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

• 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 2^nd 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)