Recon: Boehringer Licenses Yuhan’s NASH Pipeline for up to $870M

• Health Brands Hims And Hers Flout Facebook’s Rules On Drug Ads (Wired)
• The biotech scorecard for the third quarter: 12 stock-moving events to watch (STAT)
• Theranos founder Elizabeth Holmes, top deputy ordered to stand trial in 2020 (Reuters) (AP) (WSJ)
• Drug prices in 2019 are surging, with hikes at 5 times inflation (CBS)
• At Purdue Pharma, Business Slumps as Opioid Lawsuits Mount (WSJ)
• Senate Finance Leaders Question Health Groups’ Ties to Opioid Makers (Senate Finance)
• Versant, Bayer bet big on iPS cells to tackle price, efficacy of CAR therapies (BioCentury) (Endpoints) (Fierce) (BioPharmaDive) (Press)
• Pfizer’s gamble on a new lease on life for aging sildenafil franchise fizzles in PhIII (Endpoints) (Pharmafile) (Press)
• Nancy Pelosi’s latest Medicare proposal would pass drug discounts to all consumers (CNBC)
• ‘Flawed’ study shows possible lasting effects from drug exposure in the womb (Boston Globe)
• US FDA's Integrated Review Document Would Dramatically Downsize Public Information (Pink Sheet-$)
• Array pushed Pfizer for a higher price to get deal done (BioPharmaDive) (Endpoints)

• Yuhan Corp. licenses out NASH pipeline to Boehringer Ingelheim for $870m (Korea Herald) (Korea Biomedical Review) (Press)
• Strides Pharma arm signs pacts for sale of Australian business to Arrow Pharma (Economic Times)
• China tightens vaccine management after scandals (Reuters)
• Swine fever toll in China may be twice as high as reported, industry insiders say (Reuters)
• The psychedelics evangelist: A German financier wants to turn magic mushrooms into modern medicine (STAT)
• French health watchdog recommends ending reimbursement for homeopathic drugs (Reuters)
• Bristol-Myers Squibb Completes Divestment of UPSA (Press)
• UK’s O’Neill ‘Frustrated’ By G20’s ‘Paltry’ AMR Message (Scrip-$)
• UN report: Two-thirds of drug use disorder deaths in 2017 were from opioid use (The Hill)
• Novartis unloading sterile production facility to Lonza  (Fierce)
• Neil Woodford refreshes portfolio with fire sale while investors ponder future of suspended fund (Endpoints)

• Sarepta surges after Pfizer gene therapy data raises safety concerns (Reuters) (Fierce)
• Have Cancer, Must Travel: Patients Left In Lurch After Hospital Closes (KHN)
• Biotech backs down in 2Q19 (BioCentury)
• Pfizer Completes Acquisition of Therachon (Press)
• CBER Plans Draft Guidance on ‘Sameness’ of Gene Therapies Under Orphan Drug Regulations (Focus)
• FDA Draft Guidance on Voluntary Recalls Draws Concerns of Inconsistency (Focus)
• Semma steps toward the clinic after demonstrating effect of potential diabetes cure in landmark animal studies (Endpoints)
• Analysts see promise in FibroGen's early Duchenne study — now they want to see a pivotal trial (Endpoints)
• Tesaro vet jumps to an Irish oncology upstart and shifts focus to the US, eyeing fundraising (Endpoints)
• In another shakeup, uBiome brings in outside help to revamp a microbiome testing operation under FBI scrutiny (Endpoints)
• Coherus BioSciences Production Exceeds Four-Hundred Thousand UDENYCA® (pegfilgrastim-cbqv) Pre-Filled Syringes (Press)
• The Relationship between Competitive Pricing and Direct-to-Consumer Advertising (Journal of Advertising Research)
• Individual- and Ad-Level Predictors of Perceptions of Serious and Actionable Risks in Direct-to-Consumer Prescription Drug TV Advertising (Journal of Health Communication)
• Pharma shells out $3B to doctors and hospitals—with Roche, Sanofi leading: CMS (Fierce)
• Once 'bodies for hire,' CROs are finding a new role as data specialists (BioPharmaDive)
• Digital is bringing the change clinical trials need, DIA head says (BioPharmaDive)
• Generic Industry Wants US FDA To Consider Allowing Foreign Reference Products For ANDAs (Pink Sheet-$)
• Sage strategy for postpartum depression drug Zulresso keys on patient support (Fierce)
• What CBD And Grapefruit Have In Common When It Comes To Drug Interactions: Risks You Should Know (Forbes)
• Localization Barriers To Trade In Medicines And Health Care Products: The Tricky Business Of Balancing Competing Interests (Pink Sheet-$)
• Patient-innovators fill gaps that industry hasn’t addressed — or can’t (STAT)
• In conversation with Raj Krishnan, CEO of Biological Dynamics (Fierce)
• CBER Advanced Technologies Program (FDA)

• Pfizer Announces Positive Top-Line Results from Phase 4 Study of Crisaborole Ointment, 2%, in Children Aged 3 Months to Less Than 24 Months with Mild to Moderate Atopic Dermatitis (PResss)
• Alnylam Submits Marketing Authorization Application to the European Medicines Agency for Givosiran for the Treatment of Acute Hepatic Porphyria (Press)
• Puma Biotechnology Submits a Supplemental New Drug Application to U.S. FDA for Neratinib to Treat HER2-Positive Metastatic Breast Cancer (Press)
• Vedanta Biosciences Announces First Patient Enrolled in VE416 Phase 1b/2 Food Allergy Clinical Study (Press)
• Bicycle Therapeutics Announces Positive Topline Results from Oxurion’s Phase I Trial Using a Novel Bicycle-based Plasma Kallikrein Inhibitor for the Treatment of Diabetic Macular Edema (Press)
• Biohaven Enrolls First Patient in Phase 2 Clinical Trial of Rimegepant, Oral CGRP Receptor Antagonist, for Treatment Refractory Trigeminal Neuralgia (Press)
• ActoBio Therapeutics™ Progresses AG019 to Next Stage of a Phase Ib/IIa Clinical Study for the Treatment of Type 1 Diabetes (Press)

• Fresenius Kabi recalls infusion pump, software (MassDevice)
• Innovative Health lands another catheter reprocessing clearance (MassDevice)
• Critical Innovations receives breakthrough device designation for FOAM device (MassDevice)
• Medtronic Insulin Pumps Yanked For Possible Hacking Threat (Law360-$) (CISA)
• Request for Nominations on Device Good Manufacturing Practice Advisory Committee (FDA)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation) (FDA)

• The Gap Between Rich And Poor Americans' Health Is Widening (NPR)
• The HHS conscience-rights rule is delayed (Politico)
• J&J Hit With $500K Verdict In Latest Philly Mesh Case (Law360-$) (MassDevice)
• Ediscovery for Defendants in Practice (Drug & Device Law)

• FDA Advisory Committee Calendar
• Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review/CBER; Public Workshop Draft Agenda – 15-16 July 2019

• EC Seeks Feedback on New and Revised MDR/IVDR Standards (Focus)
• EMA’s CHMP Rejects Another Drug Approved by US FDA (Focus)
• ABPI finds £377 million spent on UK R&D (EPR)
• Withdrawal Of The United Kingdom And Eu Rules In The Field Of Good Laboratory Practice (GLP) (EC)

• Alembic Pharma gets USFDA nod for seizure treatment drug (Economic Times)
• TN govt to set up comprehensive pharma park with separate units for formulations, devices and APIs soon (PharmaBiz)

• International work-sharing Initiative - Niraparib (Zejula®) (TGA)

• Novartis says it did not send substances for chemical weapons to Syria (Pharmafile)