Recon: Warning signs for US medical stockpile; NY jury urged to hold drugmakers liable for opioid crisis
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- NY jury urged to hold drugmakers liable for US opioid crisis (Reuters)
- US medical stockpile running low as Delta variant threat looms (Politico)
- Poll: Most neurologists and primary care doctors disagree with FDA’s approval of Alzheimer’s drug (STAT)
- Is 9 years too long to run a confirmatory study for a drug like aducanumab? In Sarepta’s case, it isn’t enough time (Endpoints)
- Revised analysis nudges up cost-effective price for Aduhelm drug to $3,000 to $8,400 a year (STAT)
- Heart inflammation after COVID-19 shots higher than expected in study of US military (Reuters)
- Health Canada recommends people with rare blood condition not get AstraZeneca vaccine (Reuters)
- India's Bharat Biotech says regulatory steps taken for Brazil vaccine contract (Reuters)
- Cuba begins coronavirus vaccine trials on children (Reuters)
- AstraZeneca Pharma India moves Delhi High Court against NPPA demand notice (Economic Times)
- Japan’s Top Court Upholds Not-Guilty Ruling over Novartis Data (Nippon) (PharmaJapan)
- Indivior raises sales guidance on strong demand for opioid abuse treatment (FT)
- MHRA grants bluebird bio’s LentiGlobin gene therapy an ‘innovation passport’ (PMLive)
- Use of antibiotics in animals is decreasing (EMA) (Report)
- Deputy Executive Director Noël Wathion retires after 25 years of service (EMA)
- Pre-submission meet held, Covaxin's 'rolling data' to start in July: WHO (Economic Times)
- Masks Again? Delta Variant’s Spread Prompts Reconsideration of Precautions. (NYTimes)
- Putin says he had Russia's Sputnik V COVID-19 vaccine (Reuters)
- China's Clover to supply up to 414 mln COVID-19 doses to COVAX scheme (Reuters)
- Swiss give 4 mln AstraZeneca shots to COVAX, keep mRNA shots for domestic use (Reuters)
- Romania to sell excess COVID-19 vaccines to Denmark (Reuters)
- Roche partner sees promise for anti-COVID 19 pill in early study (BioPharmaDive)
- Abbott’s rapid antigen COVID-19 test cleared in Europe for at-home, direct-to-consumer sales (Fierce)
- What mRNA is Good For, And What It Maybe Isn’t (In The Pipeline)
- Jazz's reworked narcolepsy drug wins 7 years of orphan exclusivity thanks to rare 'clinical superiority' finding from FDA (Endpoints)
- EMA Cites EU Data Protection Rules, HQ Relocation For 2020 Transparency Dip (Pink Sheet)
- Deals surge, returns slip: takeaways from a record half for biotech IPOs (BioPharmaDive)
- MHRA grants bluebird bio’s LentiGlobin gene therapy an ‘innovation passport’ (PMLive)
- Bayer's gene therapy CDMO Viralgen cuts ribbon on first phase of $142M viral vector expansion (Fierce)
- Fujifilm's multibillion-dollar expansion spree rolls on with $850M capacity boost in U.S., U.K. (Fierce)
- AbbVie says Rinvoq shines again as maintenance therapy for ulcerative colitis — but safety concerns still loom over JAK class (Endpoints)
- Patient experience data in regulatory decisions: Questions abound in first FDA report (Endpoints)
- GenSight's gene therapy mystery continues, as patients improve in another failed trial (Endpoints)
- Basking in limelight of a CRISPR breakthrough, Intellia bags $600M cash raise as shares soar to all-time high (Endpoints)
- Altimmune abandons ship on intranasal Covid-19 vaccine, refocusing on liver, obesity programs after trial flop (Endpoints)
- A dry-powder lung disease drug and next-gen antibiotics: Two more biotechs land on Wall Street with big ideas (Endpoints)
- Joe Jimenez and Mark Fishman sign up their 5th drug candidate — and they have another big target in their crosshairs (Endpoints)
- Say goodbye to plants: Synbio player Antheia earns new backers in quest to redesign flora-derived medicine manufacturing (Endpoints)
- An Indiana CDMO with big-name clients sets up plans for lentiviral production site (Endpoints)
- Cerevel's stock rockets up on release of early data in schizophrenia, followed by an offering (Endpoints)
- EU approves Merck’s treatment for oesophageal cancer (Pharmafile)
- EU approves BMS’s treatment for metastatic colorectal cancer (Phamafile)
- FDA nod in sight, Insulet's Omnipod 5 boosts time in range in diabetes subset (MedtechDive)
- Medtronic smart insulin pen improved time in target blood glucose levels: study (MedtechDive)
- Robotic abdominal surgery has no advantage over open, laparoscopic surgeries: meta-analysis (MedtechDive)
- Procept Biorobotics reels in $85M to make a splash with water-based robotic system for prostate surgery (Fierce)
- Philips puts forward new MRI method enabling total heart scans in less than one minute (Fierce)
- Demand is growing for continuous glucose monitoring for type 2 diabetes. Primary care doctors need to prepare (STAT)
- Teva Seeks To Revoke IP For J&J Unit's Schizophrenia Drug (Law360)
- Ruling Needed Now On Calif. Pay-For-Delay Law, Court Told (Law360)
- High Court Limit On Patent Challenges To Spur More Fights (Law360)
- 2 Ono Employees Found Guilty for Onoact Bribery Charges; Scholarship Donation in Spotlight (PharmaJapan)
- Amid rush of scandals, Eli Lilly settles sex discrimination, harassment suit with former lobbyist (Fierce)
- US Supreme Court Limits Estoppel Rule In Minerva Surgical v. Hologic (MedtechInsight)
- COVID-19 Causes Further Delay To Canada’s Controversial Pricing Reforms (Pink Sheet)
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