Recon: Moderna to manufacture mRNA vaccines in Canada; Boston Scientific recalls 48000 Ingenio pacemakers - Regulatory Focus

Posted 10 August 2021 | By Michael Mezher

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)

In Focus: International

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)

Coronavirus Pandemic

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)

Pharma & Biotech

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)

Medtech

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)

Government, Regulatory & Legal

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)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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