Recon: Senators Urge More FTC Scrutiny for Pharma Mega-Mergers; WHO Panel Warns on Pandemic Risk

• Grassley's fight to win over GOP on drug prices (Politico)
• Hearing on "Profits Over Consumers: Exposing How Pharmaceutical Companies Game The System" (House E&C)
• Medicare Part D rebates ‘substantially’ reduced drug spending, but not enough to offset price hikes (STAT)
• US Senators urge FTC to scrutinize multi-billion dollar pharma mergers (Reuters) (STAT)
• Merck's Ebola vaccine tees up FDA date, aiming for first status (Fierce) (Press)
• Roche bid to recycle Gayzva for lupus nephritis wins FDA breakthrough tag (Reuters) (Press)
• Connecticut Governor Ned Lamont Plans to End Religious Exemption For Vaccinations (WSJ)
• Biogen loses another pipeline drug to toxicity concerns (PMLive) (BioPharmaDive)
• Vertex hits a biomarker bump on road to new drug (BioPharmaDive)
• Google swallows DeepMind Health (BBC) (Google)
• 'Right to Try' twin startups, Trump's claims stir confusion, bioethicists say (S&P Global)

• World at risk of pandemics that could kill millions, panel warns (Reuters) (CNN)
• US attack on WHO 'hindering morphine drive in poor countries' (The Guardian)
• Brazil and Paraguay launch campaign to intensify vaccination in border areas (PAHO)
• India bans e-cigarettes in setback for Juul, Philip Morris (Reuters)
• UK Politicians Want NICE To Use Conditional Reimbursement (Pink Sheet-$)
• NICE recommends Takeda's Takhzyro to prevent hereditary angioedema attacks (Pharmafile)
• New agreement gives AstraZeneca full responsibility for Linzess in China (Pharmafile)
• FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs (Focus)

• TV personality Dr. Oz is now on the board of a biotech company (STAT)
• Nano-Sized Solution for Efficient and Versatile CRISPR Gene Editing (NIH)
• John Wilkinson: Are Today’s Regulatory Paradigms Fit for the Future? (AAMI Blog)
• Population Pharmacokinetics: Drugmakers Seek Clarity and Additions to Revised FDA Guidance (Focus)
• NORD, FDA Hope New Data Platform Leads To New Rare Disease Cures (IHP-$)
• TCPro simulates immune system response to biotherapeutic drugs (FDA)
• NASEM, Royal Society Consult on Human Genome Editing Framework (Focus)
• Preclinical cancer biotech IGM Biosciences sets stage for upsized $175M IPO (Endpoints)
• Antibiotics Tied to Heart Valve Problems (NYTimes)
• Evolution In Clinical Outcome Assessments Reflected In US FDA’s Revised Gastroparesis Guidance (Pink Sheet-$)
• US FDA’s Project Orbis Could Streamline Global Clinical Trials In Cancer (Pink Sheet-$)
• Swiss biotech raises $16M to test 'undelivery mechanism' for rare liver disease (Endpoints)
• EASD: Novo's Ozempic tops Victoza, J&J's Invokana in double head-to-head win (Fierce)
• EASD: Lilly, BI tout new Jardiance kidney analysis as rival J&J nears FDA nod (Fierce)
• EASD: Sanofi trumpets sustained Soliqua benefits for GLP-1 switchers (Fierce)
• Schwarzman: I’m hearing that China is quickly working to stop illicit fentanyl shipments to the US (CNBC)
• CBER and CDER Directors Offer Insights on Overcoming Hurdles to Biomanufacturing Innovation at NIIMBL Annual Meeting (IPQ)
• It's Not Just Insulin: Diabetes Patients Struggle To Get Crucial Supplies (NPR)
• Themis raises €40M to run phase 3 chikungunya vaccine trial (Fierce) (Endpoints)
• Versantis raises cash to take liver failure drug to clinical POC (Fierce)
• Perspectum Announces FDA Grant Award for LiverMultiScan to Help NASH Patients (Press)
• Meet the Family Behind Opioid Maker Purdue Pharma (Bloomberg)
• Purdue Pharma began cutting its opioid sales force last year, attorney says in bankruptcy hearing (CNN)
• Envision Pharma Group relocates to support expansion (PMLive)

• FDA Approves KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma (Press)
• U.S. FDA Approves Supplemental New Drug Application (sNDA) for ERLEADA® (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (Press)
• REVOLUTION Medicines Announces Dosing of First Patient in RMC-4630-02, a Phase 1b/2 Trial Combining RMC-4630 with a MEK Inhibitor (Press)
• Positive preliminary results from ATL1102 for DMD Phase II trial (Press)

• Mesh implants have similar outcomes to hysterectomy for vaginal prolapse repair (NIH)
• Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection
• and/or Diagnosis of Zika Virus (FDA)
• CDRH Warns Idaho Wheelchair Manufacturer for Unapproved Modifications (Focus)
• US FDA finalizes guidance for special and abbreviated 510(k) programs (Emergo)
• The 20 largest medical device companies in the world (MassDevice)
• Orchestra BioMed wins breakthrough nod for Virtue SEB (MassDevice)
• Siemens Healthineers wins FDA nod for Artis Icono angiography line (MassDevice)
• FDA OKS Avita Medical trial for Recell in soft tissue reconstruction (MassDevice)
• Foldax touts FIH procedure for Tria polymer heart valve (MassDevice)
• Zimmer Biomet warns on Rosa Brain robot software issue (MassDevice)
• Abbott wins CE Mark for pediatric heart devices (MassDevice)
• Canon Xephilio OCT-A1 Optical Coherence Tomography Device Receives FDA 510(k) Clearance (Press)

• Pharma Giants Can't Shake Ariz. Hospital's Opioid RICO Suit (Law360-$)
• McConnell Wants CBD Enforcement Guidelines, Now (Law360-$)
• Merck Trade Secret Suit A Ploy To Aid Patent Case, Pfizer Says (Law360-$)
• Clinical Stage Biopharma Co. Sienna Hits Ch. 11 In Del. (Law360-$)
• New York first state to enact ban of flavored e-cigarettes amid deaths linked to vaping (NBC)
• Seventh person dies from vaping-associated lung disease (CNBC)
• Schedules of Controlled Substances: Control of the Immediate Precursor Norfentanyl Used in the Illicit Manufacture of Fentanyl as Schedule II (DEA)
• Is California Dreamin? Reverse Payment Agreements Presumptively Anticompetitive (FDA Law Blog)
• Mayo Foundation for Medical Education and Research v. Iancu (Fed. Cir. 2019) (Patent Docs)

• FDA Advisory Committee Calendar

• MHRA Updates on Biologics Pharmacopoeial Quality Strategy (Focus)
• Orphan AML Products Face CHMP Questioning (Pink Sheet-$)
• NICE Tackles Antibiotic Resistance In New UK Guidance (Pink Sheet-$)
• France to give iodine to more people living close to nuclear plants (Reuters)
• Parallel import licenses granted in August 2019 (MHRA)
• Marketing authorisations granted in August 2019 (MHRA)

• Asia Regulatory Roundup: Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs (Focus)

• Novartis Takes Piqray To India With Affordability Pledge (Scrip-$)
• Gujarat FDCA partners with US FDA for capacity building of drug inspectors (Pharmabiz)
• India joins Global Antimicrobial Resistance Research and Development Hub (Pharmabiz)

• Presentation: Clinical evidence requirement of 'Software as a Medical Device' (SaMD) (TGA)

• Gates Foundation Says World Not On Track To Meet Goal Of Ending Poverty By 2030 (NPR)
• Estimating dyskinesia severity in Parkinson’s disease by using a waist-worn sensor: concurrent validity study (Nature)