Recon: Placebo Outperforms vTv Alzheimer’s Drug, Pfizer Moves HQ

• The drumbeat of Alzheimer’s PhIII failures continues as vTv drug is outperformed by a placebo, shares crash 3 (Endpoints) (Fierce) (pharmaphorum) (BioPharma Dive)
• Get ready, Pfizer HQ staffers: You’re moving on up to a slick new Spiral skyscraper (Fierce) (New York Post) (Endpoints)
• Google is teaming up with the largest doctor group for a medical data challenge (CNBC) (Healthcare IT News) (Business Standard) (MassDevice) (Fierce) (AMA)
• FDA to take closer look at liver data, delaying AbbVie's elagolix (BioPharma Dive) (Reuters)
• Biotech activist Alex Denner’s next target: Ironwood Pharma (CNBC) (Fierce) (Endpoints)
• Pfizer latest pharma to join TriNetX, aims to boost real world data use (Fierce) (Outsourcing-Pharma) (Pharmaceutical Processing)
• FDA restricts sale of Essure contraceptive device, requires that women be informed of risks (The Washington Post) (CNBC) (STAT) (Focus)
• Few Americans aware of cancer drug shortages (Reuters) (MedPage Today)
• Loxo, Illumina to partner for diagnostic tool targeting cancer (Reuters) (Drug Delivery Business News) (Fierce)
• This Gene May Explain Why Alzheimer's Treatments Succeed With Mice But Fail With Humans (Forbes) (The Telegraph)
• Trump administration issues rule further watering down Obamacare (Reuters) (CNN) (The Hill)

• Mylan to buy MS drug marketing rights from Israel's Mapi Pharma (Reuters)
• Biotech resurrects a long faded Novartis cancer drug star, using a biomarker strategy to push ahead (Endpoints) (Fierce)
• Promethera Biosciences acquires Baliopharm (The Pharma Letter-$) (Fierce)
• Israeli Startup Ayala Taking BMS Cancer Drug Into Phase II With $17m Financing (Pharma Intelligence-$) (Fierce)
• Sanofi executives face more requests for charges in Dengvaxia mess as suspicious deaths mount (Fierce) (Philippine Star)
• Teva lawsuit over Rimsa buy fizzles out (Globes) (Fierce)
• Lonza's virus factory shows gene therapy's Texas-sized promise (Reuters) (Fosters)

• The Best Companies to Work for in Health Care and Biopharma (Fortune)
• Biotech Buyer Prays a Monster Premium Will Be Enough (Bloomberg)
• Pharma Dollars Appear to Sway Oncologist Rx Habits (MedPage Today)
• How A Drugmaker Turned The Abortion Pill Into A Rare-Disease Profit Machine (KHN)
• The stint that never happened? Biotech vet David Hung wipes Axovant from his work history (STAT)
• Aetna auditor accuses CVS of improperly reporting generic prices to Medicare (STAT-$)
• Despite reports from Merck and Johnson & Johnson, pharma's net prices 'likely not coming down': analyst (Fierce)
• Frazier Healthcare Partners closes $780M growth buyout fund (Fierce)

• Drug Yields 93% Response in TRK-Fusion Pediatric Cancers (MedPage Today)
• VTV pivots to diabetes after Alzheimer’s flop (EP Vantage)
• Quiet Modul halt puts the pressure on Exelixis (EP Vantage)
• Don't sweat Prevnar's problems, Pfizer R&D chief says. New vaccines are on their way (Fierce)
• Selecta slumps as interim gout data gets frosty reception (Fierce)
• The next naloxone? Companies, academics search for better overdose-reversal drugs (STAT)
• Researchers propose new Alzheimer's definition based on biology (Reuters)
• Here’s what’s in the FDA plan to include pregnant women in clinical trials (STAT-$)
• Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications (FDA)
• Reviva Pharmaceuticals Receives FDA Orphan Designation for RP5063 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) (Press)
• Wave Life Sciences and Deep Genomics Form Collaboration to Discover Novel Therapies for Genetic Neuromuscular Disorders (Press)
• Spectrum Pharmaceuticals Announces Update of MD Anderson’s Phase 2 Data Studying Poziotinib in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer Patients (Press)
• Selecta Biosciences Presents Positive New Data from Ongoing Phase 2 Trial of SEL-212, in Development for Chronic Severe Gout, at PANLAR 2018 Congress (Press)
• Kadmon Receives FDA Guidance on Pivotal Clinical Trial Design for KD025 in Chronic Graft-Versus-Host Disease (Press)
• BeiGene Initiates Global Phase 2 Trial of Anti-PD-1 Antibody Tislelizumab in Patients with Previously Treated Hepatocellular Carcinoma (Press)

• Apple faces new lawsuit over tech behind its heart rate monitor (mobihealthnews)
• Change Healthcare, Doctor On Demand partner for telehealth lab tests (Healthcare IT News)
• US FDA Preps Enhancements to Global Unique Device Identification Database (Emergo Group)
• Medical Device Maker Partially Shakes Investor Fraud Suit (Law360-$)
• Inspire Medical plans $86m IPO (MassDevice)
• Akili Digital Medicine Technology Platform Granted Multiple Patents (Press)
• Medtronic to Unveil Additional Clinical Data on HVAD System at ISHLT 2018 (Press)
• Varian Launches Velocity 4.0 Cancer Imaging Software with Selective Internal Radiation Therapy Dosimetry Analysis (Press)
• Tactile Medical Launches Next-Generation Flexitouch System: Flexitouch Plus (Press)
• Device Evaluation Intern Program (CDRH) (FDA)
• Medicare Program; Reconciling National Coverage Determinations on Positron Emission Tomography (PET) Neuroimaging for Dementia (CMS)

• Fifth Circuit Provides Relief for Providers Facing Medicare Appeal Backlogs (Lexology)
• Microhospitals and healthplexes offer a peek at the future of health care (STAT)
• Mississippi's last abortion clinic expands lawsuit on restrictions (Reuters)
• Conversation with the NESTcc Governing Committee Member: Vance Moore (NESTcc)
• 5 Attys Tapped For Pharmacy Negotiating Team In Opioid MDL (Law360-$)
• White House Asked To Produce Info On Opioid Crisis Work (Law360-$)
• Got Skim Milk? Dairy Farmer Sues FDA Over its Skim Milk Requirements (FDA Law Blog)
• Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal (FDA)

• FDA Advisory Committee Calendar

• GW Pharma and Orchard biggest UK biotech fundraisers in Q1 (pharmaphorum)
• A year till Brexit, money still flowing into UK biotech (The Pharma Letter-$)
• Medtronic Expands Visualase MRI-Guided Laser Ablation System to European Markets with CE Mark Approval (Press)
• Swiss Advanced Vision Launches Active Intraocular Lens Concept with Real-Time Autofocus for Cataract Surgery (Press)
• Achaogen Announces Multiple Plazomicin Presentations at European Congress of Clinical Microbiology and Infectious Diseases (Press)

• Tapping a biotech boom, China gene editing CRO Biocytogen bags $65M round for global expansion (Endpoints)
• Exclusive: Medtronic to buy Israeli co Visionsense for $75m (Globes)
• Japanese Regulators Raise Medical Device Registration Fees (Emergo Group)
• Chinese patients get these cancers at an alarming rate. Now drug makers see an opportunity (STAT-$)
• Ayala's IMI forges touch sensor venture in Japan (ABS-CBN News)
• Caladrius Biosciences Receives SAKIGAKE Expedited Review Designation in Japan for CLBS12 for Treating Critical Limb Ischemia (Press)

• Roche looks to bring evidence-based medicine tech to India (Economic Times)
• Govt proposes draft amendment to Drugs and Cosmetics Rules to add clause on stem cell products (Pharmabiz)
• Govt gets ready for USTR talks amid hectic MNC lobbying on medical device pricing (Pharmabiz)

• New microbiopsy device could revolutionize testing for skin cancer, other diseases (News Medical Life Sciences)
• Final decisions amending, or not amending, the current Poisons Standard, April 2018 (TGA)
• Safety advisory: Street Overlord Strong tablets (pills) (TGA)
• Reformatting Product Information: Frequently asked questions (TGA)
• Advertising of vaccination services (TGA)

• This trial could determine the future of public healthcare in Canada (VICE)
• PENTHROX Receives Marketing Authorization from Health Canada for Adult Patients Requiring Relief from Moderate to Severe Acute Pain Associated with Trauma or Interventional Medical Procedures (Press)
• Health Canada Accepts Mitsubishi Tanabe Pharma Corporation's NDS Filing for Edaravone to Treat ALS, Grants Priority Review (Press)
• Trillium Therapeutics Provides Update on Its TTI-621 and TTI-622 Clinical Programs (Press)

• Want To Avoid Unnecessary Antibiotics? Be Careful What Time Of Day You See Your Doctor (Forbes)
• Obamacare is now so expensive it keeps patients away from their doctors (Washington Examiner)
• Chlamydia, Gonorrhea Rates Climb, But Few Young Women Feel At Risk (Forbes)
• Our Addiction To Selfies Means Big Business For Plastic Surgeons (Forbes)
• How to Operate a Healthcare Facility That Keeps Workers Happy (Fortune)