Recon: Philips Under Investigation for Graft in Brazil; Pfizer Invests $500M in NC Gene Therapy Facility

• Pfizer invests $500 million in expanding gene therapy facility (Reuters) (Endpoints) (Press)
• FDA on Novartis data manipulation controversy: ‘We happened to be lucky’ (STAT)
• Apple health team faces departures as tensions rise over differing visions for the future (CNBC)
• Exclusive: Federal scientists urged public warning on opioids in 2006 (Politico)
• US imposes sanctions on three Chinese accused of fentanyl trafficking (Reuters) (White House)
• Drugmakers Endo, Allergan agree to $15 million in settlements in major opioid case (Reuters)
• Expert panel updates advice on BRCA cancer gene screening (Reuters)
• HHS to provide $23 million to Merck for Ebola vaccine production (Reuters)
• When a $2.1 Million Drug Could Cure Your Child’s Fatal Disease (Bloomberg)

• Philips, under investigation in US and Brazil, fired whistleblower who warned of graft (Reuters)
• AstraZeneca Imfinzi combination fails advanced lung cancer study (Reuters) (Endpoints)
• GSK files anaemia drug daprodustat in Japan, its first market (PMLive) (Fierce) (Press)
• Nigeria's three-year milestone takes Africa towards polio eradication (Reuters) (WHO)
• Prices Go Up for 37% of Drugs, Down or Intact for 63% in Tax Hike Re-Pricing (PharmaJapan)
• Richter launches Forsteo biosimilar in EU (PharmaTimes)
• NICE’s fast-track catapults Skyrizi into market (PMLive)
• NHS England to fund Hemlibra for patients with severe haemophilia (Pharmafile)
• UK Govt Asks: Are Trial Sponsors Ready For No-Deal Brexit? (Pink Sheet-$)
• Call for applications for the third EDL (WHO)

• The cost of diabetes drugs is causing more Americans to skip their meds (STAT)
• Has the FDA been approving some drugs without proper evidence? (MedCity)
• FDA Warns Chinese OTC Drug Manufacturer for Falsifying Documents (Focus)
• FDA Updates COA Compendium for First Time Since 2016 (Focus)
• NIH Awards Color $4.6 Million As Genetic Counselor Provider for 1 Million Person Study (Forbes) (NIH)
• NIH will soon share genetic data with those who participated in precision medicine study (STAT)
• CD24 — a novel ‘don’t eat me’ signal (Nature)
• Futility analysis augurs defeat in pivotal trial testing of NuCana's lead drug in metastatic pancreatic cancer (Endpoints)
• What's the definition of insanity? Dr. Reddy's knocked by the FDA for the fifth time this year (Fierce)
• Video: Putting the AI in R&D — with Badhri Srinivasan, Tony Wood, Rosana Kapeller, Hugo Ceulemans, Saurabh Saha and Shoibal Datta (Endpoints)
• Oncorus Adds $79.5M to Steer Cancer-Fighting Virus to Human Testing (Xconomy) (Endpoints)
• Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing; Correction (FDA)

• MDMA, now in Phase III, shows promise as a PTSD treatment (Endpoints)
• Priority review for Vertex's CF triple combo (BioCentury)
• Aimmune Enrolls First Patient in Phase 2 Trial of AR201 for Egg Allergy (Press)
• BioInvent Will Conduct Phase l/lla Trial With BI-1206 in Combination With Pembrolizumab (Keytruda) in Solid Tumors (Press)
• Cassiopea Announces FDA Submission of New Drug Application for Clascoterone Cream 1%, the First New Mechanism of Action for Acne in Nearly 40 Years (Press)
• ChemomAb Ltd., Announces Data from Phase 1 Study of CM-101 Subcutaneous Formulation Demonstrating Comparable Exposure to The Intravenous CM-101 Formulation (Press)
• Cidara Therapeutics to Present Data from its Cloudbreak Antiviral Program at the Options X for the Control of Influenza Conference (Press)

• Study: No difference between Biotronik, Medtronic or Boston Scientific stents (MassDevice)
• Alcon slides on Q2 earnings miss (MassDevice)
• FDA warns Innovative Sterilization Technologies on marketing language (MassDevice)
• The convergence of medical device cybersecurity requirements in Australia, Canada and the USA (Emergo)

• SEC Charges TherapeuticsMD for Selectively Disclosing Info From FDA Meeting (Focus)
• FDA Wins Court Case to Not Put Vasopressin on Compounding List (Focus)
• Appealing court ruling, Trump administration renews fight to require drug prices in TV ads (STAT)
• FTC Refunds Consumers Who Bought Deceptively Marketed and Advertised “Nobetes” Diabetes Treatment Supplement (FTC)
• Trump is trying to end secret health care price negotiations. You should be on his side (STAT)
• Fed. Circ.'s Arduous Legal Landscape For Diagnostic Patents (Law360-$)
• Endo, Perrigo Strike Deal In Nasal Spray Patent Suit (Law360-$)
• Pfizer Says It Shouldn't Be Included In EpiPen Class Cert. Bid (Law360-$)
• Appeals court upholds Medtronic win in wrongful termination suit (MassDevice)
• Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2019) (Patent Docs)
• Hip Hip Hurray for D.Utah Rulings in Hip Implant Case (Drug & Device Law)
• “Wine-ing” about FDA Involvement in Regulating Alcohol Labels (FDA Law Blog)
• Cardinal Health warns ongoing opioid-related lawsuits to hit business (Reuters)

• FDA Advisory Committee Calendar
• Joint Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee; Notice of Meeting – 27 September 2019
• Psychopharmacologic Drugs Advisory Committee Meeting - Cancellation

• MHRA to Land a New Interim Chief Executive Ahead of Brexit (Focus)
• EMA Offers Q&A on Exemptions From Batch Re-Testing for Imported ATMPs (Focus)
• Chancellor accelerates Brexit preparations for businesses (GOV.UK)
• Big Pharma Nibbles As Turkey’s Localization Policy Yields Limited Results (Scrip-$)

• China releases preliminary reimbursement list (BioCentury)
• Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications (HK Department of Health)

• Temasek, TrueNorth-CPPIB seek to invest in Biocon Biologics (Economic Times)
• Pharma trade to save Rs. 500 crore with govt waiver on 12% GST for expired products (Pharmabiz)

• Canadian Drug Pricing Reforms Could Lead To Medicine Shortages (Pink Sheet-$)

• Brazil Introduces New Measures To Tackle ‘Judicialization’ Of Access To Medicines (Pink Sheet-$)

• Factbox: 10 facts on how mosquitoes pose a threat to half the world (Reuters)