Recon: FDA Panel Backs New Indications for Keytruda, Lynparza; FTC Moves to Block Illumina’s PacBio Acquisition

• Drug Importation Plans: Lots of Exclusions, Unclear Timeline (Focus)
• The FTC moves to block DNA sequencer Illumina’s acquisition of PacBio, calling company a ‘monopolist’ (STAT) (Endpoints) (Law360-$) (FTC)
• US sues CVS for fraudulently billing Medicare, Medicaid for invalid prescriptions (Reuters) (STAT)
• FDA Supports Budget Bill’s Changes to Chemically Synthesized Polypeptides (Focus) (STAT)
• FDA panel clears Keytruda for hard-to-treat bladder cancer (PMLive) (Pharmafile) (Press)
• FDA panel backs use of Lynparza in pancreatic cancer (Endpoints) (Pink Sheet-$) (Press)
• Most US opioid overdose deaths accidental, 4% are suicide (AP)
• Elizabeth Warren claims Eli Lilly failed on cheaper insulin. CEO says ‘nonsense’ (CNBC)

• No pain, no gain: Company-building French VC scores €250M for life sciences fund (Endpoints)
• Boehringer's $250M NASH drug hits the skids as development path gets rockier (Fierce)
• CR UK, Vaccitech strike deal for new immunotherapeutic vaccine (PharmaTimes)
• NICE Increases Options For Hyperkalemia Patients In England (Pink Sheet-$)
• EMA Explains Comparability Requirements For ATMPs (Pink Sheet-$)
• Why Dengue Fever Cases Are Hitting Record Highs In Latin America (NPR)
• 4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety system (EMA)
• Swissmedic and the Korean regulatory authority extend their cooperation in the area of therapeutic products (Swissmedic)
• ICH Assembly in Singapore, November 2019 - Expert meeting adopts new Guidelines on quality and medicinal product safety (ICH)
• Regulators Launch International Sterile Medicines Inspection Pilot (Focus)

• Cutting-edge therapies promise one-time cures, but not without risk. Can biotech make them safer? (STAT)
• Eli Lilly spotlights early oncology in first pipeline review since R&D shift (Endpoints) (Fierce)
• David Meek hands in his CEO title at Ipsen, leaping across the Atlantic to run a startup prepping its first US drug launch (Endpoints)
• New DSCSA Track And Trace Governing Body Up And Running (Pink Sheet-$)
• ESMO I-O: Roche silences Tecentriq doubters with latest lung cancer analysis (Fierce)
• CDER OSE MAPP: Risk Evaluation and Mitigation Strategy (REMS) Assessment (FDA)
• After taking a hard look at the data, Novartis punts Aduro’s STING drug — the latest in a long line of setbacks (Endpoints) (Fierce)
• ALS Fund Talks Investments and Strategy as it Kicks Off $100M Campaign (Xconomy)
• The Cost Of PrEP, The HIV Prevention Pill (KHN)
• Advances in oral peptide therapeutics (Nature)
• How should we define “unmet need”? (Healthcare Economist)
• Scientists Reach Out To Minority Communities To Diversify Alzheimer's Studies (NPR)
• Pfizer and Mylan Announce Two Future Viatris Board Members (Press)
• AGC Biologics expands plasmid DNA capacity as gene therapies move front and center (Fierce)
• GlaxoSmithKline's Benlysta eyes lupus sales boost after kidney trial win (Fierce)
• Canaan backs Pathios' search for small molecule drugs that hit 'orphan' GCPR (Endpoints)
• Psychedelic research gains momentum, as early trial suggests micro-dosing LSD is safe (Endpoints)
• ARCH-backed biotech emerges with $85M and a bold claim: A new human hormone can reverse a key effect of aging (Endpoints)
• Tune in: Pharma rides audio's surge with podcasts and streaming radio ads (Fierce)
• On tap for pharma marketing in 2020? Caregivers, podcasts and, of course, more digital (Fierce)
• Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity (FDA)

• Versus Vertex, Proteostasis' triplet CF data fall short, wilting stock (Endpoints)
• After SABCS stunner, Seattle Genetics nabs FDA breakthrough tag for tucatinib (Fierce) (Press)
• U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy (Press)
• DiaMedica Therapeutics Announces First Patient Dosed in REDUX Phase II Clinical Trial of DM199 for the Treatment of Chronic Kidney Disease (Press)
• U.S. FDA Acknowledges Receipt of Evofem Biosciences' New Drug Application Resubmission for Amphora® for the Prevention of Pregnancy (Press)
• Mycovia Pharmaceuticals Completes Enrollment in its Third Phase 3 Clinical Trial for VT-1161 (ultraVIOLET) in Patients with Recurrent Vulvovaginal Candidiasis (Press)
• Zentalis Pharmaceuticals Announces FDA Clearance of the IND for Its Third Oncology Drug Candidate, ZN-c3, a WEE1 Inhibitor, and the Dosing of the First Patient in a Phase 1/2 Clinical Trial (Press)
• REGENXBIO Announces Interim Data from Phase I/II Trial of RGX-121 for the Treatment of Mucopolysaccharidosis Type II (MPS II) (Press)
• Poxel Announces Positive Results for PXL065 Phase 1b Trial and Provides Program Update (Press)
• OBI Pharma Announces Initiation of a Phase 1/2 Study of Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999 (Press)
• MODAG Initiates First-in-Human Phase 1 Clinical Trial for Anle138b (Press)
• Eleusis Announces Phase 1 Trial Results of Lysergic Acid Diethylamide (LSD) in Healthy Older Volunteers, Potential to Evaluate as Disease Modifying Therapy for Alzheimer’s Disease (Press)
• ​NeuClone Completes Dosing in Phase I Clinical Trial of Stelara® (ustekinumab) Biosimilar Candidate (Press)

• Medtronic acquires meal detection tech to bolster personalized closed loop system (MedtechDive)
• Moody’s maintains positive outlook on medical devices, lowers growth forecast (MassDevice)
• FDA Clears DiaSorin Molecular VZV Test (GenomeWeb)
• Cook Medical issues Class I recall of CrossCath Support Catheters (MassDevice) (FDA)
• Medtronic wins FDA clearance for brain surgery guidance system (MassDevice)
• Fujifilm to acquire Hitachi’s medical imaging biz for $1.56 billion (MassDevice)

• Democrats say HHS stonewalling probe into Verma’s PR contracts (Politico)
• Trump intervened to slash Puerto Rico Medicaid funding (Politico)
• Special Report: FDA targets e-cigs that hook teens but don't help smokers quit (Reuters)
• FDA under fire for years of delays on e-cigarette regulation (Reuters)
• Michigan Sues Opioid Distributors Under Drug Dealer Law (AP)
• Pennsylvania Doctor Pleads Guilty to Fraud and Drug Importation Charges (DOJ)
• West Virginia Medical Doctor Sentenced to Prison for Unlawfully Distributing Opioids (DOJ)
• Court Rejects Aiding/Abetting and Conspiracy Claims Against Breast Implant Manufacturer (Drug & Device Law)
• Bipartisan Bill Would Have Pharmacies Fork Over Info To DEA (Law360-$)
• Sens. Say DEA's 8B Opioid Production Quota Is Too High (Law360-$)
• Broad Files Reply Brief to Berkeley's Opposition to Substantive Motion No. 1 (Patent Docs)
• The Court of Appeals for the D.C. Circuit Upholds FDA’s Deeming Rule (FDA Law Blog)
• Eagle, Eli Lilly Drop Dueling Cancer Drug Patent Claims (Law360-$)
• House Panel Greenlights Revised North American Trade Pact (Law360-$)
• EpiPen Buyers Seek Class Status In ERISA Suit (Law360-$)
• Ex-Theranos CEO Says Indictment 'Flunks The Constitution' (Law360-$)

• FDA Advisory Committee Calendar

• BioNTech Gets €50 million Loan from European Investment Bank (Press)

• Database of TGA listed medicine compliance review results (TGA)

• At Mayo Clinic, AI engineers face an ‘acid test’: Will their algorithms help real patients? (STAT)