Recon: FDA rejects Merck’s chronic cough drug; Sanofi abandons lung cancer drug after Phase III miss

• US FDA declines to approve Merck's chronic cough drug (Reuters)
• FDA approves first DNA test for risk of opioid use disorder (MedTech Dive)
• Clene says FDA finds ALS drug data not enough for accelerated nod (Reuters)
• J&J buys eye disease gene therapy from MeiraGTx, giving the biotech the cash infusion it was seeking (Endpoints)
• SEC charges former CEO of pain relief device company with $41 million fraud (STAT)
• Obesity drugs’ next tests, and rising threats: 3 chronic disease stories to watch (STAT)
• Drugs are still mostly tested in white men. Will the FDA change that next year? (STAT)
• Why haven’t health care cost increases exceeded inflation? There’s a very good reason (STAT)
• The 2023 winners and losers list: Who was up and who was down in biopharma (Endpoints)

• Sanofi to end cancer research programme evaluating tusamitamab ravtansine (Reuters)
• MTI 100 Feature: Manufacturing Devices In The Rollercoaster UK Market (MedTech Insight)
• Industry Must Play Its Part In International Regulatory Collaboration, Says ICMRA Chief (Pink Sheet)
• EMA: Five-Year Regulatory Network Strategy Still ‘Valid And Relevant’ At Midway Point (Pink Sheet)
• EMA Hopes To Fuel Advances In Acute Kidney Injury Treatments With New Guidance (Pink Sheet)
• France Takes Aim At Off-Label Use Of GLP-1s Amid Continuing Shortages (Pink Sheet)
• WHO prequalifies a second malaria vaccine, a significant milestone in prevention of the disease (WHO)

• BioMarin appeases an activist (STAT)
• Clene’s FDA update; JCR ends ties with Takeda, partners with AstraZeneca; Gilead ups stake in Hookipa (Endpoints)
• Lilly partners with startup Fauna Bio to see if a squirrel’s hibernation could lead to new obesity drugs (Endpoints)
• Tonix raises $144M in a direct offering following positive PhIII data for its fibromyalgia drug (Endpoints)
• Immunovant unveils positive early data for PhII Graves' disease drug (Endpoints)
• Scoop: Resilience downsizes technical R&D and quality assurance divisions (Endpoints)
• Exclusive: Sudo Biosciences secures $116M to start trials of its oral and topical TYK2 candidates (Endpoints)

• Roundup: Illumina’s long goodbye to cancer test maker Grail (MedTech Dive)
• Olympus receives Class I recall label for another bronchoscope safety issue (MedTech Dive)
• Stryker buys joint replacement business Serf Sas (MedTech Dive)
• ‘We Are Definitely In Uncharted Territory’: AI Innovation, Regulation And Health Equity Prospects (MedTech Insight)
• MedTech Europe’s Position Paper Aims To Smooth Certification Pathway For High-Risk IVDs (MedTech Insight)
• Explosion Risk Results In Class I Recall Of Philips MRI Machine (MedTech Insight)

• Patent thickets and terminal disclaimers: How pharma blocks biosimilars from the marketplace (STAT)
• Bristol Myers gets regulatory clearance to close Mirati deal as FTC increases pressure on pharma M&A (Endpoints)
• HP&M’s Larry Houck Presenting “HHS’ Cannabis Rescheduling Recommendation: A Long Strange Trip with Potholes” (FDA Law Blog)
• ANDA Sponsors Need US FDA Permission To Avoid Last-Minute Label Update Delays (Pink Sheet)
• Sanofi/AstraZeneca Resolving Beyfortus Shortage By Reallocating Southern Hemisphere Supply (Pink Sheet)