Recon: NHS to Cover Vertex CF Drug Orkambi; FDA Expands GSK’s Zejula for Advanced Cancers

• Amgen sets one lower list price for its cholesterol drug (Reuters) (Press)
• DEA unveils new rule on opioid manufacturers after criticism (The Hill)
• GSK gets FDA nod for wider use of ovarian cancer drug Zejula (Reuters)
• Pelosi's drug package slides to November (Politico)
• Several states wary of $48 billion opioid settlement proposal (Reuters)
• Teva’s proposed opioid settlement could cost drugmaker pennies on the dollar (Reuters)
• J&J slashes third-quarter profit by $3 billion over proposed opioid deal (Reuters)
• Baxter named in opioid complaint, reveals internal accounting probe (Reuters)
• New York, states reach $700 million settlement with Reckitt over opioid probes (Reuters)
• FDA says carcinogen not found in alternatives of Zantac and its generics (Reuters)

• AstraZeneca lifts sales outlook on further boost from new drugs (Financial Times) (PMLive)
• AstraZeneca dumps phase 3 renal cell carcinoma program (Fierce)
• Vertex’ Orkambi drug to be available in England after pricing deal (Reuters) (STAT) (The Guardian)
• Two of three polio viruses eradicated in 'historic' step: WHO (Reuters)
• UK Regulators Propose Blocking $1.2B Illumina, PacBio Deal (GenomeWeb) (CMA)
• Despite warnings, many U.K. clinical trial sponsors still fail to report their results (STAT)

• To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality — Not Just Medicine (FDA)
• Sprout’s Addyi Loses Blanket Alcohol Contraindication And REMS Distribution Restrictions (Pink Sheet-$)
• Public Funds Help Late-Stage Development of About 25% of New Drugs, Study Finds (Focus)
• Postcard From Germany: Moved For School, Stayed For Insulin (Time)
• United Therapeutics receives permit for cell therapy facility build-out at Mayo (Daily Record)
• From $0 to $12B in an instant. Here's why biopharma loves risky Alzheimer's studies (Endpoints)
• The Overdose Crisis Involves More Than Just Opioids (Pew)
• NIH launches new collaboration to develop gene-based cures for sickle cell disease and HIV on global scale (NIH)
• Discovered in the valley of the one-eyed lambs, a toxic weed fuels a cancer-drug gold rush — and a quandary (STAT)
• Acorda's Ron Cohen brings the ax back out as new drug sales only trickle in while cash cow is led to the slaughter (Endpoints)
• Clopidogrel Pharmacogenetics — Why the Wait? (NEJM)
• Vyleesi’s Approval Delayed By Blood Pressure Study Conducted During NDA Review (Pink Sheet-$)
• Allievex launches with Pappas cash and rare disease drug from BioMarin (Endpoints)
• AstraZeneca blood cancer drug heading for showdown with AbbVie's (BioPharmaDive)
• Kronos Bio nabs Gilead, Baylor College of Medicine researchers (Fierce)
• FDA Struggles To Foster An Affordable Biosimilar Insulin (Law360-$)
• Gene Therapy Manufacturing Hitch Solved, Bluebird Aims For European Debut In 2020 (Scrip-$)
• Chemical inhibitors make their RNA epigenetic mark (Nature)
• Rubius' roller coaster ride set to accelerate with first clinical results (BioPharmaDive)
• Germany’s Vivoryon raises €43m for Alzheimer’s drug trial (PMLive)
• UK team sheds light on how AnaptysBio’s anti- IL-33 eczema drug tamps down inflammation (Fierce)
• Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product (FDA)
• Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market (FDA)
• Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S. (FDA)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary (FDA)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data to Support Social and Behavioral Research as Used by the Food and Drug Administration (FDA)

• Provention Bio Announces PRV-031 (Teplizumab) Granted PRIME Designation by the European Medicines Agency (Press)
• AVROBIO Receives Orphan-Drug Designation from the U.S. FDA for AVR‑RD‑02 for the Treatment of Gaucher Disease (Press)
• FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy (Press)
• Mirati Therapeutics Announces Presentation Of Interim Phase 2 Sitravatinib Data In Urothelial Carcinoma And Oral Cavity Squamous Cell Carcinoma At The SITC 34th Annual Meeting (Press)
• Aerie Pharmaceuticals Completes Enrollment in the Phase 2 Trial of AR-1105 (Dexamethasone Intravitreal Implant) in Patients with Macular Edema Associated with Retinal Vein Occlusion Ahead of Schedule (Press)
• MaxCyte Advances Phase I Clinical Trial of Lead CARMA™ mRNA-based Cell Therapy to Third Cohort of Patients (Press)
• Actinium to Announce Interim Results from Pivotal Phase 3 SIERRA Trial on Conference Call Scheduled for Monday, October 28^th (Press)
• Asana BioSciences to Present Phase 1 Clinical Safety and Efficacy Data of Oral, Once-Weekly, ASN007, a Novel ERK 1/2 Inhibitor, at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference (Press)
• New Combined Data from the Phase 2 and Phase 3 Teprotumumab Clinical Trials to be Presented during the American Thyroid Association Annual Meeting (Press)
• Syros Announces New Data from Phase 2 Trial of SY-1425 in Combination with Azacitidine Demonstrating High Response Rates, Rapid Onset of Action and Favorable Tolerability Profile in RARA-Positive Newly Diagnosed Unfit AML Patients (Press)
• Brain Cancer Patients Display Appropriate Immune Responses and Decreasing Tumor Biomarkers in AIVITA Biomedical's Phase 2 Clinical Trial (Press)

• FDA Calls for New Warning on Breast Implants (Focus)
• FDA Modifies List of Standards for Premarket Device Reviews (Focus)
• Diagnostics specialists win the US device approval race (Evaluate)
• Blood test maker Guardant enters race for liquid biopsy with colon cancer study (STAT)
• New diagnostic tools are essential in the battle against antibiotic resistance (STAT)
• Brazil’s ANVISA proposes updates to medical device, IVD registration requirements (Emergo)
• European regulators update Q&A resource for Notified Body requirements ahead of MDR (Emergo)
• In brief: Medical device, IVD regulatory updates announced by Indian CDSCO (Emergo)
• FDA grants “Breakthrough Device Designation” to CorFlow Therapeutics to expedite clinical development and regulatory review of its CoFI™ (COF-fee) System (Press)
• U.S. FDA Clears GI Scientific’s ScopeSeal®, the Only Single-Use Disposable Device Indicated to Significantly Reduce Duodenoscope Contamination During ERCP Procedures (Press)

• 5 insights from a chat with Larry Merlo, CEO of CVS Health (HealthcareDive)
• Many High-Profile Hospitals Resist Suing Opioid Makers (NPR)
• Amazon acquires start-up Health Navigator, its first health-related purchase since PillPack (CNBC)
• USPTO Issues Proposed Rules on Burden of Proof for Motions to Amend in Post-Grant Proceedings (Patent Docs)
• When FDA and the Practice of (Tele)Medicine Collide (FDA Law Blog)
• Direct-Filed MDL Case On Thin Ice For Personal Jurisdiction (Drug & Device Law)

• FDA Advisory Committee Calendar
• Public Meeting on CDER Standard Core Sets Clinical Outcome Assessments and Endpoints Grant Program – 5 December 2019
• Pediatric Stakeholder Meeting; Public Meeting – 21 November 2019

• EU Regulatory Roundup: CHMP Questions Delay Novartis Gene Therapy Approval Timeline (Focus)
• EMA to Cease Printing and Dispatching of CPPs During Relocation to Permanent Building (Focus)
• Thumbs Up For EU Guidance On Advanced Therapy Trials (Pink Sheet-$)
• Single Annual EMA Fee Proposal Holds Most Promise For Pharma (Pink Sheet-$)
• European Commission Approves Opdivo (nivolumab) Four-Week Dosing Schedule for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection (Press)

• China Opens New Registration Regs For Comment, Industry Urged To 'Weigh In' (Pink Sheet-$)

• CDSCO releases Draft Medical Devices Amendment Rules for registration of medical devices (Pharmabiz)
• CDSCO urges pharma cos to submit stability studies as per New Drugs and Clinical Trials Rules (Pharmabiz)
• Alembic Pharma gets USFDA nod for Desonide Ointment (Economic Times)
• Cadila Healthcare gets USFDA nod for Haloperidol Decanoate injection (Economic Times)
• Aurobindo Pharma gets USFDA nod for its expectorant tablets (Economic Times)

• Therapeutic Goods (Foreign Countries and Foreign Jurisdictions) Determination 2019 (TGA)
• Submissions received: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems (TGA)
• Submissions received: Potential reclassification of active medical devices for diagnosis and patient therapy (TGA)
• Submissions received: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance (TGA)

• High blood pressure meds work better taken at bedtime (Reuters)
• Drinking with certain drugs tied to fall risk for seniors (Reuters)