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