Regulatory Focus™ > News Articles > 11 > Recon: Sandoz Drops Plans for US Rituxan Biosimilar; Lilly Says Diabetes Drug Trulicity Cuts Heart R

Recon: Sandoz Drops Plans for US Rituxan Biosimilar; Lilly Says Diabetes Drug Trulicity Cuts Heart Risks

Posted 05 November 2018 | By Michael Mezher 

Recon: Sandoz Drops Plans for US Rituxan Biosimilar; Lilly Says Diabetes Drug Trulicity Cuts Heart Risks

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA Approves Powerful New Opioid Despite Warnings of Likely Abuse (NYTimes) (STAT) (Reuters) (The Hill) (WSJ) (Press) (Gottlieb)
  • Trevena opioid painkiller fails to win FDA approval, shares plunge (Reuters)
  • Lilly says diabetes drug Trulicity reduces heart risks in trial (Reuters) (Endpoints)
  • Sandoz abandons effort for US approval of biosimilar rituximab (Reuters) (Endpoints) (Center for Biosimilars)
  • FDA approves Pfizer's treatment for certain lung cancer patients (Reuters) (Fierce) (Press)
  • FDA panel recommends Sage's postpartum depression treatment (Reuters) (Endpoints) (Xconomy) (Press)
  • The FDA, but with guns: How far should a little-known office go to track down counterfeit drugs? (STAT)
  • New rules could chill Chinese investment in biotech. Here’s what you need to know (STAT)
  • FDA and DoD formalize collaboration to advance medical products in support of American military personnel (FDA)
  • Priority Review Vouchers Revitalizing Neglected Disease Drug Development (Forbes)
  • One number keeps me from taking part in cystic fibrosis trials. That’s wrong (STAT)
  • Thousands of sickle cell and hemophilia patients are waiting for gene therapies. Can manufacturers keep up? (STAT)
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In Focus: International
  • Industry Picks Holes In UK Plans For Post-Brexit Drug Regulation (Pink Sheet-$)
  • Novo Nordisk, Embark Seek Obesity Drugs That Boost Body's Energy Use (SCRIP-$)
  • Takeda licenses Crescendo’s Humabodies (PharmaTimes)
  • UK pharma Enesi links with Australian biotech Sementis (PharmaTimes)
  • China Finalizes List Of Foreign Drugs Eligible For Priority Review (BioCentury)
  • Novartis CEO Vas Narasimhan lines up his late-stage blockbuster contenders — mixing old favorites and add-ons (Endpoints) (Novartis)
  • Comparable Overseas Reports (COR-A) pathway - First registration decision (TGA)
  • Federal Council approves Swissmedic's strategic goals for 2019–22 (Swissmedic)
  • Another Postponement Of Turkish Medical Device Tender Raises Eyebrows (Medtech Insight-$)
  • Bulletin of the World Health Organization November 2018 (WHO)
Pharmaceuticals & Biotechnology
  • AbbVie/arthritis drugs: copycat flap (Financial Times)
  • Digital R&D: The Next Frontier for Biopharmaceuticals (McKinsey)
  • Coherus looks to disrupt Amgen’s $4B Neulasta franchise as analysts look for a deep discount on its copycat price (Endpoints)
  • Blood Pressure Medication Recall: What Is In This That May Cause Cancer? (Forbes)
  • Need alternative funding channels? Perceptive Advisors now has $675M devoted to those deals (Endpoints)
  • Clearside slides as eye drug Xipere flunks combination study (Fierce) (Endpoints)
  • In another try at lung cancer niche, J&J nabs a potential Tagrisso rival for $50M-plus (Endpoints)
  • Win $2 Million to Solve Alzheimer’s: New Prize Will Reward Fresh Ideas (Xconomy)
  • Abeona bags rights to Regenxbio AAV9 vector in rare lysosomal storage disorders (Fierce)
  • AbbVie Gains Parkinson’s Pipeline From Bioarctic (BioCentury)
  • Life sciences VC investment trends similar to tech, but there are differences (MedCity)
  • Seres Therapeutics to Host Third Quarter 2018 Financial Results and Operational Progress Conference Call and Webcast on November 8, 2018 (Press)
  • Mylan and Pfizer report new issues affecting some EpiPens that can delay treatment (Fierce)
  • Aquestive wins FDA nod for seizure oral film (Drug Delivery)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Bristol-Myers Squibb and Infinity Pharmaceuticals Announce a New Clinical Collaboration to Evaluate Opdivo (Nivolumab) in Combination with IPI-549 in Urothelial Cancer (Press)
  • Seattle Genetics Submits Supplemental Biologics License Application for ADCETRIS® (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas (Press)
  • SpringWorks Therapeutics Receives FDA Orphan Drug Designation for MEK Inhibitor (PD-0325901) for the Treatment of Neurofibromatosis Type 1 (Press)
  • Genkyotex Meets Both Primary and Secondary Interim Efficacy Endpoints in Phase 2 Trial of GKT831 in Primary Biliary Cholangitis (Press)
  • Onxeo Announces Positive Interim Results from Phase 1 Study of AsiDNATM, a First-In-Class DNA Damage Response Inhibitor (Press)
  • Acesion Pharma Announces Positive Results for Novel Drug Targeting Atrial Fibrillation (Press)
  • FLX Bio Announces Clinical Trial Collaboration Agreement With Merck for Ongoing Phase 1/2 Study of FLX475 (Press)
Medical Devices
  • FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery (FDA)
  • Diabetics are hacking old insulin pumps to make them smarter — here's what happened when I tried it (CNBC)
  • ResMed to pay $750m for MatrixCare (MassDevice)
  • Axonics closes $120m IPO (MassDevice)
  • McKesson CEO to retire in 2019 (MedCityNews)
  • Halfway to the New European Medical Device Regulation, U.S. Manufacturers Feel the Pinch (MDDI)
  • FDA issues Class I recall for Roche Diagnostics’ warfarin test strips (Drug Delivery)
  • Illumina Shows That Big Medtech Deals Are Far from Over (MDDI)
  • NinePoint Medical Announces FDA Clearance of an Artificial Intelligence Software Upgrade for the NvisionVLE® Imaging System (Press)
  • Breaking Through the Bias: Debunking Common Misconceptions About Usability Studies (MDDI)
US: Assorted & Government
  • Final polls: Democrats have commanding health care lead (Politico)
  • 4 things you need to know about the administration’s latest Part B proposal (PhRMA)
  • Pharmacies still blocking U.S. teens looking for emergency contraception (Reuters)
  • Virginia facing high unexpected Medicaid costs (AP)
  • Draft Report on Health Research and Development To Stem the Opioid Crisis: A Federal Roadmap; Request for Comments (Federal Register)
  • Settlement Reached In Stryker Hip Replacement Suits (Law360-$)
  • For pharma, a flipped House would be noisy, but real action? It's all about the Senate (Fierce)
  • The Obesity Epidemic: FDA’s Waistline Continues to Expand! (FDA Law Blog)
  • Updating Our Post-Bauman 50-State Survey on General Jurisdiction by Consent (Drug & Device Law)
Upcoming Meetings & Events Europe
  • Ukraine Steps Up Plan For "Professional" Procurement Agency (Pink Sheet-$)
India
  • Lupin recalls 6,752 bottles of Testosterone topical solution from US (Economic Times)
  • Aurobindo recalls hypertensive drug in US citing cancer risk (Economic Times)
  • Indian pharma companies maintaining good compliance standards: Frances Zipp, CEO, Lachman Consultants (Economic Times)
Australia
  • Database of section 19A approvals to import and supply medicines to address medicine shortages (TGA)
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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