Recon: Japan’s Asahi Kasei to Buy Veloxis for $1.3B; Spanish Antitrust Regulator Probes Merck

• How a billionaire couple greased the skids for Nancy Pelosi’s drug pricing bill (STAT)
• FDA approves Global Blood Therapeutics sickle cell disease drug (Reuters) (STAT) (FDA)
• Pharma execs tell researchers that multiple sclerosis drug pricing is based on competition, not R&D costs (STAT)
• FDA approves J&J spinout's device for kids with recurring ear infections (MedtechDive) (FDA)
• In pricing our gene therapy, Bluebird weighed value, shared risk, and a lifetime cap (STAT)
• US heart patients cut back on life-saving drugs due to cost (Reuters)
• US charges former Outcome Health executives in $1 billion fraud (Reuters) (WSJ) (AP)

• New Roche flu drug can drive resistance in influenza viruses: researchers (Reuters) (Endpoints)
• Cancer Drug Doubled Korean Pharma Stock on Award It Never Won (Bloomberg)
• Veloxis wins $1.3B buyout deal, and the new owner plans to follow up with new deals (Endpoints) (Japan Times)
• Merck is probed by Spain’s antitrust regulator for allegedly delaying competition for a contraceptive (STAT)
• After FDA OK, SK to breath new life into Korean biotech with $850M IPO (Endpoints)
• Cancer vaccine play MaxiVAX shoots for 'hard endpoint' in PhII head & neck cancer test (Endpoints)
• Mavenclad granted accelerated access by NICE (PharmaTimes)
• Europe approves first subcutaneous version of biosimilar infliximab (Pharmafile)
• Singapore and South Korea agree to cooperate on Good Manufacturing Practice (Pharmafile)
• Measles Cases Continue to Rise Around the World (NYTimes)

• US lawmakers call for FDA office in Israel (Pharmafile)
• Pharma execs: Thirst for profit drives high drug prices (The Oregonian)
• OND Reorganization Continues Apace (Focus)
• There’s one endpoint that the booming biopharma industry has failed at miserably: financial toxicity (Endpoints)
• FDA Updates its Thinking on Immunogenicity Studies for Insulin Biosimilars, Interchangeables (Focus)
• OPDP Letter Criticizes Drug Company for Failing to Disclose Risk Info Online (Focus)
• Presence of Piracetam in Cognitive Enhancement Dietary Supplements (JAMA)
• Our drug policy often prioritizes eliminating rare disease. One researcher asks: Is that the right goal? (STAT)
• ICER gets on board with AbbVie's Rinvoq for RA but frets over 'fair pricing' of next-gen drugs (Fierce)
• FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns (FDA)
• Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game? (The Niche)
• US FDA's New Neurology Leadership Likely To Face Two Big Reviews In 2020 (Pink Sheet-$)
• Complex Generics May Need New Communications Options In GDUFA III (Pink Sheet-$)
• Comparative Claims: CFL Guidance Gives Opening; OPDP Research May Close It (Pink Sheet-$)
• Karuna's 'A-ha moment': A billion-dollar stock swing and new expectations (BioPharmaDive)
• La Jolla CEO decamps just as biotech faces a reckoning for iron overload drug (Endpoints)
• Five Questions With a16z’s Vijay Pande on AI and Making New Drugs (Xconomy)
• Acadia's sweeping hunt for better Nuplazid data bags mixed results for schizophrenia (Endpoints)
• Prospective Grant of an Exclusive Patent License: Gene Therapy for Ocular Disease (NIH)

• Janssen's INVOKANA (canagliflozin) Gets Boost Over Competitors with FDA Approval for Diabetic Kidney Disease and a Newly Minted Collaboration with Renal Giant, Vifor Pharma (Press)
• Imbrium Therapeutics L.P. and SpineThera, Inc. Announce First Patient Dosed in Phase 1/2 Clinical Study (Press)
• Delta-Fly Pharma, Inc. Initiated Phase 3 Clinical Study of DFP-10917 and Phase 1 Clinical Study of DFP-14927 (Press)
• VFMCRP and ChemoCentryx Announce Positive Topline Data From Pivotal Phase-III ADVOCATE Trial Demonstrating Avacopan’s Superiority Over Standard of Care in ANCA Associated Vasculitis (Press)
• Poxel Announces Positive Topline Results for Imeglimin Phase 3 Trial (TIMES 3 36-week) for the Treatment of Type 2 Diabetes in Japan (Press)
• Cerevel Therapeutics to Present Safety, Tolerability, and Pharmacokinetics Results From Phase 1 Trial of CVL-865 (Press)
• Prokarium Announces MHRA Acceptance to Run Phase I Trial of Lead Vaccine Against Enteric Fever (Press)

• Second MDR Corrigendum Targets Class I Devices (Focus)
• CDRH Unveils Pilot Project for Sterilization Changes (Focus)
• Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis (MedtechDive)
• 5 insights into Dexcom's year ahead from CEO Kevin Sayer (MedtechDive)
• US Medical Innovations Receives FDA 510(k) Clearance for the Canady Plasma Smart XL-1000 Generator (Press)
• Tusker Medical’s pediatric ear tubes land breakthrough device designation (MassDevice)
• Venus Concept wins CE Mark and Health Canada approval (MassDevice)

• Continuing Resolution Keeps FDA Funded Through Dec. 20 (FDA News-$)
• Time to Talk Turkey … Once Again (Alliance for a Stronger FDA)
• Upton and DeGette Begin Work on Cures Act Reprise (Focus)
• Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation (Big Molecule Watch)
• Standards body urged to add device identifiers to insurance claims forms (MedtechDive)
• The $11 Million Dollar Medicare Tool That Gives Seniors the Wrong Insurance Information (ProPublica)
• CRISPR Housekeeping (Patent Docs)
• What a Difference a Year Makes (Or Not) (Drug & Device Law)
• Justices Decline Pfizer's LA Court Fight, Hospital FCA Cases (Law360-$)
• Takeda Wants Immediate Appeal Of Actos Order 'Uncertainty' (Law360-$)
• Humira Buyers Say They've Proven AbbVie's 'Patent Thicket' (Law360-$)
• Roche Hit With $137M Verdict For Infringing Lab Test Patents (Law360-$)
• Boston Scientific Gets Sanctions Nixed In FCA Suit (Law360-$) (MassDevice)

• FDA Advisory Committee Calendar
• Repurposing Off-Patent Drugs: Research & Regulatory Challenges – 5-6 December 2019
• Regulatory Education for Industry (REdI): 2019 CDER Prescription Drug Labeling Conference – 4-5 December 2019       

• MedTech Europe slams EU over lack of preparation for MDR/IVDR (MassDevice)
• With 6 months until new EU medical device rules, what's the state of play? (MedtechDive)
• National Assembly adopts historic amendment on transparency (Mediapart)
• Russian drugmaker to receive compulsory license for Pfizer’s drug (Pharmaletter-$)
• Ireland Relaxes Stance On Biosimilar Switching (Pink Sheet-$)

• Merck’s KEYTRUDA® (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy (Press)
• Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) (Press)
• Japan's Kyowa Kirin reorganizes quality responsibilities (Fierce)

• Booster dose for Indian medical device makers (Economic Times)
• Ceiling price of drugs should be fixed by giving extra margin to traders on all category of drugs: AIOCD urges NPPA (Pharmabiz)
• Glenmark Pharma gets USFDA nod for diabetes management drug (Economic Times)
• Indoco Remedies receives EIR from USFDA (Economic Times)
• US health regulator finds Silvassa unit non-compliant with CGMP: Ipca Labs (Economic Times)

• Knight and TherapeuticsMD Announce Filing of New Drug Submission for BIJUVA® in Canada (Press)

• TGA response to federal court decision on urogynaecological mesh class action (TGA)
• Update to listed medicine ingredients in November 2019 (TGA)

• New WHO Public Inspection Report (WHOPIR) published (WHO)
• Revised Appendix for Bioequivalence Trial Information (BTIF) (WHO)

• Cannabis tied to severe heart attack risk in younger adults (Reuters)
• How Much Should Big Tech Know About Our Personal Health Data And History? (NPR)
• Health Officials in “Cancer Alley” Will Study if Living Near a Controversial Chemical Plant Causes Cancer (ProPublica)