Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Pazdur Says Too Many Companies Chasing Same Cancer Strategy; Merck C. Diff D

Regulatory Recon: FDA's Pazdur Says Too Many Companies Chasing Same Cancer Strategy Merck C. Diff Drug Backed by AdComm (10 June 2016)

Posted 10 June 2016 | By Michael Mezher 

Regulatory Recon: FDA's Pazdur Says Too Many Companies Chasing Same Cancer Strategy Merck C. Diff Drug Backed by AdComm (10 June 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Therapy focus – First-line lung cancer is an Opdivo vs Ketruda showdown (EP Vantage)
  • FDA's Pazdur: too many drugmakers chasing same cancer strategy (Reuters)
  • US Panel Backs Approval for Merck C. Diff drug (Reuters) (Press) (BioCentury)
  • FDA, International Authorities Shutter Thousands of Illegal Online Drug Stores (Focus)
  • FDA Offers New Draft Guidance on How Device Manufacturers Can Share Data With Patients (Focus)
  • Drugs for schizophrenics regularly dispensed to foster kids (Reuters)
  • Medtronic Wins $1.4Bn U.S. Tax Case (WSJ-$) (MassDevice)
  • Why Do Health Costs Keep Rising? These People Know (NYTimes)
  • Is This the Diagnostic Tool We've Been Waiting for in Concussion Testing? (MIT Technology Review)
  • Merck to Acquire Biotech Company Afferent (WSJ-$) (BioCentury) (Press)
  • US to send rapid-response teams when Zika hits here (Washington Post)
  • Valeant pays $54 million to settle U.S. kickback, fraud claims (Reuters)
  • Senate Appropriations Bill Targets FDA Rulemaking Agenda (National Law Review)

In Focus: International

  • NZ's PHARMAC to Fund Opdivo, Five Other Treatments (PharmaLetter-$) (Fierce) (Pharmac)
  • Delay Pregnancy in Areas With Zika, WHO Suggests (NYTimes)
  • The Netherlands to track switching of biologicals (GaBI)
  • Two-hour test boosts HIV care in rural Africa (Reuters)
  • In yellow fever war, WHO readies plan to stretch vaccine supply (Reuters)
  • Eurasian Governments Issue New Harmonized Medical Device Regulations (Emergo)
  • EMA Warns of Possible Chemotherapy Shortage in Four Countries Due to Sanofi Manufacturing Snafu (Focus)
  • European Regulatory Roundup: EMA to Waive Some Scientific Advice Fees for Accelerated Access Program (Focus)
  • Tackling antimicrobial resistance (OECD)

US: Pharmaceuticals & Biotechnology

  • Who defines value? Quintiles talks changing reimbursement landscape (Outsourcing-Pharma)
  • Digital Health in Clinical Trials (LifeSciVC)
  • With tens of millions on hand, drug makers fight state efforts to force down prices (STAT)
  • Research Traces Link Between Combat Blasts and PTSD (NYTimes) (IEEE Spectrum)
  • Silicon Valley joins the search for cures in medicine (MedCityNews)
  • BIO 2016 Notebook: Patient Perspectives, Risk-Sharing, Microbiomes and Incubating Success (SCRIP-$)
  • Lilly and American Migraine Foundation Announce $1 Million Grant for Launch of First Patient Registry to Advance Research and Development in Migraine (Press)
  • CRISPR/Cas9 already is a revolution in molecular biology (MedCityNews)
  • Decoding The Immune System To Speed Vaccine/Immunotherapy R&D (SCRIP-$)
  • Sandoz Enbrel Copycat Next Biosimilar To Get Panel Treatment (SCRIP-$)
  • Here Is Why Big Pharma Stock Pfizer Is the Best Bet in the Sector (The Street)
  • Sell Valeant's Dead-Cat Bounce (The Street)
  • Developing gene therapy to treat cystic fibrosis: challenges and successes (Pharmaceutical Journal-$)
  • Celltrion/Pfizer Agree To Wait For Mid-September Inflectra Launch (SCRIP-$)
  • Social Media And Clinical Trial Recruitment: Be Careful What You Ask For (Pink Sheet-$)
  • Study finds biosimilar switching not suitable for all patients (EPR)
  • The Martin Shkreli Musical No One Wanted Is Happening (Vanity Fair) (SCRIP-$)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; POMALYST (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; TANZEUM (FDA)

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

  • Janssen says its immunotherapy daratumumab extends progression-free survival in combination study to treat multiple myeloma (Pharmafile)
  • Teva's biological drug improves chronic migraine symptoms (Pharmaceutical Journal)
  • Amgen's erenumab passes Phase II chronic migraine test (BioCentury)
  • Novartis presents strong results in rare blood disorder trials (Pharmafile)
  • Data in The Lancet Show Olaratumab Plus Doxorubicin Offered 11.8-Month Increase in Overall Survival in Patients with Advanced Soft Tissue Sarcoma, as Reported by Lilly and Memorial Sloan Kettering Researchers (Press)
  • New high-risk treatment can halt MS, claim researchers (Pharmafile)
  • ViiV Healthcare Announces FDA Approval to Lower the Weight Limit for dolutegravir in Children and Adolescents Living With HIV (Press)
  • Acceleron and Celgene Announce Updated Results from an Ongoing Phase 2 Study of Luspatercept in Myelodysplastic Syndromes at the 21st Congress of the European Hematology Association (Press)
  • Acceleron and Celgene Announce Updated Results from an Ongoing Phase 2 Study of Luspatercept in Beta-Thalassemia Presented at the 21st Congress of the European Hematology Association (Press)
  • Ra Pharmaceuticals Presents Clinical Data on Complement C5 Inhibitor RA101495 at the 21st Congress of the European Hematology Association (Press)
  • GlycoMimetics' GMI-1271 Yields High Remission Rates and Favorable Tolerability in Phase 1 Portion of Phase 1/2 Clinical Trial for AML (Press)
  • New Data on Bristol-Myers Squibb's Opdivo (nivolumab) Indicate Benefit in Heavily Pre-Treated Classical Hodgkin Lymphoma Patients in Phase 2, Single-Arm Pivotal Trial (Press)
  • New Phase 3 Data Show Jakafi (ruxolitinib) is Superior to Best Available Therapy in Patients with Polycythemia Vera (PV) (Press)
  • Upsher-Smith Granted Tentative FDA Approval For Qudexy XR (topiramate) Extended-Release Capsules For Prophylaxis Of Migraine Headache In Adults (Press)

US: Medical Devices

  • Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device (FDA)
  • FDA reinstates clearance process for Iradimed's MR-safe MRidium 3860 infusion pump (MassDevice)
  • Struggling GlaxoSmithKline bets big on neural implants to fuel turnaround (MassDevice)
  • Q1 Snapshot: Device Recalls Fell Over Past Two Quarters; Troubles With Quality, Labeling Top List Of Recall Causes (Gray Sheet-$)
  • Diasend, Abbott ink diabetes data management pact (MassDevice)
  • Endocure Technologies Gets 510(k) Clearance For The Manufacture Of Its New Endocure Model EUR078A Urology Endoscope (Press)
  • Sandstone Diagnostics Announces FDA 510(k) Clearance for the Trak Male Fertility Testing System (Press) (MobiHealthNews)
  • FIRE AND ICE Data Show Fewer Repeat Ablations and Hospitalizations for AF Patients Treated with Medtronic Cryoballoon (Press)

US: Assorted & Government

  • Developments in Compassionate Use and Right To Try Laws (Drug and Device Law)
  • U.S. Files Antitrust Case Against North Carolina's Largest Health System (WSJ-$)
  • California Supreme Court To Consider Innovator Liability (Drug and Device Law)
  • Who May Die? California Patients and Doctors Wrestle With Assisted Suicide (NYTimes)
  • FDA, CMS, IDEs, an IA, and an MOU…Hopefully Lead to YES, You're Covered! (FDA Law Blog)
  • Legislation to Reduce Consumer Cost-Sharing Takes a Back Burner in the Drug Pricing Debate (National Law Review)
  • Dismissing Drug Design Defect Based on Preemption (Drug and Device Law)
  • Off-Label Use Was Focus Of Training At Acclarent, Rep Says (Law360-$)
  • Novartis Gets No Fees Despite 'Exceptional' Patent Case (Law360-$)
  • Calif. High Court To Review Novartis Generic Drug Suit (Law360-$)
  • Medicare Fee-For-Service: Opportunities Remain to Improve Appeals Process (GAO)

Upcoming Meetings & Events

Europe

  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2016 (EMA)
  • UK drug industry output grew in April according to latest ONS data (In-PharmaTechnologist)

Asia

  • Hovione aims to be big in Japan, citing growing demand for generic APIs (In-PharmaTechnologist)
  • Takeda licenses global rights to Theravance Biopharma's TD-8954 (PharmaLetter-$)
  • AstraZeneca off-loads anesthetic portfolio to Aspen (BioSpectrum)
  • Probiodrug's Alzheimer's drug secures two patents in Japan (BioSpectrum)

India

  • National reference standards for vaccines released in India (PharmaLetter-$)
  • India's pharma market dips to a 2-year low in May (Economic Times)
  • Government weighs relaxing FDI norms in brownfield pharma companies (Economic Times)
  • FDA approves Aurobindo's generic Dilaudid (DSN)
  • Drug regulators need to support pharmacovigilance to keep up safety of patients: Dr V Gopal (Pharmabiz)

Australia

  • Sequenom files patent infringement lawsuit in Australia (BioSpectrum)

Zika

  • U.S. researcher contracts Zika during experiment: media (Reuters)

Other International

  • Valeant May Sell Egyptian Drugmaker Amoun (Pharmaceutical Manufacturing)
  • UNAIDS and PEPFAR Announce Dramatic Reductions In New HIV Infections Among Children In The 21 Countries Most Affected By HIV In Africa (UNAIDS)

General Health & Other Interesting Articles

  • Against Parkinson's, Muhammad Ali Proved Himself Again (NYTimes)

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe