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

• 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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• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar
• Hearing On Securing The US Drug Supply Chain: Oversight Of FDA’s Foreign Inspection Program – 10 December 2019
• Hearing On "Flu Season: US Public Health Preparedness And Response" – 4 December 2019

• Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use (MDA/2019/041) (MHRA)

• 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)

• Comparable overseas bodies (COBs) for complementary medicines (TGA)