Recon: Generic drugmakers face narrow win in price-fixing case; German authority recommends Imvanex monkeypox vaccine

ReconRecon | 09 June 2022 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • ‘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)
Government, Regulatory & Legal
  • 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)
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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