Regulatory Focus™ > News Articles > 7 > Recon: Mylan Signs Licensing Deal on Humira with AbbVie

Recon: Mylan Signs Licensing Deal on Humira with AbbVie

Posted 17 July 2018 | By Ana Mulero 

Recon: Mylan Signs Licensing Deal on Humira with AbbVie

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In Focus: US Advertisement: Introducing BSI's Fall Medical Device Roadshow

Join leading global medical device Notified Body/ISO 13485 registrar BSI's full day Roadshow for our current experiences, best practices and latest expectations of the European MDR and quality assurance requirements. Topics include MDR implementation limitations, clinical requirements, labelling and UDI, technical documentation best practices, MDSAP, ISO 14971 application and the Quality Management System (QMS) aspects of the MDR. Click here for full agenda, dates and locations.

In Focus: International Pharmaceuticals & Biotechnology
  • Microsoft, Walmart ink AI, cloud pact to take on Amazon (Healthcare IT News)
  • Tammy Baldwin wants "permanent" price cuts for Pfizer's drug (Axios)
  • Ogilvy CommonHealth’s North America CEO snags new chief creative officer (Fierce)
  • Purdue defends against opioid lawsuits by pointing to FDA regulations it helped create (Fierce)
  • CRISPR-Cas3 Platform Developer Locus Biosciences Acquires EpiBiome Phage Technology (GEN)
  • Hospitals can save money on drugs without Washington’s help (STAT)
  • Three years after steep price hike, Martin Shkreli’s drug company is losing money, documents show (STAT-$)
  • That CRISPR study, in the cold, clear light of morning: why it’s raising concerns (STAT-$)
  • Susan Collins expresses doubt on Trump proposal to post drug prices on ads (Washington Examiner)
  • Could Amgen Eye Alexion as a M&A Target to Offset Neulasta Decline? (BioSpace)
  • 5 drugs to watch as biotechs report Q2 (BioPharma Dive)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Pfizer begins late-stage testing of Spark's hemophilia B gene therapy (Philadelphia Business Journal-$) (Press)
  • Potential DNA damage from CRISPR has been ‘seriously underestimated,’ study finds (STAT) (The Conversation) (New Scientist) (Reuters) (Fierce)
  • June was a Busy Month for the FDA, Which Approved 7 Novel Drug Approvals (BioSpace)
  • Pharmacology of CAR-T Cells (News Medical)
  • No more ‘sledgehammer’: As gonorrhea grows resistant to antibiotics, researchers look to bespoke treatments (STAT)
  • Amyloid Plaques Better Understood through Use of High-Resolution Nanoscope (GEN)
  • Llama-Derived Nanobody May Tread Narrow Anticancer Path (GEN)
  • Artificial Intelligence may predict side effects of drug combinations (EPR)
  • Drug derived from chilli peppers aids a loss (Deccan Chronicle)
  • CytoDyn touts new data in drug-resistant HIV patients (BioPharma Dive)
  • Arcus Biosciences Announces Final Safety Results From Phase 1 Trial for AB928 in Healthy Volunteers (Press)
  • Viking Therapeutics Announces VK5211 Phase 2 Study Results Selected for Plenary Oral Presentation at ASBMR 2018 Annual Meeting (Press)
  • Voyager Therapeutics Receives FDA Guidance on Development Path for VY-AADC for Parkinson’s Disease and Provides Clinical Update (Press)
  • Asterias Provides Six Month Data Readout for its AST-OPC1 Phase 1/2a Clinical Trial in Severe Spinal Cord Injury (Press)
Medical Devices
  • Next-gen clinical decision support tools: Analytics and health data in the EHR workflow (Healthcare IT News)
  • MTaI organises 'Medical Packaging Seminar’ to educate professionals on new medical device rules introduced in Europe (Pharmabiz) (Business Standard)
  • Abbott’s St. Jude Medical must face negligence suit over Riata leads (MassDevice)
  • BD’s Bard wins third IVC filter bellwether (MassDevice)
  • Insulet settles shareholder suit over Omnipod Eros device (DDBN)
  • CeQur acquires Johnson & Johnson's Calibra insulin delivery patch (MobiHealthNews)
  • Medical device connectivity market could exceed $1B by 2022 (Healthcare Dive)
  • Quidel Receives FDA Clearance for Solana Bordetella Complete Molecular Diagnostic Assay for the Detection of Pertussis (Whooping Cough), Parapertussis Infections (Press)
US: Assorted & Government
  • UnitedHealth Raises Profit Outlook (WSJ)
  • Next battleground for Big Tech: retail prescription drugs (Axios)
  • Is Baby Powder Dangerous? Does Industry Even Care? (NYT)
  • In prescription drug business, will Amazon partner with PBMs, or seek to conquer them? (STAT-$)
  • Drug industry takes center stage in Senate race, as Hugin punches back against Menendez (STAT-$)
  • CMS new rule: Industry reacts to big changes to telehealth, clinical documentation, and interoperability (MobiHealthNews)
  • Texas' fetal remains burial law shames women, abortion providers argue in trial (Dallas News)
  • Judge rules for Trump administration in suit over family-planning program shift (Reuters)
  • White House: U.S. Can’t Afford Veterans’ Health Care Without Cuts (New York Magazine)
Upcoming Meetings & Events Europe
  • U.K. health officials make a counteroffer to Vertex for its pricey cystic fibrosis drugs (STAT-$)
  • Vertex says it's glad England made another offer for CF drugs, but it'll have to do bette (Fierce)
  • Russian President calls for reform of national drugs procurement system (The Pharma Letter-$)
  • Fast-growing e-cigarette maker Juul to launch in UK (Reuters)
  • UK ethics body says gene-edited babies may be 'morally permissible (Reuters)
  • Probiotics studies often don’t disclose safety data or risks, report finds (STAT)
  • Lumendi wins CE Mark, launches DiLumen EIP in EU (MassDevice)
  • Brand new x-ray technology set for production in the UK (Gov UK)
  • Updated: Decide if your product is a medicine or a medical device (MHRA)
  • Pause on the use of vaginally inserted surgical mesh for stress urinary incontinence. (MHRA)
Asia
  • China FDA Eases Country-of-Origin Requirements for Hong Kong-based Medical Device Registrants (Emergo Group)
  • Fetal Gene Therapy Prevents Fatal Form of Gaucher Disease (GEN)
  • Qatar Health Ministry recalls 7 pharma products (BioSpectrum)
  • Israel Govt to grant funds to GE, Change & Medtronic (BioSpectrum)
  • Korean take more drugs than OECD average (Korea Biomedical Review)
  • When will Seoul update drug review system for cell therapies? (Korea Biomedical Review)
  • Mesoblast Enters Into Strategic Cardiovascular Alliance for China With Tasly Pharmaceutical Group (Press)
India
  • India, Bahrain make pharma a key area of cooperation (CNBC)
  • India is getting its first public healthcare record system to track the health of all citizens! (India Today)
  • Biosimilar Ranibizumab Effective in Treating RVO in a Real-World Setting (The Center for Biosimilars)
  • Essential list of medicines to be revised; medical devices and consumable may be included (Times of India)
  • Leading 100 Indian pharma companies post dismal performance in 2017-18 with single digit growth in sales (Pharmabiz)
  • Gujarat FDCA serves notices to five blood banks for dispatching unsafe blood to govt hospitals (Pharmabiz)
  • LeapFrog Acquires Majority Stake in Ascent Meditech, a Leading Indian Medical Products Company (Press)
Australia
  • Experimental blood test could detect melanoma skin cancer early, study finds (CNN)
  • My Health Record: privacy, cybersecurity and the hacking risk (The Guardian)
  • Cancer’s Grip May Be Loosened by Tampering with DNA Clamp (GEN)
  • TGA business portals scheduled maintenance, 27-29 July 2018 (TGA)
Canada General Health & Other Interesting Articles
  • Why Don’t More Americans Use PrEP? (NYT)
  • Liver cancer death rate in US surged 43% in 16 years (CNN)
  • Hospitals can save money on drugs without Washington’s help (STAT)
  • Health Insurers Are Vacuuming Up Details About You — And It Could Raise Your Rates (NPR)
  • Legal same-sex marriage helps gay men's health, research shows (NBC)
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.
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