Recon: US Attorney Investigating Pfizer Subsidiary Meridian; Philippines to Charge Sanofi Officials Over Dengue Vaccine

• Pfizer unit Meridian under civil investigation by US Attorney (Reuters)
• The Side Effects of Million-Dollar Drugs (WSJ)
• Poll: Americans Support Government Action To Curb Prescription Drug Prices (NPR)
• Ultomiris: Can drug innovation be too expensive? (STAT)
• States, eager to lower drug prices, regroup after courts strike down Maryland ‘price-gouging’ law (STAT)
• As more lawmakers look to import cheaper meds, FDA warns a Canadian broker (STAT)
• Big Pharma’s Hunt for New Drugs Is Pushing Up Cost of Deals (NYTimes)
• States Move To Restrict Parents' Refusal To Vaccinate Their Kids (NPR)
• ImmunoGen drug fails cancer study, shares slide 40 percent (Reuters) (Endpoints) (Press)

• Philippines to charge officials of Sanofi, government over dengue vaccine (Reuters) (STAT) (Endpoints) (Financial Times)
• Sanofi 'strongly disagrees' with Philippines prosecutors over its dengue vaccine (Reuters)
• Bristol-Myers Squibb Issues Statement in Response to Starboard’s Letter (Press)
• Gilead’s Kite pens 10-target CAR-T tech deal with MaxCyte (Fierce) (LSE) (Press)
• EMA follows FDA in putting Pfizer’s Xeljanz under the microscope for safety concerns (Fierce) (Endpoints)
• Eager to think bigger than China, Ascletis woos top Merck exec to run R&D (Endpoints) (Fierce)
• Brazil Sets Sights On Biogen’s Spinraza For First Risk Sharing Deal (Pink Sheet-$)
• Biogen Gets Chinese Approval For Spinraza (BioCentury)
• UK Accuses Drugmakers Of Anti-Competitive Agreements (Law360-$)
• After attacks, MSF suspends Ebola treatment in epicenter of Congo outbreak (Reuters)
• PAHO calls for countries in Latin America and the Caribbean to prepare for possible outbreaks of dengue (PAHO)
• Meeting highlights from the Committee for Medicinal Products for Human Use (EMA)
• First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban (EMA)
• New add-on treatment to insulin for treatment of certain patients with type 1 diabetes (EMA)
• First treatment for rare disease characterised by high levels of triglycerides in blood (EMA)
• CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease (EMA)

• Nearly half of childhood cancer cases go untreated and undiagnosed (Pharmafile)
• Industry Groups Call on FDA to Dispel Biosimilar Misinformation (Focus)
• 2018 in Generic Drugs: Approvals Shine but Questions Remain on Competition (Focus)
• FDA Touts Quality Office’s Achievements in 2018 (Focus)
• Long-Term Opioid Efficacy Studies Will Take Years, Gottlieb Says (Pink Sheet-$)
• Rebates And Drug Costs: What The New Proposal Would Mean (Forbes)
• Sanofi, Bayer and Roche execs underscore the value of digital therapeutics (MedCity)
• FDA Pushes PDUFA Date For Nektar Opioid Analgesic (BioCentury)
• University of California breaks up with major publisher over research access dispute (STAT)
• CRISPR base editing, known for precision, hits a snag with off-target mutations (STAT)
• Abpro bags $60M in near-term R&D cash in tie-up with China’s NJCTTQ, with eyes on bispecific T cell engagers (Endpoints)
• After thyroid eye drug scores in PhIII test, Horizon Pharma readies marketing application (Endpoints)
• Johnson & Johnson keeps the heat on Tremfya's rivals with at-home injector nod (Fierce)
• New insight into how Biogen's Tecfidera works may lead to better MS therapies (Fierce)
• Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API) (FDA)
• International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta (FDA)

• Novo Nordisk files for a label update for Fiasp® to the EMA and the FDA seeking approval for use in children and adolescents (Press)
• Concert Pharmaceuticals Presents Interim CTP-543 Phase 2 Data in Alopecia Areata during Late-Breaker Session at American Academy of Dermatology Annual Meeting (Press)
• Adlon Therapeutics L.P. Announces FDA Approval for Adhansia XR™ (methylphenidate HCl) Extended-Release Capsules CII for the Treatment of ADHD (Press)
• Aesculap Biologics, LLC Reaches Halfway Mark for Enrollment in Pivotal Phase 3 Clinical Trial of NOVOCART® 3D in Patients with Articular Cartilage Defects of the Knee (Press)
• Endo Will Showcase Late-Breaking Phase 3 CCH Data at the 2019 American Academy of Dermatology Annual Meeting (Press)
• Lupus Therapeutics Partners with Takeda on Phase 1 Trial (Press)
• New Data Affirms Strength of UCB Immuno-Dermatology Portfolio (Press)

• Buttock implants linked to deadly cancer for the first time, study finds (NBC)
• Vaginal laser treatment tied to complications like scarring (Reuters)
• Novocure shares dip on Q4, 2018 earnings miss (MassDevice)
• Glaukos rises on Street-beating Q4, 2018 earnings (MassDevice)
• BTG shareholders OK $4B Boston Scientific buyout (MassDevice)
• Dexcom broke $1B in revenue in 2018, plans to outsource some customer support (mobihealthnews)
• Abbott wins $35m Defense contract for TBI assay (MassDevice)
• T2 Biosystems wins FDA breakthrough nod for drug resistance blood test (MassDevice)
• FDA sounds an alarm on using robotic devices in cancer surgeries, citing concerns about safety and results (STAT) (Focus)
• Study of Boston Scientific’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years (MassDevice)
• Pulse Biosciences Submits 510(K) to U.S. FDA for CellFX™ System (Press)
• Guest Post – 510(k) Clearance of a Class II Device Can Be, as a Matter of Law, a Finding of No Potential Unreasonable Risk. (Drug & Device Law)

• Uninsured Americans were ignored when Congress grilled pharma execs (STAT)
• Inside HHS' standoff with the House Ethics chair (Politico)
• Big Pharma Targeted at Senate Hearing on Opioid Crisis (Medpage)
• Sanofi Mature IP v. Mylan Laboratories Ltd. (Fed. Cir. 2019) (Patent Docs)
• Fed. Circ. Clears Perrigo's Generic Pepcid In Patent Case (Law360-$)
• Original FTC V. Actavis Case Ends With AbbVie AndroGel Deal (Law360-$)
• Judge Throws Out Teva Lawsuit Against FDA Generic Exclusivity Policy (FDANews-$)
• Former Missouri Professor Stole Student’s Research to Sell New Drug, Lawsuit Alleges (NYTimes)
• CVS Falsely Told Docs Patients Wanted Scripts, Suit Says (Law360-$)
• Abbott Test Strip Fight Triggers Defense Duty: Wis. Justices (Law360-$)
• Legal News: Teva V. FDA, Pay-For-Delay, Citizen Petitions, User Fee Scheme (Pink Sheet-$)
• Medicare should stop blocking access to next-generation sequencing for people with hereditary cancer (STAT)

• FDA Advisory Committee Calendar
• Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities; Public Meeting – 29 April 2019

• EMA Kicks Off Series of EU MDR/IVDR Guidance (Focus)

• India’s bid to bring OTC drug regulations gains momentum; 3-member panel in place to examine expert recommendations (PharmaBiz)
• IDMA urges DoP to set up separate pricing mechanism for new patented drugs to make them affordable (PharmaBiz)
• IPC to conduct pharmacovigilance training for WHO member countries in collaboration with UMC, Sweden (PharmaBiz)

• ISO 13485:2016 transition period ending (TGA)