Regulatory Focus™ > News Articles > 3 > Recon: First Allogeneic Stem Cell Therapy Authorized in EU

Recon: First Allogeneic Stem Cell Therapy Authorized in EU

Posted 26 March 2018 | By Ana Mulero 

Recon: First Allogeneic Stem Cell Therapy Authorized in EU

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

In Focus: US In Focus: International Pharmaceuticals & Biotechnology
  • Sell, Spin or Keep? Pfizer in a Quandary on Advil-Chapstick Unit (Bloomberg)
  • Trump opioid plan writes in favoritism to single company’s addiction medication (STAT)
  • Investors in AbbVie, Lilly, Amgen and more set to vote on executive pay, drug pricing (Fierce)
  • Seasoned reps could help Aclaris' Eskata with a pleasantly surprising launch: analyst (Fierce)
  • A billionaire couple is pumping money into the drug pricing debate. Can they loosen pharma’s grip? (STAT)
  • SEC greenlights shareholder proposals for several big drug makers over pricing (STAT-$)
  • Pharma's social media strategies are growing up—and working better, too, report finds (Fierce)
  • NovaQuest Capital Management acquires CutisPharma (The Pharma Letter-$) (Press)
  • Improving health literacy is in pharma’s interests (pharmaphorum)
  • What's more prescribed than opioids? Weirdly, a thyroid drug (BioPharma Dive)
  • Novo Holdings looks to boost life sciences investments (Fierce)
  • Drugmaker's Investors Sue For Books On $885M In Sanctions (Law360-$)
  • Final rule: technical amendment to reflect organizational change for the Office of Regulatory Policy, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco (FDA)
  • Request for nominations to serve on the Pharmacy Compounding Advisory Committee, Division of Advisory Committee Consultant Management, Center for Drug Evaluation and Research (FDA)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Targeting liver enzyme may combat obesity-induced diabetes (Fierce)
  • FDA hands a ‘breakthrough’ designation to Seattle Genetics’ pivotal-stage cancer drug enfortumab (Endpoints) (Press)
  • Beating out market leaders in PhII, antibiotic-maker Allecra readies for Phase III trials (Endpoints) (Press)
  • Surface Oncology, Mereo BioPharma gun for $156M Nasdaq IPOs (Fierce)
  • Novo Nordisk's Tresiba snags label boost that could sharpen its safety edge (Fierce) (Press)
  • New Preclinical Data for THIO in BRAF-Mutant Mouse Melanoma Models (Press)
  • Evotec Launches INDIGO, A Unique Integrated Drug Development Solution for Accelerating Early Drug Candidates into the Clinic (Press)
  • Interview – Novartis goes all in on digital trials (EP Vantage)
  • Glaxo CEO Dispenses Bitter Pill to Fix R&D (WSJ
Medical Devices
  • Medtronic plans $1.2B debt, share buyback plan (MassDevice)
  • DarioHealth wins FDA nod for iPhone-compatible glucose meter (MassDevice) (Press)
  • Roche, Voluntis expand digital therapeutics pact into solid tumors (Fierce) (Press)
  • Polarean Imaging seeks to raise $4.3M in IPO on London Exchange (Fierce)
  • A 3-D spinal cord atlas will improve treatment of difficult injuries (STAT)
  • Cancer immunotherapy implants get boost by Novartis licensing (STAT-$)
  • Canon Medical Systems’ Premium Ultrasound Provides New And Unique Features For A Wide Range Of Liver Analysis (Press)
  • Carrot collaborates to roll-out digital smoking cessation service (pharmaphorum)
  • Edwards Lifesciences touts win in transcath heart valve patent spat with Boston Scientific (MassDevice) (Press)
  • Drayson remote monitoring app misses endpoint in gestational diabetes trial (Fierce)
  • FDA 510(k) Clears ORTHO CONNECT Middleware Solution from Ortho Clinical Diagnostics (Press)
  • Samsung wins FDA nod for next-gen RS85A ultrasound (MassDevice) (Press)
  • Opinion: No, FDA Didn’t Really Approve 23andMe’s BRCA Test (The Scientist)
  • Amendment to the notice of public workshop entitled “Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices” (FDA)
  • Neurotrack gets $13.7M to back its digital tools designed to assess memory skills (BioWorld MedTech)
  • FDA Considering Updates to Quality System Requirements (AAMI)
  • Philips enhances point-of-care ultrasound with Reacts platform for remote collaboration and virtual training (Press)
US: Assorted & Government
  • California's drug transparency law yields early surprises (Politico)
  • AI. Telemedicine. Quantum. New Novartis Boss Says Tech Will Finally Change The Drug Biz (Forbes)
  • Trump's Health Secretary Wants To Transform Healthcare. Can He? (Forbes)
  • Trump Says Fed. Gov't Will Sue Drugmakers Over Opioids (Law360-$)
  • Where PTAB Reform May Be Headed (Law360-$)
  • U.S. Health Care Is Tied Up in Red Tape (Bloomberg)
  • Amazon Is Already Reshaping Health Care (Bloomberg)
  • CVS-Aetna wants to be in your neighborhood because ZIP codes shape people's health (Chicago Tribune)
  • $142 Million For Quack Medicine Buried Inside The New 2018 Budget (Forbes)
Upcoming Meetings & Events Europe
  • Positive Phase IIb results under GeNeuro and Servier MS collaboration (The Pharma Letter-$) (Press)
  • MorphoSys files registration for ADS offering (European Biotechnology)
  • Irish deputy PM drops resistance to easing of abortion law (Reuters)
  • What The UK Product Recall Code Of Practice Means For Cos. (Law360-$)
  • Pythagoras Medical wins CE Mark for renal nerve mapping device (MassDevice)
  • How to manage a Brexit-enforced move (Financial Times)
  • Protecting citizens against health threats (EC)
  • Advertising investigations: January 2018 (MHRA)
  • EU recommendations for 2018/2019 seasonal flu vaccine composition (EMA)
Asia
  • Further approval for Humira usage in Japan (The Pharma Letter) (Press)
  • Shionogi and Kyoto University in new phase of psychiatric disorders project (The Pharma Letter-$) (Press)
  • Singapore pharma on recovery path after worst output in decades (Reuters)
  • Gilead cancer research director heads to Compugen (Fierce) (Press)
  • Ex-Abiomed Asia VP sues over termination, stock option issues (MassDevice)
India
  • Why India’s private hospitals can get away with overcharging patients (Quartz)
  • TPG Said to Near Deal for $1.2 Billion Indian Hospital Chain (Bloomberg)
  • Why Health Insurance Is Not a Luxury, But a Necessity (Telegraph India)
  • In 42nd Mann ki Baat, Narendra Modi bats for 'fit, healthy India', promises MSP for crops at one-and-half of cost (FirstPost)
  • Public Perception towards Mental Health in India (BioSpectrum)
  • A Look at Preventive Care Amidst Health Care Chaos (Forbes India)
  • Why 2018 will be a challenging year for pharmaceuticals (Financial Express)
  • ‘Udta’ north India: Abuse of pharma drugs rampant across most states (Times of India)
  • India drugmaker Strides eyes sale as endgame after business ramps up (Business Times)
Australia
  • $2 million for medical research on epilepsy (The Hon Grug Hunt MP Minister for Health)
  • Doctors name and shame health insurers as profits and complaints soar (The Sydney Morning Herald)
  • James Packer's admission highlights the need for better mental health awareness (The Sydney Morning Herald)
  • Caesarean babies at greater risk of health problems (The West Australian)
  • AusPAR: Alectinib: Australian Public Assessment Report (TGA)
  • The TGA statement in relation to ABC’s Fact Check article on deaths from OTC codeine (TGA)
  • Completing a determination or designation application form in TGA Business Services (TGA)
Canada
  • Activist group says Canada needs a national pain strategy (The Toronto Star)
  • How artificial intelligence can completely revolutionize Canadian health care (The Globe and Mail)
  • Alberta spends $2.4M an hour on health care —​ here's what's being done to reduce it (CBC News)
  • Late-Stage ACMPR applicant, Canary, enters 'active review' with Health Canada (Press)
  • Why It's So Hard to Reform Canadian Health Care (NYT)
General Health & Other Interesting Articles
  • New lungs could help my patient live. She also needed people to surround her (STAT)
  • Why Some Americans Are Risking It and Skipping Health Insurance (Bloomberg)
  • As Trump Targets Immigrants, Elderly Brace To Lose Caregivers (KHN)
  • She Was Given Three Years To Live. So She Transformed Cancer Research (Forbes)
  • FitBit Versa Review: First Impressions After 24 Hours Of Testing (Forbes)
  • Poll: 44% Of Americans Skip Doctor Visits Due To Cost (Forbes)
  • Knifed with a Smile (The New York 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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