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


Posted 01 July 2019 | By Michael Mezher 

Recon: Boehringer Licenses Yuhan’s NASH Pipeline for up to $870M
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • 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)

In Focus: International

  • 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)

Pharmaceuticals & Biotechnology

  • 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)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • 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)

Medical Devices

  • 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)

US: Assorted & Government

  • 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)

Upcoming Meetings & Events

Europe

  • 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)

India

  • 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)

Australia

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

Other International

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

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
 
A story’s inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.




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