Recon: CHMP Recommends Five New Medicines; AbbVie’s Humira Expected to Remain Top Selling Drug

• AbbVie raises guidance as cancer treatments boost sales (Financial Times)
• Humira set to remain world's best selling drug (Reuters)
• McKinsey Advised Johnson & Johnson on Increasing Opioid Sales (NYTimes)
• 76 Billion Pills, 6 Companies And An Opioid Trial For The Ages (1A)
• Litigation Over America's Opioid Crisis Is Heating Up (NPR)
• Robotic Surgical Tool, Not Medical Evidence, Drives Free Hernia Screenings (KHN)
• They May Owe Nothing — Half-Million-Dollar Dialysis Bill Canceled (KHN)
• Nektar takes a hit as the FDA swerves away from opioid reviews (Endpoints)
• Following EMA, FDA restricts use of high-dose Xeljanz, warning of added risks for the blockbuster JAK (Endpoints) (FDA)
• J&J touts their head-to-head win against Sanofi on MS, steering another S1P drug to the FDA (Endpoints) (BioPharmaDive) (Fierce)
• Merck to build Gardasil 9 plant in NC and add 425 jobs, but will cut 150 elsewhere (Fierce)

• 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).

• EMA Recommends Conditional Approval for First Tissue-Agnostic Cancer Treatment (Focus)
• Roche's Tecentriq recommended for EU approval to treat lung cancer form (Reuters) (Press)
• European panel okays GW Pharma cannabis drug for epilepsy (Reuters)
• CHMP backs Bristol-Myers' Empliciti combo for multiple myeloma (Seeking Alpha) (Press)
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019 (EMA)
• The top 10 pipeline blowups, setbacks and snafus for H1 2019 (Endpoints)
• WHO, preparing for the worst, makes plans for reduced doses of Ebola vaccine (STAT)
• WHO says it could use more U.S. help on the ground in Ebola fight (Reuters)
• Congo Draws Up a New Battle Plan Against Ebola Amid Power Struggle (NYTimes)
• Consumer groups urge Italian and Belgian authorities to investigate Biogen over Spinraza pricing (STAT)
• Lynparza cleared as ovarian cancer maintenance therapy on Cancer Drugs Fund (PMLive)
• CMA Accuses Pharmas Of Divvying Market For UTI Treatment (Law360-$)
• How To Bring Cancer Care To The World's Poorest Children (NPR)

• Study: 2% of women have ‘persistent’ opioid use after childbirth (STAT)
• A richly funded CRISPR alternative has a reproducibility problem (STAT)
• Got It All Ready For You, Mr. FDA Inspector (In the Pipeline)
• Regulating Digital Health: Novartis CEO Seeks Further Modernization (Focus)
• Duchenne Advocates Start Casimir, Aiming to Capture Missing Data (Xconomy)
• FDA to make decision on Epizyme drug for rare cancer by January 2020 (MedCity)
• AbbVie scraps an anti-tau study, and that may foretell more big trouble for a beleaguered Biogen (Endpoints)
• Vertex rushes to assure Wall Street that Jeff Leiden is keeping a hand on the reins as one analyst questions succession plans (Endpoints)
• Jupiter biotech scores $56M to defeat herpes, in a field littered with failure (Endpoints)
• Don’t Panic: The FDA’s Guide To Saving Drug Approvals From Suspect Data (Pink Sheet-$)
• Worries about accuracy of widely used dementia test prompt training requirement (STAT)
• Boston's NeuroBo to use bruised Gemphire to make Nasdaq debut (Endpoints)
• Peer Review: Rubius recruits BD chief; Epizyme hires Novartis vet as CFO (Endpoints)
• Generic Drug User Fee Rates for Fiscal Year 2020 (FDA)

• FDA accepts Brinavess resubmission (PharmaTimes)

• What the Trade War with China Means to the Medical Industry (Harvard Bill of Health)
• Merit Medical plunges on Q2 miss, lowered outlook (MassDevice)
• FDA approves delivery system for Intersect ENT’s Propel implant (MassDevice)
• FDA Finalizes Guidance on Metal Expandable Biliary Stent 510(k)s (Focus)
• Zimmer Biomet beats Q2 expectations, raises outlook (MassDevice)
• Stryker beats The Street with Q2 results (MassDevice)
• Medtronic Looks to Expand Reach of Artificial Pancreas with New Submission (MDDI)
• Ocular Therapeutix’s ophthalmic device gains Medicare coverage early (MassDevice)

• As Stem Cell Clinics Proliferate, E&C Leaders Seek to Hear FDA’s Plan (Focus)
• Klobuchar Says DC Has Enough Drug Lobbyists To Double-Team Lawmakers (KHN)
• Senate Committee Advances Bipartisan Drug Pricing Package (Focus)
• GOP Senators Distance Themselves From Grassley And Trump’s Efforts To Cut Drug Prices (KHN)
• Sen. Chuck Grassley: We can find areas of consensus when it comes to health care. Here's proof (FoxNews)
• Senators vow to bring transparency to drug pricing (The Hill)
• In Roundup case, U.S. judge cuts $2 billion verdict against Bayer to $86 million (Reuters)
• Prevagen maker must face FTC, New York claims that memory supplement does not work (Reuters)
• HHS auditors may target $436M in improper Florida payments (Politico)
• Vaccine Act Dismissal Affirmed—An Intended Component Cannot Be A “Contaminant” (Drug & Device Law)

• FDA Advisory Committee Calendar

• EC Offers Specifications for Reprocessing Single-use Devices Under MDR (Focus)
• Novartis’s Zolgensma Loses EU Accelerated Assessment (Scrip-$)
• MHRA: requests under the Freedom of Information Act (FOIA) (MHRA)

• Finally, a govt side story to quell India's misgivings about Modicare (Economic Times)
• Pakistan imports over $36 million worth of anti-rabies, anti-venom vaccines from India (Economic Times)
• Indoco Remedies gets EIR from USFDA for 2 plants in Goa (Economic Times)
• Health ministry constitutes MDTAG to advise CDSCO on matters related to regulation of medical devices (PharmaBiz)
• ]Pharmexcil urges industry to utilise opportunity to develop generics for recently off-patented drugs listed by US FDA (PharmaBiz)

• European implementation of Medical Device and IVD Regulations - Implications for Australia (TGA)
• Improved medicines information for consumers (TGA)
• Thermography should not be relied on for early detection of breast cancer (TGA)

• Johannesburg court approves $353 million silicosis settlement (Reuters)

• Can This Ancient Greek Medicine Cure Humanity? (NYTimes)