Regulatory Focus™ > News Articles > 2019 > 1 > Recon: Verily Picks up $1B in Funding; NICE Backs Pfizer's Xeljanz for Ulcerative Colitis

Recon: Verily Picks up $1B in Funding; NICE Backs Pfizer's Xeljanz for Ulcerative Colitis

Posted 04 January 2019 | By Michael Mezher 

Recon: Verily Picks up $1B in Funding; NICE Backs Pfizer's Xeljanz for Ulcerative Colitis

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Alphabet's Verily gets $1 billion in funding round led by Silver Lake (CNBC) (Endpoints)
  • Payers expect drug prices to rise 3 percent to 5 percent annually over the next three years (STAT)
  • Scoop: MedImmune chief Bahija Jallal is leaving AstraZeneca and joining the trek into biotech (Endpoints)
  • Biotech IPO Market: Closing The Books On 2018’s Crazy Year (LifeSciVC)
  • Genetic screening for newborns yields some answers, more questions (NBC)
  • Medicaid Patients In Puerto Rico Don’t Get Coverage For Drugs To Cure Hepatitis C (KHN)
  • When Medicine Makes Patients Sicker (KHN)
  • House Democrats make Day 1 largely about health care (Politico)
  • Drug pricing is pharma’s top concern in 2019 (PMLive)
  • How The Federal Shutdown Is Affecting Health Programs (NPR)
  • Mom: High insulin prices led to son's death (CBS)
  • Trump’s FDA Might Greenlight Drug-Prescribing Apps for Chronic Ailments (Bloomberg)
  • The FDA is still letting doctors implant untested devices into our bodies (Washington Post)
In Focus: International
  • ‘Neglected diseases’ are anything but neglected by the billion-plus people living with them (STAT)
  • Daiichi Sankyo lines up a $900M deal for rights to a cholesterol drug looking to disrupt a blockbuster market (Endpoints)
  • Sanofi sharpens focus on mRNA for cancer with equity investment in Germany’s BioNTech (Endpoints)
  • Swiss biotech Oculis raises cash, nabs Novartis eye drug in extended series B (Fierce)
  • EU Court Ruling Puts Pressure On Orphan Drug Developers (Pink Sheet-$)
  • NICE approves Xeljanz for Ulcerative Colitis (PharmaTimes)
  • Patient who visited Burundi tested in Sweden as possible Ebola case (Reuters)
Pharmaceuticals & Biotechnology
  • Startup Spotlight: Vedanta Biosciences eyes large-scale clinical trials for microbiome drugs (STAT)
  • Orphan Drugs Compose Majority Of Novel US Approvals For First Time Ever In 2018 (Pink Sheet-$)
  • FDA Ups Pressure On Stem Cell Therapy Makers To Follow Product Approval Rules (Pink Sheet-$)
  • FDA Picks Wave's DMD Program For Innovative Trial Pilot (BioCentury)
  • The Claim By Bristol-Myers Squibb CEO That The New Company Will Be A 'Magnet For Talent' Is Naïve (Forbes)
  • Novo Nordisk’s first diabetes innovation challenge winners head to the lab (Fierce)
  • AmpliPhi Biosciences and C3J Therapeutics Agree to Merge (Press)
  • Bristol-Myers Squibb And Celgene's Big Winner? Los Angeles Billionaire Patrick Soon-Shiong (Forbes)
  • For CAR-T Cancer Fighters in the Real World, Two Roads Diverge (Xconomy)
  • Jazz triggers Codiak’s first exosome alliance with a $76M ante and up to $1B-plus in milestones (Endpoints)
  • Tizona Lands $105M from AbbVie in Cancer Drug R&D Alliance (Xconomy)
  • Fujifilm Cellular Dynamics to Invest $21M in Facility Near Madison HQ (Xconomy)
  • Verrica To Submit NDA For Contagious Skin Disease Therapy (BioCentury)
  • Joining forces with Skyhawk, C4 Therapeutics, Biogen buys more shots on goal on SMA, Alzheimer’s (Endpoints)
  • Juno founders set their sights on creating an ‘epic’ new biotech with high-rolling investors at their back (Endpoints)
  • Deserted by Takeda, Mersana abandons lead drug (Endpoints)
  • A biotech startup breaks a 3-year silence, displaying a $65M raise and a next-gen approach to PARP (Endpoints)
  • Axing staff and shelving cancer programs, Selecta hopes laser focus on gout will prove a way out (Endpoints)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Pfizer Initiates Phase 2b/3 Clinical Trial for PF-06651600, an Oral JAK3 Inhibitor, for the Treatment of Patients with Moderate to Severe Alopecia Areata (Press)
  • Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis (NEJM)
  • FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer (NEJM)
  • Apixaban to Prevent Venous Thromboembolism in Patients with Cancer (NEJM)
    OncoNano Receives Authorization to Proceed from FDA for IND Application and Fast Track Designation for ONM-100, Intraoperative Imaging Agent to Detect Tumors and Metastatic Lymph Nodes That Often Go Undetected During Surgery (Press)
  • Aura Biosciences Announces Successful Outcome of End of Phase 2 Meeting with FDA for AU-011 for the Treatment of Patients with Choroidal Melanoma (Press)
  • Aerie Pharmaceuticals Announces Positive Topline Results of Netarsudil Ophthalmic Solution in Pilot Phase 2 Study Supporting Clinical Development in Japan (Press)
  • BerGenBio Announces Start of Phase II Investigator Initiated Trial Evaluating Selective AXL Inhibitor Bemcentinib in High-risk MDS (Press)
Medical Devices
  • What Will 2019 Bring for Medtech? (MDDI)
  • Endologix recalls Nellix stent graft, bans off-label use (MassDevice)
  • Senseonics touts first U.S. trial implant of 180-day CGM (Drug Delivery)
  • Click Therapeutics teams up with Otsuka on digital therapeutic for major depressive disorder (mobihealthnews)
US: Assorted & Government
  • As Hospitals Post Sticker Prices Online, Most Patients Will Remain Befuddled (KHN)
  • Most U.S. patients not using online medical portals (Reuters)
  • PhRMA comments to administration on International Pricing Index Model (PhRMA)
  • Coming Soon for Expanded Access Policies (FDA Law Blog)
  • The Latest on Predictive Coding (Drug & Device Law)
Upcoming Meetings & Events Australia
  • South Australian man faces criminal charges for dealing with counterfeit and unapproved medicines (TGA)
General Health & Other Interesting Articles 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.
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