Recon: Pfizer CEO Read to Retire in January, COO Bourla Tapped as Replacement

• Drugmaker Pfizer’s CEO Read to be replaced by COO Bourla (AP) (Financial Times) (Press)
• 2018 Nobel Prize in Medicine Awarded to 2 Cancer Immunotherapy Researchers (NYTimes) (Reuters)
• Sloan Kettering Executive Turns Over Windfall Stake in Biotech Start-Up (NYTimes)
• Insmed's treatment-resistant lung disease drug gets FDA approval (Reuters) (FDA)
• Sanofi, Regeneron skin cancer drug gets FDA nod (Reuters) (STAT) (Press) (FDA)
• FDA halts imports from China's Huahai after heart drug recall (Reuters)
• Drugmakers Play The Patent Game To Lock In Prices, Block Competitors (NPR)
• New bipartisan bill would give FDA the power to add off-label uses to generic drug labels (STAT)
• Breakthrough Leukemia Treatment Backfires in a Rare Case (NYTimes)
• Antares Pharma's testosterone drug gets FDA approval (Reuters)
• FDA approves first NGS test to detect minimal residual disease in two blood cancers (MedCity) (FDA) (Press)
• Biotech Climate Change (LifeSciVC)
• Medicare's competitive purchasing plan draws limited support (Politico)

• Contaminated Vaccines put India's Polio Free Status at Risk (Times of India)
• Mankind Pharma eyes $1 billion topline by 2021 (Economic Times)
• Ebola Likely to Spread From Congo to Uganda, W.H.O. Says (NYTimes)
• China's health care crisis: Lines before dawn, violence and 'no trust' (NYTimes)
• Novartis-backed cell therapy startup Gamida files for IPO (Fierce)
• Forbion closes fourth EU-focused biotech fund at €360M (Fierce)
• NHS England to fund availability of Janssen’s single tablet HIV combo Symtuza (Pharmafile)
• WHO Endorses TCM. Expect Deaths To Rise. (Forbes)
• Cost of lifesaving heroin withdrawal drug soars by 700% (The Guardian)
• UK regulator certifies use of some out-of-date EpiPens over shortages (The Guardian     )

• The Risk of Alternative Cancer Treatments (NYTimes)
• Why Payers Sometimes Restrict Access To Single Tablet Regimens For HIV Patients (Forbes)
• Dragonfly Therapeutics in $695M cancer R&D pact with Merck (Fierce)
• FDA Approves Genentech's Xolair (Omalizumab) Prefilled Syringe Formulation (Press)
• Nektar’s long-acting IL-2 NKTR-214 has 'zero value,' claims analyst (Fierce)
• Personalized cancer vaccine represents new approach to treating HER2-positive tumors (Fierce)
• Ipsen appoints two leading R&D experts in bid to strengthen oncology arm (Pharmafile)
• FDA Expects Drug GMP Warning Letter Tally To Reach 90 This Year (Pink Sheet-$)
• How CMS Focus On PROs For CAR-Ts Complements Work By FDA And Others (BioCentury)
• Janet Woodcock on CDER’s Needs and Opportunities (Alliance for a Stronger FDA)
• Drug Companies Call for Interchangeability Information in Purple Book (FDA News-$)
• Brammer Bio advancing 3 year, $200m program: 700 employees expected by mid-2019 (Outsourcing Pharma)
• Opioid Approvals: Congress Wants US FDA Guidance On Abuse Potential (Pink Sheet-$)

• Shield files Feraccru with the FDA (PharmaTimes)
• First Patient Dosed in a Phase III Trial of Anti-PD-1 Antibody Sintilimab as First-line Treatment for Patients with Advanced Squamous Non-Small Cell Lung Cancer (Press)
• Seattle Genetics and Takeda Announce Positive Results from Phase 3 ECHELON-2 Clinical Trial Evaluating ADCETRIS® (Brentuximab Vedotin) in Frontline CD30-Expressing Peripheral T-Cell Lymphoma (Press)
• Viking Therapeutics Presents Results from Phase 2 Study of VK5211 in Patients Recovering from Hip Fracture in Plenary Oral Presentation at ASBMR 2018 Annual Meeting (Press)
• The Medicines Company Announces Recommendation by Independent Data Monitoring Committee to Continue Inclisiran Phase III Trials Following Fourth Review of Unblinded Data (Press)
• AVEO Oncology Announces Initiation of Topline Analysis of Phase 3 TIVO-3 Trial (Press)
• Five Prime Therapeutics and Zai Lab Dosed First Patient in Phase 3, Global Registrational Trial of Bemarituzumab in Front-Line Advanced Gastric and Gastroesophageal Junction Cancers (Press)
• Ocugen Initiates Phase 3 Clinical Trial of OCU310 for Dry Eye Disease (Press)
• Inotrem Announces Positive Results From the Phase IIa Study of Its Lead Compound, Nangibotide (LR12), in the Treatment of Septic Shock (Press)
• Innovent Receives an Approval from the US FDA to Initiate Clinical Trials for its Anti-CD47 Monoclonal Antibody IBI-188 (Press)
• PharmaCyte Biotech Reports Completion of Crucial FDA-Required Study for Pancreatic Cancer Trial (Press)

• Stryker pays $220m for HyperBranch Medical (MassDevice)
• Perspective: A Heart Device Can Save Lives, But Doctors Need To Explain The Downsides (NPR)
• The CEO behind General Electric's health unit on cutting ties from struggling parent GE (CNBC)
• Obalon Therapeutics wins FDA nod for Obalon Touch inflation system (MassDevice)
• FDA Approves Expanded Use of Qiagen EGFR CDx in Lung Cancer (GenomeWeb)

• Beto O'Rourke pushes Medicaid (Politico)
• DEA Limits Rescheduling of CBD to FDA-Approved Epidiolex (FDA Law Blog)
• Opioid Task Force Arrests 76 After Raid On Tribal Land (Law360-$)
• UnitedHealth Group division combining with Genoa Healthcare (Star Tribune)
• Teva Revives Patent Fight After FDA OKs Lilly's Migraine Drug (Law360-$)
• SEC Accuses Drugmaker of Venomous Deceptions (Law360-$)
• Stryker pays $8m to settle second SEC beef (MassDevice)
• Sensipar Exclusivity Expires, Ending Amgen's DC Circ. Fight (Law360-$)
• Patent Law 101: New Guidance May Make It Easier To Patent Diagnostics, Biomarkers And Natural Products (BioCentury)
• IRS Considering Biotech-Friendly Spinout Rule (BioCentury)
• The Next Lexecon? (Drug & Device Law)

• FDA Advisory Committee Calendar

• TransEnterix wins CE Mark for Senhance Ultrasonic instrument package (MassDevice)
• Abbott’s next-gen FreeStyle Libre wins CE Mark (Drug Delivery)

• Medical technology sector may hit $9.6 bn in 2022: Report (Economic Times)
• Dr Reddy's terminates Armis Biopharma's investigation license of DFA-02 (Economic Times)
• Made in India coronary stents as good as foreign ones: Study (Economic Times)
• Drug eTailers face traditional pharma retailers’ wrath as policy evolves (Economic Times)
• Nationwide inspection of drug cos, importers planned to assess pharmacovigilance practices (PharmaBiz)
• Telangana govt fails in implementing of National policy for treatment of rare diseases (PharmaBiz)