Regulatory Reconnaissance (30 September 2013)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. We're coming to you from Boston this week for the 2013 RAPS Regulatory Convergence-our annual gathering of thousands of regulatory professionals. If you see us walking around, come say "Hello"! We'd love to meet you. In the meantime, got any tips or gripes? Shoot us an email at [email protected].

In Focus: US

• Government Shutdown Date: 12:01 AM EST on 1 October 2013
• Legal Group Takes Aim at FDA's Regulation of Autologous Stem Cell Procedures (FDA Law Blog)
• HELP Committee Members Call for Senate Passage of Drug Quality and Security Act (Senate)
• When Will Gene Therapy Come to the U.S.? (MIT Tech Review)
• FDA approval far away from Achillion's hepatitis C drug as clinical hold remains (MedCity News) (BioCentury) (SCRIP-$) (Fierce)
• CDRH Officials Talk New Guidance, Post-Market Surveillance And 510(k)s At AdvaMed (Gray Sheet-$)
• FDA Validates Tool For Incorporating Patient Preferences In Regulatory Decisions (Gray Sheet-$)

In Focus: International

• Genentech plays science card to spike Her-2 biosimilars (SCRIP-$)
• NICE to update ovarian cancer drug guidelines (PMLive)
• Indian Supreme Court: No clinical trial of untested drugs in absence of mechanism (India Times)
• Indian Parliamentary panel starts scrutiny of Drugs & Cosmetics (Amendment) Bill, 2013 (PharmaBiz)
• Rising global regulatory checks & warnings may tighten noose on India pharma: Eisai India Chief (PharmaBiz)
• Brazilian Presidential Decree Opens Door To Less Stringent GMP Certification Requirements For Foreign Firms (Gray Sheet-$)

Comments? Suggestions? Email me at [email protected].

US: Pharmaceuticals/Biotechnology

• Legal Group Takes Aim at FDA's Regulation of Autologous Stem Cell Procedures (FDA Law Blog)
• HELP Committee Members Call for Senate Passage of Drug Quality and Security Act (Senate)
• When Will Gene Therapy Come to the U.S.? (MIT Tech Review)
• FDA approval far away from Achillion's hepatitis C drug as clinical hold remains (MedCity News) (BioCentury) (SCRIP-$) (Fierce)
• Pediatric Study Waiver, Deferral Determinations Could Harm Approvals, Firms Tell FDA (Pink Sheet-$)
• Searching For Surrogate Endpoints Requires Teamwork (Pink Sheet-$)
• Roche immunotherapy drug may be 'game changer' in lung cancer (Reuters)
• CBO Releases Cost Estimate for Drug Quality and Security Act (CBO)
• Meth-Deterring Pseudoephedrine Product, Nexafed, Bioequivalent to Sudafed (Forbes)
• After One Year of GDUFA, Stakeholders and FDA Confident As Review Goals Near (Pink Sheet-$)
• GDUFA Hiring Ahead Of Pace But Still Faces A Long Road (Pink Sheet-$)
• Durata seeks FDA OK for dalbavancin in ABSSSI (SCRIP-$)
• Merck Serono Is Hoping It Pays To Plan Ahead With New Phase III Trial For Tecemotide (Pink Sheet-$)
• Nektar Considers New Phase III Designs For NKTR-181 After Phase II Failure (Pink Sheet-$)
• Pa. Judge Denies GSK's Attempts To Nix Thalidomide Suits (Law 360-$)
• FDA clears UCB's Cimzia for psoriatic arthritis treatment (Reuters)
• Congress, FDA playing blame game on outbreak (Livingston Daily)
• Bristol-Myers' Yervoy extends lives by three years for one-fifth of melanoma patients (SCRIP-$)
• Genentech's Kadcyla 'should be standard of care' in metastatic breast cancer (Genentech) (SCRIP-$)
• Merck Serono's Erbitux Significantly Extends Survival by 7.5 Months in mCRC RAS Wild-Type Patients (Merck)
• Boehringer's Nintedanib extended survival beyond one year for advanced adenocarcinoma patients after prior first-line chemotherapy (BI)
• Astellas reports positive topline phase 3 results for antifungal isavuconazole - Isavuconazole phase 3 invasive aspergillosis study (SECURE) meets primary endpoint (Astellas)
• Ipsen touts results from CLARINET Phase III clinical trial for Somatuline (Ipsen)
• Glenmark gets USFDA nod for skin infections cream (India Times)

US: Pharmaceuticals and Biotechnology: General

• BARDA awards up to $355.1M for countermeasures (BioCentury)
• Opinion: When Big Pharma comes to town, drug costs tend to rise (Sacramento Bee)

US: Medical Devices

• CDRH Officials Talk New Guidance, Post-Market Surveillance And 510(k)s At AdvaMed (Gray Sheet-$)
• FDA Validates Tool For Incorporating Patient Preferences In Regulatory Decisions (Gray Sheet-$)
• 5 Takeaways From FDA's Unique Device ID Rule (Law 360-$)
• Class 1 Recall for King Systems' Universal Flex2 Breathing Circuit Due to Latex labeling Mixup (FDA)

US: Assorted And Government

• Government Shutdown Date: 12:01 AM EST on 1 October 2013
• House votes to repeal medical device tax, delay Obamacare (Mass Device)
• SCRIP's Capitol Capsule (SCRIP-$)

Upcoming Meetings And Events

• 29 Sept. - 2 Oct. 2013: 2013 RAPS Regulatory Convergence (RAPS)
• October 8-9, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
• 9-10 October 2013: AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings (AAMI)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• Genentech plays science card to spike Her-2 biosimilars (SCRIP-$)
• Marketing Authorisation Application for AZ's naloxegol, olaparib accepted by European Medicines Agency (AZ) (2) (Pharma letter-$) (BioCentury)
• Positive new data for Novartis drug Lucentis across four indications (Pharma Letter-$)
• European payers push back on orphan drug prices (Pharma letter-$)
• NICE to update ovarian cancer drug guidelines (PMLive)
• UK to Boost Cancer Fund by 400 Million Pounds (DOH) (PMLive)

Asia

• Indian Supreme Court: No clinical trial of untested drugs in absence of mechanism (India Times)
• Indian Parliamentary panel starts scrutiny of Drugs & Cosmetics (Amendment) Bill, 2013 (PharmaBiz)
• Rising global regulatory checks & warnings may tighten noose on India pharma: Eisai India Chief (PharmaBiz)
• First approval for Medivir's simeprevir in Japan (BioCentury) (SCRIP-$)
• Bayer Submits Nexavar (Sorafenib) for Marketing Authorization in Thyroid Cancer in Japan (Bayer)
• Ruxolitinib filed in Japan for myelofibrosis (SCRIP-$)

Other International

• Brazilian Presidential Decree Opens Door To Less Stringent GMP Certification Requirements For Foreign Firms (Gray Sheet-$)

General Regulatory And Interesting Articles

• Looks good on paper: A flawed system for judging research is leading to academic fraud (The Economist)
• The Pharma Bureaucracy Index: Who's Nimble, and Who's Sloooowww? (Xconomy)

Regulatory Reconnaissance #167 - 30 September 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].