Recon: Drugmakers to raise US prices for hundreds of drugs; EU offers free COVID vaccines to China

ReconRecon | 03 January 2023 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Drugmakers to raise prices on at least 350 drugs in U.S. in January (Reuters)
  • Congressional report: U.S. FDA broke own protocols in approving Biogen Alzheimer's drug (Reuters) (STAT)
  • Novartis to pay $245 mln to end antitrust cases over Exforge drug generics (Reuters)
  • U.S. sues AmerisourceBergen, says distributor helped ignite opioid epidemic (Reuters)
  • Pfizer's hemophilia B gene therapy succeeds in late-stage study (Reuters)
  • DEA Pressed ADHD-Drug Makers About Impact of Telehealth Firms on Surging Demand (WSJ)
  • Once-favored Covid drugs ineffective on Omicron may be putting millions at risk (Politico)
  • Drug companies set sights on new Covid medicines to boost depleted arsenal (STAT)
In Focus: International
  • French biotech Cellectis takes stake in Mayflower-backed startup Primera (Reuters)
  • Advent to buy 50.1% stake in India's Suven Pharma, explore merger (Reuters)
  • EU offers China free vaccines as COVID-19 infections surge (Reuters)
  • China media plays down COVID severity as WHO seeks detail on variants (Reuters)
  • EU agrees coordinated approach in wake of changing COVID situation (Reuters)
  • UK to embark on groundbreaking new genomics projects (FT)
  • MDR and IVDR outlook for 2023 (MedicalDeviceLegal)
  • EU’s Eighth IVDR Notified Body Is Based In Austria (MedtechInsight)
Pharma & Biotech
  • 2022 FDA approvals (Nature) (Pink Sheet) (Endpoints)
  • Gilead buys out rights to cancer therapy from Jounce for $67 mln (Reuters)
  • The biotech scorecard for the first quarter: 19 stock-moving events to watch (STAT)
  • FDA rejects Ipsen rare-disease drug, more data and time needed to review (Endpoints)
  • After disastrous Galapagos deal, Gilead finds new rheumatoid arthritis partner (Endpoints)
  • A new weight loss drug could become the best-selling drug of all time. Who can afford it? (NBC)
  • FDA grants appeal for Ardelyx chronic kidney disease drug after July 2021 rejection (Endpoints)
  • U.S. FDA approves TG Therapeutics' multiple sclerosis drug; shares surge (Reuters)
  • Acer, Relief win FDA approval for rare metabolic disease after clearing inspection hurdles (Endpoints)
  • India to witness price hike for APIs, no shortage with Covid situation in China: Pharmexcil (PharmaBiz)
  • Paying research participants — a lot — may be a key to increasing diversity in studies (STAT)
  • New FDA guidance explains that Plan B is not an abortion pill (STAT)
Medtech
  • Philips says tests on recalled products show limited health risks (Reuters)
  • The FDA’s ‘breakthrough’ program for medical devices keeps gaining steam (STAT)
  • UK Proposal On Foreign Device Approval Recognition Due February (MedtechInsight)
Government, Regulatory & Legal
  • Priorities pile up for HHS, FDA, CMS, NIH, and other health agencies (STAT)
  • US puts hold on F-star's takeover by China’s Sino Biopharm, citing national security risks (Endpoints)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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