Recon: FDA grants Merck’s Keytruda new indication for lung cancer; Thermo Fisher Scientific to buy Olink for $3.1B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Merck's Keytruda gets FDA nod for expanded use in lung cancer (Reuters)
- Aldeyra Anticipates FDA Rejection of Dry Eye Drug Following Regulatory Meeting (BioSpace)
- Studies highlight risks of excluding people with obesity from drug trials (STAT)
- Teva sues Colorado over ‘unconstitutional’ program to lower cost of epinephrine injectors (STAT)
- As Pfizer slashes revenue projections, Moderna says it “remains comfortable” (STAT)
- Price of lifesaving Covid-19 antiviral Paxlovid expected to rise next year, raising concerns about access (CNN)
- Community pharmacists launch company to recover DIR fees (Modern Healthcare)
In Focus: International
- EU regulator backs use of Merck's viral infection drug (Reuters)
- EU HTA Regulation: Industry’s Missed Opportunity & The PICO Process (Pink Sheet)
- Merck to open £1bn London research centre with plea for government support of industry (Financial Times)
- New WHO Group To Advise On Drug Pricing Policies (Pink Sheet)
- No Pandemic Accord Without Intellectual Property Protection, says German Health Minister (Health Policy Watch)
- Deadly Indonesian cough syrup was almost pure toxin, court papers show (Reuters)
Pharma & Biotech
- Thermo Fisher Scientific to buy Olink in $3.1 billion deal (Reuters)
- Semaglutide's Weight-Loss Benefit Also Seen in Patients on Antidepressants (Medpage Today)
- How one scientist’s determination made Novo Nordisk an obesity-drug powerhouse (STAT)
- Roche enlists Monte Rosa for cancer, neuro discovery deal with $50M upfront (Endpoints)
- Ultragenyx to spin off company to develop ‘high risk, high return’ gene therapy for Alzheimer’s disease (Endpoints)
- Nkarta trims headcount as it sets sights on autoimmune cell therapy (Endpoints)
- Gilead makes a $100M bet that Assembly Bio can advance antivirals, tossing lifeline to struggling biotech (Endpoints)
- Jingle all the way? Pharma marketers adapt their music strategies for channels like TikTok (Endpoints)
- Apellis’ C3 inhibitor shows biomarker impact in small PhII rare kidney disease trial (Endpoints)
- MarketingRx roundup: Americans still divided over Covid boosters; Amgen ramps up activity on Threads (Endpoints)
- Evelo dealt another blow with a PhII fail, plans for strategic alternatives (Endpoints)
Medtech
- FDA Plans To Use Third Parties To Review LDTs (Medtech Insight)
- New GE Neonatal Incubators Pose Less Formaldehyde Risk, FDA Says (Medtech Insight)
- Amazon’s head of health services shares why consumers could be a disruptive force to the healthcare industry (Endpoints)
- Breast cancer is deadlier for Black women. A study of mammograms could help close the gap (STAT)
- J&J to restructure orthopedics business (MedTech Dive)
- Medtech can cope with GLP-1s but ‘fear and doubt’ suppressing stocks: analysts (MedTech Dive)
- GE HealthCare cuts formaldehyde levels in neonatal incubators with revised process (MedTech Dive)
- New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations (FDA Law Blog)
Government, Regulatory & Legal
- Eye docs urge Medicare to lower insurance hurdles amid shortage of repackaged Avastin (STAT)
- It’s time for the FDA to halt Cassava Sciences’ Alzheimer’s clinical trials (STAT)
- When Medicare paid doctors differently, fewer patients had heart problems (STAT)
- White House moves closer to a ban on menthol cigarettes, amid intensifying opposition from tobacco companies (STAT)
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