Intellectual Product – Page 29

Intra-Cellular’s Caplyta Shows Promising Results in Major Depressive Disorder Study

1 year ago talkbio0Tagged adjunctive therapy, blockbuster label, Caplyta, Clinical Global Impression Original Version Questionnaire, expansion, Intra-Cellular Therapies, Lumateperone, Major Depressive Disorder, MDD, Montgomery-Åsberg depression rating scale, Montgomery-Asberg Depression Rating Scale Questionnaire, Positive Clinical Trial, Study 501, Unipolar Depression

Intra-Cellular Therapies, Caplyta (lumateperone), Major Depressive Disorder (MDD), Positive clinical trial results, Study 501, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale, Adjunctive therapy, Potential blockbuster label expansion

The Transformative Future of Specialist Distribution: Adaptive Strategies and Technological Innovations

1 year ago talkbio0Tagged **Last-Mile Solutions**:, Adaptive Strategies, Artificial Intelligence, Automation, Data Integration, Global Expansion, Hospital specialist, Smart Distribution Centers, Spatial Distribution, Technological Innovations, trends qualifier, Virtual Distribution

Specialist Distribution, Future Trends, Adaptive Strategies, Technological Innovations, Automation, Artificial Intelligence, Last-Mile Solutions, Virtual Distribution, Data Integration, Global Expansion, Smart Distribution Centers

Record-Breaking 323 Medications in Active Shortage in US, ASHP Reports

1 year ago talkbio0Tagged Active shortages, Adderall, American Society of Health-System Pharmacists, Antineoplastic Agents, ASHP, Attention deficit hyperactivity disorder, Drug Enforcement Administration, Drug shortages, Drug supply chains, Generic sterile injectable medications, Policy, Recommendation, Record-high

Drug shortages, US, Record-high, American Society of Health-System Pharmacists (ASHP), 323 medications, Active shortages, Generic sterile injectable medications, Cancer chemotherapy drugs, ADHD medications, Adderall, Drug Enforcement Administration (DEA), Drug supply chains, Policy recommendations

Pfizer Discontinues Phase III Trial for Sickle Cell Treatment Amid Challenges in Patient Recruitment

1 year ago talkbio0Tagged Anemia, Sickle Cell, ClinicalTrials.gov, Grail, inclacumab, Pfizer, Phase 3 Clinical Trials, Poor Accrual, Recruitment Challenges, THRIVE Program

Pfizer, Sickle Cell Disease, Phase III Study, Inclacumab, Poor Accrual, Recruitment Challenges, THRIVE Program, ClinicalTrials.gov, Gene Therapies

Alexion Expands Indications for Long-Acting C5 Complement Inhibitor Ultomiris in Rare Autoimmune Disorder NMOSD

1 year ago talkbio0Tagged Alexion, Annals, Approved, AstraZeneca Rare Disease, C5 complement inhibitor, CHAMPIER-NMOSD trial, generalised myasthenia gravis, gMG, long-acting, Marc Dunoyer, Neurology speciality, Neuromyelitis Optica, Paroxysmal nocturnal hemoglobinuria, Publications, ravulizumab-cwvz, Ultomiris, United States Food and Drug Administration

Ultomiris, ravulizumab-cwvz, C5 complement inhibitor, neuromyelitis optica spectrum disorder (NMOSD), FDA approval, long-acting, zero relapses, CHAMPIER-NMOSD trial, Annals of Neurology publication, Marc Dunoyer, AstraZeneca Rare Disease, Alexion, generalised myasthenia gravis (gMG), paroxysmal nocturnal haemoglobinuria (PNH).

FDA Grants Emergency Authorization for Invivyd’s Pemgarda Antibody Prophylactic Against COVID-19 in Immunocompromised Individuals

1 year ago talkbio0Tagged Adolescent (age group), Adults/, Approved, Condoms, Male, COVID19 (disease), Emergency Use Authorization, Half-Life Extended Monoclonal Antibody, immune compromise, Immunocompromised Host, Invivyd, Moderate (severity modifier), Pemgarda, pemivibart, Pre-Exposure Prophylaxis, Prophylactic treatment, Severe (severity modifier), United States Food and Drug Administration, VYD222

Invivyd, Pemgarda (pemivibart; formerly VYD222), Half-Life Extended Monoclonal Antibody, COVID-19 Prophylactic, Immunocompromised Patients, Emergency Use Authorization (EUA), FDA Approval, Moderate to Severe Immune Compromise, Pre-exposure Prophylaxis (Prevention) of COVID-19 in Adults/ Adolescents

Regeneron Antitrust Suit Against Novartis Gains Momentum with Appellate Ruling

1 year ago talkbio0Tagged Antitrust, Appeal court backing, Eye treatments, Eylea & Lucentis, Legal patent, Novartis, Regeneron

Regeneron, Novartis, Antitrust lawsuit, Appeal court backing, Eye treatments (Eylea & Lucentis), Patent dispute

FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

1 year ago talkbio0Tagged Accelerated Approval, Aduhelm, Anticipated, Approved, aspects of adverse effects, Central Nervous System Agents, Cerebral Edema, Clinical Trials, Deferred, Donanemab, Effectiveness, eli lilly, Full approval, Hemorrhage, Leqembi, PCNS, Peripheral, precedent, Review [Publication Type], Safety, United States Food and Drug Administration

Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.

Biden Ramps Up Fight Against High Drug Prices in State of the Union Address

1 year ago talkbio0Tagged Addresses (publication format), Biden administration, Big Pharma, Commercial Drug Sales, drug price, Generic Drug Cost-Sharing Limit, Cell & Gene Therapy, Inflation Reduction Act, Medicare Drug Negotiations, Out-of-Pocket Cap Expansion, Private insurance, Protections, Study models, Union

State of the Union Address, Biden Administration, Big Pharma, Drug Prices, Inflation Reduction Act, Medicare Drug Negotiations, Out-of-Pocket Cap Expansion, Private Insurance Protections, Generic Drug Cost-Sharing Limit, Cell & Gene Therapy Access Model, Commercial Drug Sales Rebates

Boundless Bio Joins 2024 IPO Surge Amidst Prominent Oncology Trial Outcomes

1 year ago talkbio0Tagged Bio, Boundless, Cancer-focused biotech, Clinical Data, IPO, Oncology trials, Public Offering, rally

Boundless Bio, Initial Public Offering (IPO), Cancer-focused biotech, 2024 IPO rally, Oncology trials, Clinical data readouts