Regulatory Focus™ > News Articles > 2019 > 1 > Recon: Amgen's Osteoporosis Drug Evenity Approved First in Japan

Recon: Amgen's Osteoporosis Drug Evenity Approved First in Japan

Posted 09 January 2019 | By Michael Mezher 

Recon: Amgen's Osteoporosis Drug Evenity Approved First in Japan

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Trump summons advisers to White House over drug price hikes (Politico)
  • Democrats seek early victories on drug prices (The Hill)
  • Shutdown drags on (Politico)
  • FDA employees think shutdown could be deadly (CNN)
  • Where’s Big Tech at biopharma’s big bash? (STAT)
  • Investors get dose of government shutdown as FDA chief loses audio while delivering keynote speech via video call at J.P. Morgan conference (CNBC)
  • Shutdown has Aimmune waiting on FDA on multiple fronts — a sign of broader delays for biopharma (STAT)
  • Allergan CEO: We stuck to the spirit of our social contract with recent price hikes (STAT)
  • Cramer: Jamie Dimon should bring Apple into his joint health venture with Bezos and Buffett (CNBC)
  • IBM isn’t retreating from using Watson in health care, CEO Rometty says (STAT)
  • With its stock in a slump, Moderna makes the case for its big-money valuation (STAT)
  • Akorn gets FDA warning letter for Illinois plant (Reuters) (Press)
  • ‘Nominal pricing’ can help prisons and jails treat hepatitis C without breaking the bank (STAT)
In Focus: International
  • Amgen gets first OK for Evenity in Japan as FDA panel looms (Fierce) (PharmaLetter-$)
  • GlaxoSmithKline to look for early-stage assets: CEO (Reuters)
  • Norway Drugmaker Turns Oil Trader And Quickly Loses Millions (Bloomberg) (Financial Times)
  • New Ebola-like virus is discovered in China (STAT)
  • Pfizer to stop manufacturing in its Chennai and Aurangabad facilities (Economic Times) (Pharmafile)
  • Stivarga final NICE recommendation for hepatocellular carcinoma (PharmaTimes)
  • As it digests Shire, Takeda plans to shed $10B in non-core assets to relieve debt burden (Endpoints) (Financial Times)
  • EU Pharma Slams ICH Proposal For Selective Adoption Of Quality Guideline (Pink Sheet-$)
  • Brazil Tightens Outsourcing Restrictions Just Months After Easing Them (Pink Sheet-$)
  • ABPI Code “Tidy Up” Reflects Digital Developments (Pink Sheet-$)
  • Ramping up in-house drug development, API maker BrightGene bags $80M round led by Sequoia China (Endpoints)
Pharmaceuticals & Biotechnology
  • Opinion: Price Drugs According to What They Do (WSJ)
  • Botox May Help Prevent Migraines (NYTimes)
  • J.P. Morgan Notebook Day 2: Biogen, GSK, Bluebird, Roche, Amgen, Biohaven And Lilly (Pink Sheet-$)
  • JP Morgan 2019 day two roundup – after the party a harsh reality (Evaluate)
  • Lupin recalls over 23,000 bottles of antibiotic drug in US (Economic Times)
  • Digitization, automation, and online testing: The future of pharma quality control (McKinsey)
  • The FDA is investigating stem cell clinics that peddle unproven treatments (Vox)
  • Can The Record Breaking Number Of FDA New Drug Approvals Continue? (Forbes)
  • ERC-USA Initiates Therapy Under Right to Try Law With First Patient In California Using Investigational Compound ERC1671 for Treatment of Glioblastoma (Press)
  • How Miniature Human Hearts Will Revolutionize Drug Testing (Forbes)
  • Nektar confirms BMS deal for NKTR-214 is on track (PMLive)
  • US FDA's Brexit: One Staffer Moving, But Impact Still May Loom Large (Pink Sheet-$)
  • With pivot to less-rare diseases, Alexion needs a new sticker-price plan, CEO says (Fierce)
  • Gene Therapies: Accelerated Approval Open For Some, But Not All, Neurodegenerative Disease Treatments (Pink Sheet-$)
  • Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application (Pink Sheet-$)
  • ‘It’s us against the world’: And George Yancopoulos wants you to know they are beating the world (Endpoints)
  • Tetra Inks Deal with Shionogi to Support Fragile X, Alzheimer’s R&D (Xconomy)
  • How to build a biotech unicorn: Get the star team in place, attract deep-pocket VCs, paint a big picture and raise up to $1B (Endpoints)
  • Anti-aging startup Unity dives into eye diseases as partnership with Ascentage bears fruit (Endpoints)
  • Denali broadens tech to infiltrate the blood-brain barrier with Sirion deal (Endpoints)
  • Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass (FDA)
  • Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Seattle Genetics Announces Publication of North American Subgroup Data from ECHELON-1 Phase 3 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Newly Diagnosed Advanced Hodgkin Lymphoma (Press)
  • UroGen’s UGN-101 clears 57% of tumors in pivotal trial (Fierce)
  • NantKwest Announces Launch of Merkel Cell Carcinoma Phase II Trial Deploying Novel Triple Combination of off-the-Shelf Natural Killer haNK Cell Therapy with Superagonist IL-15 Cytokine Therapy and PD-L1 Checkpoint Inhibitor Therapy (Press)
  • Basilea Announces Positive Interim Results from Registrational Phase 2 Study with Oncology Drug Candidate Derazantinib in Intrahepatic Cholangiocarcinoma (iCCA) (Press)
Medical Devices
  • Medtronic CEO pushes back on critics who claim the medical device giant has a 'spotty record' (CNBC)
  • Amgen touts lowered prices for Repatha delivery devices (Drug Delivery)
  • Sandoz, Pear launch digital therapy for opioid use disorder (Drug Delivery)
  • Insulet taps former Medtronic finance exec McMillan as CFO (MassDevice)
US: Assorted & Government
  • New York City launches $100 million universal health insurance program (Reuters)
  • US health care industry spends $30 billion a year on marketing (Reuters)
  • FDA Focus: What Venable's Practice Chair Is Watching (Law360-$)
  • Third Circuit Affirms Dismissal of Avandia Failure-to-Warn Claims (Drug & Device Law)
Upcoming Meetings & Events Europe
  • bluebird bio reveals new UK General Manager (Pharmafile)
  • Letters and drug alerts sent to healthcare professionals in December 2018 (MHRA)
  • Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation (MHRA)
  • Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines (MHRA)
Asia India
  • Health ministry to amend MD Rules to do away with mandatory submission of TSE, BSE certificates by medical device makers (Pharmabiz)
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.
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