Recon: FDA approves Luye’s long-acting schizophrenia drug Rykindo; EU proposes changes to pharma law to avoid shortages
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Entering J&J’s fiefdom, Luye wins FDA approval of long-acting schizophrenia drug (Fierce) (Pharmaphorum)
- Reversing abortion drug's approval would harm public interest, U.S. FDA says (Reuters)
- Orphan Drug Exclusivity Remains a Priority in 2023, Says FDA Deputy Commissioner (FDAnews)
- FDA’s Biosimilar Regulatory Science Pilot Launches With Five Projects (FDAnews)
- No Increased Stroke Risk Linked to Pfizer’s Covid Boosters, Federal Officials Say (NYT)
- Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax (Pink Sheet)
- FDA Reforms Missed By FDORA Could Find Vehicle In Animal Drug User Fee, Pandemic Bills (Pink Sheet)
- 9/11 Survivors See Uterine Cancer Added to Health Coverage List (Bloomberg)
- Med PAC Members Applaud Proposals to Change Part B Drug Payments to Docs (MedPage Today)
- Covid during pregnancy increases risk of maternal death, study finds (Washington Post)
- The addiction crisis is causing a spike in endocarditis cases. Hospitals are struggling to respond (STAT)
- Merck Is Set to Remove Cancer-Causing Chemical From Top Diabetes Drugs (Bloomberg)
- EU plans changes to pharmaceuticals law to avoid medicine shortages (Reuters)
- EU To Consult On Plans For Holistic Dialog On Clinical Trials (Pink Sheet)
- Pfizer to sell all its drugs in low-income countries at non-profit price (Reuters) (Fierce)
- EMA Safety Committee Calls for Restrictions on JAK Inhibitors (FDAnews)
- Novartis To Alert EU Doctors About Liver Failure Deaths In Zolgensma Patients (Pink Sheet)
- WHO Proposes Regulatory Flexibilities For Testing MAbs Against Infectious Diseases (Pink Sheet)
- In Yemen, medical shortages compound suffering of cancer patients (Reuters)
- Following Alzheimer’s drug approval, analysts dish on what they expect from Biogen in 2023 (Endpoints)
- Bayer feeling more heat from activist investors, this time from Bluebell (Fierce)
- NewAmsterdam notches another win in resurrection of Amgen cardio drug (Endpoints)
- A trio of biotechs consolidate as M&A fails to materialize at JPM (Fierce)
- Aeterna discontinues vaccine development; Idera rebrands as Aceragen (Endpoints)
- Cancer vaccine developer jumps to Nasdaq via reverse merger (Endpoints)
- India’s Eris Lifesciences to buy some dermatology brands from Glenmark Pharma (Reuters)
- Leap Jumps Ahead in Cancer Game with Flame Merger (Biospace)
- Elicio Therapeutics Enters Into Merger Agreement with Angion Biomedica (Biospace) (Fierce)
- DAOs Might Be Cure for Biotech Startups and New Drug Development (Bloomberg)
- TC and MD Anderson Partner to Decide Role of GDT Cells in Cancer (Biospace)
- 80% Of MDR Device-Related Codes Are Offered By Over 20 Notified Bodies (MedTech Insight)
- International Initiative Tackles Paucity Of Rare Disease Devices (MedTech Insight)
- ‘Mixed signals’ from medtech management suggest industry had bumpy end to 2022: analysts (MedTech Dive)
- Pikdare’s DropSafe Sicura Safety Needle Cleared (FDANews)
- Shockwave Medical’s heart disease business gets a jolt with $100M Neovasc buy (Fierce)
- Biobeat Demonstrates Prediction Capabilities of Its Devices in Heart Failure Patients under Diuresis (Biospace)
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