Recon: FDA approves Mirati’s lung cancer drug; Takeda buys Nimbus psoriasis drug for up to $6B

ReconRecon | 13 December 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Mirati Challenges Amgen in KRS Space with FDA Accelerated Approval (Biospace) (Endpoints) (STAT)
  • US FDA Wants More Generic-Specific Experience In Next Office of Generic Drugs Director (Pink Sheet)
  • Warren Urges Pfizer to ‘Back Off’ From Covid Vaccine Price Hike (Bloomberg)
  • ICER Hemophilia Gene Therapy Reviews Show Clear ‘Net Health Benefit’ But Caution On Patient, Payer Fronts Given Upfront Costs (Pink Sheet)
  • Take-Home Opioid Treatment Drug Rules to Loosen Under HHS Push (Bloomberg)
  • Covid vaccines averted 3 million deaths in U.S., according to new study (STAT)
  • HHS Proposal Aims to Expand Access to Behavioral Health Care (Bloomberg)
  • What Will FDA Do In Battle Over Medication Abortion Access? (Pink Sheet)
In Focus: International
  • Pharma Industry ‘Cautious’ Over EU Packaging & Recycling Proposals (Pink Sheet)
  • EU Under Pressure To Act On Vaccine Supply, Hesitancy & Disinformation (Pink Sheet)
  • UK Pricing Scheme Negotiations Should Include Broader Representation (Pink Sheet)
  • An early lesson from the Uganda Ebola vaccine trial: Shots must be ready to go before the next outbreak strikes (STAT)
  • Too soon to call end to COVID-19 emergency, GAVI chief says (Reuters)
  • China faces ‘tough’ zero-COVID exit, WHO says (Reuters)
  • China health app starts online sales of Pfizer's Paxlovid for COVID treatment (Reuters)
  • WHO names Jeremy Farrar, director of the Wellcome Trust, as chief scientist (STAT)
  • Indonesia to produce Merck’s HPV vaccines to combat cervical cancer (Reuters)
  • Haiti received first shipments of cholera vaccines: WHO (Reuters)
Pharma & Biotech
  • In bid to beat Bristol Myers, Takeda buys Nimbus’ anti-inflammatory drug for $4 billion (STAT) (Reuters) (Fierce) (Biospace)
  • Moderna, Merck & Co. mRNA cancer vaccine slashes melanoma recurrence in Keytruda combo trial (Fierce) (Endpoints) (STAT)
  • #ASH22: Regeneron claims it has set a ‘new benchmark’ in follicular lymphoma (Endpoints)
  • ASH: Novartis says rare disease med ‘stands on its own,’ diving deeper into head-to-head win against AstraZeneca (Fierce)
  • Seagen rolls out data for Adcetris combination to treat Hodgkin lymphoma (Endpoints)
  • Clinical trial branding? Biotechs and pharmas migrate name and identity strategies even earlier (Endpoints)
  • Rheumatoid Arthritis Treatment Seen as Substandard for Most Patients (MedPage Today)
  • After Viftor acquisition and gene therapy approval, CSL taps McKenzie as its next CEO (Fierce)
  • Templates Available For Sponsors Of IVD Performance Studies Pending Eudamed Availability (MedTech Insight)
  • Tandem inks $216M deal for AMF Medical and its insulin patch pump (Fierce)
  • Cardiosense lands $15M for AI to predict worsening heart failure from wearables (Fierce)
  • Recall Of Remel Diagnostic For Bacterial Infection Gets Class I Designation (MedTech Insight)
Government, Regulatory & Legal
  • Vanda Loses Patent Ruling on Hetlioz Sleep-Disorder Drug Copies (Bloomberg)
  • Bausch Health Investors Seek to Block Eye-Care Business Spinoff (Bloomberg)
  • US Federal Circuit Kills Roche Electrochemical Sensor Patent (MedTech Insight)
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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