Regulatory Focus™ > News Articles > 5 > Recon: Portola Bleeding Antidote Wins FDA Approval

Recon: Portola Bleeding Antidote Wins FDA Approval

Posted 07 May 2018 | By Ana Mulero 

Recon: Portola Bleeding Antidote Wins FDA Approval

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In Focus: International Pharmaceuticals & Biotechnology
  • As Trump Prepares Plan to Lower Drug Prices, Big Pharma Girds for a Fight (NYT)
  • The problem with prescription drug prices (CBS News)
  • Sarepta CEO Ingram nets $57M in 2017 pay, after half a year on the job (Fierce)
  • Drug Plans Drop After Trump Official Targets PBMs Ahead of Speech (Bloomberg)
  • As a prominent analyst predicts drug price controls, biopharma braces for a blow while Trump balls his fist (Endpoints)
  • Drug distributors get hauled to the Hill to face questions on opioids (STAT-$)
  • Arie Belldegrun, building out his new CAR-T startup, pursues senior biotech sell-sider for CFO post (STAT-$)
  • Trump often goes off script. What does that mean for his drug pricing speech? (STAT)
  • Here's what to expect when Trump outlines his policy to bring down drug prices (CNBC)
  • Tech workers are paying $7,000 to freeze their stem cells in hope of extending life (CNBC)
  • Infuscience FDA Form 483 Inspection Observations (FDA)
  • Evolus Appoints Allergan Aesthetics Head as President and Chief Executive Officer (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Turning CRISPR from a gene-editing hatchet to a ‘word processor’ (Fierce)
  • Promore sells rights to PXL01 in spinal surgery to PharmaResearch (Fierce)
  • Why did Merck issue an unusual press release? It knows investors are hyperfocused on I-O data (Fierce)
  • Controlling CAR-T: How scientists plan to make the engineered T cell therapy safer, and work for more cancers (C&EN)
  • Sarepta still shines, despite setbacks (EP Vantage)
  • Pfizer Selects Final Two Targets in Hepatic Disease Partnership with Wave Life Sciences (GEN)
  • Is biopharma’s first $1.5M therapy now in Phase III? (Endpoints)
  • Zydus Cadila gets USFDA nod for anesthesia drug (Economic Times)
  • Antipsychotics during pregnancy may raise risk of gestational diabetes (European Pharmaceutical Review)
  • Amneal Initiates Phase 3 Study for IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa (CD-LD) in Advanced Parkinson's Disease Patients (Press)
  • NantHealth and NantOmics Announce Publication of Study Highlighting High Error Rates in Tumor-Only Sequencing for Cancer Treatment (Press)
  • Melinta Therapeutics Receives Up to $6.2 Million from CARB-X to Advance Clinical Development of a Novel Antimicrobial to Combat Antibiotic-Resistant Bacteria (Press)
Medical Devices
  • Sarepta taps Invitae to identify participants for DMD trials (Fierce) (Press)
  • CardioFocus wins FDA nod for HeartLight AF balloon (MassDevice) (Press)
  • Siemens Healthineers and Hill-Rom team up to provide diabetes tools to primary care providers (Drug Delivery Business News) (Press)
  • NN closes $375m Paragon Medical buyout (MassDevice) (Press)
  • Screening Mammography Lowers Breast Cancer Patients' Needs For Aggressive Treatment, Study Finds (Forbes)
  • A 66-Year-Old Woman's Brain Implant Was Shut Off By a Lightning Strike (Fortune)
  • Mike Weinstein to Join Medtronic as Senior Vice President of Strategy (Press)
  • Using BrainScope One in Urgent Care Centers Shows Potential 75% Reduction in Head Injury Referrals to Emergency Departments (Press)
  • Castle Biosciences Presents Prospective Data Supporting Use of DecisionDx-Melanoma Test to Inform Sentinel Lymph Node Biopsy Recommendations (Press)
  • Cardiva Medical Announces Completion of the AMBULATE Pivotal Trial Evaluating the VASCADE MVP System for Multi-Vessel Closure Following Electrophysiology Procedures (Press)
  • Exact Imaging Receives FDA 510(k) Clearance for Adding the FusionVu Application to the ExactVu Micro-Ultrasound Platform (Press)
US: Assorted & Government
  • Fred's Pharmacies Should Get Plenty Of Bidders Amid Merger Wave (Forbes)
  • Trump administration draws a line on Medicaid rollbacks (Axios)
  • Longtime head of pharmacy benefit manager trade group to step down (STAT-$)
  • PEG 3350 Rx ANDA Holder Gets Things Moving in the D.C. Circuit (FDA Law Blog)
  • Theranos Cost Business and Government Leaders More Than $600 Million (WSJ)
  • Iowa governor signs 'fetal heartbeat' abortion ban into law (Reuters)
  • Paul Singer's Elliott makes all-cash offer for Athenahealth of $160 a share (CNBC)
  • ObamaCare rule requiring calorie counts on menus takes effect (The Hill)
  • Berkshire Hathaway, Amazon and JPMorgan Are Close to Hiring a CEO for Their Healthcare Venture (Fortune)
  • Hospitals sue BD, distributors, GPOs over alleged safety syringe monopoly (MassDevice)
  • All of Us Needs All of You (NIH Director’s Blog)
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling (FDA)
  • Proposed Rule: Medicare Program; Hospital Inpatient Prospective Payment Systems (Centers for Medical and Medicaid Service)
Upcoming Meetings & Events Europe
  • European Medicines Agency closed 9-11 May 2018 (EMA)
  • Two years of PRIME: Driving innovation to where it is most needed (EMA)
  • EMA gives go-ahead to new Auris trial for hearing loss drug (Fierce)
  • Precisioneffect boots digital chops, global reach with U.K. agency buy (Fierce)
  • Setback for Sarepta’s DMD drug in Europe (The Pharma Letter)
  • NHS IT glitch ‘caused deaths by cancelling cancer screening’ (pharmaphorum)
  • Spot Ex Endoscopic Tattoo Receives CE Mark - Launches in Europe (Press)
  • Transforming health systems through Data, Digital technology and Design - Part 1 (OpenGov)
  • Medtronic deals stake in China’s LifeTech Scientific (MassDevice)
  • Number of children in Japan shrinks to new record low (CNN)
  • Latest bid for India's Fortis "more risky", says Manipal CEO (Economic Times)
  • Govt may push for regulating manufacture, sale, import of implantable medical devices (Livemint)
  • Health ministry issues labelling norms for Schedule H, H1 and X drugs; to come into effect from Nov 1, 2018 (Pharmabiz)
  • Gujarat FDCA appoints 90 medical device officers to implement new MD rules (Pharmabiz)
  • Private Healthcare in India Part I: Artificially-inflated cost of medicine, consumables make non-govt hospitals inaccessible to most (Firstpost)
  • India must focus on making universal health coverage a reality (Hindustan Times)
  • Conflicts of interest and confidentiality obligations: Guidance for TGA advisory committee members (TGA)
  • Medical devices and IVDs: Cancellations from the ARTG (TGA)
  • Doctors raise alarm about ancient HTLV-1 virus: 'Prevalence is off the charts' in Australia (CNN)
  • Changes to PBS payment arrangements for certain medicines (The Pharma Letter-$)
  • Making Health Data Public Would Give Canada's Economy A Leg Up (HuffPost)
  • Health Canada's prescription opioid stickers and leaflets get a qualified welcome (CBC News)
  • Sask. health covers 56 prescriptions of abortion pill, no plans to introduce universal coverage (CBC News)
  • Medical-device companies say new safety rules will boost costs, force some companies out of Canada (The Globe and Mail)
  • Why did the maker of OxyContin pay Canadian doctors nearly three-and-a-half times more money per capita than it doled out to U.S. prescribers? (Toronto Star)
  • Government of Canada helps internationally trained health care professionals get their credentials and experience recognized in Canada (Employment and Social Development Canada)
General Health & Other Interesting Articles
  • New directory lists mental health providers with diabetes expertise (Reuters)
  • Banks are working to woo new doctors into home mortgages (CNBC)
  • A simple change of direction can make restaurant calorie labels more effective (STAT)
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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