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

• United Therapeutics puts $216m on the table to buy rival SteadyMed (Drug Delivery Business News) (Endpoints) (Fierce) (BioPharma Dive)
• Jazz grabs Spark’s priority review voucher for $110M (Fierce) (Endpoints) (Philadelphia Business Journal-$) (Focus)
• Allergan CEO opposes fundamental shift in strategy, shares fall (Reuters) (BioPharma Dive) (Fierce) (Business Insider) (Reuters) (Endpoints)
• US priority review for Sanofi, Regeneron’s cemiplimab (PharmaTimes) (The Pharma Letter)
• Fitbit will use Google Cloud to make its data available to doctors (TechCrunch) (Modern Healthcare) (Business Insider) (CNBC)
• Leena Gandhi steps out of Keytruda spotlight and into a top research job at I/O laggard Eli Lilly (Endpoints) (Fierce)
• Bill Gates got President Trump fired up about a universal flu vaccine — and also (maybe) got a job offer (STAT)

• Law maker asks PM to reject US pressure on bringing medical devices like stents & knee implants under ceiling price (Pharmabiz) (Times of India) (The Tribune) (Business Today)
• LivaNova closes $190 CRM sale to MicroPort (MassDevice) (Fierce)
• Crescendo snares $70M Series B for its tumor-fighting tech (Endpoints) (Fierce)
• Vertex facing pressures to cut prices on both sides of Atlantic (The Pharma Letter) (pharmaphorum)
• Updated:  EMA tracking tool: relocation to Amsterdam (EMA)
• CFDA proposes 12-year data exclusivity for innovative biologics (BioCentury)
• China slashes value added tax on over 100 cancer drugs (S&P Global)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• 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 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)

• 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)

• 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)