Regulatory Focus™ > News Articles > 12 > Recon: Takeda Shareholders Approve $62B Shire Takeover

Recon: Takeda Shareholders Approve $62B Shire Takeover

Posted 05 December 2018 | By Michael Mezher 

Recon: Takeda Shareholders Approve $62B Shire Takeover

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Investor activists win again and persuade Endo to catalog opioid risks (STAT)
  • CVS boasts that a new pricing model will lower drug costs for health plans. Will it? (STAT) (Forbes)
  • Four big questions ahead of Moderna’s public debut — biotech’s biggest ever (STAT)
  • Top biotech lobbyist: Industry under 'greater threat' than ever before (The Hill)
  • Bipartisan senators introduce new drug pricing bill (The Hill)
  • Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics (FDA)
  • FDA Delays Review Goal Dates by up to One Day for Deadlines Falling on 5-7 December (FDA)
  • With new drug pricing legislation, Grassley and Wyden hint at the next steps for a powerful Senate committee (STAT)
  • What do Martin Shkreli, Gilead and Takeda have in common? They all figure prominently in the new top-20 list of the world’s most expensive drugs (Endpoints)
  • Cancer-Testing Startup Backed by Bezos Weighs U.S. IPO Over Hong Kong (Bloomberg) (Endpoints)
  • Johnson & Johnson's multiple myeloma drug reduces risk of death in late-stage study (Reuters)
  • JNJ-AbbVie cancer drug Imbruvica succeeds in late-stage trial (Reuters)
  • Mylan to recall all batches of blood pressure medicine valsartan in US (Reuters)
  • Is US health system trending the wrong way? (Politico)
In Focus: International
  • Takeda's Long Battle for $62 Billion Shire Deal Gets Victory (Bloomberg) (Financial Times)
  • Will Vertex finally reach a deal with the UK over its cystic fibrosis drug? (STAT)
  • Triple defeat puts May’s Brexit deal up against the wall (PMLive)
  • The ‘CRISPR babies’ experiment was more flawed than scientists first realized (STAT)
  • Bayer halts vilaprisan drug trials due to toxicology data (Reuters) (Endpoints)
  • UCB to spend £200M to create U.K. R&D hub (Fierce)
  • State-of-play of joint assessments of Notified Bodies in the medical device sector (European Commission)
  • Chinese drugmaker pours $145M into plant with plan to produce innovative biologics (Fierce)
  • Australian researchers develop 10-minute cancer test (CNN) (USA Today)
  • Set, Ready, Afford: China Rushes To Access Innovation Amid New Drug Dash (SCRIP-$)
  • Mismanagement allegations send Sun Pharma stock tumbling: What we know so far (Fierce)
  • ‘From Nothing to Gangbusters’: A Treatment for Sickle-Cell Disease Proves Effective in Africa (NYTimes)
Pharmaceuticals & Biotechnology
  • Ferreting out prescription drug scams on social media (STAT)
  • FDA removes safety warning from Smith & Nephew's diabetic gel (Reuters)
  • CAR-Ts take centre stage as ASH18 comes to a close (PMLive)
  • Retired FDA research monkeys find new home and music in Florida (CNN)
  • FDA Form 483 Issued to Gadea Biopharma (FDA)
  • Therapeutic strategies for sickle cell disease: towards a multi-agent approach (Nature)
  • Should Non-opioid Analgesics have “Opioid Sparing” as a Label Claim? (Harvard Bill of Health)
  • FDA Partially Grants Petition for Hypnotic Drug Labeling (FDANews-$)
  • AstraZeneca's Calquence found success in lymphoma. Will CLL follow? (Fierce)
  • As Amazon takes page from pharma's EHR playbook, smarter DTC could be on the way (Fierce)
  • Mereo reverse merges with a flailing OncoMed and preps for a back flip onto Nasdaq (Endpoints)
  • Sanofi merges biology and tech with research deal for digital asthma lab (Fierce)
  • Troubled MiMedx axes a quarter of its workforce in the wake of a C-suite purge (Endpoints)
  • Bristol-Myers Squibb to Announce Results for Fourth Quarter 2018 on January 24 (Press)
  • Bayer to drive value creation as company pursues ambitious growth targets through 2022 (Press)
  • SmartZyme spins off protein tech company for a metabolic disease partnership with Hemoshear (Fierce)
  • Relay adds executives to its chemistry, R&D teams as it transitions to the development stage (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Roche's Tecentriq wins speedy FDA review for small cell lung cancer (Reuters) (Press)
  • Roche’s Kadcyla cut the risk of disease recurring by half compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment (Press)
  • Exelixis and Ipsen Initiate Phase 3 Pivotal Trial (COSMIC-312) of Cabozantinib in Combination with Atezolizumab versus Sorafenib in Previously Untreated Advanced Hepatocellular Carcinoma (Press)
  • Gamida Cell Announces Publication of Phase 1/2 Clinical Data of NiCord® in the Journal of Clinical Oncology (Press)
  • Innovent Receives an Approval from the US FDA to Initiate Clinical Trials for its Anti-OX40 Monoclonal Antibody IBI101 (Press)
Medical Devices
  • FDA Advisors Say Yes to Optimizer Smart Device in Heart Failure (Medpage)
  • What Can Medtech Expect with the New Congress? (MDDI)
  • Edwards wins FDA nod for next-gen HemoSphere platform (MassDevice)
  • Is 2019 Going to Be a Standout Year for TAVR? (MDDI)
  • Medtronic Announces Worldwide Voluntary Field Corrective Action; Company Issues Software Update for Puritan Bennett(TM) 980 (PB980) Ventilator Series (Press)
US: Assorted & Government
  • Fed. Circ. Questions How Aventis Cancer Drug Is Inventive (Law360-$)
  • Solicitor general to back Merck at Supreme Court in Fosamax pre-emption case (Fierce)
  • US judge concerned over government nod for CVS-Aetna deal (Reuters)
  • No Private Right of Action to Enforce Controlled Substances Act (Drug & Device Law)
  • More US pregnant women using opioids and meth (Reuters)
  • HHS Making Bundled Payments Mandatory Again (Forbes)
Upcoming Meetings & Events Europe
  • UK MHRA Outlines 'Safety Feature' Challenges Facing Wholesale Sector (Pink Sheet-$)
India
  • USFDA makes 22 observations post inspection of Lupin's Mandideep facilities (Economic Times)
  • Novartis India MD Milan Paleja to step down (Economic Times)
Australia
  • Updates to the Database of TGA laboratory testing results (TGA)
  • TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November (TGA)
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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