Recon: FDA Approves Pfizer’s Talazoparib; Humira Biosimilars Launch in Europe

• FDA approves Pfizer’s talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer (FDA)
• Drugmakers Funnel Millions To Lawmakers; A Few Dozen Get $100,000-Plus (KHN)
• Trump Rule Would Compel Drug Makers to Disclose Prices in TV Commercials (NYTimes) (STAT) (Focus)
• There’s a legal battle looming over Trump’s new proposal on drug ads. Here’s what’s at the heart of it (STAT)
• J&J agrees with US proposal on drug prices in TV ads (Reuters)
• Families say disclosing drug prices in TV ads not enough (CBS)
• Johnson & Johnson edges past profit estimates, lifts outlook (Reuters) (CNBC)
• How the Navy brought a once-derided scientist out of retirement — and into the virus-selling business (STAT)
• Taiho antes up an extra $250M for its venture arm as it gets serious about ‘global oncology’ deals (Endpoints) (Fierce)
• The Results of Your Genetic Test Are Reassuring. But That Can Change. (NYTimes)
• Republicans Are Suddenly Running Ads on Pre-existing Conditions. But How Accurate Are They? (NYTimes)
• Officials Say a Child Is First to Die in Florida Flu Season (NYTimes)
• Meet the new director of Medicaid (Politico)

• Amgen, Novartis kick off fight for AbbVie blockbuster drug in EU (Reuters) (Pharmafile) (WSJ) (Evaluate)
• China's Changsheng Bio-technology hit by heavy penalties in vaccine scandal (Reuters)
• Emergent completes acquisition of Dublin-based Adapt Pharma (Irish Times)
• AstraZeneca halting UK investment due to Brexit uncertainty (Pharmafile) (Endpoints) (Fierce)
• WHO to meet on Congo's Ebola outbreak as toll soars (Reuters)
• Congo confirms 33 Ebola cases in past week, of whom 24 died (Reuters)
• Sales of antibiotics for use in food-producing animals drop across the EU (EMA)
• Novartis and Bayer seek to oppose High Court ruling over NHS decision to use cheaper drug (Pharmafile)
• Study On Patient Support Program Impact Piques EMA's Interest (Pink Sheet-$)

• 10 Things For Pfizer's New CEO To Worry About (Pink Sheet-$)
• Guest column: The real cost of drug development (Endpoints)
• Pharma Failures Actually Advance Medicine (Forbes)
• US FDA Clarifies Human Subject Requirements for Clinical Investigations (Emergo)
• Merck KGaA Foresees Mid-2019 US Launch Of Oral MS Therapy Mavenclad (SCRIP-$)
• Lessons Learned: Here’s why this Broad Institute exec is jumping to a biotech startup (STAT)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Disease Awareness and Prescription Drug Promotion on Television (FDA)
• US FDA Appoints Another Orphan Products Development Office Head Amid Growth Expectations (Pink Sheet-$)
• Ethimedix Submits Its SmartBottle® Opioid Administration Technology to FDA Innovation Challenge (Press)
• Pharnext rare disease drug scores in late-stage study, teeing up applications at the FDA and EMA (Endpoints)
• HPV vaccination not linked with rise in teen risky sex (Reuters)
• Novartis says 5-year data reinforce cosentyx leadership in spondyloarthritis (Reuters)
• Doctors Fret As Men's Health Startup Moves Into Migraine Treatment (Forbes)
• Acacia Pharma updates on FDA talks post CRL (PharmaLetter-$)

• Regeneron, Sanofi talks up potential blockbuster franchise as Dupixent sweeps in rhinosinusitis PhIII (Endpoints) (PharmaTimes) (Press)
• U.S. FDA Grants LYNPARZA® (olaparib) Orphan Drug Designation for Pancreatic Cancer (Press)
• Nearing phase 3, resTORbio posts new data on infection drug (Fierce)
• Kala seeks FDA nod for dry eye disease drug (Drug Delivery) (Press)
• Cellenkos, Inc. Announces FDA Clearance of Investigational New Drug Application for CK0801 for Treatment-Resistant Guillain-Barré Syndrome (Press)
• Five Prime Therapeutics Initiates Patient Dosing in The Dose Exploration Cohort of Its Phase 1 Trial of Novel First-in-Class B7-H4 Antibody FPA150 (Press)
• Melior Pharmaceuticals Enrolls Last Subject in Phase 2b Study with Tolimidone for Type 2 Diabetes (Press)
• Advicenne Receives Health Canada Clearance to Extend its Pivotal Phase III Trial of ADV7103 in Canada (Press)
• PellePharm Presents Updated Data from Two Phase 2 Studies Demonstrating the Potential of Patidegib Topical Gel to Treat Basal Cell Carcinomas in Patients with Gorlin Syndrome and in Patients with Non-Gorlin Sporadic BCCs (Press)

• Zimmer Biomet launches clinical trial with Apple Watch (MassDevice) (MDDI)
• Medtronic Launches the Control Workflow(SM) to Help Eliminate Oral Opioids and Provide Effective Pain Relief (Press)
• Abiomed Responds to MedSun Report on Two Impella Pumps (MDDI)
• What Could the Midterm Elections Mean for Medtech? (MDDI)
• Micro Interventional Devices begins study of tech for heart valve repair (MassDevice)
• Vascular Therapies raises $12m for drug-eluting vascular access implant (Drug Delivery)

• Abbott Says Former Exec Stole Marketing 'Playbook' (Law360-$)
• Next Step After “Right To Try”? Senate Hearing Includes Call To Reopen Orphan Drug Act (Pink Sheet-$)
• Health Care CEO Pleads Guilty to $150 Million Health Care Fraud Scheme Involving Harmful Injections and Unnecessary Prescription of Millions of Opioids (DoJ)
• What You Can Do To Control How Your Health And Medical Data Is Used (NPR)
• Competitive Generic Therapy 180-Day Exclusivity Gets . . . . Well, Umm . . . Competitive! (FDA Law Blog)
• Plaintiffs’ Sanctions Request Emphatically Denied (Drug & Device Law)
• CMS Proposes to Require WAC Disclosure in TV Ads for Rx Drugs (FDA Law Blog)

• FDA Advisory Committee Calendar

• UK Pharmacists turning patients away as flu vaccination supplies dwindle (Pharmaceutical Journal)

• Faulty hip implants: Johnson & Johnson victims rue government panel's role in compensation (Economic Times)
• Ajay Piramal eyes $1 billion in contract pharma sale (Economic Times)
• Big pharma companies plan cheaper alternatives for Ayushman Bharat (Economic Times)
• Experts advocate Indian cos to adopt Indian certification to address product compliance in domestic and int’l mkt (PharmaBiz)

• The burden of congenital Chagas disease and implementation of molecular diagnostic tools in Latin America (DNDi)