Regulatory Recon: Biotech M&A Falls Off E&C Presses HHS on Pandemic Flu Plan (21 April 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                      

• Committee Leaders Press HHS for Status of Pandemic Influenza Plan, Amidst Global Concerns (Energy & Commerce) (Letter)
• Biotech M&A Falls Off as Trump Dashes Hopes of a New Pharma Boom (Bloomberg)
• Generic drug woes aren’t going away (Bloomberg)
• The drug industry is addicted to price increases, report shows (CNBC)
• FDA Staff Call for Broader Cancer Trial Eligibility Criteria (BioCentury-$)
• Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting (FDA)
• A Citizen’s Pathway Gone Astray — Delaying Competition from Generic Drugs (NEJM-$)
• Novartis drug development chief outlines CAR-T research commitment (Fierce)
• New Legislation Seeks Limits on Opioid Prescriptions for Acute Pain, But Will it Reduce Opioid Abuse? (FDA Law Blog)

In Focus: International

• Brexit: UK Could Be Asked To Foot EMA Relocation Bill; Bidding Criteria Drafted (Pink Sheet-$)
• WHO urges action over growing hepatitis epidemic (Reuters)
• WHO on World Malaria Day, 25 April 2017 (WHO)
• Japan's Sawai buys U.S. firm Upsher-Smith's generic drugs unit for $1.1 billion (Reuters)
• A global attack on long-neglected tropical diseases is succeeding (Economist)
• XBiotech slumps on likely EMA rejection of cancer drug (Fierce) (TheStreet)
• India develops National Action Plan to combat Antimicrobial Resistance (Government of India)
• Oxford Cancer Biomarkers Licenses China Rights for Three Colorectal Cancer Tests (GEN)
• EMA Reviews Experience With Deferring PIPs: Will it Result In Earlier Pediatric Trials? (Pink Sheet-$)
• EMA and FDA Discuss Joint Accelerated Assessments (Focus)

Pharmaceuticals and Biotechnology

• GSK must pay $3 million in generic Paxil suicide lawsuit: U.S. jury (Reuters) (Stat-$)
• Stalling Translation (BioCentury-$)
• Amgen sues Sanofi and Regeneron over eczema drug (PMLive)
• Valeant prices psoriasis treatment at $3,500 per month (Reuters)
• Ashland to buy Pharmachem for $660 million (C&EN)
• OGD Workload Bigger than Ever (Lachman Consultants)
• Form 483 for ZS Pharma (FDA)
• Pressuring GSK's Advair, Teva launches both AirDuo RespiClick and authorized generic (Fierce)
• Questions for Chemist Derek Lowe (Reddit)
• Chutes & Ladders—Embattled Juno taps new R&D head (Fierce)
• Pfizer Unveils ATLAS, An Interactive, User-Friendly Website That Provides Global Antibiotic Resistance Surveillance Data Across 60 Countries (Press)
• Cornell, Illumina Settle Long-Running DNA Analysis IP Suit (Law360-$)
• Momenta, Sandoz Again Try To Nix Amphastar's Antitrust Suit (Law360-$)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

• Gilead says first data on Nimbus NASH candidate are positive (Fierce) (Endpoints)
• Syros Announces $35 Million Private Placement (Press)
• Vernalis falls after FDA knocks back cough-cold drug filing (Fierce)
• Bio Roundup: Spinraza Woes, Science March, Baseline Launch & More (Xconomy)

Medical Devices

• The go to gene sequencing machine with strange results (Wired)
• This is why a direct-to-consumer medical device company is a risky undertaking (MedCity News)
• Stryker Cut From Zimmer's Howmedica Trade Secrets Suit (Law360-$)
• Diabetes control tied to heart stent outcomes (Reuters)

US: Assorted and Government

• Guerbet Group; Withdrawal of Approval of Two New Drug Applications (FDA)
• Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop (FDA)
• Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting (FDA)
• H.R.2113 - To require the Food and Drug Administration to expedite review of pharmaceuticals that are approved for marketing in the European Union (Bill)
• Klobuchar Statement on Justice Department Investigation of Intravenous Saline Solution Manufacturers for Possible Anticompetitive Conduct (Press)
• Walgreen Co. Pays $9.86M to Settle Allegations of Improper Medi Cal Billings (Press)

Upcoming Meetings and Events             

• Advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) (FDA)
• RAPS' FDA Advisory Committee Meeting Tracker

General Health and Other Interesting Articles

• A publication dilemma (In the Pipeline)
• Science Needs Your Cells (NY Times-$)

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.