Recon: GSK Anti-BCMA Drug Hits Goal in Multiple Myeloma Study; NICE Rejects GW’s Epidyolex

• FDA Focuses on Novartis Delay in Reporting Data Manipulation (WSJ) (Bloomberg) (Endpoints)
• Clearside predicts its uveitis drug will be rejected after FDA requests more data (Endpoints)
• FTC Issues Civil Investigative Demand to J&J Regarding Remicade (Big Molecule Watch)
• Report: The Sacklers controlled Purdue like the Godfather controlled the Mafia (STAT)
• HHS proposes making it easier for doctors to know if patient has addiction history (CNBC) (STAT)
• Why would Amgen want to buy Alexion? Analysts call hotly rumored takeover unlikely (Endpoints)
• Time for FDA to Release Complete Responses Letters? Debate Reignites (Focus)
• Mylan Partially Beats Amgen Neulasta Biosimilar Claims (Law360-$)
• Ohio Balks at Endo, Allergan Opioid Deals as Trial Approaches (Bloomberg)
• Dialysis Industry Spends Big To Protect Profits (KHN)

• GSK builds oncology pipeline as drug shown to help myeloma patients (Reuters) (Fierce) (Endpoints) (Press)
• Early ‘no’ for GW Pharma’s epilepsy drug, but NICE vows to collaborate (PMLive) (The Telegraph)
• Zika Was Soaring Across Cuba. Few Outside the Country Knew. (NYTimes)
• This Daily Pill Cut Heart Attacks by Half. Why Isn’t Everyone Getting It? (NYTimes) (Financial Times)
• WHO says eradicating malaria 'can be done', but first aim is to control it (Reuters)
• Glenmark in talks to sell up to 30% in API biz to PremjiInvest (Economic Times)
• The Invisible Children With Cancer (NPR)
• NICE recommends antiseptics over antibiotics for impetigo (PharmaTimes)
• EMA accepts license extension submission for Invokana and Vokanamet (PharmaTimes)
• HSE reimburses Braftovi combo (PharmaTimes)

• Amgen’s R&D chief on the ‘slow-moving tsunami’ of Alzheimer’s and the future of disease research (STAT)
• Lack Of Diversity In Genetic Databases Hampers Research (NPR)
• Finch Therapeutics bags $53m for microbiome therapies (PMLive)
• A moon shot for the opioid crisis (Boston Globe)
• Tales Of Corporate Painkiller Pushing: 'The Death Rates Just Soared' (NPR)
• Final ALS Drug Development Guidance Coming Soon (Focus)
• Prescription Drug Monitoring Programs — Friend or Folly in Addressing the Opioid-Overdose Crisis? (NEJM)
• Speech by Dr. Amy Abernethy at the National Coordinator for Health IT Third Interoperability Forum (FDA)
• ICER Value Framework Update Reaffirms Support For Real-World Evidence (Pink Sheet-$)
• As supply shortages persist, ADMA relaunches immune globulin drug (BioPharmaDive)
• The Weekly: Episode 11: ‘The Six Million Dollar Claim’ (NYTimes)
• Man dies unable to afford his insulin prescription; states tackle the rising cost (NBC)
• Community engagement is key to clinical trial recruitment and diversity (STAT)
• Memory T cells shelter in bone marrow, boosting immunity in mice with restricted diets (NIH)
• An Estimated 92% of Cancers Caused by HPV Could be Prevented by Vaccine (CDC)
• Chinook Raises $65M Series A For Kidney Disease Treatments (Law360-$)
• Ignyta founder boosts team at his new cancer startup; Cytomx CMO hits the exit (Endpoints)
• Building on successful PD-1 pact, Eli Lilly licenses diabetes drug to Chinese partners at Innovent (Endpoints)
• Patient groups top pharma when it comes to providing support, survey says (Fierce)
• Making an Impact: Journal of Law and the Biosciences Scores High (Harvard Bill of Health)
• Hemispherx Biopharma, Inc. Changes Name to AIM ImmunoTech Inc. Reflecting Ampligen’s® Immuno Modulation Progress in Ongoing Oncology Clinical Trials and ME/CFS (Press)
• Scorpion toxin uncovers insights into pain that could inspire non-opioid treatments (Fierce)

• Mustang Bio gene therapy for bubble boy disease nabs RMAT tag in U.S.; shares up 12% premarket (Seeking Alpha)
• CStone completes registration filing for the Phase I trial of CDK4/6 inhibitor CS3002 in Australia and will soon initiate the study (Press)
• Satsuma Pharmaceuticals Announces First Patient Dosed in EMERGE™, a Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine (Press)
• STALICLA Announces Completion of pre-IND Meeting With FDA on STP1 for Subgroup of Patients With Autism Spectrum Disorder (ASD) (Press)

• CDRH Details Top Regulatory Science Priorities (Focus)
• Nucleic Acid Extraction System From Systaaq Diagnostic CE Marked (GenomeWeb)
• Senseonics Brings Real-World Data to Super-Competitive CGM Market (MDDI)

• Student borrowers with cancer can now pause their payments (CNBC)
• Ruling in Oklahoma opioids lawsuit imminent (Politico)
• Trump has made a priority of trying to lower drug prices. But many of his most ardent supporters don’t know it (STAT)
• FTC Refunds Consumers Who Bought FlexiPrin Joint Pain Supplement (FTC)
• Insys Ch. 11 Sales For Two Drug Lines Approved In Del. (Law360-$)
• PBMs: Driving Up Costs and Lowering Quality Care in America (Forbes)
• Decreasing Prescription Abandonment with Price Transparency (Drug Channels)
• An Anti-Vax Activist Assaulted A California Lawmaker While Streaming Live On Facebook (BuzzFeed)
• Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH (Fed. Cir. 2019) (Patent Docs)
• You Don’t Have to Be Old to Be Mature – FDA Likes “Mature” Quality Organizations, and Offers Tips (FDA Law Blog)

• FDA Advisory Committee Calendar

• Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance (Focus)
• New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases (EMA)
• One in seven five-year-olds don’t have MMR jabs (PharmaTimes)
• OxThera’s Oxabact PIP gets thumbs up from EMA (PharmaLetter-$)

• Lupin divests Kyowa Criticare to Neopharma group (PharmaLetter-$)
• BRIEF—Another Tecentriq approval in Japan (PharmaLetter-$)

• Johnson & Johnson pays Rs 25 lakh each to three victims of faulty hip implants (Economic Times)
• DCGI sub-committee drafts document guidance on formulation development as per WHO guidelines (PharmaBiz)
• Health ministry plans to regulate nicotine delivery devices as drugs towards public health safety (PharmaBiz)

• Medical device incident reporting (MDIR) guide (TGA)