Regulatory Reconnaissance (2 July 2013)
Welcome to the 100th edition of Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
- Merck Receives Complete Response Letter for Suvorexant, Merck's Investigational Medicine for Insomnia (Merck) (Pink Sheet) (NYTimes) (Pharma Times) (Pharmalot) (Reuters) (AP) (Fierce) (MM&M) (SCRIP) (Pharma Letter) (MedPage Today) (BioCentury)
- Nonhormonal hot flash drug: Why FDA approved Brisdelle after panel voted it down (CBS)
- FDA grants Roche's Perjeta regimen Priority Review for use before surgery in HER2-positive early-stage breast cancer (Roche) (Pharma Letter)
- Medtronic Petitions FCC to Postpone FCC's Market Trials Rule (FCC)
- Achillion shares skid lower after FDA puts a hold on hep C drug (Fierce) (SCRIP) (BioCentury)
In Focus: International
- Indian technical body suggests major fine-tuning of trial compensation norms (SCRIP)
- Glaxo Probe in China Follows Drug Safety Agency Revamp (Bloomberg)
- South Korea revises medical device regulations (Mass Device)
- Malaysia's new device regs poised to heighten the competition (Fierce)
- Disarray: Indian pharma cos head to global sites for trials as regulatory environment remain uncertain (PharmaBiz)
- EMA Says International Collaboration and New Laws Mean Reliable API Imports (In-Pharma Technologist)
- EC Wants Info on API Import Law-Related Shortages (In-Pharma Technologist)
- EU Releases Updated Application for Renewal of Marketing Authorisations (EU)
Comments? Suggestions? Email me at [email protected].
US
Pharmaceuticals/Biotechnology
- Merck Receives Complete Response Letter for Suvorexant, Merck's Investigational Medicine for Insomnia (Merck) (Pink Sheet) (NYTimes) (Pharma Times) (Pharmalot) (Reuters) (AP) (Fierce) (MM&M) (SCRIP) (Pharma Letter) (MedPage Today) (BioCentury)
- Nonhormonal hot flash drug: Why FDA approved Brisdelle after panel voted it down (CBS)
- FDA to CNN: Many online pharmacies selling fake medicine (CNN)
- Pew Report: A New Pathway for Antibiotic Innovation (Pew)
- FDA grants Roche's Perjeta regimen Priority Review for use before surgery in HER2-positive early-stage breast cancer (Roche) (Pharma Letter)
- Bayer and Onyx Pharmaceuticals Announce Submission of FDA and EMA Applications for Nexavar (sorafenib) Thyroid Cancer (Drugs.com)
- FDA to review MDCO's cangrelor (BioCentury)
- Insmed shares routed on head-to-head antibiotic Phase III results (Fierce) (BioCentury) (Bloomberg)
- Achillion shares skid lower after FDA puts a hold on hep C drug (Fierce) (SCRIP) (BioCentury)
- FDA Approves New U.S. Labeling for Merck's HIV Treatment Isentress (raltegravir) (Merck)
- Alnylam says amyloidosis drug found effective in mid-stage trial (BioFlash) (Xconomy)
- Gamida Cell Reports FDA Recommending Further Study of StemEx (Gamida)
- Aurobindo, Glenmark, Natco get USFDA nod for migraine tablets (India Times) (India Times)
- Schumer: Stop the no-paper prescription bill (Post Star)
- Drug labels acquire more functionality to improve health outcomes (Pharmaceutical Commerce)
- US increases pressure on India over generics industry (PMLive) (India Times) (Pharma Times)
- Pfizer Files More Suits To Block Generic Toviaz (Law 360)
- AstraZeneca Sues Mylan Over Planned Vimovo Generic (Law 360)
- ISTA Settlement Includes Divestiture and Debarment (Policy and Medicine)
- FDA Posts MOU Between it and the Animal and Plant Health Inspection Service (FDA)
Pharmaceuticals: General
- A Rap Sheet For Medicare's Prescription Drug Program (ProPublica)
- Few Signs of a Taste for Diet Pills (NYTimes)
Medical Devices
- Siemens wins FDA clearance for mammography software (Mass Device)
- Medtronic Petitions FCC to Postpone FCC's Market Trials Rule (FCC)
- 24-Hour Summary of the General and Plastic Surgery Devices Panel Meeting on Blood Lancets (FDA)
- Most patients want their doctors to prescribe apps (MobiHealth News)
Assorted And Government
- FDA"s Jesse Goodman: Working Together to Address the Challenges of Rare and Neglected Diseases (FDA)
- S.1244 -- Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014 (Congress)
- H.R.2542 -- Regulatory Flexibility Improvements Act of 2013 (Congress)
- FDA Forges Partnerships in Latin America (FDA)
Upcoming Meetings And Events
- 2 July 2013: FDA Webinar on FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations (FDA)
- Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)
Europe
- EMA Says International Collaboration and New Laws Mean Reliable API Imports (In-Pharma Technologist)
- EC Wants Info on API Import Law-Related Shortages (In-Pharma Technologist)
- EU Releases Updated Application for Renewal of Marketing Authorisations (EU)
- Declaration of Conformity is More Than a Simple Document (MDDI)
- Genzyme Initiates Recall for Thymoglobuline Due to Stability Problems (MHRA)
Asia
- Indian technical body suggests major fine-tuning of trial compensation norms (SCRIP)
- Glaxo Probe in China Follows Drug Safety Agency Revamp (Bloomberg)
- South Korea revises medical device regulations (Mass Device)
- Malaysia's new device regs poised to heighten the competition (Fierce)
- Disarray: Indian pharma cos head to global sites for trials as regulatory environment remain uncertain (PharmaBiz)
- Alembic challenges Indian government's new drug price guidelines (India Times)
- Diabetes drug ban to help companies like USV, Sun Pharma, Lupin (India Times)
- IMA's Tamil Nadu branch withdraws caution letter against Ranbaxy (India Times)
- DCGI open to revoking of ban on pioglitazone based on scientific evidence (PharmaBiz)
Other International
- WHO updates HIV recommendations (BioCentury)
- Spurious Tuberculosis Drugs Pose a Threat (NYTimes)
- Australia's PBS adds batch of new generation medicines (Pharma Letter)
- TÜV SÜD PSB appoints Richard Hong as CEO (BioSpectrum)
General Regulatory And Interesting Articles
- Tiny tech quickly detects antibiotic efficacy (Fierce)
- Ethical dilemma: Should brain wave games be called devices? (Mass Device)
- Mind Over Matter: Debunking Alternative Medicines (NYTimes)
- To Avoid Root Canals, Teeth That Replace Themselves (WSJ)
Regulatory Reconnaissance #100 - 2 July 2013
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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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].