Recon: First Allogeneic Stem Cell Therapy Authorized in EU

• Biohaven plunges as investors pit migraine data against Allergan's drug (Reuters) (CNA Finance) (STAT-$) (Endpoints) (Fierce)
• Shire links with NanoMedSyn to work on new ERT (PharmaTimes) (The Pharma Letter)
• Gaining steam in PD-1/L1 race, Roche reports positive PhIII OS data on Tecentriq combo in NSCLC (Endpoints) (Reuters) (BioPharma Dive)
• Protagonist cans ulcerative colitis trial after flunking interim review (Fierce) (Endpoints)
• FDA Drafts Guidance on List of Substances for Drug Compounding (Focus) (BioPharma Dive) (STAT-$) (Reuters)
• Alere pays $33M to settle claim it knowingly sold unreliable devices (Fierce) (Drug Delivery Business News) (Law360-$)

• Plotting a global path to blockbuster sales, GSK grabs Shingrix nods in Europe, Japan (Fierce) (Medscape) (The Pharma Letter)
• Syngene International inks R&D agreement with GSK (Business Standard) (Business Line)
• Reig Jofre and LeanBio launch Syna Therapeutics (PMLiVE) (The Pharma Letter)
• Indivior slumps after negative patent ruling (The Pharma Letter) (The Times)
• Ablynx drug fails in mid-stage lupus trial (pharmaphorum) (European Biotechnology) (Endpoints) (Fierce) (BioPharma Dive)
• Israel to Invest $275 Million in Digital Health Project (Bloomberg) (Reuters)
• Mitsubishi and Hitachi to use AI to hasten drug R&D (pharmaphorum) (The Pharma Letter-$)
• US, EU filings imminent for Novartis’ MS therapy siponimod (PharmaTimes) (The Pharma Letter-$)
• Industry welcomes progress on Brexit (PharmaTimes) (Pharmacy Business)
• Drug shortages cripple Angola's health service (Reuters)
• Health Canada speeding up access to prescription heroin, methadone (iPolitics) (The Toronto Star)
• Coming around the Home Stretch, Heading for the Finish Line – It’s China by a Nose? (Lachman Consultants)
• First ‘off-the-shelf' stem cell therapy gains central authorization in EU (The Pharma Letter-$) (PharmaTimes) (Press)

• 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)

• 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) 

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• 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)

• $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)

• 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)

• 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)