Recon: US signs $3.2B deal for Pfizer-BioNTech vaccines; Novartis said to lean toward spinoff of generics unit

ReconRecon
| 30 June 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA recommends inclusion of BA.4, BA.5 subvariants in COVID boosters (Reuters)
  • As booster season awaits, US re-ups supply of Pfizer Covid-19 vaccine with new $3.2B deal (Endpoints) (Reuters) (Fierce) (Bloomberg)
  • Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid (Reuters)
  • Is It Time To Think Beyond mRNA For COVID Vaccines? FDA Advisors Intrigued by Novavax As Booster (The Pink Sheet)
  • FDA pumps brakes on Sanofi’s $3.7B multiple sclerosis bet, imposing partial hold over liver injuries (Fierce) (Biospace)
  • US spends $275M more on Eli Lilly's Covid mAb as about half of supplies have been administered so far (Endpoints)
  • 5 FDA decisions to watch in the third quarter (BioPharma Dive)
  • FDA sidelines Paul Hudson's $3.7B MS drug after establishing link to liver damage (Endpoints)
  • HHS to distribute 1.6M monkeypox vaccine doses this year (Endpoints)
  • Biosimilars Forum Welcomes PBM Transparency Act (Generics Bulletin)
  • Covid Shots for Youngest Kids Demand Clear Messaging by Doctors (Bloomberg)
In Focus: International
  • European Commission says it doesn't have texts between president Ursula von der Leyen and Pfizer CEO Albert Bourla (Endpoints)
  • Novartis Said to Lean Toward Spinoff of $25 Billion Generics Arm (Bloomberg)
  • UK Must Act Now To Reverse Decline In Life Sciences Sector (The Pink Sheet)
  • New eczema meds from AbbVie, Pfizer and Leo Pharma score NICE backing (Fierce)
  • S.Korea authorises AstraZeneca COVID therapy Evusheld for vulnerable people (Reuters)
  • WHO warns 'sustained transmission' of monkeypox risks vulnerable groups (Reuters)
  • Africa in need of test kits, vaccines as monkeypox spreads (Reuters)
Pharma & Biotech
  • Fujifilm invests another $1.6B into its CDMO arm to upgrade facilities in the US and Europe (Endpoints)
  • AstraZeneca says Imfinzi combo shows promise in late-stage lung cancer trial (Reuters)
  • Catching up with Bristol Myers and Merck, AstraZeneca declares neoadjuvant win for PD-L1/chemo combo (Endpoints)
  • Novartis resumes production of radioligand therapy medicines (Reuters) (Fierce)
  • Little biotech makes deep cuts as it struggles to get narcolepsy drug approved amid months of regulatory limbo (Endpoints)
  • More anguish for Angion as safety signal sinks midphase kidney disease trial (Fierce)
  • Amgen sells its Turkish manufacturing arm for $135M (Endpoints)
  • Fierce Next Gen: Amgen avoids ‘low-hanging fruit’ in quest to tackle undruggable targets (Fierce)
Medtech
  • Akra: Time To Acknowledge EU’s Real Implementation Problems And Stop Scapegoating (MedTech Insight)
  • GE Healthcare recalls 117K ventilator backup batteries linked to 1,500 complaints (Fierce)
  • Boston Scientific Plans New Facility In Georgia (MedTech Insight)
  • Philips taps Biodesix’s blood tests for lung cancer screening system (Fierce)
  • Fierce Next Gen: Biopharma begins to hand AI the keys to the research car (Fierce)
Government, Regulatory & Legal
  • Drugmaker Endo Misses Bond Payment as Potential Bankruptcy Looms (Bloomberg)
  • British Columbia reaches $116 mln settlement with Purdue Pharma over opioid crisis (Reuters)
  • Pill Mill Ruling Raises Burden for Opioid Cases Against Doctors (Bloomberg)
  • ITC Ruling Hands AliveCor Big Win Against Tech Giant
  • (MedTech Insight)
  • Gilead scores a $33M settlement from its campaign against ‘colossal financial fraud’ (Endpoints)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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