Recon: FDA Rejects Sarepta’s Second Duchenne Treatment Citing Safety Concerns

• FDA declines to approve Sarepta's second Duchenne treatment (Reuters) (PMLive) (STAT 1, 2) (Endpoints) (Press)
• Teva to launch generic version of EpiPen for young children (Reuters) (MassDevice)
• Brand-name drug prices still rising - but at slower pace, lower amounts (NBC)
• Who is next in big pharma's merger spree? (Reuters)
• Nabriva gets first approval in novel antibiotic class (BioCentury) (Endpoints) (FDA)
• Nabriva prices two pneumonia antibiotic versions at over $200 per day (Reuters)
• Two Drugmakers Closing In on Opioid Settlements (WSJ)
• Drugmaker Endo to pay $10 million to settle opioid case ahead of trial (Reuters) (STAT) (Press)
• AIDS activists say Gilead put profits over patients — and misled Congress about an HIV pill (STAT)
• Top scientist categorically denies any wrongdoing in Novartis data manipulation scandal (STAT) (Endpoints)

• UK officials will stop attending most EU meetings from 1 September (GOV.UK)
• Graft Trail: Top Level Indian Regulatory Official Arrested (Pink Sheet-$) (Economic Times)
• AstraZeneca diabetes drug shows promise in heart failure (Reuters) (PMLive) (Endpoints) (Press)
• Bayer to sell animal health business to Elanco for $7.6bn (Financial Times) (WSJ) (Endpoints) (Press)
• WuXi builds revenues, capacity as competition boils among Asian CDMOs (Fierce)
• Will Pharma Firms Bear Cost Of UK Govt’s Latest No-Deal Brexit Supply Plans? (Pink Sheet-$)
• EC Adds IMQ as Fourth Notified Body Designated Under MDR (Focus)

• FDA decision on Vertex's CF triple will come just ahead of planned CEO shakeup (Endpoints)
• An MIT spinout kills one of its ‘living therapeutics’ after flunking an early-stage study — shares routed (Endpoints)
• FDA Warns Chinese OTC Drug Manufacturer for Falsifying Documents (Focus)
• FDA Warns Turkish Drugmaker Over Penicillin Cross-Contamination Issues (Focus)
• CDER Plots Pilot Project to Test CDISC Standard (Focus)
• USP Consults on Impurity Reporting Threshold Changes (Focus)
• Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal (Focus)
• FDA to hold Pediatric Advisory Committee meeting to discuss safety review of certain drugs in pediatric population (FDA)
• Fresh from $102M haul, IGM Bio pitches $100M IPO as it plots first-in-human trial of new antibodies (Endpoints)
• A drug maker replaces an old treatment and boosts the price by 1,300% (STAT)
• FDA should use its existing program to qualify new tools for drug safety testing (STAT)
• Restrictions On Abortion Medication Deserve A Second Look, Says A Former FDA Head (NPR)
• ‘Maisie’s Army’: How a grassroots group is mobilizing to help toddlers access a lifesaving drug (STAT)
• Pfizer's charity backs infectious disease projects (Fierce) (Press)
• Search for motor neurone disease cure gathers pace (Financial Times)
• Novartis Delayed Reveal Of Bad Data For $2.1 Million Gene Therapy. Now Patients And Pharma Suffer. (Forbes)
• Hikma picks up Insys naloxone spray, equipment in $12M bankruptcy buy (Fierce)
• Synlogic scraps ammonia-lowering drug after early phase fail (Fierce)
• FDA Warns Texas Compounder for Misbranded Drugs (FDANews-$)
• 4 Life Science Cos. Lead 5 IPO Filings Totaling $476M (Law360-$)
• Pharma-sponsored rare disease film festival doubles in size, readies for West Coast debut (Fierce)

• Moderna Receives FDA Fast Track Designation for Zika Vaccine mRNA-1893 (Press)
• BioInvent's Partner Oxurion NV has Reported Topline Month 3 Results of Phase lla Study Evaluating THR-317 (anti-PLGF), in Combination With Ranibizumab, for DME (Press)
• FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment (Press)
• Landos Biopharma Announces First Patient Dosed in Global Phase 2 Clinical Trial of BT-11 in Mild to Moderate Ulcerative Colitis (Press)
• Researchers to Present New Data on Appili Therapeutics Infectious Disease Programs at the 2019 Military Health System Research Symposium (Press)
• On Target Completes OTL38 Phase 2 Clinical Trial in Lung Cancer (Press)

• Medtronic Reports First Quarter Financial Results (Press)
• FDA OKs Adagio Medical’s cryoablation afib trial (MassDevice)
• AliveCor stops selling KardiaBand ECG for Apple Watch (MassDevice)
• Boston Scientific Announces FDA Approval Of ImageReady™ MRI For Vercise Gevia™ Deep Brain Stimulation System (Press)
• Adagio Medical Announces US FDA Investigational Device Exemption Approval With Conditions To Conduct A Clinical Study For Treatment Of Persistent Atrial Fibrillation Using The Ultra-Low Temperature Cryoablation System (Press)

• False claims suits pose new patent challenge pathway (Politico)
• Advances On the Biosimilar Litigation Battlefield (Pink Sheet-$)
• California man gets prison for smuggling erectile dysfunction drug (LA Times)
• Cures 2.0: Can Congress Recapture The Legislative Magic? (Pink Sheet-$)
• First Warning Letter for Failure to Develop Foreign Supplier Verification Program (FDA Law Blog)
• Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc. (Fed. Cir. 2019) (Patent Docs)
• Tenth Circuit Finally Shuts the Door Completely on Cerevny (Drug & Device Law)
• ConforMIS sues Zimmer Biomet for alleged patent infringement (MassDevice)
• IQVIA Says 'Duplicative' Antitrust Claims Belong In NJ (Law360-$)
• California Rests Case In Ethicon Mesh False-Marketing Trial (Law360-$)

• FDA Advisory Committee Calendar

• Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines (EMA)
• Drop in prescriptions for antibiotic leads to fewer cases of superbug in Wales (Pharmafile)

• Patient centric: Slogan or strategy in Japan? (PharmaLetter-$)
• Asia Regulatory Roundup: India to Add EU to List of Regions Covered by Clinical Trial Waiver (Focus)

• Dr Reddy's launches generic oral anti-epileptic drug in US (Economic Times)
• Experts urge PvPI to support ICMR institutions for pharmacovigilance research (Pharmabiz)
• CDSCO to recommend for amendment of DMROA Act to enable SLAs to crack whip on manufacturers for misleading advertisements (Pharmabiz)