Recon: Court let Merck Hide Propecia Data; Sanofi to Pay Lexicon $260M to end Partnership

• Court let Merck hide secrets about a popular drug’s risks (Reuters)
• Why Aren’t There Better Cancer Drugs? Scientists May Have Picked the Wrong Targets (NYTimes) (STAT) (Science) (Study)
• ICER dings Novo's new oral diabetes drug (BioPharmaDive)
• Purdue Close to Settlement with Cities and Half of States Over Opioid Crisis (WSJ) (Reuters) (CNBC)
• Merck KGaA touts FDA 'breakthrough' status, blockbuster potential in bid to woo investors (Endpoints) (Reuters)
• FDA is inspecting more foreign plants, but fewer domestic facilities (STAT)
• No surprises in FDA staff review for Aimmune peanut allergy therapy (Endpoints) (FDA)
• Trump Plans to Ban Most Vaping Flavors (WSJ) (CNBC) (Politico)
• Apple will oversee new studies focusing on women’s health, hearing and mobility (CNBC) (NIH)
• Scientists rethink Alzheimer’s, diversifying the drug search (AP)
• Medicaid’s Dark Secret (The Atlantic)

• £200m largest ever genetics project launched to combat deadly diseases (Pharmafile) (UK Biobank)
• Sanofi to pay Lexicon $260 million for terminated partnership (Reuters) (Endpoints)
• After plenty of due diligence, GSK buys one biotech pup in the ‘$500M’ Avalon litter for its pipeline (Endpoints) (Pharmafile) (Press)
• Italian gene therapy player draws new investor from China for its answer to CAR-T relapses (Endpoints)
• How about a $477M biotech IPO amid Hong Kong protests? Henlius will find out (Endpoints)
• Hong Kong strife holds up almost $100M of BioNTech's Series B haul (Endpoints)
• Woodford fallout to blame for shrinking biotech valuations, co-investor says (Endpoints)
• Novartis Inhaler is First Device to be Certified Under MDR (Focus)
• EC Explains New MDR, IVDR Rules for Designating Expert Device Panels (Focus)

• When are RCTs Required for Breakthrough Drugs, HDEs? JAMA Study Investigates (Focus)
• BIO’s new board chair on the industry’s bad reputation: ‘That’s ridiculous’ (STAT)
• Pfizer hires ex-FDA, MD Anderson researcher as clinical oncology lead (Fierce)
• Changing of the guard at Swiss biotech Vifor; nabs Sanofi exec as new CMO (Fierce)
• GAO Reports on FDA, Drugmaker Efforts to Boost Access to Investigational Drugs (Focus)
• Investors lost big as Alzheimer’s R&D went over the cliff in 2019. Will they ever come back? (Endpoints)
• Penn team repurposes CAR-T cancer tech to treat heart disease (Fierce)
• BioMarin talks down worries on gene therapy data differences (BioPharmaDive)
• Most kids can manage pain after surgery without opioids (Reuters)
• HPV vaccine offers some protection to men who aren't vaccinated, study finds (NBC)
• Acadia calls early halt to Nuplazid psychosis trial after promising interim results (Fierce)
• AI is changing the face of healthcare (Novartis)
• FDA's Biosimilars Meeting Management Should Improve After Reorg In New Drug Office (Pink Sheet-$)
• Gilead, Elton John AIDS Foundation launch HIV initiative (PharmaTimes)
• Xeris scores first FDA nod with shelf-stable glucagon injector, syringe (Fierce)
• Promising autoimmune biotech bought out as celiac drug heads for the clinic with a fresh infusion of cash (Endpoints)
• Two commonly used uveitis drugs perform similarly in NIH-funded clinical trial (NIH)

• Merck takes evobrutinib for MS into phase 3, on mixed data (PMLive)
• FDA Confirms Omeros’ Schedule for Rolling Review of the Company’s BLA for Narsoplimab in the Treatment of HSCT-TMA (Press)
• Puma Biotechnology Announces U.S. FDA Acceptance of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer (Press)
• United Therapeutics Announces FDA Acceptance Of Trevyent New Drug Application For Review (Press)
• Disarm Therapeutics Presents Data at ECTRIMS 2019 Supporting SARM1 as a Novel Therapeutic Target for Multiple Sclerosis (Press)
• Nevakar Completes Enrollment for its Phase III CHAMP Study of NVK-002 (Press)
• FORMA Therapeutics Announces Data for IDH1m Inhibitor Olutasidenib in Glioma to Be Presented at the 2019 Society for NeuroOncology Annual Meeting (Press)

• CDRH Committee Discusses Challenges in Communicating Cybersecurity Concerns (Focus)
• Checkpoint Surgical Receives FDA Breakthrough Designation for Nerve Regeneration Device (Press)
• Scratching the surface: Medical device companies’ evolving efforts to tackle cybersecurity (Emergo)
• European MDR covers cosmetic and aesthetic products: Are these firms ready? (Emergo)
• PerkinElmer prices $850m offering (MassDevice)
• iRhythm closes $115m offering (MassDevice)
• Medtronic letter reveals Micra pacemaker deployment troubles (MassDevice)
• Functional Neuromodulation launches Alzheimer’s DBS trial (MassDevice)

• Not so fast: CDC isn't ready to blame illicit 'street vapes' for illnesses (Reuters)
• FDA Bulk Drug List Updates Could Lead To Litigation (Law360-$)
• FDA Giveth and Taketh Away as It Publishes Its Second Proposed Rule Concerning the Section 503A Bulk Substances List (FDA Law Blog)
• It just got very hard for Amazon’s online pharmacy to access patient medication data (CNBC)
• Google, Mayo Clinic strike sweeping partnership on patient data (STAT)
• PML Valsartan Order (Drug & Device Law)
• Dr. Reddy's, Hospira Want Full Fed. Circ. To Redo Lilly IP Win (Law360-$)
• Stem Cell Biz Facing Fraud Claims Declares Bankruptcy (Law360-$)

• FDA Advisory Committee Calendar

• EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante (Focus)
• Payment For Outcomes Key To EU Market Access for Yescarta (Pink Sheet-$)
• Infographic: Europe’s potential for biotech innovation (McKinsey)
• Dutch Court Clears Doctor in Euthanasia of Dementia Patient (NYTimes)

• DCGI approves manufacturing of new drugs at manufacturers’ multiple facilities (Pharmabiz)
• DoP bans single-use plastic products in pharma trade, law to come into force from September 11 (Pharmabiz)

• Teva’s biosimilar Herzuma cleared in Canada (PharmaLetter-$)

• In Congo, Ebola Is Just One More Thing To Worry About (NPR)

• Teens with illnesses want role in decision-making (Reuters)
• Patients at for-profit dialysis centers less likely to get kidney transplants (Reuters)
• Scientists Create A Device That Can Mass-Produce 'Synthetic' Human Embryos (NPR)