Regulatory Focus™ > News Articles > 4 > Recon: United Therapeutics Seeks to Buy Rival SteadyMed for $216m

Recon: United Therapeutics Seeks to Buy Rival SteadyMed for $216m

Posted 30 April 2018 | By Ana Mulero 

Recon: United Therapeutics Seeks to Buy Rival SteadyMed for $216m

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

In Focus: US In Focus: International Pharmaceuticals & Biotechnology
  • MSF: USTR Special 301 Report Calls Out Countries for Protecting Public Health (Doctors Without Borders)
  • PhRMA Welcomes 2018 Special 301 Report, Applauds Administration for Combatting Discriminatory Pricing and Intellectual Property Barriers Abroad (PhRMA)
  • Sam Isaly leaves OrbiMed months after harassment allegations (STAT) (Fierce) (MassDevice)
  • How A Drug Company Under Pressure For High Prices Ratchets Up Political Activity (KHN)
  • Drugmakers push back against lawmakers’ calls to tax opioids (AP News)
  • Who’s the top earning CEO in biopharma? Martine Rothblatt once again hits top slot with $37M pay package (Endpoints)
  • Biogen CEO’s pay jumps as he takes the top seat, but the stock's still falling (Fierce)
  • GSK's Shingrix blows past sales projections, pushing 2018 estimates to $600M (Fierce)
  • Sermo's 'Yelp for drugs' platform chalks up 665K doctor reviews in just 1 year (Fierce)
  • Aerie launches glaucoma drug in U.S. (Drug Delivery Business News) (Press)
  • States consider forcing drugmakers to pay for opioid addiction rehab (Axios)
  • Teva to reduce size of board after June shareholders meeting (Reuters)
  • Biogen Must Face FCA Suit Minus 17 State-Level Claims (Law360-$)
  • Celgene’s beaten-down stock is cheap, but only if investors regain trust in its financial outlook (STAT-$)
  • Another Trophy Quarter For VC-Backed Biotech Funding (Life Sci VC)
  • Novo Nordisk ties discounts to adherence in SMS pilot (pharmaphorum)
  • GSK strengthens core prescription business with Sin hire (pharmaphorum)
  • Allergan May Need More Than a Facelift (Bloomberg)
  • AbbVie Must Escape the Shadow of Humira's Decline(Bloomberg)
  • Celgene Corporation Announces Appointment of Jennifer Dudinak to Senior Vice President of Global Regulatory Affairs (Press)
  • Spectrum Pharmaceuticals Announces Corporate Governance Enhancements and Board Changes (Press)
  • 4DMT and ROCHE Expand Ophthalmology Partnership to Develop and Commercialize Multiple AAV Gene Therapy Products (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • PARP Drugs Help Some Metastatic Breast Cancer Patients, But They're No Magic Bullet (Forbes)
  • Boehringer cracks the lab door, reveals cancer, immunology and neurology projects (EP Vantage)
  • Interview – Addex looks up from abyss (EP Vantage)
  • FDA calls for more studies for Vertex's VX-561 (BioPharma Dive)
  • Allergan defends ubrogepant's marketability (BioPharma Dive)
  • FDA clears Pluristem radiation treatment for emergency use (Reuters)
  • AbbVie halts trial of Stemcentrx-sourced ADC for cancer (Fierce)
  • Synthorx reels in $63M to push synthetic cytokines into the clinic (Fierce)
  • No change in FDA's position on Parkinson's drug Nuplazid (San Diego Tribune)
  • Pharma giants are looking to ketamine for clues to the next blockbuster depression drug — and science says they're onto something big (Business Insider)
  • Richard Lehman’s journal review—30 April 2018 (The BMJ Opinion)
  • Researchers find no chronic wasting disease transmissibility in macaque (Pharmabiz)
  • ALS researchers begin recreating human spinal cords on a chip (NIH)
  • FDA Briefing Document: Plazomicin sulfate Injection: Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC) (FDA)
  • Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (Press)
  • NanOlogy Completes Dose Escalation Portion of Phase 2 Clinical Trial of NanoPac for Treatment of Prostate Cancer (Press)
  • TAVALISSE (fostamatinib disodium hexahydrate) Phase 3 Data Published in the American Journal of Hematology Describes Pivotal Data and Overall Response Rate Versus Placebo (Press)
  • FDA Grants Priority Review to Merck’s sBLA for KEYTRUDA (pembrolizumab) in Combination with Pemetrexed (ALIMTA) and Platinum Chemotherapy Based on Results from Phase 3 KEYNOTE-189 Trial as First-Line Treatment of Metastatic Nonsquamous NSCLC (Press)
  • Capricor Announces Initiation of HOPE-2 Clinical Trial of CAP-1002 for Duchenne Muscular Dystrophy (Press)
Medical Devices
  • FDA chief sees big things for AI in healthcare (Healthcare IT News)
  • Delays in adding new newborn screening tests harm babies, families (STAT)
  • Navamedic's Sippcoat for digital urine handling and bacteria control receives US patents (Pharmabiz) (Press)
  • Roivant’s Datavant raises $41M, buys data de-identification firm UPK (Fierce)
  • Boston Scientific closes $400m NxThera buy (MassDevice) (Press)
  • DePuy Wins Infringement Damages Cap For Missing IP Marks (Law360-$)
  • Butterfly wings inspire light-manipulating surface for medical implants (Science X)
  • Is FDA Really Streamlining Its PMA and 510(k) Processes? (MD+DI)
  • Terumo Aortic launches feasibility study of RelayBranch thoracic stent-graft (MassDevice)
  • William Hyman: Will Unique Device Identifiers Live Up to the Hype? (AAMI)
  • Medtronic Announces FDA Approval of Infuse Bone Graft in New Spine Surgery Indications Using PEEK Interbody Implants (Press)
  • Meditech Spine expands its lumbar plating options by adding the CURE LP iView and QMax to its growing portfolio of spinal implants (Press)
US: Assorted & Government
  • Bipartisan group pushes opioid action plan (BioPharma Dive)
  • A Supreme Court victory for lowering drug prices (The Hill)
  • D.C. Week: House, Senate Move on Opioids (MedPage Today)
  • Aside From Trump, Democrats See Public Option As Key To Blue Wave (Forbes)
  • Dissecting The Rhetoric Vs. Reality Of Trump’s Tough Talk On Drug Prices (KHN)
  • Right to try bill stalled indefinitely in Congress (The Pharma Letter)
  • Medicare's proposed direct-contracting model carries both rewards and risk (Modern Healthcare)
  • Ascension's Tersigni on short list for VA secretary (Modern Healthcare)
  • Senate approves full new slate of FTC commissioners (Politico)
  • All you need to know for round 2 of the CRISPR patent fight (STAT)
  • What Veterans Affairs needs to fix its deeper issues (Axios)
  • Ninety-eight now sick from romaine lettuce-linked E. coli: CDC (Reuters)
  • A Tale of Two Guidances: FDA Issues Final Next Generation Sequencing Guidances (FDA Law Blog)
  • Ambitious precision medicine project starting up (Politico)
  • Capitol Checkup: CRISPR appeal; Trump doc ordeal; biodefense bill (S&P Global)
  • Use of Genealogy Data to Track Golden State Killer Raises Privacy Questions (WSJ)
  • Advancing the Development of Treatments for Neurological Disorders (FDA)
  • Advancing the Science of Nanotechnology in Drug Development (FDA)
  • Senator Murray calls for scrutiny of CDC Director pay (Letter to HHS)
  • Fixing health care: Driving value through smart purchasing and policy (AEI)
Upcoming Meetings & Events Europe
  • Not so unified: Brexit means uncertainty for European patent law (EP Vantage)
  • ABPI Conference Speech - Lisa Anson, President of the ABPI (ABPI)
  • Civil society representatives wanted for EMA's Management Board and Pharmacovigilance Committee (EMA)
  • Field Safety Notice - 23 to 27 April 2018 (MHRA)
  • BD Vacutainer EDTA & BD Vacutainer Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology (MHRA)
  • Independent opportunities: How splitting from EMA could create opportunities for MHRA to innovate post-Brexit (BioCentury)
  • NHS considers AI-based therapy training for staff (pharmaphorum)
  • Final NICE nod for Keytruda in bladder cancer (PharmaTimes)
  • Tandem Diabetes Care Receives CE Mark for t:slim X2 Insulin Pump (Press)
  • Terumo Acquires CE Marking for Ultimaster Tansei Drug Eluting Stent (Press)
  • Terumo Aortic Announces European Launch of Relay Pro Thoracic Stent Graft System at Charing Cross 2018 (Press)
Asia
  • Ono Pharma submits marketing approval of metyrosine in Japan (The Pharma Letter)
  • AstraZeneca set for Japanese approval in lung cancer (The Pharma Letter)
  • Nepal's medical drones bring healthcare to the Himalayas (The Straits Times)
  • The secret burden of mental illness in Hong Kong (CNN)
  • Hong Kong scrambles for talent in battle for Nasdaq's biotech crown (Reuters)
  • Singapore, home to strict drug laws, looks to develop synthetic marijuana compounds (CNBC)
India
  • CDSCO waives need for NOC for importing drugs of dual use (Pharmabiz)
  • NPPA raises price of Abbott’s phenytoin, keeps Sun's nitrofurantoin 100mg rate at Rs.7.13 (Pharmabiz)
  • Maha FDA to implement new MD Rules with appointment of notified bodies at CDSCO soon (Pharmabiz)
  • India Leads in Vaccine Production but Not in Vaccination (The Wire)
  • Healthcare: India mustn’t give in to US policy pressures (Business Line)
  • Firm blow to health tests (The Telegraph)
  • Rampant evergreening in Indian pharma industry (Livemint)
  • AICTE gets 600 applications for pharma institutes (Economic Times)
  • Government to demarcate 'stem cell therapy' from 'stem cell drug' (Economic Times)
Australia
  • Australia opens new research hub to drive technological advances in medical devices (OpenGov)
  • Digital health and big data highlighted in Victoria's Melbourne Biomedical Precinct Strategic Plan (OpenGov)
  • Palliative Care Jobs Boost For Regional Victoria (Minister for Health)
  • Ventilators: TGA product safety review (TGA)
Canada
  • Canadian researchers create tiny 'lab on a chip' to test for infectious diseases (CTV News)
  • Canada is urged to open criminal probe into Purdue over opioid crisis (STAT-$)
  • Trade negotiations could be hampered by large pharmaceutical companies, putting Canadians at risk (The Guardian)
General Health & Other Interesting Articles
  • Injecting Drugs Can Ruin a Heart. How Many Second Chances Should a User Get? (NYT)
  • For Cancer Centers, Proton Therapy’s Promise Is Undercut by Lagging Demand (NYT)
  • AI-Powered Systems Target Mental Health (WSJ)
  • These DNA testing companies are mainly trying to sell you other stuff (MIT Technology Review)
  • Bill Gates is glad Amazon is getting into health care — but cautions it’s complicated (STAT-$)
  • Why Health Isn't Digital (Forbes)
  • Miracle cures or modern quackery? Stem cell clinics multiply, with heartbreaking results for some patients. (The Washington Post)
  • How to Accelerate the Adoption of Digital Health Technology (Harvard Business Review)
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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