Regulatory Recon: FDA Approves New Renal Cell Carcinoma Drug Reduced ANVISA Fees for Some Due to Lawsuit (26 April 2016)

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

 In Focus: US

• Advisers to FDA Vote Against Duchenne Muscular Dystrophy Drug (Focus) (NY Times) (Washington Post) (FierceBiotech) (Bloomberg) (STAT) (CNBC) (WSJ-$) (SCRIP-$)  (PR)
• Here Are Three Ways To Prevent Tragic Battles Between The FDA And Patients (Forbes)
• Generic drug labels don’t always list known side effects. Time to change that (STAT)
• U.S. Health Regulators Release Lightly Redacted Theranos Letter, Inspection Report (WSJ-$)
• Catalyst Pharmaceuticals hit by FDA extra studies request for Firdapse (FierceBiotech) (In the Pipeline) (PR)
• Ackman to Testify With Pearson at Senate Drug-Pricing Hearing (AP) (Bloomberg News) (Senate Aging Committee)
• What the cancer 'moonshot' needs to fix (Politico)
• Turns out hedge funds have an incentive to control drug prices (NPR’s Marketplace)
• The Next Wave for Probiotics? (FDA Law Blog)
• Supreme Court skeptical in case backed by drugmakers (STAT) (WSJ-$)
• Drug makers spend big to fight California price control referendum (Politico)
• California: Next front in drug price wars, and more links (Politico’s Prescription Pulse)
• FDA Approval of Cabometyx (Cabozantinib) for Advanced Renal Cell Carcinoma (San Francisco Business Times) (OncLive) (PR)
• FDA’s Breakthrough Therapy Designation and Expedited Review Programs: Part II (FDA)
• National Drug Take Back Day: A Great Time to Dispose of Prescription Medications Cluttering Your Cabinets (FDAVoice)

In Focus: International

• A Dose of the TPP's Medicine (Foreign Affairs)
• Chinese labs modify deadly fentanyl to circumvent ban on sales in US (STAT)
• Gilead bags EU approval for next-generation HIV drug (PMLive) (Pharmafile)
• It’s Past Time for a More Holistic Response to Malaria (PLOS)
• Lawsuit in Brazil allows some manufacturers to pay reduced ANVISA fees sooner (Mass Device)
• EU Symbols Standard For Devices Moves Closer To Being Harmonized (SCRIP-$)
• Brexit: MHRA Grilling Gives A Regulator's View Of The Stakes (SCRIP-$)
• Notice: Medical Device Single Audit Program (MDSAP) Transition Plan – Frequently Asked Questions (Health Canada)
• Yellow fever vaccination essential for Angola, WHO reminds travelers (WHO) (Reuters)

US: Pharmaceuticals and Biotechnology

• Vaccines are among big pharma’s best-selling products (Financial Times-$)
• GSK doubles down on Zymeworks’ platform technologies with $908M deal (FierceBiotech)
• AstraZeneca sells U.S. gout drug rights to Ironwood for up to $265 million (Reuters) (GEN)
• Bayer Profit Beats Estimates as Newest Drugs Buoy Demand (Bloomberg News)
• Breaking barriers: Can continuous manufacturing prevail despite hurdles (In-Pharma Technologist)
• Lessons from the biotech trenches (STAT)
• Healthcare coalition targets PhRMA with drug-pricing plan (The Hill)
• AZ’s Bevaspi Aerosphere approved in US (Pharmaphorum) (Pharma Times)

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

• Correction of Misleading Information in Prescription Drug Television Advertising: The Roles of Advertisement Similarity and Time Delay (Research in Social and Administrative Pharmacy)
• Uncovered: fatal safety issues linked with Ironwood’s drug, Linzess (Phase Five Research)
• New York Insurers to Change Coverage of Hepatitis C Drugs (WSJ-$)

US: Medical Devices

• Questions surface about Palmaz Scientific’s fundraising (Mass Device)
• Fecal Transplant Stool Banks Face Potential Regulatory Changes; May Affect Physicians, Patients (GenomeWeb-$)
• Ortho after the Carlyle takeover: A Q&A with CEO Martin Madaus (FierceMedicalDevices)
• Federal judge tosses out 150 vaginal mesh cases against Bard (FierceMedicalDevices)
• Philips receives FDA 510(k) clearance of CT imaging solutions for lung cancer screening (PR)
• AtriCure Receives FDA Clearance for New AtriClip Device (PR)

US: Assorted and Government

• CMS final rule modernizing the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems (CMS) (Politico Pulse)
• Daily Water Intake Among U.S. Men and Women, 2009–2012 (CDC)

Upcoming Meetings and Events              

• Public Meeting on Patient-Focused Drug Development for Patients Who Have Received an Organ Transplant (FDA)
• RAPS' FDA Advisory Committee Meeting Tracker

Europe

• Advertising investigations: March 2016 (MHRA)
• Merck opens 55m Euro Irish plants supporting downstream consumables (BioPharma-Reporter)

India

• Gujarat FDCA to work closely with USP to strengthen regulatory apparatus (PharmaBiz)
• HC nod to desi cos' version of cancer drug, but with curbs (Times of India)

Zika

• Senators Seek to Settle Zika Bill's Cost (Roll Call)
• U.S. fight against Zika mosquito depends on local effort (USA Today)
• Canada confirms its first sexually transmitted Zika case (Fox News)

General Health and Other Interesting Articles

• The chemistry book: from gunpowder to graphene – 250 milestones in the history of chemistry (ChemistryWorld)
• The building blocks of life weren’t that hard to put together (Washington Post)

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