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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

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

• 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)

• Publishing results of listed medicine compliance reviews (TGA)

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

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