Regulatory Focus™ > News Articles > Regulatory Recon: Drug Companies Release Study Results at ASCO (1 June 2015)

Regulatory Recon: Drug Companies Release Study Results at ASCO (1 June 2015)

Posted 01 June 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Drug Companies Release Study Results at ASCO (1 June 2015)

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

In Focus: US

  • FDA Would Establish Conditions For Swift Manufacturing Changes (Pink Sheet-$) (BioCentury) (In-Pharma)
  • Ensuring the Safe and Effective FDA Regulation of Fecal Microbiota Transplantation (SSRN)
  • U.S. Drug Shortages Frustrate Doctors, Patients (WSJ-$)
  • FDA says it won't allow lethal injection drug into US (AP)
  • Groups Push for FDA Approval of 'Female Viagra' (NYTimes)
  • High Prices for Drugs Attacked at Meeting (WSJ-$)

In Focus: International

  • DCGI to recruit 200 drug inspectors to strengthen Central regulatory system soon (PharmaBiz)
  • Slowdown in drug approvals, currency volatility pose stern test for Indian pharma companies (BusinessToday)
  • Pediatric trials in EU increase as overall trials decline, Commission report says (Outsourcing Pharma)
  • EU to pilot new risk-based model for postmarket drug testing (SCRIP RA-$)
  • New EMA Guidelines on Human Plasma Derived Products (EMA) (EMA) (EMA)
  • China FDA issues 'user-friendly' guidance on medical device registration studies; waivers may prove a challenge (SCRIP RA-$)

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US: Pharmaceuticals and Biotechnology (In-Pharma)

  • FDA Would Establish Conditions For Swift Manufacturing Changes (Pink Sheet-$) (BioCentury) (In-Pharma)
  • Ensuring the Safe and Effective FDA Regulation of Fecal Microbiota Transplantation (SSRN)
  • U.S. Drug Shortages Frustrate Doctors, Patients (WSJ-$)
  • FDA says it won't allow lethal injection drug into US (AP)
  • Groups Push for FDA Approval of 'Female Viagra' (NYTimes)
  • The “Program” At Half-Time: Report Finds Happy Sponsors, But Tweaks Suggested (RPM Report-$)
  • Critical Path Institute Secures Regulatory Support for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Biomarker (Press)
  • FDA Asked To Add HIV Warning To Birth Control Label (Law 360-$)
  • Soaring Cost, Toxic Effects Drive Race for Cancer Tests (Bloomberg)
  • FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding (EBG)
  • 3PL Operation Under The DSCSA (RxTrace)
  • Actavis Loses Nameda Appeal Over “Hot Documents” (FDA Life)
  • CA Bill would require docs to check prescription drug database (AP)
  • EWG Report Smears Most Sunscreens, Questions Cancer Prevention Efficacy (Tan Sheet-$)

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

  • OPKO Announces Submission of Rayaldee™ New Drug Application to FDA (Press)
  • ASCO '15: Merck, Bristol Drugs Boost Immune System to Kill Broad Swath of Cancer Types (The Street)
  • Bristol-Myers’s cancer treatment Opdivo yields benefits in clinical trial (WSJ-$) (NYTimes) (Reuters) (WSJ-$) (Fierce) (Fierce) (BioCentury)
  • FDA Accepts Supplemental Biologics License Application for Opdivo+Yervoy Regimen in Patients with Previously Untreated Advanced Melanoma (Press)
  • OPKO Submits Rayaldee NDA To FDA (RTT)
  • PharmaEngine Announces Filing New Drug Application (NDA) of MM-398 (PEP02) to Taiwan FDA as a Treatment for Post-Gemcitabine Metastatic Pancreatic Cancer (Press)
  • Merck immunotherapy appears effective in head and neck cancer-study (Reuters)
  • Amgen preps an FDA pitch for its late-stage kidney drug (Fierce) (SCRIP-$)
  • Boehringer: Positive Results for Afatanib in Advanced Squamous Cell Carcinoma of the Lung (Press)
  • Pfizer's Ibrance drug slows progression of breast cancer (Reuters) (Fierce)
  • J&J multiple myeloma drug offers hope after others stop working: study (Reuters) (Fierce)
  • Roche's Gazyva doubles remission time for non-Hodgkin lymphoma patients (Fierce)
  • Farydak/Kyprolis ORR tops Velcade combo in MM (BioCentury)
  • Eisai drug extends survival in patients with rare cancers (Reuters)
  • Alabama Right to Try Bill Awaits Governor's Signature (Press)
  • New standout Imbruvica data bode well for market expansion in CLL (Fierce)
  • Celldex Immunotherapy Maintains Survival Benefit for Recurrent Brain Tumor Patients (The Street) (Fierce)
  • Clovis boasts promising ovarian cancer data as lung cancer results fade (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • High Prices for Drugs Attacked at Meeting (WSJ-$)
  • Doctors Seek Test for Deploying New Life-Extending Cancer Drugs (NYTimes)
  • Can The Nosebleed-High Prices Of Cancer Drugs Ever Be Contained? (Forbes)
  • Making precision medicine a 'reality' in cancer, other diseases (SCRIP-$)

US: Medical Devices

  • FDA Approves ViMove for Expanded Use in the United States (Press)
  • Rivanna Medical has Received FDA Clearance for Accuro (Press)

US: Assorted And Government

  • Weekly PwC Regulatory Update (PwC)
  • Large U.S. cancer trial to match genetic glitches to targeted drugs (Reuters)
  • OIG Releases Updates Work Plan (DHHS OIG)
  • Weekly FDA Enforcement Report (FDA)

Upcoming Meetings and Events

Europe

  • Pediatric trials in EU increase as overall trials decline, Commission report says (Outsourcing Pharma)
  • EU to pilot new risk-based model for postmarket drug testing (SCRIP RA-$)
  • New EMA Guidelines on Human Plasma Derived Products (EMA) (EMA) (EMA)
  • EC Authorizes Use of Hospira's Voriconazole (EC)
  • Eisai Receives European Commission Approval Of Anticancer Agent Lenvima For Treatment Of Advanced Thyroid Cancer Refractory To Radioactive Iodine (Eisai)
  • Access to new medicines: shifting the blame (PharmaPhorum)

India

  • DCGI to recruit 200 drug inspectors to strengthen Central regulatory system soon (PharmaBiz)
  • Slowdown in drug approvals, currency volatility pose stern test for Indian pharma companies (BusinessToday)
  • A Closer Look at DGFT’S Revised Notification On Track & Trace (24 Insight)
  • DCGI urged to issue norms on printing expiry dates on tubes containing ointments & creams (PharmaBiz)
  • DCGI urged to ban Power Morcellator used in hysterectomy as it causes cancer (PharmaBiz)

China

  • China FDA issues 'user-friendly' guidance on medical device registration studies; waivers may prove a challenge (SCRIP RA-$)

Canada

  • Inside look into Health Canada battle with Apotex (Toronto Star)
  • Canada Releases New Guidance on Plain Language Labelling Regulations (HC)
  • Canada Adopts ICH Q4B Guidances (HC) (HC) (HC) (HC)

Other International

  • Regulators and industry tackle dose-finding issues (Nature)
  • Study in Nigeria Finds 1 in 10 Malaria Drugs Are Poor Quality (Press)

General Regulatory And Interesting Articles

  • New Study Questions Use of Whole-Brain Radiation to Treat Cancer (WSJ-$)

Regulatory Reconnaissance #566 – 1 April 2015

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 @AlecGaffney 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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