Recon: Democrats Push Back Against 10-Year Biologic Exclusivity in Nafta Rewrite; Snapchat Looks to Woo Pharma Advertisers

• Snap to drug advertisers: We’re the friendlier social network (CNBC)
• Drug Company Protections Are Latest Stumbling Block for Nafta Rewrite (NYTimes) (Fierce)
• House Democrats request Purdue opioid documents, focusing on the role of the Sacklers (STAT)
• J&J to record $700 million charge related to abandoned drug program (Reuters) (Endpoints)
• Massive lawsuit says Sackler family broke laws to profit from opioids (The Guardian)
• What next for Alzheimer’s research after latest drug failure? (Financial Times)
• It Will Take More Than Transparency To Reduce Drug Prices, Economists Say (NPR)
• Specialty drug costs skyrocketed to $32.8B in Medicare Part D in 2015 (BioPharmaDive)
• Why Should Americans Be Grateful for $137 Insulin? Germans Get It for $55 (NYTimes)
• Senate panel to hear from pharmacy middlemen on drug prices (The Hill)
• Biogen’s stock plummet shows the ‘investment model in drug development is all wrong,’ says former Aetna CEO (CNBC)
• Kentucky launches probe into drug overcharges by pharmacy benefit managers (Reuters)

• EU Approves Brexit Extension, but Chaotic Departure Still Looms (NYTimes)
• Novartis says listing of Alcon eye care business expected on April 9 (Reuters)
• Pharma fears “lack of focus” on no-deal Brexit preparations (PMLive)
• Eisai starts phase 3 trials for second Alzheimer’s drug after first’s failure (Reuters) (Endpoints) (Press)
• Shanghai-based cancer drugmaker Abbisko lines up $42M B round as it makes a leap for the clinic (Endpoints)
• Only One In Seven PRIME Applications Meet EMA Test (Pink Sheet-$)
• GSK reports positive data for experimental blood cancer drug (Reuters) (PMLive)
• ICH Consults On Guideline To Improve Bioanalytical Data Consistency (Pink Sheet-$)
• EMA Management Board: highlights of March 2019 meeting Share (EMA)

• Reorganization of FDA’s Office of the Commissioner to Begin Soon (Focus)
• To Prevent Losartan Shortages, FDA Allows Higher Impurity Levels (Focus)
• FDA's Gottlieb defends agency response to valsartan contamination (BioPharmaDive)
• FDA’s OCP Works to Modernize Review Functions (Focus)
• Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals (Focus)
• FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records (KHN)
• Little Conatus’ Novartis-partnered liver drug suffers third straight defeat, but CEO Mento is still holding out hope (Endpoints)
• FDA warns doctors, myeloma patients of doubled death risk from AbbVie, Roche's Venclexta (Fierce) (FDA)
• Long-term hormone use after menopause tied to Alzheimer's risk (Reuters)
• FT Health: The power of genomics (Financial Times)
• Sage’s CEO reflects on progress treating postpartum depression and what Biogen’s big Alzheimer’s failure means (STAT)
• For Urinary Incontinence, Try Behavioral Treatments or Drugs, or Both (NYTimes)
• Hacking into macrophage attack circuits, Stanford scientists pitch a better early-warning alert system for tumors (STAT)
• Hard-charging GSK research chief Hal Barron touts improved anti-BCMA data, aiming for fast applications (Endpoints)
• After landing a historic FDA OK, Alnylam chief John Maraganore scores a big raise (Endpoints)
• Bone-marrow focused Imago BioSciences scores $40M in Omega-led round (Endpoints)
• Abeona readies manufacturing ahead of Phase 3 trial (BioPharmaDive)
• Biosimilar Groups Seek ‘Structural’ Changes in U.S. Market (FDA News-$)

• Moberg Pharma Completes Enrollment for MOB-015 Phase 3 Study in Europe (Press)
• Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer (Press)

• FDA approves Otimizer Smart heart failure device from Impulse Dynamics (MassDevice) (FDA) (Press)
• Omron gets long-awaited FDA nod for combined EKG-blood pressure monitor (mobihealthnews)
• Teleflex touts real-world UroLift study data (MassDevice)
• Genetesis CardioFlux™ Platform Receives FDA 510(k) Clearance (Press)

• Name the much-criticized federal program that has saved the U.S. $2.3 trillion. Hint: it starts with Affordable (STAT)
• Idaho inches closer to limiting its Medicaid expansion (Politico)
• State Laws Ban Surprise Medical Bills. She Got One for $227K And Fought Back. (KHN)
• $1 Billion for Mental Health: The Reality of de Blasio’s ‘Revolutionary’ Plan (NYTimes)
• Canada’s legalization of marijuana offers a blueprint for the U.S. (STAT)
• Appeals court declines full review of $254m Zimmer loss to Stryker (MassDevice)
• Vt. Can Move Ahead With Opioid Suit Against Purdue Pharma (Law360-$)
• Sens. Seek Answers About Doctor-Owned Medical Suppliers (Law360-$)
• That’s The Way We Like It: Stroke Warnings Claims Preempted in Yaz Case Out of Eastern District of Tennessee (Drug & Device Law)
• Confronting Xenophobia and Racism in the Courtroom (Drug & Device Law)

• FDA Advisory Committee Calendar

• EMA on Brexit: Risk for Drug Shortages Decreases (Focus)
• EU Regulatory Roundup: Denmark Teams With WHO to Help Build Regulatory Capacity in Poorer Countries (Focus)
• EU MDR/IVDR Coordination Group Urges Exemption Clarification (Focus)
• Three further batches of blood pressure and heart medication recalled from pharmacies (MHRA)
• Reclassification of pregabalin and gabapentin to Schedule 3 drugs from 1 April 2019 (MHRA)
• Theranos Is A Cautionary Tale For European Deeptech: Staring Our Complicity In The Face (Forbes)
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019 (EMA)
• Janssen files combo multiple myeloma drug for EU approval (PharmaLetter-$)
• Denmark Signs Up To WHO’s Regulatory Strengthening Project (Pink Sheet-$)
• Stada Arz to launch generic Exforge in Europe (PharmaLetter-$)
• Class 2 Medicines recall: Accord Healthcare Limited - Losartan Potassium 50mg Film-coated Tablets, PL 20075/0022 and Losartan Potassium 100mg Film-coated Tablets, PL 20075/0023 (MHRA)

• FiercePharmaAsia—Aducanumab Alzheimer’s flop; Keytruda’s Chinese market; Samsung BioLogics probe (Fierce)
• Novartis launches COPD inhalers in China (MassDevice)

• Jubilant Life's Nanjangud facility may face regulatory action by USFDA (Economic Times)

• Monkey Birth a Step to Saving Fertility of Boys With Cancer (NYTimes)
• Human Genomics Research Has A Diversity Problem (NPR)
• Addicted to fentanyl, one man tries to avoid becoming another "overdose statistic" (CBS)