Recon: FDA Sends CRLs for Allergan's Uterine Fibroid Drug Esmya and Mallinckrodt's Newborn Hemolysis Drug Stannsoporfin

• FDA rejects Allergan's Esmya fibroid treatment (Reuters) (Endpoints) (BioCentury) (Press)
• Mallinckrodt Confirms Receipt of Stannsoporfin Complete Response Letter (Press)
• At Silicon Valley’s debutante ball for startups, there’s more biology than ever (STAT)
• Hundreds of chimps at the NIH await retirement. This senator wants to help (STAT)
• Trump administration can’t decide whether PBMs are the enemy — or part of the solution (STAT)
• How a Rapid and Well-Messaged US FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts (Pink Sheet-$)
• Medtronic’s Q1 tops The Street (MassDevice) (Press)
• Brand-name combo pills may cost more than getting drugs separately (Reuters) (JAMA)
• Prescription Pharmaceutical Price Changes since the Release of the President’s Drug Pricing Blueprint (HHS)
• Cervical cancer screening without Pap test OK for some women (Reuters) (NPR)
• Small effects from millions of genes may add up to new risk-screening tool (Reuters)
• Religious Conservatives’ Ties To Trump Officials Pay Off In AIDS Policies, Funding (KHN)
• Exact Sciences signs marketing deal with Pfizer for cancer test (Reuters) (Press)
• FDA Oversight: Leveraging Cutting-Edge Science and Protecting Public Health (Senate HELP Hearing)

• AbbVie doubles down on cancer project with EU-based biotech group Argenx (Reuters) (Endpoints)
• How 500,000 Britons are key to global assessment of disease risk (Financial Times)
• Brexit Health Alliance calls for effective planning for no-deal Brexit (Pharmafile)
• China’s first cancer immunotherapy will be priced at about half of what it costs in the U.S. (STAT)
• Congo approves more experimental Ebola treatments as cases rise (Reuters)
• Japan’s 1st Herceptin Biosimilar Now Available, but Use Limited to Gastric Cancer (PharmaJapan)
• GSK seeks mid-Sept bids for $4 billion Indian Horlicks unit: sources (Reuters)
• Focus on 20 key brands to drive growth: GlaxoSmithKline pharmaceuticals (Economic Times) (Fierce)
• Global CRO market to grow to $57 billion by 2024, report forecasts (MedCity)
• UK's NHS struggling with security after WannaCry, losing 10K patient records last year (HealthcareITNews)
• Phase III of Pre-Market Transparency Initiatives for Prescription Drugs (Health Canada)

• Mid-Year Check on the Pace of New Drug Approvals at FDA (Eye on FDA)
• A knockdown-and-replace gene therapy from Penn researchers shows promise in rare eye disease (Endpoints)
• Subsys Makes A Bad Impression On FDA REMS Panel Members (Pink Sheet-$)
• Poll: Most Americans Know About Opioid Antidote And Are Willing To Use It (NPR)
• GE Healthcare opens bioprocessing ‘test bed’ for biotechs (BioPharmaReporter)
• Achillion lures Zelenkofske from uniQure to fill CMO seat (Fierce)
• Shrink the patient group, boost the efficacy: Tonix says a retro look shows promise in select PTSD group (Endpoints) (Fierce)
• No Ovarian Failure Risk After HPV Vaccine, Study Finds (Forbes)
• Sensei brings on new CMO as it eyes phase 2 immuno-oncology trial (Fierce)

• Alnylam Completes Enrollment in ENVISION Phase 3 Study of Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyrias (AHPs) (Press)
• Imago BioSciences Completes Enrollment in Phase 1/2a Study of IMG-7289 in Acute Myeloid Leukemia and Myelodysplastic Syndrome (Press)
• Allegro Ophthalmics, prepping for phase 3, promotes CMO to CEO (Fierce) (Press)
• Vectura to advance asthma inhaler after phase 2 studies show ease of use by young children (Fierce)

• FDA Medical Device Safety Action Plan: Good or Bad for Medtech? (MDDI)
• Alpha Tau wins approval to test cancer-targeting device in the U.S. (MassDevice)
• FDA clears UVision360 hysteroscopy device (MassDevice)
• Gynesonics Receives FDA Clearance to Market Sonata® System (Press)
• Agilent Companion Diagnostic Gains Expanded FDA Approval in Urothelial Carcinoma (Press)
• Inbound Google Fit redesign brings daily heart health to the forefront (mobihealthnews)
• Class 1 Device Recall TriFlo''" Subglottic Suction System (FDA)

• EpiPen partners Mylan, Pfizer have to fight class action over 'egregious' antitrust claims (Fierce)
• Smith & Nephew escapes False Claims suit alleging gov’t hospital overcharging (MassDevice)
• Taking Out the Laundry With TwIqbal (Drug & Device Law)
• FTC Pushes For Separate Trial In AndroGel Antitrust Suit (Law360-$)
• Feds Ordered To Hand Over Insys Docs From 10 Agencies (Law360-$)
• St. Regis Mohawk Tribe Petitions Federal Circuit for En Banc Review of Panel Decision Voiding Sovereign Immunity in Inter Partes Review (Patent Docs)
• Third Circuit Affirms False Claims Act Dismissal Based on Reasonable Interpretation (FDA Law Blog)
• FDA Focus: What Mayer Brown's Practice Chair Is Watching (Law360-$)
• Internal Docs Led To Couple’s $117M Win In J&J Talc Case (Law360-$)
• HHS reassigns CIO Beth Killoran in latest staffing shake-up (HealthcareITNews)

• FDA Advisory Committee Calendar

• 2015 vs 2018 – MHRA Data Integrity Guidance (FDAZilla)

• India to use ‘India-Japan Medical Products Regulatory symposium’ to explore opportunity for exports into Japan (PharmaBiz)
• India may find it tough to introduce bedaquiline-based therapy for MDR-TB despite new WHO guidelines (PharmaBiz)

• Tracking Cancer and Ancestry, With Mysteries in Each (NYTimes)
• Consumer baby monitors may get vital signs wrong (Reuters)