Recon: FDA approves Perrigo’s Opill as first OTC birth control pill; HHS presses drugmakers to set ‘reasonable’ COVID vaccine prices
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA approves first over-the-counter birth control pill (STAT) (Reuters) (FDA)
- HHS leader to vaccine makers: Set ‘reasonable’ prices for your next round of Covid-19 vaccines (STAT) (Reuters) (HHS)
- Priority review voucher reauthorization likely falling off PAHPA (Politico Pro)
- There’s a bill well-suited for drug shortage reforms, but Congress isn’t interested (STAT)
- Eisai’s Breakthrough Alzheimer’s Drug Faces Bumpy Rollout (Bloomberg Law)
- Regenerative Medicine: Therapeutic Applications, Challenges, and Policy Options (GAO)
- Uninsured US patients pay up to $330 for Eli Lilly’s $25 insulin, Senator Warren says (Reuters)
- U.S. watchdog lifts price estimate for Bluebird, Vertex/CRISPR gene therapies to $2.1 million (Reuters)
- FDA's top cancer leaders want to shift how companion diagnostics are regulated (Endpoints)
- Europe issues maximum antitrust fine of $475 million to Illumina over Grail deal (STAT) (Reuters)
- Panadol maker plans sweeping job cuts a year after being spun off from GSK (The Guardian)
- Thousands of unlicensed medical products seized in morning of raids in Bolton (MHRA)
- All Eyes On International Pilots For Streamlining Regulatory Assessments & Inspections (Pink Sheet)
- AIDS can be ended by 2030 with investments in prevention and treatment, UN says (Reuters)
- Merck KGaA, MilliporeSigma make investments in the US and China manufacturing (Endpoints)
- FDA backs new $82M mRNA manufacturing center at MIT (Endpoints)
- Roche shortens delivery time for multiple sclerosis drug from hours to minutes in trial (STAT)
- A young girl’s custom gene therapy hints at a framework for tailored rare disease treatments (STAT)
- Doctors use precision medicine to show melanoma drugs can shrink rare brain tumor by 90% (STAT)
- Bicycle rides to $200M payday, while lung disease biotech raises $80M (Endpoints)
- Roche licenses KSQ's PhI cancer small molecule, with cash infusion to help bankroll biotech's TIL cell therapies (Endpoints)
- First Wave’s mid-stage trial for yeast-derived cystic fibrosis drug ‘likely’ failed, company says (Endpoints)
- Causaly, an AI startup helping with preclinical discovery, nabs $60M from VCs and former J&J chief Alex Gorsky (Endpoints)
- US FDA’s Oncology Divisions Have Been Providing Live Meeting Minutes For Years. Will Others Follow? (Pink Sheet)
- Supplemental Filings: CBER/CDER Real-Time Comms, DCT Fall Off, Mifepristone REMS (Pink Sheet)
- Analysis shows paclitaxel-coated devices unlikely to increase death risk, leading FDA to withdraw warning (MedtechDive)
- Tandem’s Mobi insulin pump could reaccelerate growth next year: analyst (MedtechDive)
- Hummingbird Diagnostics buzzes with lung cancer blood test results (Fierce)
- FDA approves Boston Scientific's upgraded software for Parkinson's neurostim programming (Fierce)
- What Regulators Want To See From AI And Software-Based Devices (MedtechInsight )
- Urotronic wins FDA approval to challenge Boston Scientific, Teleflex for prostate market (MedtechDive)
- OTC nasal, ear care product manufacturer handed a warning letter (Endpoints)
- AccurKardia's automated ECG analysis software snags FDA nod (Fierce)
- US trade body again delays decision on Apple-Masimo patent dispute (MedtechDive)
- CureVac puts more patent claims on the table in its COVID-19 vaccine suits against Pfizer and BioNTech (Fierce)
- Johnson & Johnson sues researchers who linked talc to cancer (Reuters)
- Merck asks federal court for summary judgment in IRA case (Endpoints)
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