Recon: Gilead, Galapagos Report Positive Phase III Results for RA Drug Filgotinib

• Americans are hoping Amazon can save them from sky-high drug prices (Quartz)
• Gilead, Galapagos report competitive numbers for first big PhIII readout for filgotinib in RA (Endpoints) (Fierce) (Press)
• Galapagos shares soar on $4-6 billion hopes for new drug (Reuters)
• Gilead partners with gene-editing upstart Precision Bio in hunt to cure hep B (Endpoints) (Press)
• General Atlantic Takes Majority Stake in OneOncology, a Startup for Running Cancer-Doctor Practices (WSJ)
• Takeda shuttering Chicago complex with 1,000 staffers in lead-up to Shire merger (Endpoints) (BioCentury)
• Pfizer suspending operations at US injectables plant as hurricane approaches (Fierce)
• Bristol-Myers plaque psoriasis drug shows promise in mid-stage trial (Reuters) (Endpoints) (Press) (NEJM)
• The cost of drug monopolies in the United States (Harvard Bill of Health)
• Teva to hold Indivior generic drug launch pending US ruling (Reuters)
• Opinion: Are We Being Misled About Precision Medicine? (NYTimes)
• The CRISPR patent decision didn’t get the science right. That doesn’t mean it was wrong (STAT)

• Bayer adds label warning after death linked to stomach relief drops (Reuters)
• Price Tussle Starts Over $371,000 Breakthrough Cancer Drug (Bloomberg)
• Cancer drugs: Greater access for patients in Northern Ireland (BBC) (ABPI)
• Civil society groups call for end to Gilead’s unwarranted hepatitis C drug monopoly in Europe (MSF)
• Zimbabwe police ban public gatherings in capital to contain cholera outbreak (Reuters)
• NPA asked to lobby wholesalers to limit generic price rises (Pharmaceutical Journal)
• Over-65s to be given more effective flu vaccine (The Guardian)
• Shire’s Veyvondi approved in Europe for bleeding disorder (PharmaTimes)
• New French Pharma Industry Head Faces Tough Challenges On Drug Spending (Pink Sheet-$)
• Dealing With Powerful ‘Vaders’ A Lingering Challenge For Japan’s AMED (Pink Sheet-$)
• Roche Wants More Flexibility For UK’s NICE To Consider Indication-Based Pricing (Pink Sheet-$)
• Brazil’s ANVISA Opens Consultation on Medical Devices (ANVISA)
• NICE nixes Opdivo as postsurgery melanoma therapy but leaves door open (Fierce)
• Protesters in Manchester call on NICE to approve Biogen's $750,000 drug Spinraza (Pharmafile)
• Transparency, IP Issues Dominate Discussion On WHO's Roadmap To Improve Drug Access (Pink Sheet-$)
• ‘Regulatory Reliance’ Projects Bearing Fruit In Caribbean & Africa (Pink Sheet-$)
• Defining orphan conditions in the context of the European orphan regulation: challenges and evolution (Nature)

• The Curious Case Of Gleevec Pricing (Forbes)
• Vital Therapies shares dive as liver system fails trial (Reuters)
• Gene therapy for neurological disorders: progress and prospects (Nature)
• Startup Uses ‘Mini Brains’ and Software to Power Drug Research (WSJ)
• Siga lands $629m BARDA contract to stockpile smallpox treatment (Drug Delivery)
• Vivo Capital bags $635M for its new biotech public company fund (Endpoints)
• Biosimilars: Is Small Dip in Development Indicative Of Sustained Downward Trend? (Pink Sheet-$)
• ASCO Fears CMS Proposals 'Endanger' Access To Cancer Care (BioCentury)
• Former Gilead CMO Cheng joins Akero as CEO, as company moves HQ (Fierce)
• Crescendo names ex-Roche leader Pisa as CMO (Fierce)
• Simulations Plus Receives New Grant Award from the FDA (Press)
• Could US Solve Drug Shortages With 'Heightened' M&A Scrutiny? (Pink Sheet-$)
• Startup Spotlight: Pfizer taps two neuroscience startups for incubator prize (STAT)
• With Clear Regulatory Path, Endocyte Raises $175M (BioCentury)
• Study shows it takes longer to develop and approve CNS drugs than non-CNS products (PharmaLetter-$)
• Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom (FDA)
• Mike Narachi gets a $19M shot at a new approach to gene therapy — and he has another big market in mind (Endpoints)
• Atreca banks a $125M mega-round as it builds a pipeline of antibodies for cancer and ponders IPO timing (Endpoints) (Fierce)
• Seqirus receives FDA approval on cell-based flu vaccine manufacturing process (BioPharmaReporter)
• Xenon frees itself of some XEN1101 milestone obligations (Fierce)
• OncoResponse raises $40M for cancer patient-sourced antibodies (Fierce)
• Reviews: Qualification of Biomarker: clusterin (CLU), Cystatin-C (CysC), Kidney Injury Molecule-1 (KIM-1), N-acetyl-beta-D-glucosaminidase (NAG), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and osteopontin (OPN) (FDA)
• The Devil is in the Details:  Requirements for State Boards of Pharmacy under the Draft Standard MOU Regarding 503A Compounding and Intrastate and Interstate Distribution (Lachman Consultants)

• Foamix acne drug meets main goals in late-stage trial, shares surge (Reuters)
• Biosimilar Cyltezo® demonstrates clinical equivalence to Humira® in patients with moderate-to-severe plaque psoriasis (Press)
• J&J raises a flag in early-stage lung cancer with first-ever contest in the field (Fierce)
• Vital Therapies eviscerated as PhIII disaster forces it to discard sole asset (Endpoints)
• FDA awards another non-opioid pain drug breakthrough status (PMLive)
• FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Monotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Patients Whose Tumors Express PD-L1 (TPS ≥1%) (Press)
• FDA to review supplemental Biologics License Application for Praluent® (alirocumab) Injection as potential treatment to reduce major adverse cardiovascular events (Press)
• Virpax Pharmaceuticals Reports Pre-IND Guidance From FDA for DSF100 (Press)

• Stryker Goes after Another from Most Attractive M&A List (MDDI)
• Boston Scientific touts Acurate Neo2 CE Mark study (MassDevice)
• Modernizing the Medtech Supply Chain (MDDI)
• Poll: Is the FDA Pre-Cert program an effective way to regulate digital health products? (mobihealthnews)

• What ACOs say: We are saving Medicare money (Politico)
• Better Data And Better Outcomes: Reducing Maternal Mortality In The US (House E&C)
• E&C to Markup Bills to Improve Patient Care, Reduce Health Care Fraud, & Modernize the Strategic Petroleum Reserve (House E&C)
• Updated Part B Data: Hospitals Are Displacing Physician Offices Even Faster Than We Thought (Drug Channels)
• FDA Hiring Needs Impacted by Narrow Hiring Protocols: Report (BioSpace)
• AbbVie strikes tentative deal to settle 4,000-plus AndroGel lawsuits (Fierce)
• Many 'Recovery Houses' Won't Let Residents Use Medicine To Quit Opioids (NPR)
• What’s in Your Wallet? Less Money With an Increased GDUFA ANDA Holder Program Fee . . . But Consider an Alternative (FDA Law Blog)
• IVC Filters MDL Court Permits Defendants to Use IFU and Medical Guidelines Against Design Defect Claims (Drug & Device Law)
• Low Health Literacy Costs US Employers $5 Billion A Year (Forbes)
• House Subcommittee Votes To Give Medpac Access To Drug Rebate Data (BioCentury)
• Bristol-Myers Looks To Ax Investor Suit Over Clinical Trial (Law360-$)

• FDA Advisory Committee Calendar
• Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting – 22 October 2018
• EMA Risk assessment guideline focus group meeting – 19 September 2018

• CEO of New UK Cell And Gene Therapy Hub Says 'All Systems Are Go' (SCRIP-$)
• Britain reports two separate cases of rare monkeypox infection (Reuters)
• Gilead optimistic about Yescarta deal in UK (PMLive)
• MHRA permits cell/gene therapy production at CGT Catapult site (PharmaTimes)

• Immunomedics and Samsung BioLogics Announce Strategic Manufacturing Partnership (Press)

• AiMeD urges govt to push domestic medtech industry to avoid costly imports (PharmaBiz)
• Health ministry to ban 328 combination medicines over safety concerns (Economic Times)
• J&J case: Government asks 'victims' to approach central or state panel (Economic Times)

• Update on the Compliance Verification (CV) GMP clearance applications backlog (TGA)
• Submissions received and next steps: Prescription strong (Schedule 8) opioid use and misuse in Australia - options for a regulatory response (TGA)

• Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers (Emergo)

• Biologists checked out this NBA player’s DNA for clues to his immense height (MIT Technology Review)