Recon: GSK, Pfizer Form Biggest OTC Drug Supplier

• A huge lawsuit accuses nearly 20 big drug companies, a billionaire and two brothers-in-law of cozying up to hike drug prices. Here's the inside story. (Business Insider)
• Ready to consummate its Shire buyout, Takeda plans US dual listing while NYSE loses a major pharma to Nasdaq (Endpoints)
• Molecular Partners agrees cancer immunotherapy deal with Amgen (Reuters) (Endpoints) (Fierce)
• More Lawsuits = Higher Drug Prices (WSJ)
• Congressional report: Drug companies, DEA failed to stop flow of millions of opioid pills (Washington Post)
• General Electric files paperwork to spin out health-care unit in IPO (CNBC) (Bloomberg)
• Bipartisan bill aimed at fighting sickle cell disease signed into law by Trump (NBC)
• FTC Approves Teva Petition to Reopen and Modify Decision and Order in Case Involving Watson Pharmaceuticals Inc.’s Acquisition of Actavis Inc. (FTC)

• Glaxo-Pfizer Deal Creates Biggest Over-the-Counter Drug Supplier (Bloomberg) (STAT) (Endpoints) (Reuters) (NYTimes) (Press)
• Pharma industry returns on R&D investment hit nine-year low (Reuters) (Deloitte)
• Business warning as talk of Brexit ‘No deal’ grows (PMLive)
• J&J says Indian drug regulators visited facilities, took talc samples (Reuters)
• Novartis, China's Gan & Lee push into insulin amid diabetes epidemic (Reuters) (Press)
• Novartis unit teams up with medical marijuana producer, marking milestone for pharma (STAT) (Endpoints) (CNBC)
• Mylan and Biocon's Trastuzumab Biosimilar Gains European Marketing Authorization (Center for Biosimilars)
• IBM Watson’s bet on China, a lucrative market for health business, starts to look shaky (STAT)
• Bristol-Myers Squibb Announces Offer from Taisho Pharmaceutical Holdings Co., Ltd to Purchase UPSA (Press)
• NICE recommends Lenvima as alternative first-line therapy for advanced liver cancer (Pharmafile)
• EU & NICE authorise MSD's Keytruda for stage III melanoma (PharmaTimes)
• New Pfizer CEO's top priorities? Think China and pipeline, not deals: analyst (Fierce)
• Allergan Halts Sales in Europe of Textured Breast Implants Linked to Rare Cancer (NYTimes)
• Mallinckrodt spinoff to include 7 manufacturing sites in US and Japan (Fierce)
• Health Canada Setting Pre-market Medical Device Cybersecurity Requirements (Emergo)
• European Medicines Agency closed 21 December 2018 to 2 January 2019 Share (EMA)

• As potential shutdown nears, FDA starts to prepare for furloughs (STAT)
• A dangerous plan for rationing essential prescription drugs (Boston Globe)
• Elizabeth Warren's silly drugmaking scheme (Washington Examiner)
• Developing a new gene therapy was hard. So was figuring out how to get it to patients (STAT)
• Moving towards a cure in genetics: what is needed to bring somatic gene therapy to the clinic? (Nature)
• Novartis, still struggling with Kymriah manufacturing, is providing some out-of-spec doses to patients who ask (Fierce)
• Patient Engagement Collaborative Meeting Summary (FDA)
• Guideline group turns gaze to opioid epidemic (Reuters)
• Roivant strikes broad pipeline pact with Daiichi (Fierce)
• Sanofi to Transfer U.S. Stock Exchange Listing to Nasdaq (Press)
• Gilead dangles $105M in quick cash to sign Scholar Rock to a discovery deal for its growing NASH pipeline (Endpoints)
• Little Tetra is prepping a PhII Alzheimer’s study. In fact, they just got $40M to fund it (Endpoints)
• Hep C And Drug Abuse Often Go Hand In Hand, But Screening For Infection Lags (KHN)
• Two dozen drugs could go generic this year and next, but the biggest change could happen in Congress (Medcity)
• Surface Oncology reins back its lead program after tracking low-dose toxicity for CD47 drug (Endpoints)
• Aiming to shed last-place rep, Eli Lilly touts its PhIII pipeline and promises a faster game in R&D (Endpoints)
• Roche, Alexion ripe for showdown in a race to treat rare CNS disorder (Endpoints)
• Annexon grabs $75M to pay for push into PhII studies for C1q drugs (Endpoints)
• John Johnson is back trying his hand as a turnaround artist for a troubled biotech. Can he win this time? (Endpoints)
• RiverVest ready to roll with Fund IV after closing the till with $184M (Endpoints)
• Time To Spare? US FDA “Opioid-Sparing” Guidance May Take Longer Than Expected (Pink Sheet-$)
• FDA extends comment period for Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations rule (Federal Register)
• EEPI's sofosbuvir prequalified (WHO)

• Chugai preps filings for IL-6 drug in rare disease, chasing Soliris (Fierce) (Press)
• ArTara Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with FDA on Choline Chloride for Injection for Intestinal Failure Associated Liver Disease (IFALD) (Press)
• Cerus Announces First Patient Enrolled in the Phase 3 ReCePI Study (Press)
• Aimmune Therapeutics Initiates Phase 3 POSEIDON Trial for Treatment of Peanut Allergy in 1–3-Year-Old Children (Press)
• Kyn Therapeutics Announces Initiation of Phase 1b/2 Clinical Studies of ARY-007 in Collaboration with Merck (Press)
• MiNA Therapeutics Announces Enrolment of Patients in Expansion of Phase Ib Trial Evaluating MTL-CEBPA in Combination with Sorafenib (Press)
• Carmot Therapeutics Initiates Phase 1 Trial to Treat Type 2 Diabetes (Press)

• Medtronic closes $1.7B Mazor Robotics buy (MassDevice) (Press)
• Cardiva Medical wins FDA PMA for Vascade MVP vascular closure device (MassDevice)
• Vetex Medical launches first-in-human thrombectomy cath trial (MassDevice)
• Medtronic Announces Worldwide Voluntary Field Corrective Action; Company Issues Software Update for Puritan Bennett™ 980 (Pb980) Ventilator Series (FDA)
• Smith & Nephew to pay up to $105m for Ceterix Orthopaedics (MassDevice)
• FDA approves Medtronic’s multi-implant smart programmer (mobihealthnews)
• FDA expands indication for Insightec’s Exablate Neuro in Parkinson’s (MassDevice) (Press)
• Cardiva Medical Announces FDA Approval of the VASCADE MVP Vascular Closure System for Multi-Site Vessel Closure Following Electrophysiology Procedures (Press)
• Systaaq HBV Assay Receives CE Mark (GenomeWeb)

• An Opioid Epidemic Nobody Talks About (Washington Post)
• What's being overlooked in the Obamacare ruling: The middle class (Politico)
• DOJ: A Company Created To File Lawsuits Has Wasted 1,500 Hours Of The Government's Time (Forbes)
• SF sues drug companies over marketing of addictive painkillers (SF Chronicle)
• Anti-abortion groups demand ouster of NIH chief over fetal tissue (Politico)
• Judge Seeks Monitoring of CVS and Aetna During Antitrust Review (NYTimes)
• Spineology, Inc. v. Wright Medical Technology, Inc. (Fed. Cir. 2018) (Patent Docs)
• Comment on FDA’s Notice of Intent to Consider the Appropriate Classification of Hyaluronic Acid Intra-articular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence (FDA Law Blog)
• The VA’s Private Care Program Gave Companies Billions and Vets Longer Waits (ProPublica)
• California doctor accused of prescribing drugs in 5 deaths (ABC)
• New Hampshire physician assistant guilty of Insys opioid kickback scheme (Reuters)
• The State Of Pharma Class Certification After Asacol (Law360-$)
• Ariz. High Court Rejects 9th Circ. Preemption Ruling (Law360-$) (Drug & Device Law)
• DOJ Aims Torpedo At 11 FCA Kickback Suits (Law360-$)
• EpiPen MDL Gets Special Master To Deal With Disputed Docs (Law360-$)

• FDA Advisory Committee Calendar

• Pharmaceutical industry reacts to immigration White Paper (ABPI)
• MHRA gender pay gap report (MHRA)
• Herbal skin cream found to contain steroids (MHRA)

• Key Wins In US By Indian Firms - Keep An Eye On These In 2019 (Scrip-$)

• Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018 (TGA)
• Alkyl nitrites - public meetings (TGA)