Recon: Cummings, Sanders Question Mylan, Teva & Heritage for Obstructing Price Fixing Probe

• Cummings, Sanders investigate drug companies for 'obstructing' probe (The Hill) (STAT) (Politico) (Reuters) (House Oversight)
• Novartis ousted top scientists over Zolgensma data manipulation (STAT) (Endpoints) (Reuters)
• Novartis violated FDA’s sacred principle: In God we trust, all others must bring data (STAT)
• Novartis chooses internal replacement for US pharma president role (PMLive)
• This Drug Will Save Children’s Lives. It Costs $2 Million. (NYTimes)
• Regeneron drug proves effective in genetic form of high cholesterol (STAT) (Endpoints) (Press)
• AstraZeneca scores win in race to treat ovarian cancer (Reuters) (Endpoints) (Press)
• AZ’ Calquence granted US Breakthrough Therapy Designation (PharmaTimes) (Press)
• Lilly psoriasis drug beats J&J's Tremfya in head-to-head trial (PMLive) (Endpoints)
• Dr. Reddy’s Copaxone, NuvaRing generics derailed by FDA (Fierce)

• At BSI's full-day EU Medical Device Roadshow, learn the challenges in meeting European CE-marking regulatory and compliance expectations for the new MDR/IVDR requirements. BSI will be sharing our current experiences, best practice and expectations from the perspective of the first notified body designated under the MDR (EU 2017/745).

• NHS gets £8m payout over drug firm's anti-competitive practices (The Guardian) (Financial Times)
• Drug companies are putting a price on the lives of those with cystic fibrosis (The Guardian)
• Clinical trials for medicines: authorisation assessment performance (GOV.UK)
• Modern science has delivered the world powerful tools to defeat Ebola. It is not enough (STAT)
• Uganda says malaria prevalence surges, cites climate change and refugees (Reuters)
• AZ's Brilinta Patents 'Vulnerable' To Challenge In India (Scrip-$)

• Should The FDA Regulate Al? (Forbes)
• JPMorgan Chase set to scoop record fee for Allergan sale (Financial Times)
• The small-molecule antibiotics pipeline: 2014–2018 (Nature)
• Regeneron plots $800M New York production push—along with 1,500 new jobs (Fierce)
• Adaptive Biotechnologies stock tumbles after first earnings report since IPO (CNBC)
• The hidden value of improved capital-expenditure management in pharma (McKinsey)
• Biotech targeting rare heart mutation with gene therapy scores $11M in Series A haul (Endpoints)
• Zeldin joins Immunovant as CMO months after Acceleron split (Fierce)
• How should pharma be using AI? New series explores that very question (Fierce)
• Humira TV ad buys heat up summer airwaves, blasting competition (Fierce)
• As Hospitals Pursue Specialty Pharmacy (and Walgreens Bets More on 340B), PBMs Become Their Best Frenemies (Drug Channels)
• As disaster struck, AbbVie’s Rick Gonzalez swooped in on Allergan with an offer Brent Saunders couldn’t say no to (Endpoints) (Fierce)
• As investors fret about Xyrem durability, Jazz spends $52M+ upfront to swallow neuro-focused biotech (Endpoints)
• Johns Hopkins scientists raise $137M megaround for a trio of spinouts looking to tackle Alzheimer’s, Parkinson’s and fibrosis (Endpoints) (Fierce)
• MDMA, Aka Ecstasy, Shows Promise As A PTSD Treatment (NPR)

• Windtree Announces FDA Fast Track Designation for Istaroxime (Press)
• Neuropore Receives Orphan Drug Designation for NPT520-34 for the Treatment of Amyotrophic Lateral Sclerosis (Press)
• Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT2506, a Proposed Biosimilar of Simponi® (Golimumab) (Press)
• Emalex Biosciences Announces First Patient Enrolled in Phase 2b Clinical Study to Evaluate the Efficacy and Safety of Ecopipam Tablets for the Treatment of Pediatric Patients with Tourette Syndrome (Press)
• Mallinckrodt Announces Publication of Results of Phase 1b Clinical Trial of StrataGraft® Regenerative Tissue in Burns (Press)

• Concept Medical Granted “Breakthrough Device Designation” by FDA for MagicTouch PTA Sirolimus Coated Balloon (Press)
• User research and design in the era of AI: giving voice to what can’t be seen (Emergo)
• More companies apply early-use testing in product development (Emergo)
• Medtronic Partners With Capital District Physicians’ Health Plan, Inc. (CDPHP) on Outcomes-based Agreement to Increase Quality and Improve Access to Critical Diabetes Care (Press)

• Illinois passes law requiring insurance companies to cover EpiPen injections for children in historic first (The Hill)
• Social Security And Medicare: Improved Schedule Management Needed for More Timely Trust Fund Reports (GAO)
• Medicare Part D: Use of Pharmacy Benefit Managers and Efforts to Manage Drug Expenditures and Utilization (GAO)
• Taxotere Court Excludes Expert Opinion on How the Medical Community Would Have Reacted to a Different Warning (Drug & Device Law)
• Patent Opportunities In FDA Bispecific Antibody Guidance (Law360-$)
• Sanofi, Novo, Lilly Look To Ditch Minn. AG's Insulin Suit (Law360-$)
• Mesh Maker Must Face Most Claims In Bellwether Suit (Law360-$)

• FDA Advisory Committee Calendar

• UK antitrust regulators probe Kohlberg’s Nelipak-Bemis merger (MassDevice)
• Clinical trials for medicines: authorisation assessment performance (MHRA)

• Sun Pharma to make upfront payment worth Rs 2.40 bn to CSIR-IICT Hyderabad for new drug compounds (Economic Times)
• India and US soon to begin collaborative research on vaccine adjuvant development (Pharmabiz)

• Submissions received: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia (TGA)

• Canadian pot company Tilray’s stock slips after posting a wider-than-expected loss for the second quarter (CNBC)