Regulatory Recon: Genentech Bets $310M on Cancer Vaccine Tech Global Pledge on Superbugs (21 September 2016)

Welcome to Regulatory Reconnaissance. Today’s edition comes to you as the Focus team returns from Regulatory Convergence in California. If you were able to join us, we hope you enjoyed it.

In Focus: US                                      

• House committee launches review of FDA criminal office (Reuters)
• House Oversight Hearing at 2 PM ET: REVIEWING THE RISING PRICE OF EPIPENS (Oversight)
• Mylan CEO Regrets Patient Blowback, But Not Expanded EpiPen Use (Bloomberg)
• Mylan CEO's mother used position with education group to boost EpiPen sales nationwide (USA Today)
• California governor decries ‘predatory’ pricing as he signs law to make EpiPen available (Stat)
• Blame Game: The $130 Billion in Fees Mylan Says Pushes Up Prices (Bloomberg) (Bloomberg)
• The Man Who Started EpiPen’s Price Rise Won’t Face Congress (Bloomberg)
• Drugmaker raises price of acne cream to $10,000 a tube (FT-$)
• Approving A Muscular Dystrophy Drug Ignites A Civil War At The FDA (Forbes)
• Q&A with Sarepta’s CEO: ‘This is a learning process for us and the FDA’ (Stat) (Fierce) (Boston Business Journal) (Nature News)
• Sarepta Gets An Approval – Unfortunately (In the Pipeline)
• FDA more efficient now, not less (The Hill)
• Genentech dives into mRNA, betting $310M on BioNTech’s personalized cancer vaccine tech (Endpoints) (Press)
• Procedures for Sharing Non-public Information on Pending Proposed Proprietary Names (FDA)

In Focus: International

• UN agrees to fight 'the biggest threat to modern medicine': antibiotic resistance (Guardian) (BBC)
• Zika no threat to plasma-derived drugs, says EU regulator (Reuters)
• Japan Securities Watchdog to Boost Monitoring of Biotech Stocks (Bloomberg)
• Takeda Signs Research Deal To Develop Affilogic's Nanofitin-based Therapies (RTT)
• Takeda-Zydus Enter Increasingly Crowded Chikungunya Fray (SCRIP-$)
• A novel UK approach to cancer access: yes, no, or maybe? (PharmaPhorum)
• AstraZeneca withdraws cancer drug after 'differences of opinion' with regulator (Telegraph) (Reuters)
• A well-groomed ‘inside-outsider’ – GSK’s new CEO, Emma Walmsley (PharmaLetter-$)
• Destination Cuba: Regulator Prepares for Influx of Novel US Pharmaceuticals (Focus)
• Asia Regulatory Roundup: Australia Looks to Establish Expedited Approval Pathway (Focus)

US: Pharmaceuticals and Biotechnology

• Inside the 10-Year, $1 Billion Battle for the Next Critical Antibiotic (Bloomberg)
• Event – Kite shoots, but what’s the target? (EP Vantage) (Press)
• Juno Spends Big on R&D, Production in CAR-T Race to Fight Cancer (Bloomberg)
• Microsoft Develops AI to Help Cancer Doctors Find the Right Treatments (Bloomberg)
• Teva inks $2.6B deal to buy into Regeneron’s PhIII NGF pain drug (Endpoints)
• Evotec signs up for a 5-year discovery deal with Bayer focused on chronic kidney disease (Endpoints)
• Allergan goes on a buying spree for NASH drugs, adding Akarna in M&A double header (Endpoints) (EP Vantage) (Bloomberg)
• Re-Balancing Immunity via Regulatory T Cell Potentiation: Introducing Delinia (LifeSci VC)
• When to Approach FDA to Discuss CAR T Development Programs (Convergence)
• Vectors FDA has seen used in Car T Therapies (Convergence)
• LabCorp announces new Covance CEO (Modern Healthcare)
• Long-suffering Eleven hands the reins over to a new CEO with his own pipeline plans (Endpoints)
• Moderna to Build State-of-the-Art Fully Integrated GMP mRNA Clinical Manufacturing Facility in Norwood, Mass. (Press) (Boston Globe)
• PhRMA Brings Scientists to Capitol Hill (Press)

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

• Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review (PLOS)
• The Medicines Company Awarded up to $132 Million to Develop Portfolio of New Antibiotics Targeting Drug-Resistant Infections under Strategic Partnership with BARDA (Press)
• Mirna Therapeutics Halts Phase 1 Clinical Study of MRX34 (Press)
• Star-studded syndicate pumps $33.2M into preclinical DNA repair cancer startup (Fierce)
• Relapse Type and Monoclonal Antibody Choice in Multiple Myeloma (OncLive)

Medical Devices

• FDA Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (FDA)
• Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System (Federal Register)
• Reporting of Computational Modeling Studies in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability (Federal Register)
• Lamar Alexander: FDA’s Proposed “Double Regulation” Could Halt More Than 60,000 Lab-developed Tests Americans Depend on for Lifesaving Treatments, Cures (Press)

US: Assorted and Government

• Medical cures bill pushed back to lame-duck (The Hill)
• The DeCosters Battle On (FDA Law Blog)

Upcoming Meetings and Events             

• RAPS' FDA Advisory Committee Meeting Tracker
• Public Meeting: Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (FDA)

Europe                                                                                

• EU Biosimilar Review as of September 2016 (Convergence)
• Timeline of EU transition to new clinical trial system (Convergence)

General Health and Other Interesting Articles

• Tiny Creatures May Hold Clues to Bolstering Health of Human Cells (WSJ-$)
• Tipping the Balance Toward Fewer Antibiotics (JAMA)

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? Send him an email at [email protected].A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.