Regulatory Focus™ > News Articles > 6 > Recon: Amgen's Blincyto Gets Full EU Approval for Rare Leukemia; GSK, Gilead Headed for HIV Showdown

Recon: Amgen's Blincyto Gets Full EU Approval for Rare Leukemia; GSK, Gilead Headed for HIV Showdown

Posted 20 June 2018 | By Ana Mulero 

Recon: Amgen's Blincyto Gets Full EU Approval for Rare Leukemia; GSK, Gilead Headed for HIV Showdown

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

In Focus: US 

  • Finding Cancer Patients Is the Pharma Industry’s Unlikely Challenge (Bloomberg

  • OxyContin maker Purdue Pharma cuts remaining sales force (Reuters) (Bloomberg) (Vice

  • Medtronic, Nutrino partner to bring nutrition info to glucose monitoring app (MobiHealthNews)  

  • Therano’s former president has a jaw-dropping explanation for why he’s innocent (Vanity Fair

In Focus: International 

  • New human gene tally reignites debate (Nature

  • Mayo Clinic exploring blockchain EHR use cases with UK startup (Healthcare IT News

  • Ebola outbreak in Congo 'largely contained', says WHO (Reuters

Pharmaceuticals & Biotechnology 

  • Demand For Gene Therapies To Prompt Surge In Pharma M&A (Forbes

  • There Go Those Drug Companies Inventing New Diseases Again (Forbes

  • FindMeCure Does Exactly What It Says On The Tin (Forbes

  • Latecomer Sanofi looks to catch next wave of cancer therapies (Reuters

  • What's next for Elizabeth Holmes in the Theranos fraud case? (NYT

  • More tests are needed to develop a gene therapy for a rare genetic disease: Sarepta CEO (CNBC

  • Express Scripts boots another online pharmacy — CareZone — from its network (CNBC

  • Synthetic DNA as Easy as 1-2-3 with One-and-Done Enzymes (GEN

  • Eidos Therapeutics raises $106M IPO to advance ATTR med (Fierce

  • Universal flu vaccine biotech seeks Big Pharma partnership for phase 3 testing: CEO (Fierce

  • Seattle Children’s aims to cure terminal brain cancer using immunotherapy with new BrainChild initiative (GeekWire

  • Guide: 15 Boston Microbiome Startups to Watch (American Inno

  • DOJ To Participate In Opioid MDL Settlement Talks (Law360-$) 

  • Opioid Research Rules Tweaked In Bills Passed By House (Law360-$) 

  • Opioid supply levels decline in most states, report finds (BioPharma Dive

  • Mass. lost out to Rhode Island on Amgen plant, 300 jobs (Boston Business Journal-$) 

  • Opioid Ruling Could Send Purdue, Drugmakers to Court (Bloomberg

Pharmaceutical and Biotechnology: Study Results, Filings and Designations  

  • Array Hope Rises as Potential FDA Approval of Melanoma Treatment Nears (BioSpace

  • How badly does Alexion want its Soliris follow-on? Enough to use a rare fast pass (BioPharma Dive

  • What Sarepta’s game-changing data mean for biotech’s other Duchenne players (STAT-$) 

  • Former Aegerion Execs Say FDA Approval Negates FCA Case (Law360-$) 

  • argenx reports interim data from first cohort of Phase 2 proof-of-concept clinical trial of efgartigimod for the treatment of pemphigus vulgaris (Press

  • Prothena Announces Phase 1b Clinical Trial Results of PRX002/RG7935 for Parkinson's Disease Published in JAMA Neurology (Press

  • Kala Pharmaceuticals Announces Update to KPI-121 0.25% Development Plan (Press

  • Kura Oncology Appoints Chief Operating Officer, Expands Clinical Development Team as Company Prepares for First Registration-Directed Trial (Press

Medical Devices 

  • Next-gen medical devices: Security, AI, rethinking design for patient experience (Healthcare IT News

  • Top threats from weaponized organisms (Axios

  • FDA warns on leak risk with discontinued Endologix stent graft (MassDevice

  • FDA lifts Staar Surgical warning letter (MassDevice

  • Johnson & Johnson launches new self-shortening Dynacord suture (Medical Design & Outsourcing

  • Bronchoscopes still dirty after cleaning, study says (Medical Design & Outsourcing

  • Barriers to genomic testing get in the way of precision medicine (STAT

  • AngioDynamics Seeks Biolitec Patents To Satisfy $75M Award (Law360-$) 

  • Nevro Pushes For Clarity On Expert Testimony At PTAB (Law360-$) 

  • Pa. Panel Says J&J Unit Must Face Out-Of-State Plaintiffs (Law360-$) 

  • 7 challenges medical devices pose to providers (Health Data Management

  • Scammers trick seniors with ‘free’ medical devices, then bill Medicare (The Columbus Dispatch

  • Medtronic Announces Second Bone Cement Solution Indicated for Treating Sacral Fractures (Press

  • TransMed7, LLC Announces 510(k) Clearance by the U.S. FDA for its SpeedBird Soft Tissue Biopsy Device Platform (Press

  • STRATA Skin Sciences Announces 510(k) Submission for its Multi Micro Dose Tip Accessory for the XTRAC 308nm Excimer Laser (Press

US: Assorted & Government 

  • Congress Is Writing Lots of Opioid Bills. But Which Ones Will Actually Help? (NYT

  • Psychotherapeutic intervention shows promise for treating depression in preschool-aged children (NIH

  • Methadone and buprenorphine reduce risk of death after opioid overdose (NIH

  • Walmart submitted patent for blockchain, wearable, biometric scanner-based EHR system (MobiHealthNews

  • Apple taps RapidSOS to help emergency responders pinpoint iOS users' locations (MobiHealthNews

  • Like Ma Bell, I’ve Got the Ill Communications: Final Guidances Issued (FDA Law Blog

  • Google AI predicts hospital inpatient death risks with 95% accuracy (Fierce)  

  • Trump administration puts skimpy health insurance plans in place (Reuters

  • Walgreens and Humana are partnering to create senior health hubs (CNBC

  • Veritas Capital-Backed Verscend to Acquire Cotiviti for About $4.16 Billion (WSJ

  • Conservatives' latest plan to repeal the Affordable Care Act (Axios

  • Meet The Judge Who Will Decide The ACA's Fate (Law360-$) 

  • Patent No. 10,000,000 Shows Interest Strong Despite Risks (Law360-$) 

  • Facebook to redirect users searching for opioids to federal crisis help line (STAT

  • AMA Says Regulators Should Block CVS-Aetna Deal (Forbes

  • VA tackles interoperability, massive data stores with open FHIR API project (Healthcare IT News

  • Opioid crisis sending thousands of children into foster care (The Hill

Upcoming Meetings & Events 

Europe 

  • Making labels comply with MDR (PharmaTimes

  • Pancreatic cancer survival much lower than thought, research finds (PharmaTimes

  • RNA-Seq Identifies Asymptomatic Individuals Who Will Develop Active TB (GEN

  • Pfizer’s 'Living With Cancer' wowed Cannes attendees, if not the pharma jury (Fierce

  • Lions Health: Mylan CEO talks big and small creative ideas that make a difference (Fierce

  • Lions Health, Day 2: Fear factors, pharma humor and how can we win next year? (Fierce

  • Karuna Pharma granted $8 million to develop schizophrenia candidate (The Pharma Letter

  • Patients call for end to two-year row over CF drug funding (pharmaphorum

  • Updated Guidance: Medical devices: software applications (apps) (MHRA

  • Modernising the orphan designation process: EMA launches new submission portal today (EMA

Asia 

  • Takeda’s CEO on China, Cancer Drugs and Alzheimer’s Disease (Bloomberg

  • Takeda chief's gamble of a lifetime shakes drugmaker to the core (Nikkei Asian Review

  • With an AstraZeneca cancer drug in one hand, $37M in the other, Shanghai’s Alpha Bio zooms into a PhII study (Endpoints

  • China Biologic receives unsolicited takeover offer (The Pharma Letter

India 

  • MTaI cheers NITI Aayog concept note on trade margin, asks for non-discriminatory approach (Pharmabiz

  • CDSCO identifies 300 top brands for ‘trace and track’ mechanism, to meet firms on June 25 to discuss implementation (Pharmabiz

  • India gets its 1st ever national healthcare facility registry by Modi govt; another feather in health sector’s cap (Financial Express

  • Bangladesh’s bulk drugs policy may hurt Indian exports (Livemint

Australia 

  • Changes to fees and charges effective 1 July 2018 (TGA

  • Share your thoughts with us in the 2018 TGA surveys (TGA

  • Australia’s National Digital Health Strategy promotes interoperable and secure communication (OpenGov

  • Most Australian adults are overweight, says new report. How do you compare? (AFR

  • Is vaping really harmless? South Australian push for stronger regulations on e-cigarettes (ABC News

Canada 

  • Breast Cancer Epigenetics Study Reveals Potential Drug Targets (GEN

  • Release of information contained in drug submissions and medical device applications (Lexology-$) 

  • Darlington Nuclear to Become New Source of Lifesaving Medical Isotopes (Press

  • Significant reductions in costly pulmonary complications with use of drug-free device (Press

General Health & Other Interesting Articles 

  • Prescribing Opioids: How Many Are Too Many? (NYT

  • Maxed out your 401(k) plan? Here's another way to save (CNBC

  • A new approach can take patient safety to the next level  (STAT

  • A New Behavioral Therapy Helps Kids With Depression--And Their Parents (Forbes

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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