Recon: FDA inspectors cited Neuralink for animal testing issues; Fake weight loss drugs worry FDA chief
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Exclusive: Musk's Neuralink brain implant company cited by FDA over animal lab issues (Reuters)
- Pfizer is about to make a big push in cancer. Will investors listen? (STAT)
- Flu vaccine offering decent levels of protection this winter, new data show (STAT)
- Sarepta touts Duchenne gene therapy uptake, but warns of demand flattening before potential expanded label from FDA (Endpoints)
- Iovance’s Amtagvi sees ‘healthy demand’ after US approval (Endpoints)
- US Senate Republicans block Democrats' bill assuring right to IVF (Reuters)
- US FDA chief very concerned about fake weight loss drugs (Reuters)
- Indiana ban on gender affirming care for minors can go into effect, appeals court rules (Reuters)
- COVID Vaccines: CDC Panel Says Older People ‘Should’ Get An Extra Dose (Pink Sheet)
- Accelerated Approval Now Starting Point For Gene Therapy Development, US FDA’s Marks Says (Pink Sheet)
- EU Parliament OKs Legislation To ‘Reduce Cost & Burden’ Of Patent Extensions (Pink Sheet)
- How Lilly Is Helping To Address The UK’s ‘Postcode Lottery’ For Cancer Drugs (Pink Sheet)
- Pfizer Ponders Next Move After English HTA Rejects Oxbryta Again Despite Appeal (Pink Sheet)
- Singapore & South Korea’s Recognition Of GMP Inspections To Cut Burden For Companies (Pink Sheet)
- In atypical Big Pharma-VC pact, Gilead secures $210M from Abingworth to fund Trodelvy trials (Fierce Pharma)
- Belharra rides the sound waves, chronicling its short history in 'Birth of a Biotech Podcast' (Fierce Pharma)
- The next act for a biotech rainmaker (STAT)
- This chemist’s last startup sold for $4 billion. Now investors have poured $173 million into her next act (STAT)
- An inside look at PIPEs, the financing trend that has biotech abuzz (STAT)
- A ‘vaccine-like’ version of Wegovy is on the drawing board at Novo Nordisk (STAT)
- Q&A: A biotech VC leader shares her next big bets (STAT)
- BlossomHill raises $100M in bid to repeat founders' cancer success at Turning Point (Endpoints)
- Novo Holdings invests in macrocycle startup Orbis as once-overlooked molecules get new interest (Endpoints)
- Novo Nordisk plans for life after Wegovy, setting up roots in Boston to try and find its future (Endpoints)
- Societal CDMO to be bought by another manufacturer, CoreRx, for $1.10 a share (Endpoints)
- Sanofi's new corporate look sees it become a 2024 REBRAND 100 global award winner (Fierce Pharma)
- Apellis cites current challenges with Syfovre launch but bright prospects in the long term (Fierce Pharma)
- Icon acquires HumanFirst to boost support for digital tools in clinical trials (STAT)
- J&J begins enrolling patients in Laminar LAA pivotal trial (MedTech Dive)
- Hologic’s radiographic markers targeted in FDA safety communication (MedTech Dive)
- DOJ: False Claims Settlements Neared $2.7Bn In 2023 (MedTech Insight)
- GSK avoids trial with another Zantac settlement in California (Fierce Pharma)
- Medicare Advantage is bad for patients and bad for investors (STAT)
- Sandoz enters $265 million settlement agreement in U.S. price-fixing case (Reuters)
- UnitedHealth shares tumble after report of antitrust investigation (Reuters)
- Threat of Shutdowns No Longer Deterrent To Hiring, Staff Retention, US FDA’s Marks Says (Pink Sheet)
- FDA Still Soliciting Applications For START Pilot As Deadline For Rare Disease Program Looms (Pink Sheet)
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