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Recon: Incyte, Merck melanoma combo therapy fails in study

Posted 06 April 2018 | By Ana Mulero 

Recon: Incyte, Merck melanoma combo therapy fails in study

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

In Focus: US
  • Incyte, Merck melanoma combo therapy fails study, shares slide (Reuters) (STAT) (Fierce) (Endpoints) (Financial Times)
  • Leap of faith? Buzzy anti-aging biotech Unity pitches an $85M IPO based on mouse data (Fierce)
  • When These New Pharma Bros Show Up, Drug Prices Tend to Go Monumentally Higher (Bloomberg-$)
  • Facebook sent a doctor on a secret mission to ask hospitals to share patient data (CNBC) (The Hill) (The Verge) (Fortune)
In Focus: International
  • Novartis, still embroiled in Greek probe, faces kickback allegation in China—again (Fierce)
  • China pushes generics over brands with another round of new pharma policies (Fierce)
  • Generics likely to suffer most from Trump's trade war with China (The Pharma Letter)
  • Torrent Pharmaceuticals drops plan to buy Sanofi's Europe business (Business Standard) (Fierce)
  • Lupin gets EIR from US FDA for Pithampur facility (Economic Times) (Business Line
Pharmaceuticals & Biotechnology
  • J&J Must Pay Millions Over Banker's Baby Powder Cancer Claim (Bloomberg-$) (Reuters)
  • With a deadline looming, Takeda CEO Weber woos analysts for support of a Shire buyout (Endpoints)
  • Caravans of Biotech Immigrant Executives (Life Sci VC)
  • Sarepta Therapeutics beats bid to revive shareholder class action (Reuters)
  • Merck gets a lift, Pfizer a ding as analysts assess immuno-oncology, M&A outlook (Fierce)
  • Feds broaden the definition of ‘pharmacy’ in a bid to level playing field for startups (STAT-$)
  • Drug makers have to post policies for patients seeking experimental medicines. Not all do (STAT-$)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Hydrogel delivery enables long-lasting, ‘flare-responsive’ arthritis treatment (Fierce)
  • Trials for potential ALS treatment using stem cells spark cautious hope (STAT-$)
  • Columbia Researchers Grew Tissue That Acts Just Like Human Heart Muscle (Fortune)
  • Fine-tuning formulation with Fluid Imaging Technologies’ FlowCam (Drug Delivery Business News)
  • Clinical trials may be based on flimsy animal data (Science Magazine)
  • UCLA scientists pioneer new method for watching brain cells interact in real time (UCLA)
Medical Devices
  • LeMaitre Vascular deals Reddick surgical assets to Symmetry for $7m (MassDevice)
  • Bard Meshes Didn't Harm Woman, Harvard Doctor Tells Jury (Law360-$)
  • Researchers back outcomes-based payments for medical devices as industry braces for a shift (Fierce)
  • SEC sues Nova Oculus owner Peter Pocklington and 5 others for alleged $14M fraud (Fierce)
  • Cardiva Medical Announces FDA Approval of VASCADE Vascular Closure System for Use in Femoral Vein Closure (Press)
US: Assorted & Government
  • How Trump's New Medicare Rules Boost Amazon And Walmart (Forbes)
  • Massachusetts Wants To Drive Down Medicaid Drug Costs: Why Is The Administration So Nervous? (Health Affairs)
  • Democrats Aim to Turn Obamacare Into Asset From Burden in 2018 (Bloomberg)
  • Missing CDC worker Timothy Cunningham likely drowned, no signs of foul play: Officials (ABC  News) (CNN) (The Washington Post) (TIME)
  • CMS’ plan to ‘wind down’ federal exchanges by 2020 relies on a big ask from Congress (Fierce)
  • The CHRONIC Care Act Is A Good Start, But Caregivers Need More Help (Forbes)
  • Aetna HIV Privacy Suit Goes Back To Calif. State Court (Law360-$)
  • Registration open: FDA seminar “Management of Risk through the Product Life-Cycle” (Notice)
  • Multiple Interim Patent Term Extensions Revisited and the Rule of Three (FDA Law Blog)
  • Submission for Office of Management and Budget Review; Comment Request FDA regulations regarding infant formula requirements (FDA)
  • Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (FDA)
  • Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830 (FDA)
  • Submission for Office of Management and Budget Review; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (FDA)
  • International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9 Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; Cannabidiol; Request for Comments (FDA)
Upcoming Meetings & Events Europe
  • The Man That Launched Apple In Britain Is "Saving The Past" From His Barge (Forbes)
  • Britain's sugar tax on soft drinks comes into effect (Reuters)
  • NI digital “hub” aims to improve youngsters’ mental health (pharmaphorum)
  • Kaiku bags cash to show software improves cancer outcomes (Fierce)
  • Brexit at Halfway: Pharma and Medical Devices (Lexology)
  • EMA to review Aradigm's appliation for Linhaliq (The Pharma Letter) (Press)
  • Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: Identifying solutions for big data challenges (EMA)
  • Urgent: Recall Notification Prothrombin Complex Concentrate (Human) (FDA)
  • PMDA views on applying continuous manufacturing to pharmaceutical products for industry (provisional draft) posted (PMDA)
  • Healthcare affordability improves in Singapore (BioSpectrum)
  • China sperm bank demands Communist Party loyalty from donors (BBC News)
  • India's first ivy league healthcare management program for executives (Economic Times)
  • India must revitalise its public health system (The Asian Age)
  • Gujarat FDCA in talks with Abbott to train drug inspectors on new MD rules (pharmabiz)
  • Medical devices and IVDs: Suspensions from the ARTG (TGA)
  • TGA presentation: ARCS Regulatory Affairs Interest Area Meeting, 27 March 2018 (TGA)
  • Australia's e-health push lifts start-up Tyde (Australian Financial Review)
  • Breast cancer patients facing health cover gaps of more than $10,000, survey shows (The Guardian)
  • Unauthorized products may pose serious health risks (Health Canada)
  • Notice: (ICH) Guidance: E11(R1) Addendum (Health Canada)
  • OxyContin maker to appeal judge's decision to reject $20M Canadian settlement (CBC News)
  • Opioid Crisis The Living Legacy Of Public Health Agency's Neglect (Huffington Post Canada)
  • Veterans Affairs Canada expands access to mental health services in Kingston (Press)
General Health & Other Interesting Articles
  • Smartphones could help measure Parkinson's disease symptoms (Reuters)
  • How To Make Health Insurance Part Of Your Retirement Planning (Forbes)
  • Older People Can Still Produce New Brain Cells, Study Shows (Forbes)
  • Kindred Shareholders Approve Humana Deal Amid Walmart Speculation (Forbes)
  • The most common knee surgery for seniors is costly, and usually a waste (CNBC)
  • Doctors like me are at a loss when parents can’t agree on their child’s treatment (STAT)
  • How to Pay Less for Your Meds (Consumer Reports)
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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