Recon: Takeda Shareholders Approve $62B Shire Takeover

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• UK MHRA Outlines 'Safety Feature' Challenges Facing Wholesale Sector (Pink Sheet-$)

• USFDA makes 22 observations post inspection of Lupin's Mandideep facilities (Economic Times)
• Novartis India MD Milan Paleja to step down (Economic Times)

• Updates to the Database of TGA laboratory testing results (TGA)
• TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November (TGA)