Recon: AbbVie Drops Rova-T Drug After Late Stage Failure; US Judge Rules Against Amgen in Repatha Patent Case

• AbbVie abandons late-stage lung cancer asset Rova-T (Reuters) (Endpoints)
• AstraZeneca lupus drug shows promise after set-back last year (Reuters) (Endpoints) (Press)
• US judge rules for Regeneron, Sanofi in Amgen cholesterol drug patent fight (Reuters) (Endpoints) (Press)
• With new grants, Gates Foundation takes an early step toward a universal flu vaccine (STAT)
• Can less be more? A heretical approach to chemotherapy is extending cancer patients’ lives (STAT)
• Doctors don’t always know what patients will owe for meds (AP)
• Big Pharma Is Starting to Pay for the Opioid Crisis. Make Those Payments Count. (NYTimes)
• Johnson & Johnson Twisted the Truth. Here Are the Facts. (NYTimes)
• Not Just Purdue: Big Drug Companies Considering Settlements To Resolve Opioid Suits (NPR)
• Organoids Are Not Brains. How Are They Making Brain Waves? (NYTimes) (STAT) (Cell Stem Cell)

• Roche’s Tecentriq gains EC approval for breast cancer (Reuters) (PMLive) (Endpoints) (Press)
• AstraZeneca lupus drug shows promise after set-back last year (Reuters) (Endpoints) (Press)
• In India’s Slums, ‘Painkillers Are Part Of The Daily Routine’ (KHN)
• Drug Mix-Up in Spain Leads to ‘Werewolf Syndrome’ in Children (NYTimes)
• After disappointing investors, SillaJen gets into trouble with Korean prosecutors on suspected insider trading (Endpoints) (Korea Biomedical Review)
• New treatment to be made affordable for patients: TB Alliance (Economic Times)
• 'Therapeutic overcrowding' could hit big pharma returns (PMLive)
• Relief for Sun Pharma as regulator's probe unearths no evidence of fraud: report (Fierce) (Business Standard)
• Global measles cases three times higher than last year: WHO (Reuters)
• Johnson's move to shorten Brexit debate faces backlash (PMLive) (Pink Sheet-$)

• FDA Clarifies Impurity Risks From ARB Recalls (Focus)
• Academics and Researchers Raise Concerns With FDA’s Plan for ‘Integrated Reviews’ (Focus)
• FDA Finalizes Guidance on Placebos and Blinding for Cancer Trials (Focus)
• Rare Occurrence of Serious Liver Injury with 3 Hepatitis C Drugs, FDA Warns (Focus) (Reuters) (Endpoints)
• Biotech industry aims to spark girls’ interests in science long before high school (STAT)
• The Engineers Captivating Pharma Make Cells Not Software (Forbes)
• Promoting Pediatric Drug Research and Labeling — Outcomes of Legislation (NEJM)
• Regulators and Industry Are Probing More Deeply into the Complexities of Preservative Usage (IPQ)
• Harbour BioMed, PPD pen cancer and immunology drug development collab (Fierce)
• Tears for FAERS: Another FAERS disaster rumor slams Vertex shares in a Wall Street melee — but this time the tempest passed quickly (Endpoints)
• Are reasonable restraints on drug price increases doomed by pharma lobbying? (STAT)
• Adaptive platform trials: definition, design, conduct and reporting considerations (Nature)
• Adhesion G protein-coupled receptors: opportunities for drug discovery (Nature)
• Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program (FDA)

• SpringWorks Therapeutics Receives Breakthrough Therapy Designation for Nirogacestat for the Treatment of Adult Patients with Progressive, Unresectable, Recurrent or Refractory Desmoid Tumors (Press)
• Esperion's cholesterol-lowering drug clears test in diabetics (Fierce)
• Immunicum's dendritic cell therapy flunks co-primary endpoint in 'positive' PhII (Endpoints)
• Emalex Biosciences Receives FDA Fast Track Designation for Ecopipam for the Treatment of Patients with Tourette Syndrome (Press)
• Potential New Lupus Treatment Effectively Reduced Disease Activity in Phase III Trial (Press)
• VenatoRx Pharmaceuticals Initiates Enrollment in Phase 3 Trial of Cefepime/VNRX-5133 in Patients with Complicated Urinary Tract Infections (Press)

• Help Wanted: CDRH Seeks Experts for 18 Advisory Panels (Focus)
• FDA OKs smart cable for Edwards Lifesciences brain oxygenation sensor (MassDevice)
• FDA clears 4Web Medical’s cervical spine implant (MassDevice)
• Avra Medical Robotics starts along FDA regulatory path (MassDevice)
• Roche launches VENTANA PD-L1 (SP142) Assay in CE markets as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq (Press)

• Anti-smoking advocates bemoan “faltering” pace of FDA action (AP)
• An International Perspective On The Paradoxes Of US Health Care (Health Affairs)
• How did one Murfreesboro pharmacy earn title of state's largest purchaser of opioids? (Tennessean)
• Anyone in Washington state can now obtain opioid overdose drug Naloxone (Seattle Times)
• Medicare Part D paid millions for drugs already covered by Part A hospice benefits (STAT)
• Mixed Treatment Of Clinical Trial Liability On Summary Judgment (Drug & Device Law)
• Ease on Down the Road: DEA Still Not Ready to Evaluate Marijuana Manufacturer Registrations (FDA Law Blog)
• Patients Claim Allergan Covered Up Risks Of Breast Implants (Law360-$)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit (Focus)
• EMA recommends new methotrexate measures (PharmaTimes)
• England's NICE Prepares Guidance On Safe Use Of Drugs With Dependence Risk (Pink Sheet-$)

• Chinese NMPA publishes UDI system rules for medical device registrants (Emergo)

• Ajinomoto Bio-Pharma buys Indian API plant from JV partner (Fierce)
• Granules India to divest entire stake in Granules OmniChem to JV partner (Economic Times)
• USFDA issues warning letter to Lantech Pharma for manufacturing violations at Andhra plant (Economic Times)
• NPPA to roll out awareness campaign to educate stakeholders about medicines, medical devices under price control (Pharmabiz)

• Good Manufacturing Practice: the recipe for quality medicine (TGA)
• Consultation: Increased online access to ingredient information (TGA)
• Consultation: Proposed amendments to the Poisons Standard - ACMS and ACCS, November 2019 (TGA)
• TGA actions following 2018 stakeholder surveys (TGA)
• Australia’s TGA Considers “Commercial Sensitivities” In Excipient Naming Proposals (Pink Sheet-$)

• US to pay for thousands of doses of HIV drugs for Venezuelan migrants (Reuters)