Regulatory Focus™ > News Articles > 4 > Recon: Biogen Strikes $1B Deal With Ionis for Neurology Drug Development

Recon: Biogen Strikes $1B Deal With Ionis for Neurology Drug Development

Posted 20 April 2018 | By Ana Mulero 

Recon: Biogen Strikes $1B Deal With Ionis for Neurology Drug Development

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In Focus: International Pharmaceuticals & Biotechnology
  • Dems Blame Drug Companies for Opioid Crisis (MedPage Today)
  • Pace of drug price growth slows in US (Financial Times-$)
  • Opinion: The problem with miracle cures (NY Times-$)
  • For the first CAR-T therapy, early sales are weak but hopes are still sky high (STAT-$)
  • A stunning breakthrough in the fight against a devastating blood disease (The New Yorker)
  • Cosentyx woes, generics weakness cast cloud on otherwise solid Q1 for Novartis (Fierce)
  • Arcturus Therapeutics Files Lawsuit Against Joseph Payne and His Associates for Violations of Federal Securities Laws (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Sollis lands $50m for extended-release pain-relief drug (Drug Delivery Business News)
  • NEJM editorial slams design of GSK’s pivotal trial of 3-in-1 COPD drug Trelegy (Fierce)
  • Novartis CEO Vas Narasimhan is raising the bar on second-gen cancer drug studies (Endpoints)
  • Startup unwinds the role of chromatin to target epigenetic changes in cancer (STAT-$)
  • With Gilenya generics looming, Novartis’ siponimod team buffs up the MS data package being prepped for the FDA (Endpoints)
  • FDA ‘conflicted’ on Lilly and Incyte’s refiled baricitinib (Fierce)
  • Observing the cell in its native state: Imaging subcellular dynamics in multicellular organisms (Science Magazine)
  • What can we learn when a clinical trial is stopped? (Mosaic)
  • ICER Weekly View 04-20-18 (ICER)
  • New Novartis analyses at AAN show siponimod's efficacy on disability and cognition in secondary progressive MS patients (Press)
  • Synteract Repositions Itself with Centers of Therapeutic Development and Unveils Updated Brand Platform (Press)
  • Neurotechnology Innovations Translator (NIT) Announces Funding of up to $50 Million in Portfolio Company, Sollis Therapeutics (Press)
  • Summit Presents New 24-Week Analyses from PhaseOut DMD at the 2018 AAN Conference (Press)
Medical Devices
  • Johnson & Johnson is betting on vision care and expanding beyond contacts (CNBC)
  • New Microscope Captures Detailed 3-D Movies of Cells Deep Within Living Systems (HHMI)
  • Behind the Scenes, America’s Medical Technology Companies Are Fighting the Cybersecurity Battle (AdvaMed President and CEO Scott Whitaker)
  • Trayt debuts mobile app to track and help treat autism, ADHD (Fierce)
  • FDA approves heart monitor unanimously rejected by expert panel in 2016 (Fierce)
  • FDA Action Plan Promotes Innovation to Make Medical Devices Safer (AAMI)
  • Valeritas taps Glooko’s data management platform for next-gen insulin delivery device (MassDevice) (Press)
  • FDA OKs Opus breast implant line from Sientra (MassDevice) (Press)
  • Abbott releases firmware patch to fix cybersecurity flaws in 350,000 medical devices (Healthcare IT News)
  • AdvaMed Applauds Summit of the Americas' Focus On Importance of Business Ethics and Good Regulatory Practices (AdvaMed)
  • QIAGEN Announces FDA Approval of PartoSureTM (Press)
  • Women Treated with Hologic's NovaSure Endometrial Ablation System in New Study Reported Higher Amenorrhea Rates than Those Treated with Minerva (Press)
  • New Study Investigates the Utility of Masimo SpHb in Post-operative Red Blood Cell (RBC) Transfusion Best Practices (Press)
  • BD Unveils Suite of Diagnostic Informatics and Automation Innovations (Press)
US: Assorted & Government
  • U.S. appeals court blocks Indiana 'selective' abortion law (Reuters)
  • Spectrum of Diseases by Therapeutic Area found in Written Requests as of March 31, 2018 (FDA)
  • Pediatric Exclusivity Statistics (FDA)
  • Hedge Fund Titans Pull Money From Funds for Huge Tax Bills (Bloomberg)
  • CEO of Botox competitor: 'With scale,' we think we'll have the… (CNBC)
  • The VA Pharmacy Benefit Manager Should Take Over The Operation Of Medicare Part D (Health Affairs)
  • HSCA Releases Extensive Cybersecurity Considerations (MedTech Intelligence)
  • Federal judge enters consent decree against Cantrell Drug Company (FDA)
  • FDA/OCE Public Meeting on Relevant Molecular Targets in Pediatric Cancers: Applicability to Therapeutic Investigation FDARA 2017 (FDA)
Upcoming Meetings & Events Europe
  • Germany's Merck seeks partners for cancer and immune system drugs (Reuters)
  • NHS Gaps Stall Benefits of Genomic Data for U.K. Health Care (Bloomberg)
  • Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision (MHRA)
  • Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07) (MHRA)
  • Field Safety Notice - 16 to 20 April 2018 (MHRA)
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-19 April 2018: CVMP adopts new guideline on user safety of topically applied veterinary medicines (EMA)
  • Eye injuries in people and dogs when using Osurnia ear gel for dogs: Caution is advised when applying the medicine (EMA)
  • Civil Society representatives: Call for expressions of interest is open for the EMA Management Board (EC)
  • QIAGEN announces European launch of QIAstat-Dx, a next generation platform for syndromic insights (Press)
Asia
  • Large spleen helps explain deep-diving skills of Southeast Asian 'sea nomads' (Reuters)
  • Chinese investor group acquires Esaote (MassDevice)
  • Hong Kong clears way for pre-revenue biotech IPOs, plans to accept listing applications by May (Endpoints)
  • Glaxo has to face lawsuit by Armenians who couldn’t decipher Avandia warnings (STAT-$)
  • MHLW Sees Solid Inquiry Numbers for Conditional Early Approval System: Official (Pharma Japan)
  • Vaxart Announces $5 Million Inavir Revenue Milestone (Press)
  • Q3 Medical Devices Ltd. and the Boill Group Continue Expansion Plans in China (Press)
India
  • India can lead the way to deliver health for all (Hindustan Times)
  • Analysis  Why prosecuting Indian pharma patents could be even more difficult than it appears (IAM-$)
Australia
  • Pharmacovigilance in Australia (Lexology)
Canada
  • Health Canada should stop approving homeopathic remedies — period: Robyn Urback (CBC News)
  • Good economics and good health: How Canada’s pharmaceutical companies make an impact (National Post)
  • Sunovion Announces Health Canada Approval of Latuda (lurasidone HCl) to Treat Adolescents (13 to 17 years of age) with Bipolar Depression (Press)
  • Indivior Announces New Drug Submission to Health Canada for SUBLOCADE (Buprenorphine Extended-Release) Injection for the Treatment of Moderate to Severe Opioid Use Disorder (Press)
General Health & Other Interesting Articles
  • Concussion raises Parkinson's disease risk in large U.S. study (Reuters)
  • Early Skin Cancer is More Accurately Diagnosed by a Dermatologist Than Other Providers, New Research Shows (UPMC) (JAMA)
  • Barbara Bush Leaves A Legacy: Champion For End-Of-Life Care (Forbes)
  • Trayt's new app to help people with neurodevelopmental disorders track symptoms (Mobihealthnews)
  • Treating pain without addiction: inside the lab fighting the opioid crisis (The Guardian)
  • Consumers Are Getting Conflicting Advice on Romaine Lettuce Safety Amid the Mysterious E. Coli Outbreak (Fortune)
  • The next generation of doctors may be learning bad habits at teaching hospitals with many safety violations (STAT)
  • 3 ways to expand access to mental health care beyond adding more psychiatrists (STAT)
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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