Regulatory Focus™ > News Articles > 2019 > 2 > Recon: China Approves its First Biosimilar; Sanofi, Regeneron Lose Repatha Patent Challenge

Recon: China Approves its First Biosimilar; Sanofi, Regeneron Lose Repatha Patent Challenge

Posted 26 February 2019 | By Michael Mezher 

Recon: China Approves its First Biosimilar; Sanofi, Regeneron Lose Repatha Patent Challenge

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Sanofi, Regeneron lose U.S. patent challenge to Amgen cholesterol drug (Reuters) (Sanofi Statement)
  • 'Wacky' drug price system keeps costs high for patients paying for prescriptions, FDA chief says (CNBC)
  • Drug price hearings take center stage (Politico) (Reuters) (KHN) (CNBC)
  • Sen. Grassley says probe of 'secretive' drug industry pricing won't stop with drugmakers (CNBC)
  • Capitol Hill warns pharma: Americans are ‘tired of the blame game’ (STAT)
  • Why Abbvie May Have A Tough Time Defending Humira's Price Before Congress (Forbes)
  • These Senators Received The Biggest Checks From Pharma Companies Testifying Tuesday (Forbes)
  • Pharma’s tarnished reputation helps fuel the anti-vaccine movement (STAT)
  • Crispr Therapeutics treats its first human with gene editing (Financial Times) (MedCity)
  • Insys Call Center Revealed at Trial as Hotbed of Opioid Lies (Bloomberg)
  • Is the $74B Celgene buyout already forcing a reckoning among Bristol-Myers Squibb’s R&D partners? (Endpoints)
  • FDA takes fresh look at whether opioids are effective for chronic pain (Washington Post)
  • FDA Plans Multifaceted Response to Opioid-Abuse Epidemic (WSJ)
In Focus: International
  • Pharma industry steels itself for no-deal Brexit (Financial Times)
  • Brexit to harm UK's cherished health service, experts say (Reuters)
  • No-deal Brexit: Key Questions for Medical Device Companies (Emergo)
  • China approves its first biosimilar, a Rituxan copy from Fosun’s IPO-heading Henlius (Fierce) (NMPA)
  • Rise of drug-resistant superbugs rings alarm bells in Europe (Reuters)
  • AstraZeneca's Lynparza meets main goal in late-stage pancreatic cancer study (Reuters) (Endpoints) (Xconomy)
  • Temasek leads $85M round for Chinese biotech aiming for cheaper, faster, better CAR-T therapies (Endpoints)
  • Daiichi Sankyo shakes up its R&D leadership, dispatching Junichi Koga to the US to run global ops (Endpoints) (Scrip-$)
  • Rise in populism linked to vaccine hesitancy in Europe, study shows (Pharmafile)
  • Novartis' venture fund arm and Syncona are supporting new Switzerland-based immuno-oncology specialists Anaveon (PMLive)
  • Why Does Ebola Keep Spreading In Congo? Here's A Major Clue (NPR)
  • Google launches India program to screen diabetics for eye conditions that can cause blindness (CNBC) (Google)
Pharmaceuticals & Biotechnology
  • Oyster Point investors bet $93M on a PhIII study aimed at disrupting a major consumer market and toppling Allergan (Endpoints)
  • Ahead Of Planned Zulresso Launch, Sage Raises $500m (BioCentury)
  • Additional Exclusivity for a Cancer Treatment Could Cost the Public $3 Billion, Analyst Says (Focus)
  • FDA Cites GMP, GLP Violations at Two Sites (Focus)
  • FDA Drafts 2 New Guidances on Effects of Food on Drugs, Bioavailability Studies (Focus)
  • More Progress Toward Gene Editing for Kids with Muscular Dystrophy (NIH)
  • New data show how sharing negotiated discounts could save certain patients hundreds of dollars at the pharmacy counter (PhRMA)
  • Immunomedics CEO Michael Pehl hits the exit on the heels of a CRL and accusations of a data integrity breach (Endpoints) (Fierce)
  • The Roche way: Spark found a new owner who wants to buy and build a gene therapy leader (Endpoints)
  • Immatics, Roche ally to trial Tecentriq with cell therapy (Fierce)
  • Flatiron Expands Real-World Data Partnership With FDA (BioCentury)
  • Purdue Pharma taps TetraGenetics for ion channel-focused pain treatments in $273M discovery pact (Fierce)
  • Cornell researchers to launch early trial of gene therapy aimed — ultimately — at preventing Alzheimer’s (Endpoints)
  • Boehringer Ingelheim appoints new chief medical officer (PharmaTimes)
  • Notable Labs brings on 2 development executives ahead of its first blood cancer trials (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Positive Results Presented from Two Phase 3 Trials of Dupixent® (dupilumab) in Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) (Press)
  • FDA Breakthrough Therapy Designation for Pompe disease drug (PharmaTimes)
  • Nexien BioPharma to File Pre-IND Meeting Request with the FDA (Press)
  • ROMEG Therapeutics Receives FDA Approval of GLOPERBA® (colchicine) for Prophylaxis of Adult Gout Flares (Press)
  • Sesen Bio to Host Conference Call to Review Fourth Quarter and Full-Year 2018 Financial Results and Additional Preliminary Data from Phase 3 VISTA Trial (Press)
Medical Devices
  • Proposed Precertification Approach on In Vitro Clinical Tests Raises Questions (Focus)
  • Fresenius closes $2B NxStage buyout, settles FCPA case for $255m (MassDevice)
  • Neuroelectrics touts FDA IDE Starstim epilepsy treatment study data (MassDevice)
  • FDA clears Mauna Kea Technologies system for lung cancer detection (MassDevice)
  • FDA warn’s Getinge’s Datascope about ongoing IABP issues (MassDevice)
  • Alphatec wins FDA nod for SafeOp neuromonitoring system (MassDevice)
  • FDA clears Axilum Robotics’ system for TMS positioning (MassDevice)
  • Axonics® Submits Pivotal Clinical Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System (Press)
  • Medtronic Resolute(TM) Drug-Eluting Stent (DES) Platform Receives Expanded Indication for Treatment of Chronic Total Occlusion (CTO) (Press)
US: Assorted & Government
  • Anthem Says Bid to Save $49 Billion Deal Was ‘Cut Off at Knees’ (Bloomberg)
  • U.S. asks judge to give final approval to settlement with CVS to buy Aetna (Reuters)
  • Brand & Generic Defendants Win in Amiodarone Litigation (Drug & Device Law)
  • Third Circuit Hands the FTC a Stunning Loss (FDA Law Blog)
  • Don’t Advance Drug Antitrust Claims, Express Scripts Urges (Law360-$)
  • Pharmas Inflating Info Leak To Unseat Patent Loss, Rival Says (Law360-$)
  • Vanda Hid Off-Label Fraud Scheme From Investors, Suit Says (Law360-$)
  • U.S. trial tests claims Roundup weed killer caused cancer (Reuters)
  • Southern California Pharmacy Owner Sentenced to Prison for Her Role in Health Care and Wire Fraud Scheme (DoJ)
Upcoming Meetings & Events Europe
  • UK Seeks to Increase Clinical Trials Transparency (Focus)
  • European Commission Updates on Post-Brexit Batch Testing Requirements (Focus)
  • Irish partnership for Scottish CAR-T company (PharmaLetter-$)
Asia
  • Thermo Fisher Scientific's Oncomine Dx Target Test Receives Expanded Regulatory Approval in Japan (Press)
  • First-Day Gain For Cstone On Hong Kong Exchange (Biocentury)
India
  • Govt mini drug testing lab project starts operations at Navi Mumbai, Mumbai, Hyderabad, Bengaluru & Ahmedabad (PharmaBiz)
Australia
  • 'Sartan' blood pressure medicines (TGA)
Other International
  • Brazil health agency concludes safety evaluation of weedkiller glyphosate (Reuters)
General Health & Other Interesting Articles
  • Ginkgo Bioworks joins hunt for next Impossible Burger with billionaire investors, including Gates, Bezos and Bloomberg (CNBC)
  • ‘Incredible mind, incredible heart’: After decades fighting Ebola, a beloved expert hangs up his boots (STAT)
  • Split-Sex Animals Are Unusual, Yes, but Not as Rare as You’d Think (NYTimes)
  • CBD Is Everywhere, but Scientists Still Don’t Know Much About It (NYTimes)
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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