Regulatory Focus™ > News Articles > 4 > Recon: Placebo Outperforms vTv Alzheimer’s Drug, Pfizer Moves HQ

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

Posted 10 April 2018 | By Ana Mulero 

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

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

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In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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 $780M growth buyout fund (Fierce)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Drug Yields 93% Response in TRK-Fusion Pediatric Cancers (MedPage Today)
  • VTV pivots to diabetes after Alzheimer’s flop (EP Vantage)
  • Quiet Modul halt puts the pressure on Exelixis (EP Vantage)
  • Don't sweat Prevnar's problems, Pfizer R&D chief says. New vaccines are on their way (Fierce)
  • Selecta slumps as interim gout data gets frosty reception (Fierce)
  • The next naloxone? Companies, academics search for better overdose-reversal drugs (STAT)
  • Researchers propose new Alzheimer's definition based on biology (Reuters)
  • Here’s what’s in the FDA plan to include pregnant women in clinical trials (STAT-$)
  • 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)
Medical Devices
  • 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 $86m IPO (MassDevice)
  • Akili Digital Medicine Technology Platform Granted Multiple Patents (Press)
  • Medtronic to Unveil Additional Clinical Data on HVAD System at ISHLT 2018 (Press)
  • Varian Launches Velocity 4.0 Cancer Imaging Software with Selective Internal Radiation Therapy Dosimetry Analysis (Press)
  • Tactile Medical Launches Next-Generation Flexitouch System: Flexitouch Plus (Press)
  • Device Evaluation Intern Program (CDRH) (FDA)
  • Medicare Program; Reconciling National Coverage Determinations on Positron Emission Tomography (PET) Neuroimaging for Dementia (CMS)
US: Assorted & Government
  • Fifth Circuit Provides Relief for Providers Facing Medicare Appeal Backlogs (Lexology)
  • Microhospitals and healthplexes offer a peek at the future of health care (STAT)
  • Mississippi's last abortion clinic expands lawsuit on restrictions (Reuters)
  • Conversation with the NESTcc Governing Committee Member: Vance Moore (NESTcc)
  • 5 Attys Tapped For Pharmacy Negotiating Team In Opioid MDL (Law360-$)
  • White House Asked To Produce Info On Opioid Crisis Work (Law360-$)
  • Got Skim Milk? Dairy Farmer Sues FDA Over its Skim Milk Requirements (FDA Law Blog)
  • Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal (FDA)
Upcoming Meetings & Events Europe
  • GW Pharma and Orchard biggest UK biotech fundraisers in Q1 (pharmaphorum)
  • A year till Brexit, money still flowing into UK biotech (The Pharma Letter-$)
  • 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)
Asia
  • 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)
India
  • 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)
Australia
  • 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)
Canada
  • 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)
General Health & Other Interesting Articles
  • 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)
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.

Need to contact the editor of Regulatory Reconnaissance? Find her on Twitter at @anitamulero or send her an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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