Recon: Emergent to resume J&J vaccine production; Sanofi raises profit forecast
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Citing New Data, Pfizer Outlines Case for Booster Shots (NYTimes)
- J&J says US FDA agrees to extend shelf life of its COVID-19 vaccine (Reuters)
- Emergent to resume J&J COVID-19 vaccine production at Baltimore plant (Reuters) (WSJ)
- U.S. House panel seeks J&J documents on baby powder bankruptcy plans (Reuters)
- AstraZeneca CEO hopeful COVID-19 vaccine may still have role in U.S. (Reuters)
- U.S. FDA allows Lilly's COVID-19 drug to be taken without remdesivir (Reuters)
- Deep Genomics raises $180 million to automate drug discovery (STAT)
- Doctors Blast Biogen Alzheimer Approval as ‘Regulatory Failure’ (Bloomberg) (Endpoints) (NEJM 1, 2, 3)
- Lawmakers ask Defense Department about using a controversial maneuver to lower drug prices (STAT)
- Sanofi raises profit forecast after second quarter beat (Reuters) (FT)
- New Zealand gives provisional nod to AstraZeneca's COVID-19 vaccine (Reuters)
- AstraZeneca COVID-19 sales jump as drugmaker navigates vaccine challenges (Reuters)
- AstraZeneca exploring options for COVID-19 vaccine business – executive (Reuters)
- Israel to offer Pfizer booster jab to the over 60s – reports (Reuters)
- AstraZeneca vaccine shipped to Canada, Mexico before adequate plant inspections (Reuters)
- Pharma firm Advanz fined after thyroid drug price hike of 6,000% (The Guardian)
- Cuba says Iran to start producing one of its COVID-19 vaccines (Reuters)
- McConnell aims to boost U.S. Republican vaccination rate by countering 'bad advice' (Reuters)
- FDA approves the first interchangeable biosimilar insulin. Will it really lower the cost? (STAT)
- Here’s why simply approving Aduhelm can’t guarantee a golden age of Alzheimer’s R&D (STAT)
- Merck and Pfizer back a Michigan startup's mission to advance tumor profiling (Endpoints)
- AstraZeneca and Amgen quietly admit tezepelumab defeat as the Dupixent challenger heads to FDA (Endpoints)
- Resilience shells out $110M for bluebird bio site, kickstarting new collaboration (Endpoints)
- Flush with cash, Rakuten billionaire Mickey Mikitani looks to take his photoimmunotherapy platform global (Endpoints)
- Eli Lilly teams up with KRAS drug pioneer Yi Liu targeting small molecule I/O with $70M upfront (Endpoints)
- Dutch HTA Body Hits Out At Bluebird’s Zynteglo Pricing (Pink Sheet)
- As leading synbio players bask in spotlight, US/China startup lands $100M to find its own niche (Endpoints)
- Waiting For Inspections, Biocon Seeks US FDA Stance On Mutual Recognition Agreement Route (Pink Sheet)
- Novartis China Drive Paying Off, Sales Soar On Reimbursement Inclusion (Scrip)
- Thermo Fisher slashes COVID-19 testing guidance by $900M (MedtechDive)
- Medtronic nets heartening FDA nod for AI algorithms to detect afib, arrhythmia (Fierce)
- As Stryker boosted by electives comeback, CEO downplays delta variant risk to procedures (MedtechDive)
- Exo nabs $220M as hand-held ultrasound race heats up (Fierce)
- Baxter Reports Second-Quarter 2021 Results (Press)
- Strata Oncology gets $90M boost from Pfizer, Merck and more for genomic cancer testing (Fierce)
- Opioid Distributors Pin Blame On Others As W.Va. Trial Ends (Law360)
- Endo, Arnold & Porter Accused Of Cover-Up In Opioid MDL (Law360)
- McKinsey Says Cherokee Opioid Suit Can't Go To State Court (Law360)
- Pfizer Court Fight Could Legalize Medicare Copays and Unleash ‘Gold Rush’ in Sales (KHN)
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