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

• FDA panel undermines Lilly and Incyte’s baricitinib hopes (PMLiVE) (pharmaphorum) (The Pharma Letter) (PharmaTimes) (MedPage Today) (BioPharma Dive)
• Revolution Medicines tees up for oncology IND with $56M series B (Fierce) (Endpoints) (San Francisco Business Times-$)
• FDA orders a partial hold on Epizyme’s lead cancer drug tazemetostat following T-cell lymphoma case (Endpoints) (Fierce)
• Orexigen, seller of weight-loss drug Contrave, agrees to sale for $75 million (The San Diego Union-Tribune) (BioPharma Dive) (Endpoints) (Fierce)
• As Spinraza sales fall, Biogen talks up adult SMA opportunity (BioPharma Dive) (The Pharma Letter) (Reuters) (STAT)
• Eli Lilly's profit beats on strong sales of diabetes, cancer drugs (Reuters) (CNBC)
• Express Scripts’ plan to change drug pricing dynamic (Fox Business) (Reuters)
• New hacking group targeting healthcare infects MRI, X-ray machine (Healthcare IT News) (Forbes) (Healthcare Dive)
• AZ lung cancer combo fails to hit targets (PharmaTimes) (PMLiVE) (pharmaphorum)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• IHH Healthcare revises offer for India's Fortis (Reuters)
• SRL Diagnostics looks to increase retail presence in Kolkata (Economic Times)

• 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)

• 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)

• 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)