Regulatory Focus™ > News Articles > 2019 > 12 > Recon: Novartis Pairs With Amazon for AI in Manufacturing; Rising Pleads Guilty in Generic Price Fix

Recon: Novartis Pairs With Amazon for AI in Manufacturing; Rising Pleads Guilty in Generic Price Fixing Case

Posted 04 December 2019 | By Michael Mezher 

Recon: Novartis Pairs With Amazon for AI in Manufacturing; Rising Pleads Guilty in Generic Price Fixing Case

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • A second generic drug maker admits to price fixing as part of a far-reaching probe into generics (STAT) (Law360-$) (The Inquirer) (DoJ)
  • Roche wins FDA approval for immunotherapy cocktail against lung cancer (Reuters) (Endpoints) (Press)
  • White House claims Speaker Nancy Pelosi’s drug-pricing bill would result in 100 fewer drugs over a decade (CNBC) (Endpoints) (White House)
  • US regions hard hit by opioids to ditch class action, pursue own lawsuits (Reuters)
  • Pharmacy benefits manager Abarca inks discount deal for Amgen's Enbrel (Reuters)
  • Labor Unions Team Up With Drug Makers to Defeat Drug-Price Proposals (NYTimes)
  • Pharmacy Chains Sue Bausch, Other Drugmakers for Overcharging for Diabetes Drug (Reuters)
  • Hospital groups file lawsuit to block Trump's price transparency rule (Reuters)
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In Focus: International
  • Amazon Brings AI Expertise to Drug Industry in Novartis Pact (Bloomberg) (Endpoints) (Amazon)
  • Mexico Weighs US Plan to Strip Drugs Provision From USMCA (Bloomberg)
  • India asks states to halt online drug sales (Reuters)
  • Chiesi to invest 350 million euros in eco-friendly asthma options (PharmaLetter-$)
  • Concerns Emerge Over England’s Desire For Even Lower Drug Prices (Pink Sheet-$)
  • RAPT signs on with struggling Hanmi for Asian entrance of cancer therapy (Endpoints)
  • Brazil approves medical marijuana rules, blocks cannabis cultivation (Reuters)
  • Malaria fight stalling at 'unacceptably high level' of deaths: WHO (Reuters)
Pharmaceuticals & Biotechnology
  • US continues to lead the fight against antibiotic resistance (STAT)
  • Why your generic drugs may not be safe and the FDA may be too lax (The Conversation)
  • Will sky-high drug prices spur the US to use an obscure power over patents? (BioPharmaDive)
  • US FDA Office Of New Drugs Reorg: Phase 3 Pushed To January (Pink Sheet-$)
  • Survey: 37 percent of Americans plan to skip flu vaccine this season (The Hill)
  • Remarks by Dr. Amy Abernethy to the FDA/CMS Summit (FDA)
  • Commissioner Nominee's Required Divestitures Illustrate US FDA's Broader Recruitment Challenge (Pink Sheet-$)
  • A clinical trial for Huntington’s opens the door to hope for some patients. Only so many can get in (STAT)
  • As Trump looks overseas for drug pricing ideas, one expert says France has some useful approaches (STAT)
  • Pfizer Ventures helps gamma delta player ImCheck to $53M round (Fierce)
  • Gilead’s converting Truvada PrEP users to Descovy faster than expected: analyst (Fierce)
  • FDA Places Hold on Biostage Study for Cellspan Esophageal Implant (Press)
  • Biogen comes under renewed fire as a leading Alzheimer's expert raises serious questions about the aducanumab data (Endpoints)
  • Antibody strategy to augment versatile immune cells sparks investment in French biotech (Endpoints)
  • Nearly a year after surprise rejection, Immunomedics returns to FDA (Endpoints)
  • 4 questions key to making sense of new data on Biogen’s resurrected Alzheimer’s drug (STAT)
  • An old, controversial Pfizer drug shows mid-stage efficacy against narcolepsy (Endpoints)
  • As it shops for new deals, Akcea hires former GSK exec as COO (Endpoints)
  • 2 More CBD Cos. Accused Of Selling Illegal Products (Law360-$)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice (FDA)
  • Learning from worms to kill Gram-negative bacteria (Nature)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Eager to tout pivotal win, Omeros however keeps key parameters shrouded (Endpoints) (Endpoints)
  • Bristol-Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for ORENCIA® (abatacept) to Help Prevent Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication After Stem Cell Transplant (Press)
  • AVEO Oncology Announces Lancet Oncology Publication of Data from Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma (Press)
  • FDA Grants Orphan Drug Designation to APR Applied Pharma Research's Investigational Drug for the Treatment of Epidermolysis Bullosa (Press)
  • Ra Pharmaceuticals Announces Dosing of First Patient in Phase 2 Clinical Trial of Zilucoplan for IMNM (Press)
  • Tetra Bio-Pharma Receives FDA Orphan Drug Designation for Hepatocellular Carcinoma (Press)
  • Adastra Pharmaceuticals Announces FDA and EMA Orphan Drug Designation Has Been Granted for Zotiraciclib in the Treatment of Glioma (Press)
  • ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer (Press)
  • Vicarious Surgical Announces Breakthrough Designation by the FDA, Appoints Scott Huennekens to Board of Directors (Press)
  • Bio-Thera Solutions Announces NMPA approval of IND Application to Initiate Phase I Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab) (Press)
  • Cerevance Initiates Phase 2 Trial of CVN424 for Parkinson’s Disease (Press)
  • Karus Therapeutics to Announce Positive New Data from Phase I Relapsed/Refractory B-Cell Lymphoma Trial at ASH (Press)
  • Moleculin Announces Additional Positive Interim Results from Phase 1/2 Clinical Studies of Annamycin in Acute Myeloid Leukemia (Press)
 Medical Devices
  • FDA approves Johnson & Johnson cataract treatment (Pharmafile) (Press)
  • FDA commissioner nominee backs 'proactive, not passive' approach to device safety (MedtechDive)
  • Medtronic and Elekta form radiation therapy pacts with ViewRay (MedtechDive)
  • Saudi FDA moves to single electronic platform for medical device registrations (Emergo)
  • FDA grants breakthrough status to eye-tracking Parkinson's test (MedtechDive)
  • Viant to cease ethylene oxide sterilization at Michigan plant by year’s end (MassDevice)
  • Personal Genome Diagnostics Receives Investigational Device Exemption Approval from the FDA to Support Merck’s Precision Oncology Trial (Press)
  • EmCyte Announces FDA 510(k) Clearance for its Progenikine® Concentrating System for Adipose (Press)
  • CSA Medical wins CE Mark approval for RejuvenAir System (MassDevice)
  • Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee (FDA)
  • Request for Nominations of Voting Members on a Public Advisory Committee; National
  • Mammography Quality Assurance Advisory Committee (FDA)
  • Class 1 Device Recall Synchromed II programmable pump (FDA)
US: Assorted & Government
  • HHS Will Take Anti-Kickback Safe Harbor Proposals For Drug Contracting ‘Seriously,’ US Official Promises (Pink Sheet-$)
  • 'Medicare for All' to get its day in House commerce panel (Politico)
  • United States v. Gilead: The Fight for PrEP (Harvard Bill of Health)
  • Johnson & Johnson says new tests show no asbestos in Johnson's Baby Powder (Reuters)
  • Attys Report Broad Support For Opioid MDL Negotiation Class (Law360-$)
  • Michigan Court Rules Vaccination in Best Interest of Child (Drug & Device Law)
  • Trump Administration Considering Reduction in Biologics Exclusivity Period (Patent Docs)
  • Harsh comedown for cannabis stocks as US legalization slows (Financial Times)
Upcoming Meetings & Events Europe
  • Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use (MDA/2019/041) (MHRA)
India
  • US FDA issues Drug Master File draft guidance for industry, Indian pharma sees immense value (Pharmabiz)
  • Alembic Pharma expects better growth for pharma industry going ahead (Pharmabiz)
  • Co-Diagnostics Joint Venture Gets Clearance in India for Five MDx Tests (GenomeWeb)
  • Strides Pharma gets tentative nod from USFDA for pain relieving drug (Economic Times)
Australia
  • Comparable overseas bodies (COBs) for complementary medicines (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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