Regulatory Focus™ > News Articles > 4 > Recon: FDA Panel Deals Blow to Baricitinib, Takeda Tries Again with New Shire Bid

Recon: FDA Panel Deals Blow to Baricitinib, Takeda Tries Again with New Shire Bid

Posted 24 April 2018 | By Ana Mulero 

Recon: FDA Panel Deals Blow to Baricitinib, Takeda Tries Again with New Shire Bid

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In Focus: International
  • Shire receives new bid from Takeda as takeover deadline looms (Reuters) (Endpoints)
  • Longtime Sanofi R&D chief Elias Zerhouni is on his way out, handing the research reins to Roche vet John Reed (Endpoints) (Fierce) (Reuters) (PMLiVE) (The Pharma Letter)
  • UK bans Sanofi epilepsy drug without pregnancy prevention plan (Reuters) (Daily Mail) (PharmaTimes) (MHRA)
  • U.K. ministers urge Vertex to reach pricing deal on its cystic fibrosis drug (STAT-$) (PharmaTimes) (pharmaphorum)
  • UK-Australia trade deal an opportunity for life sciences in both countries (PharmaTimes)
  • A Remarkable New Technology That Will Diminish A Global Cancer Threat (Forbes)
  • Malaria on rise in crisis-hit Venezuela, WHO says (Reuters)
  • Medical tourism in India bringing infections into US: Health official (Financial Express)
  • The European Medicines Agency and the Netherlands agree on Seat Agreement (EMA)
Pharmaceuticals & Biotechnology
  • Barriers to entering the pharmaceutical industry are too high even for Amazon: Billionaire investor (CNBC)
  • Biotech stars Schleifer and Yancopoulos share $52M in 2017 compensation, even though Regeneron’s share price swooned (Endpoints)
  • DEA plan to stem supply of prescription drugs draws skepticism (STAT)
  • Drug makers question idea to shake up how Medicare pays for certain drugs (STAT-$)
  • Miami joins national opioids lawsuit (Axios)
  • Restless R&D executives, and a few FDA staffers, on the move to rival pharmas (Fierce)
  • Urovant poaches Allergan's key urology executive Cornelia Haag-Molkenteller (Fierce)
  • ESSA Pharma Enhances R&D Capabilities with Two New Key Hires (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Accelerated filing delay could be the least of Epizyme’s problems (EP Vantage)
  • Cedilla Therapeutics launches with $56M to target protein degradation in cancer (Fierce)
  • Is Biopharma Investing Too Much In Cancer R&D? (Forbes)
  • How Blueprint Medicines Got The Blues (Forbes)
  • Interactive Tool: Disease Modifying Therapies Drove 82% of Total Increase in Health Care Spending for People with Multiple Sclerosis (Health Care Cost Institute)
  • Start MS Drugs Early, New Guideline Says (MedPage Today)
  • New Analyses from Pivotal Phase III Trials of Oral Ozanimod in Relapsing Multiple Sclerosis To Be Presented at the 2018 American Academy of Neurology Annual Meeting (Press)
  • Once-Daily Trelegy Ellipta Gains Expanded Indication in the US for the Treatment of Patients With COPD (Press)
  • Galapagos reports initiation of FALCON clinical trial in cystic fibrosis (Press)
  • argenx to present complete data from the Phase 2 proof-of-concept trial of efgartigimod (ARGX-113) in generalized myasthenia gravis at American Academy of Neurology (AAN) Annual Meeting (Press)
  • AAN 2018: Lilly's Galcanezumab Significantly Reduced Monthly Migraine Headache Days in Patients with Migraine Who Previously Failed to Respond to Multiple Preventive Therapies (Press)
  • TESARO Announces Positive Top-Line Results From Quadra Trial of ZEJULA (Press)
  • Alnylam Reports New Clinical Results from the APOLLO Phase 3 Study of Patisiran at the American Academy of Neurology 2018 Annual Meeting (Press)
  • Intec Pharma Presented Phase 1 PK and Safety Data From Accordion Pill Carbidopa/Levodopa at American Academy of Neurology Annual Meeting (Press)
  • Cytokinetics Announces Presentation of Data From Phase 2 Clinical Study of Reldesemtiv in Patients With Spinal Muscular Atrophy at the 2018 Annual Cure SMA Conference (Press)
  • New Data from IONIS-HTT Rx Phase 1/2 Study Demonstrates Correlation Between Reduction of Disease-causing Protein and Improvement in Clinical Measures of Huntington's Disease (Press)
Medical Devices
  • Citing WannaCry, lawmakers ask how to tackle medical device cybersecurity flaws (Healthcare IT News)
  • Consent decree wipes $24M off Philips’ first-quarter earnings (Fierce)
  • Steth IO launches digital stethoscope housed within smartphone case (MobiHealthNews)
  • First Derm's new AI app helps users identify skin conditions (MobiHealthNews)
  • Terumo’s Vascutek, Bolton Medical merge to form Terumo Aortic (MassDevice)
  • FDA Issues Guidance Regarding Obtaining Risk Determinations for Investigational IVDs in Oncology Trials (FDA Law Blog)
  • Medical Device Cybersecurity: Preparing For The Worst (Law360-$)
  • Allergan To Pay $500K To End Calif. Faulty Lap-Band Claims (Law360-$)
  • 3 Sentenced In $16.6M Fraudulent Medical Device Scheme (Law360-$)
  • Boston Scientific Announces Positive Late-Breaking Data From The INTREPID Study (Press)
  • FoundationFocus CDxBRCA LOH - P160018/S001 (FDA)
  • Viz.ai Receives FDA Clearance for Automated Computed Tomography Perfusion (CTP) Software (Press)
US: Assorted & Government
  • APIs: A Path to Putting Patients at the Center (Health IT Buzz)
  • Medicare Buy-In Could Win Big In Today's Arizona Special Election (Forbes)
  • E-Cigarette Sting Operation Prompts U.S. Warnings to Retailers (Bloomberg)
  • Puerto Rico’s Oversight Board Certifies Fiscal Plan: What are the Implications for Medicaid? (CCF Georgetown University)
  • Fight brews over Shkreli's Wu-Tang album as 'pharma bro' gets banned by securities industry (CNBC)
  • DOJ taking a closer look at Cigna-Express Scripts merger (Fierce)
  • FDA reveals 40 warning letters to e-cigarette retailers for sales to youth (Reuters)
  • How a patient advocacy group is used to promote an Insys drug and other fentanyl meds (STAT-$)
  • ObamaCare call center contractor accused of wage theft (The Hill)
  • Hospitals are getting more Medicare Advantage members (Axios)
  • CDC chief makes $375K, far exceeding his predecessors’ pay (AP News)
  • CMS seeks to allow doctors to bill patients directly (Modern Healthcare)
  • How States, Federal Agencies Are Challenging Drug Prices (Law360-$)
  • The Heirs to Music Superstar Prince's Estate Are Suing Walgreens Over His Death (Fortune)
Upcoming Meetings & Events Europe
  • NHS gene sequencing project may fail to meet objectives – report (pharmaphorum)
  • Are EU Rules on Women and Antiepileptics Too Strict? (MedPage Today)
  • EU reviewing MSD’s Keytruda/chemo combo (PharmaTimes)
  • Ireland wins EU OK to tax sugary drinks on health grounds (Reuters)
  • Dr Reddy's gets EIR from USFDA for UK plant (Economic Times)
  • Guidance: Buying medical devices for personal use (MHRA)
  • Guidance: Valproate use by women and girls (MHRA)
  • Red hand letter on leaking syringes at some GSK vaccines (BASG)
  • Philips partners with the Medical University of Vienna to provide asthma and allergy sufferers with a pollen forecast (Press)
  • Philips provides Belgian Maria Middelares hospital with innovative monitoring solutions to help improve patient care (Press)
  • CellAegis Announces First Distribution Agreement for autoRIC in Europe (Press)
  • Applied BioCode Receives CE Mark Certification for BioCode MDx 3000 with 18-plex Gastrointestinal Pathogen Panel (Press)
Asia
  • Simcere and HitGen make progress in drug development pact (The Pharma Letter)
  • Shimadzu introduces new Lightvision near-infrared fluorescence imaging system to support breast cancer treatment (pharmabiz)
  • China FDA Issues Guidance on 3D Printed Medical Devices (Knobbe Martens)
India
  • IHH Healthcare revises offer for India's Fortis (Reuters)
  • SRL Diagnostics looks to increase retail presence in Kolkata (Economic Times)
Australia
  • Australian public hospitals cannot meet rising demand for obesity care, experts warn (ABC News)
  • ‘Harvesting’ of patients lifts health premiums by 6pc (The Australian)
  • What is HTLV-1? The devastating health crisis afflicting central Australia (The Guardian)
  • Medical devices and IVDs: Suspensions from the ARTG (TGA)
  • TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG) (TGA)
  • Tandem Diabetes Care Announces Agreements for Distribution of Insulin Pump Products in Australia and New Zealand (Press)
Canada
  • Indivior seeks Health Canada approval for Sublocade injection to treat moderate to severe opioid use disorder (pharmabiz)
  • It's Time For A Complete Overhaul Of Canada's Federal Health Organizations (HuffPost Canada)
General Health & Other Interesting Articles
  • Infinitesimal Odds: A Scientist Finds Her Child’s Rare Illness Stems From the Gene She Studies (NYT)
  • Why The Future Of Precision Medicine Runs Through The IVF Lab (Forbes)
  • Protein degradation 2.0? Third Rock sinks $56M into Cedilla’s unusual approach (Endpoints)
  • Wounded soldier gets world's first penis transplant in U.S. operation (Reuters)
  • They were commercial flops. But can weight loss drugs be used to treat addiction? (STAT-$)
  • Redesigning Maternal Care: Ob-Gyns Are Urged to See New Mothers Sooner And More Often (ProPublica-NPR)
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? Email us at news@raps.org.
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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