Recon: BMS Posts Mixed Results for Opdivo in Lung Cancer Phase III Study

• Pharma gets an audience with Trump (Politico)
• White House preparing order that would cut drug prices for Medicare: sources (Reuters)
• First CRISPR study inside the body to start in US (STAT)
• Eli Lilly's hypoglycemia treatment wins FDA approval (Reuters) (Endpoints) (FDA) (Press)
• Vertex Pharmaceuticals’ Jeffrey Leiden to step aside as CEO (STAT) (Endpoints) (BioPharmaDive)
• Bristol-Myers releases mixed Opdivo lung cancer results (CNBC) (Endpoints) (Press) (Press)
• Bristol-Myers posts strong second quarter earnings as Eliquis, Orencia surprise (Reuters) (Press)
• As the nation’s opioid crisis grew, the pills got stronger (AP)
• Opioid Makers Say There’s No Proof They Are Responsible For The Epidemic’s Harms (Washington Post)
• Pricey Therapies Mean NIH Needs More Money to Keep Up: Official (Bloomberg)
• Sage Therapeutics should price its experimental depression pill on ‘value’ despite political pressure, CEO says (CNBC)
• Most High-Risk Men Don’t Take PrEP to Prevent HIV (NYTimes)

• At BSI's full-day EU Medical Device Roadshow, learn the challenges in meeting European CE-marking regulatory and compliance expectations for the new MDR/IVDR requirements. BSI will be sharing our current experiences, best practice and expectations from the perspective of the first notified body designated under the MDR (EU 2017/745).

• Sanofi expects one-month delay of vaccine shipments for fall flu season (CNBC)
• AstraZeneca climbs as it raises outlook on booming sales (Financial Times)
• UK Publishes Contingency Legislation for Drugs and Medical Devices in No-Deal Scenario (GOV.UK)
• Life sciences and NHS feature in Johnson speech – but Brexit promises predominate (PMLive)
• Climate Change May Draw $200 Billion Vaccine Boom, Analyst Says (Bloomberg)
• Ebola vaccine hampered by deep distrust in eastern Congo (NBC)
• Deployment of second Ebola vaccine would not be quick fix, experts warn (Reuters)
• Roche lifts full-year outlook after first half sales rise 18% (Reuters) (Press)
• Roche CEO says committed to Spark deal, portfolio "without any question" (Reuters)
• Roche brags about faster Ocrevus sales after rival MS drug launches (Reuters)
• Roche axes early-phase inflammatory disease drug (Fierce)
• Could The NHS Really Sell Its Data For $12 Billion? (Forbes)
• A 2-year-old fledgling biotech steers into PhIII and nabs a quick $565M buyout deal (Endpoints) (BioCentury)

• Harms From Uninformative Clinical Trials (JAMA)
• Mistrust And Lack Of Genetic Diversity Slow Gains In Precision Medicine (NPR)
• Christi Shaw taken on by Gilead as Kite Pharma's new CEO (Pharmafile)
• FDA’s Woodcock Weighs in on Role of NIH in Drug Development (Focus)
• Alexion's beating forecasts with Soliris-to-Ultomiris switch. So what's up with its pesky stock price? (Fierce)
• Freenome raises $160m as it readies early detection cancer tests (Financial Times)
• What makes Hal Barron tick? Look at the people he’s teaming up with at GSK (Endpoints)
• Lyrica Generics Likely Delayed By A Pfizer Labeling Supplement (Pink Sheet-$)
• Many deadly common cancers get little charity funding (Reuters)
• FDA Seeks Input on Biomarker, Endpoint Glossary (Focus)
• After Daiichi deal, AstraZeneca's focus firmly on its own pipeline: CEO (Fierce)
• On A Mission To Help People Control Diabetes — And Save Money On Insulin (KHN)
• A GPS-like System for Single-Cell Analysis (NIH)
• Avalon seeks boost from GE cell therapy manufacturing tech (BioCentury)
• Real-World Data, Evidence Becoming More Prominent in Clinical Research (Medpage)
• Cancer Trials Often Hinge on Fragile Data (Medpage)
• Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV (NEJM)
• PARP inhibitors sometimes work beyond BRCA-mutations, researchers may finally know why (Endpoints)
• ICER backs cost-effectiveness of Vascepa, Xarelto; Epizyme's lead drug wins speedy US review (Endpoints)
• Baxter Initiates Voluntary Recall of Two Lots of IV Solutions due to Potential Presence of Particulate Matter (FDA)
• Herbal Doctor Remedies Issues Voluntary Nationwide Recall of All Drug Products Due to Marketing Without FDA Approval and Concerns with Manufacturing Practices (FDA)
• Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results (FDA)

• Aura Biosciences to Present Long-Term Clinical Data for AU-011 at the 37th Annual Scientific Meeting of the American Society of Retina Specialists (Press)
• Epizyme Announces FDA Filing Acceptance of New Drug Application and Priority Review for Tazemetostat for the Treatment of Epithelioid Sarcoma (Press)

• Allergan Pulls Textured Breast Implant Following FDA Request (Focus)
• Five Deaths Reported Prior to Recall of Intra-aortic Balloon Pumps (Focus)
• Baxter ticks up on Q2 beats (MassDevice)
• Regulating Digital Health: Novartis CEO Seeks Further Modernization (Focus)
• Improved Prosthetic Hand Has A Lighter Touch And Easy Grip (NPR)
• Life Spine Announces FDA 510(k) Clearance of the PROLIFT® Expandable Spacer System In 8mm-10mm Widths (Press)
• Edwards Lifesciences abandons Centera self-expanding TAVR for Sapien 3 Ultra push (MassDevice)

• Anthem shares sink as cost concerns overshadow earnings beat (Reuters)
• Teva claws back $50M from former execs, board members to pay for 2016 foreign bribery settlement (Fierce)
• Health Insurers Sink as Rising Spending Gauge Alarms Investors (Bloomberg)
• Improve, Don’t Repeal, ObamaCare’s Cadillac Tax (WSJ)
• Minerva Surgical claims win against Hologic (MassDevice)
• Nevro wins partial injunction in patent spat with Stimwave (MassDevice)
• Indivior Inc. v. Dr. Reddy's Laboratories, S.A. (Fed. Cir. 2019) (Patent Docs)
• Wrong Court (Drug & Device Law)
• ITC Bans Medical Device Imports That Flout Co.'s Trade Dress (Law360-$)
• Heritage Pharma, Former Execs Reach Deal In RICO Suit (Law360-$)

• FDA Advisory Committee Calendar
• 2019 Parenteral Drug Association/Food and Drug Administration Joint Conference -- Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision – 16-18 September 2019

• EU Regulatory Roundup: MHRA Finances Hit by Brexit-Triggered Drop in Income From EMA (Focus)
• € 500 per data subject – a quantification of why GDPR matters (medicaldeviceslegal)
• French medicines regulator produces first in Europe medical devices cybersecurity guidelines (Covington)
• MHRA statement on Allergan (MHRA)
• FMD Alert: Class 2 (EL (19)A/19) (MHRA)
• East London crook charged with meds crimes (MHRA)
• Relaxed UK salt policy tied to more heart disease, cancers (Reuters)

• Mega diabetes drug to be cheaper soon (Economic Times)
• Indian pharma companies get 207 ANDA approvals from US FDA during first half of 2019, tentative approvals at 55 ANDAs (Pharmabiz)

• Novartis reclaims sterile products plant in Canada after sale goes south (Fierce)
• European Echinococcus multilocularis Identified in Patients in Canada (NEJM)

• Elton John AIDS fundraiser brings in $6 million for Kenya HIV testing (Reuters)

• How an AI expert took on his toughest project ever: writing code to save his son’s life (STAT)