Recon: Vertex Touts Positive Preliminary Results for Three Drug CF Combo; AbbVie CFO to Retire

• Trump’s Drug Price Bust (WSJ)
• Orphan Drugs in the United States (IQVIA) (PharmaLetter-$)
• Abbvie CFO Chase to Retire Next Year (Reuters) (Fierce)
• Vertex Three-drug combination improves life for cystic fibrosis patients (NBC) (Press) (NEJM)
• Proteostasis shares zoom north as their cystic fibrosis doublet causes a stir in small study — triggering an online brawl (Endpoints)
• ‘Vast majority’ of NIH chimps to be moved to retirement sanctuary, agency says (STAT)
• Clovis, with new study data, hopes to be first to develop a PARP for prostate cancer (STAT) (Endpoints) (Fierce)
• Panel backing for key Shire drug beefs up Takeda's case for its $62B buyout (Fierce) (Pink Sheet-$)
• Teva Sues US FDA To Obtain 180-Day Exclusivity For Its Generic Restasis (Pink Sheet-$) (FDA Law Blog)
• FTC Stops Deceptive Health Claims by a Stem Cell Therapy Clinic (FTC)
• Merck previews an early hit with Keytruda combo for kidney cancer, putting more pressure on rival Bristol-Myers (Endpoints) (Xconomy)
• Chipping away at Gilead’s HIV empire, GSK’s ViiV submits NDA for 2-drug HIV regimen — playing voucher card for speedy FDA review (Endpoints)
• Merrimack Pharma’s stock plunges (again) on its latest cancer drug trial flop (Endpoints)
• Researchers Explore a Cancer Paradox (NYTimes)
• Project Baseline Aims to Ward Off Illness Before We Get Sick (NYTimes)
• Are Some People More Sensitive to Drug Side Effects? (NYTimes)

• Australian watchdog's appeal against Pfizer ruling dismissed by court (Reuters)
• An Ebola outbreak presents a new mystery involving children (STAT)
• #ESMO18: Cardio dreams blighted, Novartis showcases its “blockbuster” ambitions for radiopharmaceuticals (Endpoints)
• EU Launches Joint Assessment Of Pediatric & Orphan Drugs Legislation (Pink Sheet-$)
• NICE rejects Elil Lilly's Verzenio for breast cancer in draft guidance (Pharmafile)
• Amgen Makes £50M Investment In Genetic Sequencing Co. (Law360-$)
• How Brazilian Patients Might Access Sickle Cell Disease Drug Faster (Pink Sheet-$)
• Trends in the global immuno-oncology landscape (Nature)

• TP Therapeutics grabs $80M mezzanine round to fund a pivotal trial for ROS-1/NTRK-positive cancers (Endpoints) (Fierce) (Forbes)
• Looking to the future of patient-centered cancer research and treatment (Boston Globe)
• Public Citizen: US FDA Deliberately Excluded Risk Committee From Dsuvia Panel To Get Positive Vote (Pink Sheet-$)
• The Biotech Innovation That Will Transform Society Has Arrived (Hint: It's Not CRISPR) (Forbes)
• Pfizer Embraces Digitalization For In-Transit Visibility (Forbes)
• LogicBio Prices IPO Below Range, Raising $70M to Test Gene Therapy (Xconomy)
• Gallium fights infection in phase I trial (Nature)
• New antibiotic hits Gram-negative bacteria (Nature)
• Epilepsy caused by BRAF-mutated paediatric brain tumours gets a REST (Nature)
• Exact Sciences Acquires San Diego Lab Equipment Supplier Biomatrica (Xconomy)
• A New Translational Tool for Synaptopathies (LifeSciVC)
• Expediting FDA approvals for biosimilars (GaBI)
• Morphic partners with investor AbbVie on integrin inhibitor development (MedCity)
• Parker Institute teams up with Xyphos to tame CAR-Ts (Fierce)
• Determination of Regulatory Review Period for Purposes of Patent Extension; IMFINZI (FDA)
• Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug Applications (FDA)

• Apellis Pauses Phase III Trials After Single Lot Of APL-2 Causes Inflammation (BioCentury)
• Sensei Biotherapeutics Reports Results from Phase 1 Clinical Trial of SNS-301, a First-in-Class Cancer Immunotherapy Targeting ASPH, a Novel Tumor-Specific Antigen (Press)
• Deciphera Pharmaceuticals Reports Updated Preliminary Phase 1 Clinical Study Results with DCC-2618 at the European Society of Medical Oncology (ESMO) 2018 Congress (Press)
• Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer (Press)
• New Data From the MIV-711 Phase II Program Will be Presented at the ACR Annual Meeting on October 21 (Press)
• Phase 2 GEOMETRY mono-1 Trial of Investigational Medicine Capmatinib Shows Positive Results in Patients with MET-mutated Advanced NSCLC (Press)

• Long-term safety of silicone breast implants still unclear (Reuters)
• Ocular Therapeutix™ Receives FDA Warning Letter Related to ReSure® Sealant (Press)
• Exact Sciences Set to Acquire Biomatrica (MDDI)
• Atrium’s Biosurgery Division Changes Hands Yet Again (MDDI) (MassDevice)
• FDA to Update Mammography Regulations (Medpage)
• Abbott-Alere One Year Later: Was It Worth All the Fuss? (MDDI)
• FDA clears Viseon’s Voyant MIS spinal surgery tech (MassDevice)
• Novocure wins CMS review of Optune glioblastoma Tx (MassDevice)
• Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms (FDA)
• Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use (FDA)
• Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache (FDA)
• Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System (FDA)
• Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device (FDA)
• Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application (FDA)

• Seema Verma teases Medicare payment reforms (Politico) (Pink Sheet-$)
• Opioid Lawsuits On Par To Become Largest Civil Litigation Agreement In US History (Forbes)
• Time Running Out For Lawyers Suing Opioid Industry To Show Specific Proof (Forbes)
• Republican Candidates Soften Tone on Health Care as Their Leaders Dig In (NYTimes)
• PTAB Life Sciences Report (Patent Docs)
• Allergan Must Produce CEO’s Tribal Patent Docs In MDL (Law360-$)
• Glenmark Moves To Ax Zetia Pay-For-Delay Claims (Law360-$)
• Bristol-Myers, Pfizer's Blood Thinner IP Suit Axed Over Venue (Law360-$)
• Michigan Pharmacist Refused to Dispense Miscarriage Medication, Citing Religious Beliefs (NYTimes)

• FDA Advisory Committee Calendar

• The Yellow Card Scheme: guidance for healthcare professionals, patients and the public (MHRA)
• In Europe, not all countries are equal when it comes to reimbursement (PharmaLetter-$)
• Co-Diagnostics Receives CE-IVD Marking for Zika Test (GenomeWeb)
• DiaSorin Receives CE Mark for Simplexa Group B Strep Assay (GenomeWeb)
• Sustainability of biosimilars in Europe (GaBI)

• Indian pharma badly affected by US FDA scrutiny, pricing pressures and other negative factors: Rishabh Bindlish (PharmaBiz)

• Adverse event reporting made easier for GPs (TGA)

• With genome sequencing, some sick infants are getting a shot at healthy lives (STAT)
• Do You Need a Pap Smear to Get Birth Control? (NYTimes)