Recon: FDA Approves Bayer, Orion Prostate Cancer Drug Nubeqa

• Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas (Focus) (NYTimes) (Endpoints)
• Trump Administration Moves To Make Health Care Costs More Transparent (KHN)
• Democrats brawl on health care, with more to come tonight (Politico) (NYTimes)
• Orion, Bayer prostate cancer drug gets FDA approval (Reuters) (PMLive) (Endpoints) (Press)
• A Massive U.S. Drug Price-Fixing Probe Has Hit Major Roadblocks (Bloomberg)
• Amgen boosts earnings guidance amid optimism for new cancer treatment (Financial Times) (Endpoints)
• Why biotech companies are often at the whim of things they cannot control, in one chart (STAT)
• An expanded label for Amarin’s fish-oil drug looks more likely, but how fast will profits arrive? (STAT)
• Merck's Keytruda makes the cut as a second-line monotherapy for certain esophageal cancer patients (Endpoints) (Press)
• Gilead lifts full-year revenue guidance as HIV drug sales rise (Financial Times) (Endpoints) (Fierce)
• Amarin boosted as another milestone to the FDA’s big Vascepa decision flies by with no sign of an AdCom (Endpoints)
• Mylan reaches $30 million settlement in SEC's EpiPen probe (Reuters)
• Celgene to pay Mylan $62 million to resolve cancer drug antitrust case (Reuters)

• Two powerful Canadian provinces argued against federal drug price crackdown (Reuters)
• A pharma effort to combat noncommunicable diseases in developing countries gets mixed reviews (STAT)
• Second Ebola case detected in eastern Congo's main city (Reuters)
• Pluristem gets positive results from radiation treatment trials (Reuters)
• Novartis' $18.5B in M&A under Vas Narasimhan says a lot about their careful — but opportunistic — deal strategy (Endpoints)
• Wellington raises €210M fund to back European biotechs (Fierce) (Endpoints)
• BIA Presses New UK Government On No-Deal Brexit Preparations (Pink Sheet-$)
• India Proposes Safeguards For Gene Therapies (Pink Sheet-$)
• Chipscreen sets pace for biotech IPOs in Shanghai (BioCentury)
• Keytruda sales show how Merck can compete in China (BioCentury)

• Number of female biotech CEOs remains 'shockingly low,' putting spotlight on BIO (BioPharmaDive)
• Use of HIV prevention pill rising among men who have sex with men (Reuters)
• Megadeals aside, pharma M&A actually dropped in the first half of 2019: report (Fierce)
• Mylan, which bought Novartis CF drugs, circles back for the manufacturing assets (Fierce)
• Gilead looks to Galapagos deal to double research capacity (Fierce)
• Poorer U.S. patients less likely to get blood pressure controlled (Reuters)
• FDA Chides Dr. Reddy’s for Failing to Fully Investigate API Complaints (Focus)
• USP, British Pharmacopoeia Formalize Quality Standards Partnership (Focus)
• Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc. (Press)
• Atlantic Healthcare's drug fails late-stage test; Translate Bio breaks out early CF data (Endpoints)
• Just One HPV Dose May Be Enough To Prevent Several Cancers (Forbes)
• Yale and Mayo Clinic awarded FDA grant to study opioid prescribing and use (Yale)
• Targeting metabolism to regulate immune responses in autoimmunity and cancer (Nature)
• Psoriasis therapy linked to reduced coronary inflammation in patients with the skin condition (NIH)
• Risk-Based Monitoring: US FDA Clarity And Industry Standards Aren't Enough (Pink Sheet-$)
• Kanjinti’s Path To Market Complicated By GMP Issues, Reference Product Drift (Pink Sheet-$)
• FDA Regulatory Compliance Recap - July 2019 (Lexology)
• NIIMBL and FDA Sign New Agreement to Support Advanced Innovation in Biopharmaceutical Manufacturing (Press)
• Gottlieb Tells Brand Firms To Sell Samples For Generics – Or Face The Consequences (Pink Sheet-$)

• Biohaven Enrolls First Patient In Phase 3 Clinical Trial Of Verdiperstat, Oral Myeloperoxidase Inhibitor, For The Treatment Of Multiple System Atrophy (Press)
• LEO Pharma Inc. Announces U.S. Food and Drug Administration (FDA) Expanded Regulatory Approvals for Enstilar® Foam and Taclonex® Topical Suspension in Treatment of Plaque Psoriasis (Press)
• USMI and JCRI-ABTS Receive FDA Approval to Conduct the First U.S. Clinical Trial Using Cold Atmospheric Plasma for the Treatment of Cancer (Press)
• CannPal Commences Phase 2 Pilot Study for Cannabis-Derived Osteoarthritis Drug for Dogs (Press)
• FDA Grants Orchard RMAT Designation for Wiskott-Aldrich Syndrome Gene Therapy (RARE)

• First Two-Tiered Algorithm Snags FDA Clearance for Lyme Disease (Focus)
• Illumina Cuts Forecasts As Consumer Tests, Genomics Initiatives Lag (Xconomy)
• PhysIQ Inc. Receives FDA Clearance of Continuous Ambulatory Respiration Rate Algorithm Enabling Artificial Intelligence-based Analytics for Biopharma Companies and Payers (Press)
• Class 1 Device Recall Sheridan Endotracheal Tube (FDA)

• House Committee Seeks FDA Briefing on Heparin Supply (Focus)
• Beyond Meat competitor Impossible Foods receives FDA approval for bleeding' plant burger (Reuters) (FDA)
• Democratic candidates are promising big on lower drug prices. These advisers are helping formulate their plans (STAT)
• BREAKING: Arizona Files Supreme Court Lawsuit Over Opioid Crisis (Law360-$)
• Patient Drug Guides Vs. The Learned Intermediary Doctrine (Law360-$)
• Fed. Circ. Won't Rethink Ruling Invalidating 2 Vimovo Patents (Law360-$)
• Pharma Cos. Settle Patent Challenge Over Opioid Treatment (Law360-$)
• The House has OK’d a unique patient identifier. Here’s what should happen next (STAT)
• W.D. Pennsylvania Dismisses Third-Party Complaint for Lack of Personal Jurisdiction (Drug & Device Law)
• Dr. Falk Pharma GmbH v. Generico, LLC (Fed. Cir. 2019) (Patent Docs)

• FDA Advisory Committee Calendar

• MHRA Revises Clinical Investigation Guidance in Line With EU MDR (Focus)
• EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020 (Focus)
• Who's calling the shots in European healthcare? (PMLive)

• CDSCO asks stakeholders to file online applications of veterinary drugs on new SUGAM portal (Pharmabiz)
• Indian pharma to get salary increment of 10.95% as sector to witness robust growth prospects (Pharmabiz)
• Cipla seeks favourable policy for domestic pharma cos (Pharmabiz)

• Therapeutic goods advertising: update 31 July 2019 (TGA)
• TGA presentation: Hunter New England Local Health District 3D Printing Forum, 30 March 2019 (TGA)