Recon: AstraZeneca buys rare disease drugmaker Caelum; FDA considering half-dose Moderna booster
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA misses GOP deadline on booster questions (Politico)
- FDA Leans Toward Authorizing Moderna Booster at a Half Dose (Bloomberg) (Reuters)
- FDA tells drug makers to redo studies run by two contract research firms due to data integrity issues (STAT) (Endpoints)
- Side effects from a third vaccine dose are similar to those from the second, a CDC report finds. (NYTimes)
- Pfizer’s Covid-19 Vaccine for Kids May Not Be FDA Authorized Before November (WSJ)
- FDA approves AbbVie's migraine prevention drug (Reuters)
- Editas CRISPR treatment improved vision for one patient, but not others, early data show (STAT)
- As lawsuits mounted, Purdue cultivated conversations with a controversial addiction policy group (STAT)
- Drug distributors strike 1st opioid settlement with Native American tribe for $75 mln (Reuters)
- EMA implements new measures to minimise animal testing during medicines development (EMA)
- COVID-19 pandemic hurt UK trials for cancer drugs, industry body says (Reuters)
- India Aims to Produce mRNA Covid-19 Vaccine This Year (WSJ)
- AstraZeneca buys rare disease drugmaker Caelum in potential $500 mln deal (Reuters)
- I-Mab Weighing Partnership, Stake Sale to Pharma Giants (Bloomberg)
- WHO Workers Sexually Abused Women During Ebola Mission in Congo, Inquiry Finds (NYTimes)
- In COVID Fight, Nonprofits Ask White House For IP Waivers (Law360)
- The government’s Covid-19 response will continue in a shutdown, but health agencies will face major staff shortages (STAT)
- Floundering private sales of vaccines in India deal blow to Russia's Sputnik V (Reuters)
- Slovenia temporarily suspends J&J's Janssen COVID-19 vaccine (Reuters)
- Pfizer asks Brazil to authorize booster dose of its COVID-19 vaccine (Reuters)
- Swiss buy 150,000 doses of J&J COVID-19 vaccine (Reuters)
- More trouble for Biocon insulin plant in Malaysia as FDA flags six Form 483 observations (Fierce)
- In bid to attract more R&D innovation, Europe looks to rewrite its pharma legislation (Endpoints)
- Amicus spins out gene therapy unit in SPAC deal as it pivots efforts toward Pompe disease program (Endpoints)
- Pfizer's next-gen Prevnar 20 can be administered with a flu shot, study finds (Fierce)
- Alzheimer’s Drug Targets People With Mild Cognitive Impairment. What Does That Mean? (KHN)
- US FDA Aims To Speed Communications On Cell And Gene Therapy Issues With Q&A Guidance (Pink Sheet)
- Drugging RNA was once considered impossible. Now Big Pharma can't get enough of it (Endpoints)
- Medical Device Company Pleads Guilty to Dealing in Adulterated Devices, Forfeits Over $800,000 in Non-FDA Approved Devices (DOJ)
- FDA clears wireless, blood pressure-monitoring finger sensor from Caretaker Medical (Fierce)
- FDA medical device regs, safety checks questioned by AMA ethics journal (MedtechDive)
- US FDA’s Shuren Promises MDUFA Update ‘Relatively Soon’ (MedtechInsight)
- Medtronic's newly acquired radial artery catheters go global with European approval (Fierce)
- Abbott Preps For Potential VALID Act For Diagnostics While Pushing For More Clarity (MedtechInsight)
- EU Medtech Urgently Needs Greater Transparency About EU Notified Body Capacity Situation (MedtechInsight)
- What's next for RADx? The NIH drafts a to-do list for its $1.5B diagnostics competition, through COVID and beyond (Fierce)
- Bayer strengthens ties with Huma, collaborating on AI to classify lung cancer types (Fierce)
- Endo Agrees To $7.5M Deal With La. AG Over Opioid Claims (Law360)
- Drug Cos. Say DA's Opioid Settlement Objections Are Unripe (Law360
- Gilead, Bristol Myers face lawsuit from major pharmacies over HIV generic drug delays (Endpoints)
- J&J Wins Multiplaintiff Mo. Talc Trial After High Court Setback (Law360)
- Three New York Men Sentenced to Prison for Elaborate Scheme to Sell Illegally Imported Drugs (FDA)
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