Regulatory Focus™ > News Articles > 2 > Recon: J&J Partners With Theravance to Develop Next-Gen JAK Inhibitors; Rothschild Nets €345m for EU

Recon: J&J Partners With Theravance to Develop Next-Gen JAK Inhibitors; Rothschild Nets €345m for EU Focused Biotech Fund

Posted 07 February 2018 | By Michael Mezher 

Recon: J&J Partners With Theravance to Develop Next-Gen JAK Inhibitors; Rothschild Nets €345m for EU Focused Biotech Fund

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Gilead Q4 Hep C Sales Plummet; Company Sees a Further Slowdown (CNCB) (Financial Times)
  • J&J antes up on a $1B gamble that Theravance has the next blockbuster JAK for Crohn's, ulcerative colitis (Endpoints) (Press)
  • FDA declares popular alt-medicine kratom an opioid (NBC) (AP) (STAT) (FDA) (FAERS Reports)
  • When Does Digital Health Become Just Healthcare? (LifeSciVC)
  • A Brain Implant Improved Memory, Scientists Report (NYTimes) (NPR)
  • Bristol-Myers Squibb Sows Confusion (In the Pipeline)
  • Gardasil grows, Zostavax struggles as Merck posts $6.5B in 2017 vaccine sales (Fierce) (Press)
  • Verastem takes AbbVie's blood cancer castoff to the FDA (Endpoints) (Xconomy) (Press)
  • Biogen stops testing Tysabri to treat stroke after study fails (Reuters) (Endpoints) (Press)
  • FDA's Hiring Advantage: Scores In Best Places To Work Survey Continue To Rise (Pink Sheet-$)
  • Industry Lauds, Worries About FDA Hiring Going Forward (Pink Sheet-$)
  • New DNA test will look for 190 diseases in your newborn's genes (MIT Technology Review)
  • Coalition of 44 groups calls for passage of drug pricing bill (The Hill)
  • Trump's Unfilled Prescription for Lower Drug Prices (Senate Finance)
  • ACA stabilization not off the table yet (Politico)

In Focus: International

  • Edmond de Rothschild nets €345m for biotech fund (Financial Times) (Fierce) (Endpoints)
  • GSK shares rise on strong revenues and dividend commitment (Financial Times) (Reuters)
  • GSK, Bayer top global ranking for online messaging (Fierce)
  • In diabetes war, Novo Nordisk aims to break mold with new pill (Reuters)
  • Ireland procures Sobi therapies for all haemophilia patients (PharmaTimes)
  • Roche's lung drug Esbriet reserved for worse cases, says NICE (PMLive)
  • Sanofi nears generics unit sale and plots return to profit growth (Financial Times) (CNBC) (Reuters) (Endpoints) (Fierce) (Press)
  • Scotland's TCB inks CAR-T deal with Japan's NIPRO (PharmaTimes)
  • Hundreds of drug companies make and sell unapproved antibiotics in India (STAT)
  • Ireland Fears Shortage Of Medicines Co-Labeled With UK Following Brexit (Pink Sheet-$)
  • Adverse drug events in Chinese pediatric inpatients and associated risk factors: a retrospective review using the Global Trigger Tool (Scientific Reports)

Pharmaceuticals & Biotechnology

  • CEO gets the axe: Arcturus relieve Payne of position (Pharmafile) (Endpoints)
  • Hospital plumbing a 'vast, resilient reservoir' of superbugs (NCB)
  • Regenerative medicine: Cholesterol clearance restores remyelination (Nature)
  • A scientific breakthrough may lead to an effective anti-obesity drug (CNBC)
  • Frequently Asked Questions on Patents and Exclusivity (FDA)
  • Ex-MAP Execs Start Xoc with Plans to Leapfrog New Migraine Drugs (Xconomy)
  • AbbVie, Pfizer in another close TV ad spending race to kick off 2018 (Fierce)
  • Case Western Reserve and Sangamo Therapeutics Announce $11 Million NIH Grant for Study of Gene-Edited T Cells for Viral Eradication of HIV (Press)
  • Taking on lousy side effects of existing meds, NEA-backed Xoc tackles Parkinson's/migraines with $30M Series A (Endpoints)
  • Allergan bolsters skincare portfolio with Elastagen acquisition for $95 million (Pharmafile)
  • Omeros cataract surgery drug faces steep sales declines with expiration of favorable Medicare reimbursement (STAT)
  • Celltex pairs with Texas A&M on exosome therapy for Alzheimer's (Fierce)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Sage Therapeutics Receives FDA Breakthrough Therapy Designation for SAGE-217 for the Treatment of Major Depressive Disorder (Press)
  • FDA grants accelerated review for Glaxo's meningitis B vaccine in children (Seeking Alpha)
  • Takeda Announces Publication of Study Utilizing State-of-the-Art Modeling to Better Understand Optimal Treatment Positioning for Patients with Ulcerative Colitis (Press)
  • Bavarian Nordic sees positive smallpox vaccine data (BioPharmaDive)
  • Eagle Pharmaceuticals Announces Fifth Orange Book Listed Patent for RYANODEX (Press)
  • Exelixis Announces Updated Phase 1 Trial Results for Cabozantinib in Combination with Nivolumab with or without Ipilimumab in Refractory Genitourinary (GU) Tumors (Press)
  • Xcovery Announces Initiation of Phase 2 Clinical Trial for Ensartinib in Melanoma Patients with ALK Alternations (Press)
  • Symic Bio Completes the MODIFY2 Phase 2 Trial of SB-061 for the Treatment of Knee Osteoarthritis (Press)
  • Phosplatin Therapeutics Announces First Cohort Enrolled in Phase I / II Trial of PT-112 in Relapsed / Refractory Multiple Myeloma, and Receipt of FDA Orphan Drug Designation (Press)

Medical Devices

  • FDA OKs Smart Watch for Epilepsy Patients (Medpage)
  • CDRH Publishes Metrics for Third-Party 510(k) Reviews (FDA Law Blog)
  • FDA Updates PMA and 510(k) Refuse to Accept Policy for Combination Products (Emergo)
  • Titan Medical pushes FDA submission back to 2019, looks to US stock market cross listing (MassDevice)
  • Medtech Must Move Beyond the Device to Bring More Value to Health Systems (MDDI)
  • Clinical Decision Support Coalition letter criticizes FDA's stance on CDS (MobiHealthNews)
  • Qiagen Garners CE Mark for PITX2 Test to Guide Breast Cancer Treatment (GenomeWeb)
  • Mesa Biotech Receives FDA 510(k) Clearance and CLIA Waiver for Its Accula Point of Care Flu A/Flu B Test (Press)
  • Food, Drug, and Device Law Alert- FDA Makes Revisions to Two Medical Device Application Process Documents (National Law Review)
  • Vyaire Medical CareFusion Upgrade Utility Vulnerability (DHS ICS-CERT)
  • FDA dings Zimmer Biomet over issues at Indiana plant (MassDevice)
  • Allurion launches pivotal US Elipse gastric balloon trial (MassDevice)

US: Assorted & Government

  • Publix reverses, will cover HIV prevention drug for workers (ABC)
  • Lawmakers ask FDA to reject Philip Morris' iQOS application (Reuters)
  • Alabama sues OxyContin maker Purdue Pharma over opioid epidemic (Reuters)
  • IDSA Calls For Antimicrobial R&D Incentives In PAHPA Bill (BioCentury)
  • Federal Court Certifies Question to Utah Supreme Court of Whether Comment K Applies to Medical Devices (Drug & Device Law)
  • J&J's Ethicon sues Intuitive Surgical over EndoWrist cutter-stapler (MassDevice)
  • Advertising Firm Barred from Assisting in the Marketing and Sale of Weight-Loss Supplements Deceptively Pitched to Consumers (FTC)
  • How Patent Litigation Changed In 2017 (Law360-$)
  • Drop In IPRs Tied To Patent Litigation Slowdown (Law360-$)       
  • Senate OTC Monograph Bill Boosts Industry Hopes For Passage This Year (Pink Sheet-$)
  • Groundhog Day For HHS And Drug Pricing? Why It Might Be Different This Time (Pink Sheet-$)

Upcoming Meetings & Events

Europe

  • Sharing data for the Innovation Scorecard publication (UK Office of Life Sciences)
  • £54 million funding to transform health through data science (MRC)
  • PHE launches opioid treatment quality improvement programme (PHE)

Asia

  • Curetis Gets Singapore Approval for Pneumonia Test (GenomeWeb)

India

  • Lupin's JV completes global trials for RA biosimilar (Economic Times)

Australia

  • Consultation: Remaking of TGO No. 77 – Microbiological Standards for Medicines (TGA)

Other International

  • First vaccine carrier approved by World Health Organization to prevent vaccine freezing during transport commercially available (Press)
  • UNICEF appeals for $17 million to rebuild Iraq health facilities (Reuters)

General Health & Other Interesting Articles

  • Edible electronics tattooed on your food could help track your health (MIT Technology Review)
  • Tronc sells LA Times and other publications to biotech billionaire (Financial Times)

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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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