Recon: FDA approves Luye’s long-acting schizophrenia drug Rykindo; EU proposes changes to pharma law to avoid shortages

ReconRecon | 17 January 2023 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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