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