Regulatory Focus™ > News Articles > 2019 > 12 > Recon: Astellas to Buy Gene Therapy Developer Audentes for $3B

Recon: Astellas to Buy Gene Therapy Developer Audentes for $3B

Posted 03 December 2019 | By Michael Mezher 

Recon: Astellas to Buy Gene Therapy Developer Audentes for $3B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Senate Committee Advances Nomination of Hahn as FDA Commissioner (Focus)
  • US Considers Easing Drug Protections to Break Logjam Over Trade Pact (WSJ) (Reuters)
  • Medical Device Failures Brought To Light Now Bolster Lawsuits And Research (KHN)
  • Merck Cyberattack’s $1.3 Billion Question: Was It an Act of War? (Bloomberg)
  • States fight bonus pay for CEO of OxyContin maker Purdue (Reuters)
  • Health program offers free HIV prevention drug to uninsured (AP) (STAT)
  • Congress is hoping for another major medical research bill. But pharma’s not nearly as excited as before (STAT)
  • Ardelyx's kidney disease drug reduces elevated phosphate levels in late-stage study (Reuters) (Endpoints) (Press)
  • FDA bowed to industry for decades as alarms were sounded over talc (Reuters)
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In Focus: International
  • Japan's Astellas to buy Audentes for $3 billion in high-priced gene therapy bet (Reuters) (Endpoints) (Xconomy) (Press)
  • Amarin files fish oil-based heart drug Vascepa in Europe (PMLive)
  • Sangamo granted authorisation of first-in-human CAR-Treg trial (PharmaTimes)
  • Donald Trump says he wants ‘nothing to do with’ NHS (Financial Times)
  • Pfizer pulls plug on pension reforms after union rejection (The Irish Times)
  • AstraZeneca divests Seroquel rights to focus on key therapy areas (PMLive)
  • Ontario focused on rare disease drugs ahead of national drug plan talks (Reuters)
  • Greek Prosecutor requests fresh eyes on Novartis case (Ekathimerini)
  • PIC/S Looks to Help Inspectors Gauge the Effectiveness of a PQS With Risk-Based Change Management (Focus)
Pharmaceuticals & Biotechnology
  • The end of placeboes is in sight (Wired)
  • The history of OxyContin, told through unsealed Purdue documents (STAT)
  • Purdue’s Richard Sackler proposed plan to play down OxyContin risks, and wanted drug maker feared ‘like a tiger,’ files show (STAT)
  • FDA ushers Merck's star cancer drug Keytruda toward another key checkpoint (Endpoints)
  • Real World Evidence For Rare Diseases: Payers Cite Lack Of Clarity On Value (Pink Sheet-$)
  • After FDA rejection, Immunomedics tries again with breast cancer drug (BioPharmaDive)
  • Biogen’s stock could fall 10% on new Alzheimer’s drug data this week, top analyst says (CNBC)
  • FDA Finalizes Guidance on Adaptive Trial Designs (Focus)
  • Genomics Data Should Get More Attention In FDA Drug Review And Labeling, Regeneron Says (Pink Sheet-$)
  • On the heels of $225M royalty deal, Kodiak shoots for $250M raise to fund pivotal programs of its Eylea slayer (Endpoints)
  • AbbVie picks first Alzheimer's, Parkinson's targets in Mission pact; Amarin files for Vascepa OK in Europe (Endpoints)
  • Covington-Led Immunotherapy Co. IFM Lands $56M Financing (Law360-$)
  • Neurocrine Inks $50M Xenon Pharma Deal to Expand Into Epilepsy (Xconomy)
  • Blockbuster in the balance: Celgene's Reblozyl faces FDA committee for myelodysplastic syndromes (Fierce)
  • Lynparza, Keytruda Supplemental Indications Face US FDA Panel Review (Pink Sheet-$)
  • Bristol-Myers Squibb and Acceleron Pharma Announce FDA Advisory Committee Will Review Reblozyl® (luspatercept-aamt) for Use in Patients With Myelodysplastic Syndromes (Press)
  • Can Biohaven challenge the Allergan/AbbVie goliath in migraine? CEO Coric thinks so (Fierce)
  • FDA Awards DNAnexus with Five-Year, $20 Million Contract to Power precisionFDA Collaborative Omics Environment in the Cloud (Press)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Seattle Genetics and Astellas Announce Clinical Trial Collaboration with Merck to Evaluate Enfortumab Vedotin in Combination with KEYTRUDA® (pembrolizumab) in Patients with Metastatic Urothelial Cancer (Press)
  • Astellas Presents New Data on XOSPATA® (gilteritinib) in FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia at the 2019 American Society of Hematology Annual Meeting (Press)
  • Struggling Adaptimmune gets a boost from the FDA as T-cell cancer drug wins an inside track at the agency (Endpoints)
  • Biogen boasts PhII win in lupus — will anyone turn their head from Alzheimer's to notice? (Endpoints)
  • Lumosa Announces FDA Acceptance of IND Application for LT1001, an Extended-Release Analgesic Injection - Lumosa to Initiate the Bridging Study in the US (Press)
  • Censa Pharmaceuticals Announces CNSA-001 Met Primary and Secondary Endpoints in Phase 2 Trial in Patients with PKU (Press)
  • QBiotics Announces First Patient Dosed in its Phase I/II Clinical Trial of Tigilanol Tiglate for Head and Neck Cancer (Press)
  • Aerie Pharmaceuticals Submits Marketing Authorisation Application for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% in Europe (Press)
  • NantKwest Announces Phase 1 Results for First-in-Human PD-L1 Tumor-Targeted Natural Killer Cells (PD-L1.t-haNK) in Patients with Locally Advanced or Metastatic Solid Cancers (Press)
  • Aldeyra Therapeutics Announces Positive Top-Line Results from Part 1 of Adaptive Phase 3 RENEW Trial in Dry Eye Disease (Press)
  • Theravance Biopharma Announces Dosing of First Patient in Phase 2 Allergen Challenge Study of TD-8236, an Investigational, Lung-Selective, Inhaled Pan-Janus Kinase (JAK) Inhibitor for Inflammatory Lung Diseases (Press)
  • Health Canada Grants Priority Review Status for Heron Therapeutics' New Drug Submission for HTX-011 for Management of Postoperative Pain (Press)
Medical Devices
  • Dexcom says the outage that kept diabetes patients from tracking blood sugar was a ‘complete surprise’ (CNBC)
  • UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers (FDA)
  • FDA clears SynchroSeal and E-100 generator for Intuitive’s da Vinci X, Xi platforms (MassDevice)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Information on Pediatric Uses of Medical Devices (FDA)
US: Assorted & Government
  • Senators urge Medicare to prevent bias in AI tools used in health care (STAT)
  • Verma to meet with Pence (Politico)
  • Why the Less Disruptive Health Care Option Could Be Plenty Disruptive (NYTimes)
  • Kisor May Be A New Dawn For Challenges To FDA Actions (Law360-$)
  • Pfizer Claims No Link To Generic-Drug Price-Fix Plot (Law360                -$)
  • Seattle Genetics moves to dismiss ADC lawsuit with Daiichi Sankyo (PMLive)
  • FDA’s Latest Draft Guidance on Compounding Animal Drugs From Bulk Substances Seeks Industry Input! Comments Due on February 18, 2020 (FDA Law Blog)
  • When California Law Doesn’t Apply (Drug & Device Law)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • Public Workshop on Patient-Focused Drug Development: Guidance 4 – Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – 6 December 2019
  • Public Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging – 25-26 February 2020
  • Facilitating End-to-End Development of Individualized Therapeutics – 3 March 2020
  • Oncologic Drugs Advisory Committee; Notice of Meeting – 17 December 2019
  • Hearing On "Building Consumer Confidence By Empowering FDA To Improve Cosmetic Safety" – 4 December 2019
Europe
  • EC Explains What it Means to Authorize Clinical Trials With Conditions (Focus)
  • Eudamed’s 2-Year Delay: CAMD Executive Group Calls for Interim Solutions (Focus)
Asia
  • Genetron Health Gets China NMPA Approval for Clinical NGS System, Files for IPO (GenomeWeb)
  • Asia Regulatory Roundup: China’s NMPA Finds Fault With Quality Management Systems at Vaccine Facilities (Focus)
India
  • US FDA to train Gujarat FDCA inspectors on system based drug batch manufacturing records to address data integrity issues (Pharmabiz)
  • Biocon elevates Siddharth Mittal as CEO and joint MD (Economic Times)
  • Medtronic launches Mazor X robot surgery system in India (MassDevice)
  • Medtronic and Elekta form radiation therapy pacts with ViewRay (MedtechDive)
  • GE Healthcare bulks up in 3D printing, robotics, patient monitoring (MedtechDive)
Other International
  • Climate risks to health are growing but prioritized funding lacking to safeguard human health from climate change (WHO)
General Health & Other Interesting Articles
  • 'Prediabetes' common in U.S. teens, young adults (Reuters)
  • 30 Under 30 In Healthcare 2020: Fixing Healthcare At Every Scale (Forbes)
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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