Regulatory Recon: ViiV, GSK Use Priority Review Voucher for 2-Drug HIV Combo; NICE Backs Opdivo for Classical Hodgkin Lymphoma (2 June 2017)

Posted 02 June 2017 By Michael Mezher

placeholder+image

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • US FDA's Record-Breaking Month Of Breakthrough Therapy Designations (Pink Sheet-$)
  • Pediatric Studies: Must Sponsors Meet Every Detail Of US FDA Request To Get Exclusivity? (Pink Sheet-$)
  • ViiV, GSK gamble a surprise $130M chip in a high-stakes HIV playoff with Gilead (Endpoints) (Reuters)
  • U.S. state, local government lawsuits over opioids face uphill battle (Reuters)
  • Checkpoint combos for cancer are all the rage as trial sponsors line up hundreds of new studies (Endpoints)
  • More than 240 immuno-oncology treatments in development to fight cancer (PHRMA) (Report)
  • Cancer docs favored drugs from companies who paid for meals and travel (STAT)
  • TV Drug Ads: FDA May Pursue Further Research Before Policy Changes (Pink Sheet-$)
  • The Road to Lexington: RaNA's Midnight Ride Ignites the mRNA Revolution (LifeSciVC)
  • Alexion CEO fills out C-suite after last week's purge (Fierce) (Endpoints)
  • Novartis' CAR-T CTL019 Back On The Blockbuster Hit List (SCRIP-$)
  • Mylan to Meet Sen. Grassley on EpiPen Claims (The Street)
  • ViiV/Janssen's two-drug HIV regimen filed in US, EU (PharmaTimes)
  • As Government-Funded Cancer Research Sags, Scientists Fear US Is 'Losing Its Edge' (KHN)
  • Pfizer defeats appeals over Zoloft birth defects (Reuters)
  • AZ' Lynparza shows similar QoL to placebo (PharmaTimes)
  • In cancer treatment, there's more than one way to measure patient benefit (FDA Voice)
  • Celgene CEO: When It Comes to Healthcare Costs, New Medicines Are the Solution, Not the Problem (Forbes)

In Focus: International

  • EU pharma agency warns of post-Brexit levies (Financial Times) (PharmaLetter-$)
  • NICE backs Opdivo for classical Hodgkin lymphoma (PharmaTimes)
  • Botched anti-measles campaign kills 15 children in South Sudan (Reuters) (STAT) (WHO)
  • EMA Consults on Regulatory Requirements for Chronic Liver Disease Drugs (Focus)
  • European Regulatory Roundup: EU Device Regulations Come Into Force; Swissmedic Clarifies Pharmacovigilance Process  (Focus)
  • Authorities Holding Off Deployment of Experimental Ebola Vaccine in Congo (WSJ)
  • Russian partnerships: Pfizer and NovaMedica break ground on aseptic plant (InPharmaTechnologist)
  • Malaysian MDA Updates Mandatory Problem Reporting Policy for Medical Devices (Emergo)
  • Deal struck for Orkambi and Kalydeco availability in Ireland (PharmaLetter-$)
  • Change And More Change: That's What Brexit Means For Drug Companies (Pink Sheet-$)
  • ABPI appoints new Executive Director of Government Affairs (Pharmafile)
  • European Medicines Agency closed 5 June 2017 (EMA)

Pharmaceuticals & Biotechnology

  • Lilly's Cyramza Expands Its RANGE With Bladder Cancer But OS Data Needed (SCRIP-$)
  • Philips, Illumina to launch precision medicine cancer program with Navican (Drug Delivery)
  • CancerLinQ Announces Collaborations With FDA, NCI (BioCentury)
  • Endocyte slashes staff and retrenches in the wake of back-to-back R&D setbacks (Endpoints)
  • Researchers Discuss Regulatory Considerations for Tissue-Agnostic Cancer Drugs (Focus)
  • Resurrected: A controversial trial to bring the dead back to life plans a restart (STAT)
  • Pharmaceutical Product Hopping: A Proposed Framework For Antitrust Analysis (HealthAffairsBlog)
  • 28 Unique Data Integrity Deficiencies, That Aren't Really Unique. (FDAZilla)
  • #IAmHHS: Fighting Misleading Prescription Drug Ad Claims (FDA Voice)
  • Immuno-oncology Drugs And The Trouble With Market Access (Pink Sheet-$)
  • Novartis joins Glaxo and gets over its fear of heights (EP Vantage)
  • A critical opportunity to prevent prescription drug abuse (PhRMA)
  • Silence Therapeutics instate new COO (Pharmafile)
  • Cancer costs are up—but there's more to the story than rising prices, report says (Fierce)
  • Rho to support NDA for Evoke Pharma's patented nasal spray (OutsourcingPharma)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Flex Pharma's Phase 2 Trial with FLX-787 in Charcot-Marie-Tooth Endorsed by the Inherited Neuropathies Consortium (Press)
  • Opdivo (nivolumab) Data in Patients with Advanced Cervical, Vaginal and Vulvar Cancers from Phase 1/2 CheckMate -358 Presented at ASCO (Press)
  • Bristol-Myers Squibb and Seattle Genetics Expand Clinical Collaboration to Evaluate Combination of Opdivo (Nivolumab) and ADCETRIS® (Brentuximab Vedotin) in Pivotal Phase 3 Clinical Trial in Relapsed Hodgkin Lymphoma (Press)
  • With Nearly Three Years of Follow-Up, KEYTRUDA® (pembrolizumab) Data Demonstrated Improved Survival Benefit Compared to Ipilimumab in Advanced Melanoma (Press)
  • Boehringer Ingelheim and Lilly Diabetes Alliance to Present 33 Abstracts at the American Diabetes Association's 77th Scientific Sessions (Press)

Medical Devices

  • Siemens Healthineers closes Medicalis buyout (MassDevice)
  • Researchers Invent New Method for Non-Invasive Deep Brain Stimulation (IEEE) (NYTimes)
  • Sema4, Eric Schadt's Genomics Startup, Spins Out of Sinai to Raise Cash (Xconomy)
  • Integra's Massive Run-Up Expected to Continue as J&J's Surgical Business Joins the Fold (The Street)
  • Class 1 Device Recall Absorb Bioresorbable Vascular Scaffold (BVS) System, Absorb GT1 Bioresorbable Vascular Scaffold BVS (FDA)

US: Assorted & Government

  • Janssen Takes Another 'Patent Dance' Step In Remicade Case (Law360-$)
  • Tom Price Bought Drug Stocks. Then He Pushed Pharma's Agenda in Australia. (ProPublica)
  • Trump Rule Could Deny Birth Control Coverage to Hundreds of Thousands of Women (NYTimes)
  • Emergency Preparedness: Is Quarantine All We Have to Offer? (Harvard Bill of Health)
  • Considering Arbitration (Drug & Device Law)
  • First Generic Drug Price Gouging Prohibition to Become Law in Maryland (FDA Law Blog)
  • Evzio price hikes boosted Kaléo's rebate bill but it hasn't paid up, PBM lawsuit claims (Fierce)
  • Ohio Lawmaker Reveals Her Sons Are Battling Opioid Addiction (NBC)

Upcoming Meetings & Events

Europe

  • Scottish National Party manifesto: ABPI response (ABPI)

India

  • Govt expands PvPI in the country with 250 ADR centres set up till date (PharmaBiz)
  • Pharmacy experts ask gov to enlist and notify 'OTC drugs' in the wake of generic prescription becomes legally binding (PharmaBiz)
  • Zydus Cadila gets USFDA nod for levofloxacin injection (Economic Times)

Australia

  • Valium blister pack tampering leads to Australian recall for Roche and Apotex (InPharmaTechnologist)

Other International

  • MannKind inks deal to bring inhaled insulin to Brazil (Drug Delivery)

General Health & Other Interesting Articles

  • Baby teeth link autism and heavy metals, NIH study suggests (NIH)
  • L.A. health officials misstated some cases of childhood lead exposure (Reuters)
  • Breastfeeding linked to lower endometrial cancer risk ( Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community