Regulatory Recon: Seattle Genetics Halts Trials Due to Patient Deaths; Novartis' Rituxan Biosimilar Gets EU Approval (19 June 2017)

Posted 19 June 2017 By Michael Mezher

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

In Focus: US

  • White House Task Force Echoes Pharma Proposals (KHN) (Politico) (STAT)
  • Seattle Genetics ends clinical trial of leukemia drug after 'a higher rate of deaths' (Seattle Times) (GEN) (Press)
  • Mylan's Copaxone copy could face another hold-up with FDA info request (Fierce)
  • Supreme Court limits where patients can sue for injuries caused by drugs (Politico)
  • Could third time be the charm for Advair copycats? Novartis' Sandoz aims to find out (Fierce) (Drug Delivery)
  • Why Some of the Worst Cyberattacks in Health Care Go Unreported (WSJ)
  • Nevada Governor Signs Revised Price Transparency Bill (BioCentury) (Policy & Medicine)
  • Ahead of Modi visit, US lawmakers ask India to rethink price cap on stents (Reuters)
  • New test may turn AZ's Lynparza into precision drug for prostate cancer (Reuters) (Pharmafile)
  • Bedside drug production will truly enable personalized medicine (STAT)
  • With Cambridge life-sciences center, Bayer raises its profile (STAT)
  • Doctor Who Wrote 1980 Letter On Painkillers Regrets That It Fed The Opioid Crisis (NPR)
  • Even the Insured Often Can't Afford Their Medical Bills (The Atlantic)
  • FDA Science: Working at the Speed of Emerging Technologies (FDA Voice)

In Focus: International

  • Novartis throws down gauntlet to Roche with Rituxan copy (PharmaTimes) (Reuters)
  • NHS future 'uncertain' for Adcetris in ALCL (PharmaTimes)
  • FT Health: Beware donor disillusionment (Financial Times)
  • Brazil's ANVISA Now accepts both Electronic and Paper Submissions (Emergo)
  • Low Prices Cause Breast Cancer Drug Shortage In Turkey (Pink Sheet-$)
  • Israel's Gamida Cell raises $40 million for bone marrow trial (Reuters)
  • Considering Growth Options For Asian Biotechs: IPO Vs M&A (SCRIP-$)
  • UK Competition Body Backs Up Claim That Pfizer & Flynn Abused Dominant Position With 'Excessive' Prices (Pink Sheet-$) (CMA)
  • Hedge fund manager John Paulson joins Valeant board (Financial Times)
  • The 10 Brexit compromises Theresa May won't talk about (The Guardian)

Pharmaceuticals & Biotechnology

  • Making strides in hepatitis (Pharmafile)
  • Op-Ed: Reform Prescription Drug Labeling to Benefit Patients and Their Doctors (Morning Consult)
  • Editors Reconsidering CRISPR Off-Target Paper's Conclusions (BioCentury)
  • Woodford invests in Big Pharma-backed dementia fund (Fierce) (Financial Times)
  • Are genome-wide association studies fundamentally flawed? (MedCityNews)
  • Biotech Growth Slows As Cost Containment Hits Home (SCRIP-$)             
  • FDA panel to assess victoza's CV benefit, discuss risks (BioCentury)
  • Darzalex's Latest Approval To Trigger Genmab Milestones (BioCentury)
  • Early biotech financing healthy, but R&D productivity needs to look left-field (Fierce)
  • Lions Health, Day 2: Allergan on Facebook, AstraZeneca in telemedicine, and the gist? Ads are passé (Fierce)
  • Live from Lions Health: Reputation, innovation, big data and a whole lot of gossip (Fierce)
  • At Cannes Lions Health, pharma again falls short of Grand Prix standard (Fierce)
  • Novartis, GSK, Pfizer and AbbVie among pharma short-listers at Health Lions (Fierce)
  • FDA Will Investigate Pharma Promo Caveats, 'Overwarnings' (Law360-$)
  • FDA's Generic Drugs Office Passes Last Year's Record for ANDAs Received (FDANew-$)
  • Generic Manufacturers Try To Up Their Game As US Pressure Persists (SCRIP-$)
  • After The Cliff: Fewer Patent Expiries Mean Less Savings From Generics (SCRIP-$)
  • Aimmune to make peanut allergy candidate in Florida, US (BioPharmaReporter)
  • Alvogen Issues Voluntary Nationwide Recall of Clindamycin Injection Due to a Potential for a Lack of Sterility Assurance (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Clovis's ovarian cancer drug set for label expansion, shares soar (Reuters)
  • GSK's Benlysta shows sustained disease control in study (PharmaTimes)
  • GeNeuro Announces First Patient Treated in Phase 2a Study with GNbAC1 in Type 1 Diabetes (Press)
  • Genexine Receives Approval to Initiate Phase Ib/II Trial of GX-188E, HPV Therapeutic DNA Vaccine, in Combination With KEYTRUDA® (pembrolizumab), for the Treatment of HPV-Induced Cervical Cancer (Press)
  • FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA® (denosumab) To Include Multiple Myeloma Patients (Press)
  • Pfizer Begins Phase 1 Clinical Trial to Evaluate Investigational Group B Streptococcus Vaccine (Press)
  • Cerveau Technologies, Inc. Announces FDA Acceptance of Investigational New Drug (IND) for Tau Imaging Agent MK-6240 (Press)
  • Ipsen Announces FDA Approval of Dysport® (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults (Press)
  • Juno Therapeutics Presents TRANSCEND NHL 001 Trial Data at International Conference on Malignant Lymphoma (Press)

Medical Devices

  • Stryker to pay $700m for Novadaq (MassDevice)
  • Bayer gets FDA nod for app-connected injector for MS patients (MobiHealthNews)
  • How Device Makers Can Combat Rising Healthcare Costs and Prep for Policy Changes (MDDI)
  • Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps for Potential Electrical Test Failure Code (FDA)
  • Medtronic Exclusive Reactive ATP(TM) Therapy Slows Progression of Atrial Fibrillation in Real-World Patient Population (Press)
  • Medicrea Receives FDA Clearance for the UNiD™ HUB, a Data-Driven Digital Portal for Adaptive Spine Intelligence (Press)
  • Medicrea Announces FDA Clearance and Initial Experience with PASS® TULIP Top-Loading Fixation in World-First Patient-Specific Hybrid Constructs (Press)

US: Assorted & Government

  • If Amazon wants to sell prescription drugs, Whole Foods could provide the real estate (CNBC)
  • FDA: Protecting the Integrity of Horse Racing Since 1906 (FDA Law Blog)
  • Fourth Circuit Punts West Virginia Innovator Liability Issue (Drug & Device Law)
  • Six Experts Resign From President's HIV/AIDS Advisory Panel in Protest (NBC)
  • Humana Drops Pay-For-Delay Claims Against Boehringer (Law360-$)
  • Bristol-Myers Says Docs Knew Of Plavix Bleeding Risks (Law360-$)

Upcoming Meetings & Events

Europe

  • Investing In Maturity (BioCentury)
  • Agilent's Opdivo CDx Gets Expanded CE Mark in Europe (GenomeWeb)
  • Takeda completes new German manufacturing facility (PharmaLetter-$)
  • Five Years On: UK Reviews Transposition Of EU Pharmacovigilance Directive, Other Changes (Pink Sheet-$)
  • Denmark addresses patients' qualms over biosimilars (PharmaLetter-$)
  • Neovasc loses German patent case against Edwards Lifesciences unit CardiAQ Valve (MassDevice)
  • Advertising investigations: May 2017 (MHRA)

Asia

  • Daiichi Sankyo debuts cancer pain drugs in Japan (PharmaLetter-$)
  • FiercePharmaAsia—Intercontinental antibiotic program, SK gets Bristol-Myers Squibb's API plant, JSR buys Selexis (Fierce)

India

  • The World Bank invests in Indian Biopharma (BioPharmaReporter)
  • Ipca On Tailspin After Three-Plant FDA Ban (SCRIP-$)
  • Zydus Cadila gets USFDA nod to market migraine drug (Economic Times)
  • Andhra Pradesh ties up with TUV Rheinland to test medical devices (Economic Times)
  • IDMA demands rollback of proposal to make annual joint inspection of drug units mandatory (PharmaBiz)
  • Health ministry issues circular to state drug controllers to get feedback on draft PV guidelines (PharmaBiz)
  • CDSCO issues draft SOPs for handling of Not of Standard Quality drug samples (PharmaBiz)
  • IPC, US Pharmacopoeial Convention partner to strengthen quality of medicines, public health (PharmaBiz)

Australia

  • Questions & answers on the code of good manufacturing practice for medicinal products (TGA)
  • Submissions received: Accelerated assessment of medical devices - Priority Review pathway (TGA)

Other International

  • Sudanese research centre launches first-ever mycetoma trial (Pharmafile)

General Health & Other Interesting Articles

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.

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