Recon: AbbVie to buy Alzheimer’s biotech Aliada for $1.4B; Philips slashes sales forecast after slump in China
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- How a Donald Trump presidency would change health care, from Medicaid to the CDC (STAT)
- Feud between Prime and Tessera, two gene-editing companies, spills out into public (STAT)
- A drug may cause problems with chemotherapies in cancer patients with obesity. Many doctors are in the dark (STAT)
- AbbVie makes $1.4B acquisition of Alzheimer's biotech (Endpoints)
- Gene Therapies: Bluebird Bio Presses US FDA To Reverse Denial Of Lyfgenia Priority Review Voucher (Pink Sheet)
- Medicare Plans Should Halt Off-Label Avastin Step Therapy Amid Supply Disruption, CMS Told (Pink Sheet)
- Pfizer management looks to show turnaround as Starboard looms (Reuters)
- BeiGene executive reportedly under investigation in China (Endpoints)
- Future EU Health Commissioner Pledges Action On Pharma Reform, Shortages & Biotech (Pink Sheet)
- Cross-Country HTA Collaboration To Focus On Health Economics & RWE (Pink Sheet)
- Industry Wants UK Clinical Trial Diversity Plans To ‘Work Alongside’ Global Regulations (Pink Sheet)
- Italy Sets Up Project To ‘Break Industry Monopoly’ On Drug Information (Pink Sheet)
- European Parliament Wants EC’s MDR Revision Proposals By End Of March 2025 (MedTech Insight)
- India's Sun Pharma beats Q2 profit view on higher demand for specialty drugs (Reuters)
- Novartis, Seagen veteran David Epstein is back, leading a new cancer startup (STAT)
- Novartis to pay Monte Rosa $150 million upfront to develop a new class of drugs (Reuters)
- Biogen appoints insider as CFO after Michael McDonnell to retire next year (Reuters)
- Blood-based biomarkers for Alzheimer’s present complex challenges to health care system (STAT)
- Synaffix, industry's ADC partner of choice, spins out a startup pipeline (Endpoints)
- Biogen's full Ph2 data for IgA nephropathy drug; Sanofi invests in obesity biotech (Endpoints)
- HOPO Therapeutics wins up to $226M BARDA contract for heavy metal poisoning research (Endpoints)
- Philips cuts sales forecast after ‘significant deterioration’ in China (MedTech Dive)
- FDA advises clinicians to stop using Hologic radiographic markers (MedTech Dive)
- Thoughtful implementation, ongoing monitoring key to safe health AI (MedTech Dive)
- Dexcom chief commercial officer to retire (MedTech Dive)
- Edwards’ TAVR sales faced ongoing hospital constraints in Q3 (MedTech Dive)
- Medtronic wins FDA approval for Affera mapping and ablation system (MedTech Dive)
- Swiss hearing aid maker Sonova resumes supplying Costco, source says (Reuters)
- The dropped call that took down Centene’s Medicare Advantage star ratings (STAT)
- For Rare and Rapidly Progressing Disease US FDA Has Heard ‘Well and Clear’ Placebo Is Unacceptable (Pink Sheet)
- Opinion: The Fog at CDRH Is Lifting (a Bit) (MedTech Insight)
- Homeopathic Industry Group Wants Court to Exclude It From FDA’s Enforcement Plans (FDA Law Blog)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
