Regulatory Focus™ > News Articles > Regulatory Recon: AstraZeneca's Durvalumab Gets First Bladder Cancer Approval; Pfizer, Merck Beat Q1

Regulatory Recon: AstraZeneca's Durvalumab Gets First Bladder Cancer Approval Pfizer, Merck Beat Q1 Profit Estimates (2 May 2017)

Posted 02 May 2017 | By Michael Mezher 

Regulatory Recon: AstraZeneca's Durvalumab Gets First Bladder Cancer Approval Pfizer, Merck Beat Q1 Profit Estimates (2 May 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Scott Gottlieb And The Goldilocks Theory Of Bringing Change To The FDA (Health Affairs Blog)
  • Who boasts the biggest overseas cash coffers? Amgen and Gilead, to name a couple (Fierce)
  • AstraZeneca immunotherapy wins first approval in bladder cancer (Reuters) (Pink Sheet-$) (Press)
  • Defending Biomedical Science in an Era of Threatened Funding (JAMA)
  • Obstacles to the Adoption of Biosimilars for Chronic Diseases (JAMA)
  • Overcoming Opioids: When Pills Are a Hospital's Last Resort (AP)
  • Pfizer beats first-quarter profit estimates (CNBC) (Press)
  • Pfizer cuts diabetes, heart and cognitive disease meds from pipeline in Q1 (Fierce) (Endpoints)
  • Novartis takes the long view on CAR-T, grabbing licenses on new tech for next-gen therapies (Endpoints)
  • Drugmaker Merck's profit beats estimates as margins rise (CNBC) (Press)
  • U.S. Not Preparing for the Next Bio-Threat (NBC)
  • Price, Patient Groups Discuss Drug Prices (BioCentury)
  • Building A Biotech: Magenta Starts Chapter 2 With A Triple Play (LifeSciVC)
  • GSK, Hospira Trade Blame For Failed Flu Vaccine Deal (Law360-$)
  • Federal Money For State-Level Zika Tracking, Prevention May End This Summer (KHN)
  • Apotex Moves To Block Coherus' Neulasta Biosimilar; Asks FDA To Require Patient Studies (Pink Sheet-$)
  • Why Neurocrine is charging twice as much for its new drug as it said it would (MarketWatch)
  • Clues to Zika Damage Might Lie in Cases of Twins (NYTimes)
  • Sanofi, CDC and FDA Work to Avoid Yellow Fever Vaccine Shortage (Focus)
  • US Trade Report Highlights Pharma's IP, Counterfeit Issues Abroad (Focus)
  • Two states launch investigation into Eli Lilly's insulin pricing (Modern Healthcare)

In Focus: International

  • Cancer fund failure highlights the dilemma of drug pricing (Financial Times)
  • China Leads Strong AstraZeneca Emerging Markets Charge In Q1 (SCRIP-$)
  • CML patients in England win access to Incyte's Iclusig (PharmaTimes)
  • EU expands use of Janssen's Darzalex (PharmaTimes)
  • NICE recommends Janssen's Crohn's Disease biological therapy (EPR)
  • UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers (Focus)
  • Brazil: May 1 Compliance Deadline Stands for New INMETRO Certification Requirements (Emergo)
  • Patient Engagement Helped Roche's Kadcyla Get Reimbursement In Scotland (Pink Sheet-$)
  • Candidate for WHO top post David Nabarro is all for making healthcare affordable (Economic Times)
  • Despite foundering Dengvaxia launch, Sanofi puts up 13.2% vaccines growth in Q1 (Fierce)

US: Pharmaceuticals & Biotechnology

  • A New Hope: Vaccine Supply Chains Get More Attention (Forbes)
  • Novartis's Rydapt: Two Indications, Two Prices (SCRIP-$)
  • Mylan's Coury caps a year of controversy with $97M exit-pay package (Fierce)
  • Generic price erosion wreaks more pharma havoc, with no end in sight (Fierce)
  • bluebird bio Licenses Lentiviral Vector Patent Rights for Development and Commercialization of Cell Therapies (Press)
  • Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (FDA)
  • Shire Sets Sights on Dry Eye Disease with Deal for Parion Drug (Xconomy)
  • Forward Downsizing As It Preps Biogen Appeal (BioCentury)
  • Perrigo's Return To OTC Roots Restoring Investor Confidence (Pink Sheet-$)
  • FDA Hits Suzhou Amerigen for Inadequate Investigations, Quality Controls (FDANews-$)
  • Some antibiotics linked to miscarriage in early pregnancy, study says (CNBC)
  • Can Radius fight off big guns Lilly, Amgen with new bone drug Tymlos? One analyst says no (Fierce)
  • Magenta gains $50M Series B, Novartis candidate and new partnership (Fierce)
  • Hit by Generic Deflation, Cardinal Health Expects Pricing to Stabilize Through 2017 (The Street)
  • Advanced Proteome Therapeutics moves into Johnson & Johnson's Innovation lab (Drug Delivery)
  • Clinical Trials Awareness Week: Celebrating the impact of clinical research (PhRMA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Altor BioScience Corporation Announces FDA Fast Track Designation for Lead Candidate ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer (Press)
  • Kala touts Phase III data for nanoparticle ophthalmic suspension  (MassDevice) (BioCentury)
  • Concert Pharmaceuticals Initiates CTP-543 Phase 2 Trial in Alopecia Areata (Press)
  • Otsuka and Lundbeck Announce Results of Brexpiprazole on Symptoms of Agitation Related to Alzheimer's-Type Dementia (Press)
  • Ziopharm Oncology (ZIOP) Says FDA Accepts IND for CD33-Specific CAR-T Cell Therapy Targeting Relapsed/Refractory AML (StreetInsider)

US: Medical Devices

  • Teleflex Receives FDA 510(k) Clearance for the Arrow AC3 OptimusTM Intra-Aortic Balloon Pump (Press)

US: Assorted & Government

  • Aetna's Failed Humana Deal Overshadows Obamacare Exit (Forbes)
  • Anthem Not Ruling Out Long-Shot SCOTUS Review Of Cigna Deal (Forbes)
  • Bill Would Direct HHS to Study 'Psychological and Social Distress' of Patients in Clinical Trials (Congress)
  • Funding Bill Prohibits Full Risk Corridor Payments, Omits Cost-Sharing Reduction Payments; HHS Takes Over CT Reinsurance Program (Health Affairs Blog)
  • Novo Nordisk reaches whistleblower settlement in 'white-coat' sales scheme lawsuit (Fierce)
  • Comparative Fault of Government Regulators Might be a Defense (Drug & Device Law)
  • Keeping an Eye on "Perceived Disability" Litigation in California: Chadam v. Palo Alto Unified School District (Genomics Law Report)
  • Shire Asks Fed. Circ. To Undo Generic's Win In Lialda Suit (Law360-$)
  • Compensation of Medicaid Directors and Managed Care Organization Executives in Selected States in 2015 (GAO)
  • FDA Delays Restaurant Menu Labeling Rule Until May 2018 (FDA)

Upcoming Meetings & Events

Europe

  • GSK invests $139 million in Benlysta manufacturing facility (PharmaLetter-$)

Asia

  • 2016 Annual Report for National Adverse Drug Reaction Monitoring released (CFDA)

India

  • Pharma policy to pave way for creation of pharma ministry, involvement of pharmacists in policy making process: IPA (PharmaBiz)
  • Biocon Cautiously Optimistic On Earnings Prospects Amid Slower Approvals (SCRIP-$)
  • NPPA needs to consider drug price revision every quarterly or half yearly: Dr BR Jagashetty (PharmaBiz)
  • SeQuent's arm Alivira gets USFDA nod for Visakhapatnam API facility (Economic Times)

Australia

  • Absorb Bioresorbable Vascular Scaffold System (TGA)
  • TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG) (TGA)
  • Medical devices and IVDs: Suspensions from the ARTG (TGA)

General Health & Other Interesting Articles

  • One Day, a Machine Will Smell Whether You're Sick (NYTimes)
  • Criminal laws fail to deter transmission of AIDS virus (Reuters)

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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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