Recon: FDA Approves Dompé Drug Oxervate for Neurotrophic Keratitis

• Medicare struggles to even set the agenda as it weighs how to pay for CAR-T therapies (STAT)
• With Allergan’s rival on the regulatory ropes, AbbVie posts more promising late-stage data for elagolix (Endpoints)
• Sierra Oncology Acquires Gilead’s Stalled Myelofibrosis Drug (Xconomy) (Fierce)
• FDA approves first drug for neurotrophic keratitis, a rare eye disease (FDA) (Press)
• It's Official, The Transhuman Era Has Begun (Forbes)
• Snaring Doctors and Drug Dealers, Justice Dept. Intensifies Opioid Fight (NYTimes) (VOA)
• Operation Darkness Falls Results in Arrest of One of the Most Prolific Dark Net Fentanyl Vendors in the World (DoJ)
• Justice Department Takes First-of-its-Kind-Legal Action to Reduce Opioid Over-Prescription (DoJ)
• Two Chinese Nationals Charged with Operating Global Opioid and Drug Manufacturing Conspiracy Resulting in Deaths (DoJ) (Sessions Statement)
• AbbVie's Trump tax rate cut—biggest in pharma—yields another $100M donation (Fierce)

• Novartis trial win lifts profile of new breast cancer drug (Reuters) (Endpoints) (Pharmafile)
• Toxin at heart of drug recall shows holes in medical safety net (Reuters)
• AstraZeneca inhaler lags GSK drug in lung disease trial (Reuters)
• European Medicines Agency closed 27 August 2018 (EMA)
• Pharma sector warns Saudis on German drug curbs (Reuters)
• France To Speed Up Patient Access To Unapproved Drugs (Pink Sheet-$)
• China's Jilin province govt. removed its food and drug safety head: Xinhua (Reuters)
• Newborn biobetter, biosimilar maker Mabpharm pitches the latest biotech IPO in Hong Kong (Endpoints)
• Novo Nordisk and Evotec ink drug development deal (PMLive) (Fierce)
• India’s bid to create essential diagnostics list gains momentum as experts reach consensus on test catalogue (PharmaBiz)
• Lupin enters prescription dermatology segment in Brazil (Economic Times)
• China Approves Hengrui Breast Cancer Drug on Phase II Data (BioCentury)
• China's GL Capital Claims 5% Stake In UK's Oxford Biodynamics (BioCentury)

• Has Drug Development for Rare Diseases Reached an Extreme? (Medpage)
• Bluebird taps Gritstone for oncology cell therapy targets (Fierce)
• Former FDA Official Calls For 483 Reforms, Notes Caveats (Pink Sheet-$)
• Researchers hail “exciting results” in ovarian, lung cancer trial (PharmaTimes)
• The Desperate Quest for Genomic Compression Algorithms (IEEE Specgtrum)
• Faster Cures Launches Patient-Focused Drug Development Meeting Tracker (Faster Cures)
• “One Continuous Trial” In Oncology: US FDA Offers Guidance And Encouragement (Pink Sheet-$)
• FDA promotion police advance with DTC risk info, disclosure studies (Fierce)
• 2 proteins show promise as targets for treating obesity (Fierce)
• Korean biotech buys GMP-ready production facility in California (Fierce)
• Q&A: Merck KGaA Global Head Of Medical Affairs On Pipeline Persistence (SCRIP-$)
• Standardised mAb production research provides ‘benchmark’ for biosimilars (BioPharmaReporter)
• ‘Microdosing’ is touted by ’shroomers and Reddit users. Science is starting to test their claims — and finding some truth (STAT)
• Magic mushrooms might treat depression? Peter Thiel-backed Compass gets FDA OK to launch Phase IIb trials (Endpoints)
• Boehringer Ingelheim CDMO providing CMC services for Ph Ib/III trial of cancer antibody (Outsourcing Pharma)
• 2017 Perceptions and Insights of Clinical Research: An Excerpt (Part 2) (Lilly)
• Otsuka taps TrialAssure for clinical trial pipeline disclosure reporting system (Outsourcing Pharma)

• U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma (Press)
• Preliminary Results From BioCardia's Phase III Pivotal CardiAMP Heart Failure Trial Reported In Circulation Research Journal (Press)
• Pfizer and Astellas Amend Clinical Research Protocols for Two Phase 3 Trials of Enzalutamide in Patients with Hormone-Sensitive Prostate Cancer (Press)

• Meet The Award-Winning Medical Device Inspired By E-Cigarettes (Forbes)
• This Woman Is One Of The Last People In The US Who Uses An Iron Lung To Survive (BuzzFeed)
• Medtronic CEO: Our Pipeline Has Never Been Stronger (MDDI)
• Intel, Philips tout speed gains in AI-powered healthcare algorithms (MassDevice)
• FDA grants expanded clearance for MagVenture’s depression-treating TMS system (MassDevice)
• Feds give CytoSorbents’ blood filter a shot at $3 million (Medical Design & Outsourcing)
• Philips launches Epiq CVx cardiovsacular ultrasound system (MassDevice)
• FDA clears Gynesonics’ sonography-guided transcervical fibroid ablation system (Medical Design & Outsourcing)
• Which of These Medtech Companies Are on the Prowl for M&A? (MDDI)
• Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee (Federal Register)

• Gleevec antitrust suits against Novartis, after failing initially, fall short again in appeals (Fierce)
• Schumer convinced Kavanaugh would axe Roe vs. Wade (Politico)
• The Man Who Used To Run Medicaid Has A New Idea To Make It Better (Forbes)
• Nebraska obtained lethal injection from unauthorised source, says Fresenius Group (InPharmaTechnologist)
• Reed Smith Atty's Widow Loses $3M GSK Verdict On Appeal (Law360-$)
• Orexigen Says McKesson Can’t Nab $7M In Debt Setoff Fight (Law360-$)
• CBS Opioid Segments Didn't Defame Pharmacist, Judge Rules (Law360-$)
• Pfizer Chips Away At State Claims In Lipitor Antitrust MDL (Law360-$)
• Opioid Cos. Slammed With More Suits Over High Health Costs (Law360-$)
• PTAB Wrongly Axed Part Of Invisalign Patent, Fed. Circ. Says (Law360-$)

• FDA Advisory Committee Calendar

• MDR Analysis: Does your medical device fall under the scope of new European regulations? (Emergo)
• Industry Worried Over EMA's Approach To Obesity In Drug Development (Pink Sheet-$)
• GE Healthcare set to open biotech hub in Uppsala, Sweden (Pharmafile)
• NICE clears use of steam therapy for benign enlarged prostate (PharmaTimes)
• NICE’s Rejection Of Takeda’s Alofisel “Unsurprising,” Says Analyst (SCRIP-$)

• Dr Reddy's Labs gets EIR from USFDA for Srikakulam unit (Economic Times)
• Lupin gets tentative FDA green light for generic Natazia tablets (Drug Store News)

• GMP clearance - Extension application processing timeframes (TGA)
• Final decisions amending, or not amending, the current Poisons Standard, August 2018 (TGA)
• TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018 (TGA)
• An Australian Startup's Unique Approach to Imaging Lung Function (MDDI)

• A Black Eye For Blue Shield: Consumers Lash Out Over Coverage Lapses (KHN)