rf-fullcolor.png

 

June 30, 2021
by Michael Mezher

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
  •  
Government, Regulatory & Legal
  • 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)
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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.