Regulatory Focus™ > News Articles > 2019 > 10 > Recon: UCB to Buy Ra for $2.1B; Reata to Pay $330M to Reacquire Drug Rights from AbbVie

Recon: UCB to Buy Ra for $2.1B; Reata to Pay $330M to Reacquire Drug Rights from AbbVie

Posted 10 October 2019 | By Michael Mezher 

Recon: UCB to Buy Ra for $2.1B; Reata to Pay $330M to Reacquire Drug Rights from AbbVie

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Bill Gates backs Ginkgo Bioworks' $350M raise to fuel the buzzy synthetic biology 'revolution' (Endpoints)
  • AbbVie uncoupling costs Reata $330M in cold, hard cash (Endpoints) (BioPharmaDive) (Press)
  • Big Pharma Bets on Body’s Garbage-Disposal System to Beat Cancer (Bloomberg)
  • J&J hands off non-opioid painkiller to an upstart in the race for next-gen analgesics (Endpoints) (Press)
  • Gene testing firm gets 25-year ban in $42.6 million kickback settlement (Reuters) (DOJ)
  • Massive jury award against J&J highlights risks of its legal strategy (Reuters)
  • Flow of US biotech VC dollars on track to match record 2018 levels — China? Not so much (Endpoints)
  • Chairman Neal Announces A Hearing On Investing In The US Health System By Lowering Drug Prices, Reducing Out-Of-Pocket Costs, And Improving Medicare Benefits (House Ways & Means)
  • Executive Order on Promoting the Rule of Law Through Improved Agency Guidance Documents (White House)
In Focus: International
  • Belgium's UCB to buy Ra Pharmaceuticals in $2.1 billion cash deal (Reuters) (Endpoints) (BioWorld) (Press)
  • Wall Street trims cancer drug developer BioNTech's unicorn valuation (Endpoints)
  • Life Sciences and UK's future role: Sir John Bell delivers MHRA annual lecture (GOV.UK)
  • International donors pledge $14 billion to tackle AIDS: Macron (Reuters)
  • Chinese growth shot’s some years away for pharma companies (Economic Times)
  • BeiGene opens phase one of $320M plant with 180 workers (Fierce)
  • Elmiron bags draft NICE approval (PharmaTimes)
  • Chinese biotech: from copycat to innovator (Financial Times)
  • Daiichi starts challenging Astellas for Japanese AML market (PMLive)
  • Congo's Ebola outbreak slows but still entrenched in insecure areas: WHO (Reuters)
Pharmaceuticals & Biotechnology
  • With a new guide to tapering opioids, federal health officials seek a balanced approach to prescribing (STAT)
  • Alexion bags option on Stealth's phase 3 rare disease drug (Fierce)
  •  Leave No Stone Unturned: A Pipeline Story (LifeSciVC)
  • After A Life Of Painful Sickle Cell Disease, A Patient Hopes Gene-Editing Can Help (NPR)
  • Beyond ICER: Arnold Foundation Wants To Dig Deeper On R&D And Pricing (Pink Sheet-$)
  • After Biosimilar Fee Collections Fall Short, US FDA Modifies Carryover Spend-Down Plan (Pink Sheet-$)
  • Talking about Toxicity — “What We’ve Got Here Is a Failure to Communicate” (NEJM)
  • Parexel embraces real world evidence, enlisting Datavant to drill it into CRO workflow (Endpoints)
  • Influenza candidate vaccine viruses improved by amino acid substitution in hemagglutinin (FDA)
  • 3D Printing a Human Heart Valve (NIH)
  • The great escape: tumour cell plasticity in resistance to targeted therapy (Nature)
  • How Express Scripts Plans to Disrupt the Emerging Cell and Gene Therapy Channel (Drug Channels)
  • Novartis has its blockbuster Beovu OK, but its 'hot mess' label leaves something to be desired: analysts (Fierce)
  • Feeling pressure in hemophilia, Novo signs gene editing deal with Bluebird (BioPharmaDive) (PMLive)
  • Viagra May Enhance Stem Cell Treatments For Leukemia (Forbes)
  • Neglected on Wall Street, little Stealth Bio finds an affluent chum with $30M in cash and high hopes for their PhIII drug (Endpoints)
  • Flemming Ørnskov takes on a new challenge, driving a $10B dermatology spinout with some big plans for growth (Endpoints)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Frequency Therapeutics Commences Dosing in its Phase 2a Study of FX-322 for Sensorineural Hearing Loss; FDA Grants FX-322 Fast Track Designation (Press)
  • Dermira to Present Data from Phase 2b Study of Lebrikizumab in Patients with Atopic Dermatitis at Fall Clinical Dermatology Conference (Press)
  • Seattle Genetics Announces Initiation of Phase 3 Clinical Trial of Tucatinib in Combination with Ado-trastuzumab Emtansine (T-DM1, Kadcyla®) for Patients with Advanced or Metastatic HER2-Positive Breast Cancer (Press)
  • Galderma Advances Phase 3 Clinical Study with Nemolizumab in Moderate-to-Severe Atopic Dermatitis (Press)
  • Forbius: Phase 2 Clinical Data with Tumor-Selective Anti-EGFR ADC AVID100 Featured at AACR-NCI-EORTC and World ADC San Diego (Press)
  • MGB Biopharma Announces Promising Phase IIa Clinical Trial Update for MGB-BP-3, a Novel, Potent Bactericidal Antibiotic Targeting Clostridium difficile-Associated Diarrhoea (CDAD) (Press)
  • EicOsis Announces FDA Acceptance of IND Application for EC5026, the First Soluble Epoxide Hydrolase Inhibitor to Treat Pain (Press)
Medical Devices
  • Device Industry Backs Proposed Changes to Anti-Kickback Statute, Stark Law (Focus)
  • FDA Issues Two Final Guidances on Guidewires, Catheters and Delivery Systems (Focus)
  • FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials (Focus)
  • FDA’s bill of materials creates a cybersecurity blind spot for medical devices (Healthcare IT News)
  • MITA Releases National Standard For Medical Device Security (MITA)
  • THINK Surgical Receives FDA Clearance to Market Active Robot for Total Knee Replacement Procedures in the United States (Press)
  • Mobidiag Gets CE Mark for Intestinal Parasites Test (GenomeWeb)
US: Assorted & Government
  • Planned Parenthood announces first 2020 endorsements (Politico)
  • Precision Medicine Gets A Boost From Congress (Forbes)
  • The Biosimilars Forum Applauds Congressmen Paul Tonko (D-NY) and Bob Gibbs (R-OH) for Introducing Legislation Mandating a CMS Star Ratings Program for Biosimilars (Biosimilars Forum)
  • Acting FDA chief inspects two international mail facilities for illicit vaping and opioid products (CNBC)
  • Chinese Distributor Can't Shake Trade Secrets Suit (Law360-$)
  • Grogan Implies HHS Adding Part D Drugs To Int’l Pricing Index Demo (IHP-$)
  • HHS Safe Harbor For Value-Based Drug Contracts May Be On Horizon (Pink Sheet-$)
  • Following More Than Just Money (Drug & Device Law)
  • USPTO Meets Pendency Goals for FY2019 (Patent Docs)
Upcoming Meetings & Events Europe
  • 5 Ways A Hard Brexit Will Sicken Britain’s Healthcare (Forbes)
  • UK Updates on Drug Shortage Plans Ahead of Looming Brexit Deadline (Focus)
  • EU Regulatory Roundup: Ireland’s HPRA Floats Fee Increases as Brexit Creates Challenges (Focus)
  • EC Unveils First Notified Body Designation Under IVDR (Focus)
  • No-deal Brexit likely to increase cost of new medicines, Scottish government says (Pharmaceutical Journal)
  • Specific Hudson RCI Sheridan endotracheal tubes and connectors - 15 mm connector may detach from the tube before or during use (MDA/2019/036) (MHRA)
  • Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment (MDA/2019/037) (MHRA)
Asia
  • China Joins IMDRF’s Safety Information Exchange Program (Focus)
India
  • India’s Health Ministry seeking to speed approvals of vaccines (PharmaLetter-$)
  • Patients' group opposes stent categorization (Economic Times)
Canada
  • Summary Safety Review - Avalon Fetal Monitor FM20, Avalon Fetal Monitor FM30, Avalon Fetal Monitor FM40 and Avalon Fetal Monitor FM50 manufactured by Philips Medizin Systeme Boeblingen GmbH - Health Canada (Health Canada)
General Health & Other Interesting Articles
  • Stroke rates continue decline in the US (Reuters)
  • Change in memory test scoring could help catch Alzheimer's earlier in women (NBC)
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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