Recon: Biogen nabs priority review for ALS therapy, despite phase 3 miss; Pfizer, BioNTech file US suit against CureVac

ReconRecon | 26 July 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Ever the optimist, Biogen secures FDA priority review for ALS drug that flunked phase 3 (Fierce) (Reuters) (Endpoints) (STAT)
  • Novartis generics arm files for MS biosimilar, challenging Biogen; Pluristem shortens name (Endpoints)
  • Incurable Cancer Patients to See Eased Path to Clinical Trials (Bloomberg)
  • Out-of-pocket cap will increase the net price of insulin, CBO tells Senate bill sponsors (Endpoints)
  • Drug Safety Patent Fight: Avadel Sues US FDA Over Interpretation Of Xyrem REMS Patent Use Code (The Pink Sheet)
  • Drug developer sues FDA over delayed decision on narcolepsy drug (Endpoints)
  • Drug manufacturers are fighting mad about pricing legislation and they're taking the next round public (Endpoints)
  • Omicron BA.5 makes up 82% of COVID variants in U.S. – CDC (Reuters)
  • Despite their anger over high drug prices, Americans are giving pharma credit for helping contain Covid-19 (STAT)
In Focus: International
  • Global Regulators Join Hands To Boost RWE Use In Decision-Making (The Pink Sheet)
  • Transferring Existing Studies To EU Clinical Trial Portal 'Straightforward But Technical’ (The Pink Sheet)
  • British agencies win CEPI funds to develop standard monkeypox tools (Reuters)
  • China Clears HIV Oral Antiviral For COVID, Vows More Drug Approvals (The Pink Sheet)
  • Canadian Firm Explores Potential Of Nasal Spray In COVID-19 Prevention (Scrip)
  • Turkey loses bid at WTO demanding all foreign pharma companies make drugs locally (Endpoints)
Pharma & Biotech
  • 5 things to know about the FDA's flawed approach to accelerated drug approvals (NPR)
  • Merck strikes 2nd ADC deal with Kelun-Biotech, paying $35M for rights to unnamed asset (Fierce)
  • As Merck buyout buzz heats up, Seagen touts a positive update on their Padcev/Keytruda combo (Endpoints)
  • Pfizer considers antiviral options as Paxlovid use skyrockets amid worries of resistance (Endpoints)
  • J&J looks to expand Rybrevant lung cancer indication to larger EGFR-positive population (Endpoints)
  • Following a host of trial flops, Angion halts R&D work, searches for ‘strategic alternatives’ (Endpoints) (Biospace)
  • mRNA’s Next Act: Cancer Vaccines and Gene Editing (Biospace)
  • The FDA needs to get ready to evaluate synthetic cells, the next generation of therapeutics (STAT)
  • Lifetime pharma ban? ‘Pharma Bro’ returns with ‘software’ company for drug discovery (Endpoints)
  • The Good And Bad News When It Comes To EU Notified Bodies’ Designation Capacity (MedTech Insight)
  • FDA Grants EUA to Predicine’s Pooled COVID-19 Test (FDAnews)
  • FDA clears Ambu’s new bronchoscope generation (Medwatch)
  • Labelling Errors Lead to Class I Recall For Baxter Software (MedTech Insight)
  • Pear Therapeutics restructures, looks to slash development costs (MedTech Dive)
  • Philips shares hit 10-year low as supply chain challenges weigh on revenue (MedTech Dive)
  • Closed Loop Medicine Wants To Deliver Upon Its Name, Tailoring Drug Dosages (MedTech Insight)
Government, Regulatory & Legal
  • BioNTech, Pfizer Sue CureVac Over Covid Vaccine Patent Threats  (Bloomberg) (Reuters)
  • Pfizer, BioNTech rebuff CureVac’s ‘groundless’ patent infringement claims against COVID-19 shot Comirnaty (Fierce)
  • Pfizer loses U.S. appeal over co-pays for heart failure patients (Reuters) (Bloomberg)
  • Vertex Expands Patents Fight with Lupin on Cystic Fibrosis Drug (Bloomberg)
  • Novartis returns to appellate court, requesting rehearing and reversal in Gilenya patent case (Endpoints)
  • Philips and U.S. Justice Dept. in consent decree talks on sleep apnea, ventilator recall (MedTech Dive)
  • Exactech Whistleblowers Move Forward With Knee Device Fraud Suit (Bloomberg)
  • Ex-FBI trainee made $82K in illegal profits over Merck’s $1.9B Pandion acquisitions (Fierce
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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