Recon: Generic drugmakers face narrow win in price-fixing case; German authority recommends Imvanex monkeypox vaccine
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- House passes bipartisan FDA user fee legislation as it aligns with Senate on accelerated approval reforms (Endpoints) (Bloomberg)
- Bluebird Bio nears moment of truth as FDA evaluates its gene therapies (Boston Globe)
- Is A Class-Wide Myocarditis Warning Coming For COVID-19 Vaccines? (Pink Sheet)
- Unlike 1-day VRBPAC-to-EUA timeline of peers, Novavax’s Covid-19 jab awaits FDA review of recent manufacturing data (Endpoints)
- Biden administration 'not too worried' about slow pace of pre-orders of child COVID vaccine (Reuters)
- CDC awards $215 mln as part of Cancer Moonshot initiative revival (Reuters)
- Pandemic's origins obscured by lack of Chinese data - WHO panel (Reuters)
- WTO approaches a deal early next week for a Covid-19 vaccine IP waiver (Endpoints)
- German vaccine authority recommends Imvanex for adults at risk of monkeypox (Reuters)
- Spurned by FDA, FibroGen and Astellas’ anemia drug Evrenzo finds support from NICE (Fierce)
- Scotland: Are Orphan Medicines Over Incentivized? (Pink Sheet)
- India Proposes OTC List But Clarity On Pricing, Switching Pathway Awaited (The Pink Sheet)
- Japan's Shionogi says continuing Vietnam COVID projects after partner scandals (Reuters)
- ‘Runaway train’: Drug launch prices have grown 20% annually for more than a decade, and its’s time for Congress to act, researchers say (Fierce) (Endpoints) (STAT)
- Roche’s bispecific blood cancer drug Lunsumio treads on CAR-T’s turf with first global approval (Fierce)
- New GSK debuts with renewed purpose, strategy and brand identity as it says goodbye to consumer business (Endpoints)
- Following tie-up with Sanofi, transatlantic AI firm secures latest Big Pharma deal in nine-figure Bristol Myers pact (Endpoints)
- Biospring Partners closes $245 million first fund as private markets tense up (STAT) (Endpoints)
- Obesity drug race heats up as Innovent uncorks new GLP1 data (Endpoints)
- Bayer’s New Oncology Chief Wants to Compete for Biotech Deals (Bloomberg)
- Astellas opens new $100M gene therapy production plant (Fierce)
- BioNTech to soon start mRNA vaccine factory construction in Rwanda (Reuters)
- Small cancer drug trial sees tumors disappear in 100 percent of patients (Washington Post)
- Long Covid May Cause Diabetes, Hypertension, Discovery Says (Bloomberg)
- EU Offers Insight On New MDR Guidance Documents On The Horizon (MedTech Insight)
- House passes FDA user-fee package, bolstering cybersecurity, clinical trial diversity for medical devices (MedTech Dive)
- Foundation Medicine’s tumor test scores yet another companion diagnostic nod, for Genentech’s Rozlytrek (Fierce)
- ADA 2022 Wrap Up: Iterative Progress On Glucose Control, No Big Surprises (MedTech Insight)
- Abbott’s TriClip cuts heart valve leaks among patients with pacemakers (Fierce)
- States' price-fixing case against generic pharma companies trimmed (Fierce) (Reuters)
- Mylan, Teva, Others to Face Narrowed Antitrust Case by State AGs (Bloomberg)
- PhRMA Played Supporting Role In Case Questioning DTC Advertising In Product Liability Disputes (The Pink Sheet)
- Equal Employment Opportunity Commission brings Novo Nordisk to court over age discrimination case (Endpoints)
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