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

• 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)

• Read success stories from industry peers like BMS and Halozyme and get exclusive access to content on how to streamline regulatory processes and information for more efficient variation management.
• Access the resource center now >

• 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)

• 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)

• 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)

• 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)

• 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)

• 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

• 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)

• 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)

• 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)

• Climate risks to health are growing but prioritized funding lacking to safeguard human health from climate change (WHO)

• 'Prediabetes' common in U.S. teens, young adults (Reuters)
• 30 Under 30 In Healthcare 2020: Fixing Healthcare At Every Scale (Forbes)