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