Recon: Moderna to manufacture mRNA vaccines in Canada; Boston Scientific recalls 48,000 Ingenio pacemakers
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Boston Scientific recalls a decade's worth of Ingenio pacemakers over risk of unexpected system resets (Fierce) (MedtechDive)
- What full FDA approval could change about Covid vaccination (NBC)
- After leaving patients in limbo, Pfizer agrees to sell a discontinued glaucoma drug (STAT)
- A ‘frothy’ digital health market, Verily partners with Colgate, & a HIMSS dispatch (STAT)
- NIH assesses third COVID-19 vaccine dose in kidney transplant recipients (Reuters)
- Lawyers' fees from $26 bln opioid settlement capped at 15%, judge rules (Reuters)
- Moderna soars into the ranks of the world's top pharma players, now worth 3 Regenerons (Endpoints)
- Moderna to start local production of COVID-19 mRNA vaccine in Canada (Reuters) (CNBC)
- Delta outbreak piles pressure on China’s homegrown vaccines (FT)
- Inovio focused on launching global COVID-19 vaccine trial next month – CEO (Reuters)
- S. Korea approves Phase III trial of SK Bioscience's COVID-19 vaccine (Reuters)
- TGA grants provisional determination to Merck Sharp & Dohme's antiviral COVID-19 treatment Molnupiravir (TGA)
- BioNTech expects to be $18.6B richer after this year as Covid boosters churn out more data. But it won't change much (Endpoints)
- Australian researchers develop hydrogel to combat Parkinson's (Reuters)
- Guinea records West Africa's first Marburg virus death, WHO says (Reuters)
- Pentagon will seek to mandate Covid vaccine for 1.4 million troops (Politico)
- Novartis, Pfizer and Gilead roll out COVID-19 vaccination rules as Delta makes case for mandates (Fierce)
- Alabama Just Tossed 65,000 Vaccines. Turns Out It's Not Easy To Donate Unused Doses (NPR)
- Whistleblower scientist settles complaint over Trump COVID-19 response (The Hill)
- Biotech M&A tracker: After hitting new heights, deals have slowed down. Here are the latest. (BioPharmaDive)
- Will controversy over new Alzheimer’s drug spell the end for the FDA’s faster approval process? (STAT)
- Manufacturing, Impurities, and Characterization Methods Are Key Regulatory Focal Points for Peptides and Oligonucleotides (IPQ)
- Merck, Novo, Sanofi and more pull off China growth thanks to price maneuvering. But anxiety grows over outlook for biologics (Fierce)
- Paragon's Harmony Biosciences brings in $330M of debt capital and equity, looking to expand narcolepsy drug label (Endpoints)
- A Canadian startup refuels to take on a rare cardiac condition that many patients don't realize they have (Endpoints)
- AbbVie hands over $20M for Alzheimer's, Parkinson's drugs; Autolus boosted by a PIM (Endpoints)
- Kite receives positive recommendation from SMC for CAR T therapy (Pharmafile)
- Virtually unknown mRNA upstart rides SPAC to Nasdaq with a $1.5B valuation as RA-backed neuro player prices IPO (Endpoints)
- SeaGen builds cancer drug pipeline with China biotech deal (BioPharmaDive)
- US FDA Crowdsourcing Pediatric Regulatory Science Research Ideas (Pink Sheet)
- Future Alzheimer's Treatments Aim To Do More Than Clear Plaques From The Brain (NPR)
- Merck & Co. Eyes Neuroscience Advancement With US FDA’s New Receptivity To Biomarkers (Pink Sheet)
- Roche sets bar in early lymphoma treatment with Polivy study results (BioPharmaDive)
- Negative innovation: when patents are bad for patients (Nature)
- J&J's Ponvory may be late to the multiple sclerosis market, but doctors still see potential: study (Fierce)
- Sanofi, eyeing impurity concerns, pulls hypertension meds in Korea and the UK. Could the next big 'sartan' recall be on the horizon? (Fierce)
- Surgeons Cash In on Stakes in Private Medical Device Companies (KHN)
- US FDA Pediatric Panel To Discuss Product Safety Twice In September (MedtechInsight)
- Illumina Remains Committed To Grail Merger Despite Regulatory Hurdles (MedtechInsight)
- Nanox offers up to $200M to pool digital X-ray technology in Zebra Medical merger (Fierce)
- Device Giants Stryker And Baxter Embrace A ‘Quality First’ Culture – And Yield Positive Results (MedtechInsight)
- Zimmer Hip Implant Suit Tossed Over Expert Opinion (Law360)
- FTC Wants More Info On AbbVie's $550M Device Deal (Law360)
- 7th Circ. Backs Spinal Device Co. In Trade Secrets Fight (Law360)
- Glenmark, Teva Say DOJ 'Rewriting' Price-Fixing Indictment (Law360)
- GSK Redo Doesn't Cure Generics' 'Skinny Label' Uncertainty (Law360)
- Walgreens Faces Skeptical 9th Circ. In Theranos Cert. Fight (Law360)
- Bayer loses third appeals case over glyphosate weedkiller (Reuters)
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