Recon: Pfizer, Novartis Lead Global Gene Therapy Manufacturing Investment; US Prosecutors Open Opioid Criminal Probe – Regulatory Focus

Posted 27 November 2019 | By Michael Mezher 

Recon: Pfizer, Novartis Lead Global Gene Therapy Manufacturing Investment; US Prosecutors Open Opioid Criminal Probe
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • Biogen will offer discounts to a health plan if patients say its multiple sclerosis drugs don’t work (STAT)
  • Judge partly vacates convictions of opioid maker Insys' founder, executives (Reuters)
  • SEC charges ex-MiMedx execs with defrauding investors (Fierce) (Endpoints)
  • US prosecutors open criminal probe of opioid makers, distributors (Reuters) (WSJ) (Bloomberg)
  • Clock ticking on drug reform this year (Politico)
  • Analysts Predict IPI and Senate Bill Unlikely to Impact Drug Industry Like Pelosi Bill (Focus) (Pink Sheet-$)
  • Mounting drug shortages delay treatments for patients with bladder cancer (CNBC)

In Focus: International

  • Pfizer, Novartis lead $2 billion spending spree on gene therapy production (Reuters) (Endpoints)
  • Europe eyes arrival of world’s priciest drug (Politico)
  • 1 year later, mystery surrounds China’s gene-edited babies (AP)
  • Merck’s Keytruda picks up third approval for NSCLC in China (PMLive)
  • NICE rejects Keytruda for routine use in NHS bladder cancer treatment (Pharmafile)
  • AbbVie, NorthWest EHealth team up to explore autoimmune conditions (PharmaTimes)
  • Row over Labour's 'NHS for sale' claim (BBC)
  • WHO, UNICEF Evacuate Some Staff In Congolese City of Beni (NPR)
  • Second MDR Corrigendum Targets Class I Devices (Focus)

Pharmaceuticals & Biotechnology

  • Enlight Biosciences was going to ‘transform pharma R&D.’ What happened? (STAT)
  • FDA Approves 5 New Costly Drugs Well Ahead of PDUFA Dates (Focus)
  • I was a drug rep. I know how pharma companies pushed opioids. (Washington Post)
  • Insider account of UCB’s $2.1B deal to buy Ra Pharma spotlights a disciplined M&A strategy — and $120M windfall for execs (Endpoints)
  • ANDA User Fee Misses Are Mostly Part Of 'Imminent Approval' Process (Pink Sheet-$)
  • A Single Dose Of Ketamine Might Help Heavy Drinkers, Study Finds (NPR)
  • AstraZeneca, Novoheart to Co-Develop New Heart Model (Xconomy)
  • Built For Counterterrorism, This High-Tech Machine Is Now Helping Fight Fentanyl (NPR)
  • Biotech vet Paul Brennan takes helm at regenerative med biotech; Axcella names CFO (Endpoints)
  • Mass General team presents mouse data to back the case for using an old asthma drug to treat ALS (Endpoints)
  • AbbVie’s Rinvoq has ‘marginal clinical benefit’ over Humira at increased cost, says ICER (PMLive)
  • Hikma completes its FDA response for generic Advair (PharmaLetter-$)
  • Antibiotics: Leveraging Off-Label Efficacy Data Needed To Drive Appropriate Use, Reimbursement (Pink Sheet-$)
  • Former FDA Commissioner Frank Young Passes Away At 88 (Pink Sheet-$)
  • Hospira, Inc., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications (FDA)
  • James R. Casey: Final Debarment Order (FDA)

Pharmaceutical & Biotechnology: Study Results, Filings & Designations

  • ChemoCentryx surges on phase 3 vasculitis study (PMLive)
  • Evofem Biosciences re-files for FDA approval of Amphora (PharmaLetter-$)
  • Innovent Announces First Patient Dosed in Phase I Clinical Trial of Anti-PD-1/HER2 Bispecific Antibody in China (Press)

Medical Devices

  • Roundup: How major medtechs fared in Q3 (MedtechDive)
  • Coloplast recalls stents due to package sterility issue (MassDevice)
  • B. Braun recalls blood sets over risk of leakage and infection (MedtechDive)
  • US FDA Medical Device Classification Primer (Emergo)
  • Breaking down “universal,” “inclusive,” and “accessible” medical device design (Emergo)
  • Zebra Medical Vision Secures a Fourth FDA Clearance for AI for Medical Imaging (Press)
  • QIAGEN and DiaSorin Receive FDA Approval for The LIAISON QuantiFERON-TB Gold Plus Test on LIAISON Platforms and Begin Commercial Launch (Press)
  • HealthLytix Receives FDA Clearance for Breakthrough Prostate Imaging Solution, RSI-MRI+ (Press)

US: Assorted & Government

  • Azar-Verma fight splitting HHS (Politico)
  • Researchers Say FDA Has Fallen Down on E-Cigarette Testing (WSJ)
  • Merck Sharp & Dohme Corp. v. Wyeth LLC (Fed. Cir. 2019) (Patent Docs)
  • Bayer Essure Injury Suits Kicked Back To Pa. State Court (Law360-$)
  • Boston Heart to pay $26.7M to settle alleged doctor kickback scheme (MedtechDive)
  • New Jersey/Pennsylvania Doctor Pleads Guilty To Accepting Bribes To Prescribe Fentanyl in Insys Scandal (Forbes)
  • Schools Poised To Open New Front In Opioid MDL (Law360-$)
  • Mayo Tells Supreme Court Congress Should Clarify Patent Eligibility Confusion in Diagnostics (GenomeWeb)
  • Illinois Refuses to Impose Duty on Pharmacy to Warn Patient Orally (Drug & Device Law)
  • CHPA Petitions FDA to Swiftly Establish a Clear Path for CBD in Dietary Supplements (FDA Law Blog)

Upcoming Meetings & Events Europe

  • EMA to Implement Ombudsman’s Recommendations on Avoiding Bias (Focus)
  • Winding down to the EU IVD and Medical Devices Regulations Deadlines: The Finish Lines in Sight? (MedTechEurope)
  • Irish Regulator Invites Feedback On Strategic Plan For 2021-2025 (Pink Sheet-$)
  • Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, EL(19)A/38 (MHRA)
  • Alaris™ Gateway Workstation and Alaris™ Gateway Workstation web browser user interface (MDA/2019/040) (MHRA)

Asia

  • Asia Regulatory Roundup: China Opens Food and Drug Center of Excellence in Beijing (Focus)
  • Biosimilar of Forteo launched in Japan by Mochida (PharmaLetter-$)
  • Chugai sells stake in Korean joint venture (PharmaLetter-$)

India

  • Pharma Inc agrees to cap margins on non-price control drugs at 30% (Economic Times)
  • Biocon, Mylan get USFDA nod for pegfilgrastim drug substance licence (Economic Times)

Australia

  • Publishing results of listed medicine compliance reviews (TGA)

Other International

  • Organisation of Islamic Cooperation sets up new halal pharmaceuticals technical committee (Pharmafile)

General Health & Other Interesting Articles

  • US life expectancy declining due to more deaths in middle age (Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Source: https://www.raps.org/news-and-articles/news-articles/2019/11/recon-pfizer-novartis-lead-global-gene-therapy-i

« »