Recon: Senate Committee Calls on PBMs to Testify at Next Drug Pricing Hearing; FDA Approves New Generic Valsartan Amid Shortage

• Senate committee invites PBMs to third drug pricing hearing (Reuters) (STAT) (Endpoints)
• Wyden probes a patient advocacy group over its ties to opioid makers (STAT)
• FDA approves generic valsartan amid drug shortage (Reuters) (NBC) (NYTimes) (FDA)
• Key Republican says Dems left him out of process on drug pricing bills (The Hill)
• Hedge fund investing $100 million in Harvard drug research (STAT)
• Purdue CEO says bankruptcy is ‘an option’ as company faces opioid lawsuits (Washington Post)
• Purdue gets fast track designation for opioid overdose drug (Financial Times) (Press)
• Aerie scores new glaucoma drug approval (Endpoints) (Xconomy) (Press)
• One of the top late-stage drugs Bristol-Myers wants in its $74B Celgene deal faces a ‘roadblock’ — analyst (Endpoints)
• Drug-Price Watchdog ICER Dives into Trump-Fueled Pharma Rebate Debate (Xconomy) (Pink Sheet-$)
• Bristol-Myers CEO Caforio wants M&A dissidents to know there’s been no ‘high level’ overtures about buying the company since ’17 (Endpoints)
• BioNTech hires banks for IPO worth up to $800 million: sources (Reuters) (Fierce) (Endpoints)
• Opioid Litigation Brings Company Secrets Into The Public Eye (NPR)
• CDC reports 228 measles cases in 12 states (The Hill)

• Why the Italian health minister is pushing for global transparency on drug pricing (STAT)
• Brexit Deal Rejection Sounds Alarm Bells For Pharma Industry (Pink Sheet-$)
• UK will be ‘less attractive’ for clinical research post Brexit (PharmaTimes)
• EU Calls For Action To Reduce Environmental Impact Of Pharmaceuticals (Pink Sheet-$)
• MSF Access Campaign analysis of the MPP Licence Agreement with AbbVie for glecaprevir/pibrentasvir (MSF)
• GSK's Emma Walmsley becomes highest-paid female FTSE 100 chief (The Guardian) (Endpoints)
• What to expect for 2019 with MDR and IVDR implementation? (MedicalDevicesLegal)
• Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR) (Emergo)
• NICE partially clears Darzalex combo in blood cancer (PMLive)
• New Manufacturing Technologies And Regulatory Convergence Expected To Improve Access In Developing Countries (Pink Sheet-$)
• Japan's Fujifilm buys biologics unit from Biogen to boost healthcare business (Reuters) (Law360-$)
• India Cuts Prices Of 463 Anticancers But Loose Ends Remain (Scrip-$)

• Endpoints News poll: Industry insiders offer a big thumbs up for Ned Sharpless (Endpoints)
• Unblinded: Scott Gottlieb on biosimilars' precarious moment and the gene therapy boom (BioPharmaDive)
• Making Markets Work For Pharmaceuticals (Forbes)
• Exercise vs. Drugs to Treat High Blood Pressure and Reduce Fat (NYTimes)
• AstraZeneca taps microbiome specialist Seres for I-O support (Fierce)
• Karuna hires another ex-Lilly scientist in quest to resurrect Alzheimer’s drug (Fierce)
• Genes may explain why some women on the Pill still get pregnant (Reuters)
• Manufacturers, Compounders Clash As FDA Prepares Final Offer On Office Compounding (Pink Sheet-$)
• Cipla, Piramal Launch Sensipar Generics Amid Growing Antitrust Challenges to Amgen/Teva Settlement (Pink Sheet-$)
• Innate Pharma hires Jennifer Butlers to lead commercialisation of leukaemia drug Lumoxiti (Pharmafile)
• Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 (FDA)

• Lilly’s Cyramza hits first-line NSCLC trial targets (PharmaTimes)
• Celgene’s chemotherapy Abraxane stumbles in pivotal pancreatic cancer study (Endpoints)
• Janssen Submits Application to FDA Seeking Approval of DARZALEX (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible (Press)
• Alvotech Enrolls First Patient in Clinical Phase III Study Involving Biosimilar Version of HUMIRA (Press)
• Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant (Press)
• Neurotrope Completes Enrollment Of Confirmatory Phase 2 Study of Bryostatin-1 in Moderate to Severe Alzheimer's Disease (Press)

• Medtronic’s Covidien to pay $20m to settle ClosureFast kickback allegations (MassDevice)
• FDA issues ‘leap-frog’ guidance on brain/computer interfaces (MassDevice) (FDA Law Blog)
• Smith & Nephew acquires Brainlab assets, teases next-gen robotic surgical platform (MassDevice)
• Boston Scientific wins CE Mark for Watchman FLX anti-stroke implant (MassDevice)
• Admedus wins CE Mark for CardioCel 3D, VascuCel products (MassDevice)
• FDA grants de novo for the HemoSonics' Quantra® QPlus System; This Revolutionary Diagnostic Provides Unique Information for Accessing Coagulation at the Point of Care; Now Commercially Available in US (Press)

• CRISPR Patent Watch (Patent Docs)
• Medicare cuts are less than meets the eye (Politico)
• Generic-Drug Exclusivity 'Squatting' Draws Bipartisan Heat (Law360-$)
• FDA proposes stricter compliance policy for e-cigarettes (Reuters)
• The Company Accused Of Blinding Dozens Will Be Allowed To Stay Open, Judge Rules (BuzzFeed)
• Special 301 submission calls for a level playing field for American innovators (PhRMA)
• Synergy Pharma Gets OK For Ch. 11 Plan Releases (Law360-$)
• More Adventures in Personal Jurisdiction – Has Pennsylvania Fire Already Been Extinguished? (Drug & Device Law)

• FDA Advisory Committee Calendar

• Early access to medicines scheme (EAMS) scientific opinion: Atezolizumab as 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% (MHRA)

• Unichem Labs gets USFDA nod to market Allopurinol tablets (Economic Times)
• NGOs ask govt to withdraw amendment to Para 32 of DPCO as it seriously undermines access to medicines for treating rare diseases (PharmaBiz)
• Domestic API makers to face stringent quality checks as poorly bio-available products enter drug supply chain (PharmaBiz)

• Updated GMP licence application e-forms (TGA)