancer (BioPharmaDive)
- Covid vaccines for kids under 12 expected midwinter, FDA official says (NBC)
- GSK anaemia drug shows promise as treatment in kidney disease patients (Reuters)
- African countries to receive first U.S. donated COVID-19 vaccines in days – Gavi (Reuters)
- Drugmaker GSK plans $550 mln expansion of England R&D facility (Reuters) (FT)
- Lonza extends antibody drug conjugate supply deal with biotech client (Reuters)
- India orders 660 mln vaccine doses amidst warnings over shortages – media (Reuters)
- BioNTech Shot Produces 10 Times More Antibodies Than Sinovac, Study Finds (Bloomberg)
- CDC advisers to consider additional coronavirus dose for immunocompromised patients (Washington Post)
- Biden’s Covid surge teams begin rolling out to a hostile heartland (Politico)
- WHO proposes fresh coronavirus mission to China and lab audits (Reuters)
- Malaysia to seek assurances from Thailand over AstraZeneca vaccine (Reuters)
- Japan to Lower Moderna Vaccine’s Minimum Age to 12 (PharmaJapan)
- Expert panel votes down Fibrogen’s anemia pill due to safety risks, making U.S. approval unlikely (STAT)
- Regeneron plans $1.8B expansion in Hudson Valley (Westchester & Fairfield County Business Journals) (Fierce)
- Shortly after its latest mega-round, Sirnaomics CEO Patrick Lu says it's time to go public (Endpoints)
- Bristol Myers Squibb takes another late-stage loss for Opdivo-Yervoy combo in head and neck cancer (Endpoints)
- Celularity emerges from SPAC merger doubled down on cell therapies as Bob Hariri downgrades ill-fated Covid-19 program (Endpoints)
- Nasdaq rings in Jonathan Lim's next cancer play, Pfizer-backed startup and Harvard spinout with collective $534M raise under their belts (Endpoints)
- AbbVie, Lilly atopic dermatitis hopefuls hit with more delays as FDA's JAK inhibitor holdups carry on (Fierce)
- New Pharma Industry Vision to Set Out Roles of Wholesalers: MHLW Director (PharmaJapan)
- Snap Inspections at Generic Plants Conducted in 46 Prefectures, Results Due Out in August (PharmaJapan)
- Catalent lands 2 new partnerships, including for glioblastoma drug; US drops $153M into pandemic preparedness (Endpoints)
- Alexion touts new PhIII data of Soliris successor as planned AstraZeneca takeover looms (Endpoints)
- Ipsen bets up to $363M on another shot at a debilitating condition related to Parkinson's disease (Endpoints)
- As its next big bet, Sana inks long-term lease for manufacturing site for next-gen cell therapies (Endpoints)
- Generation Bio snaps up Boston area plant as it rolls out a manufacturing process it thinks will be a game changer (Endpoints)
- 'They have shown that this is not some impossible thing': Academic lab copies Google’s big biological breakthrough (Endpoints)
- CDMO AMRI rebrands and snags a pair of smaller companies to aid its shift to become a global brand name (Endpoints)
- US FDA Loss In Device Case Might Have Implications For Agency’s Work On Off-Label Rx Promotion (Pink Sheet)
- Oxford's COVID diagnostics partner Prenetics eyeing $1.3B SPAC deal: report (Fierce)
- TransMedics gets 'clear win' after FDA panel backs liver preservation device: analysts (MedtechDive)
- Canon Medical thinks Cleerly to combine AI imaging analysis with cardiac CT (Fierce)
- HeartFlow pumps up its AI-powered heart disease test with planned $2.4B SPAC deal (Fierce)
- New MDCG Forms Include Checks On Notified Body Staff Qualification And Training (MedtechInsights)
- OCS Liver System Moves One Step Closer To Approval After Panel Recommendation (MedtechInsight)
- PTAB Will Review Alzheimer's Treatment Patent (Law360)
- J&J Sued Over Carcinogen After Sunscreen Recall (Law360)
- McKesson's 'Abusive Discovery' Is FCA Dismissal Ploy: DOJ (Law360)
- Opioid Cos. Defied FDA Promo Limits, Ex-Commissioner Says (Law360)
- Novartis' Expert Accuses Rival's Atty Of Gaslighting In IP Trial (Law360)
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