Intellectual Product

Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility

4 days ago talkbio0Tagged adulteration, alpha 1-antitrypsin, Cautionary Warning, GMP violations, Hikal, India, Jigani Facility, Letter [Publication Type], Manufacturer, Metals, pharmaceutical manufacturing, Regulatory Compliance, United States Food and Drug Administration

Hikal; FDA warning letter; metal contamination; API manufacturer; GMP violations; Jigani facility; India; pharmaceutical manufacturing; regulatory compliance

PMV Pharma’s p53 Drug Shows Effect in Ovarian Cancer, but Financial Challenges Loom

4 days ago talkbio0Tagged cash runway, Clinical Trials, Familial mitral valve prolapse, File (record), Frequency of Responses, Funding, ovarian neoplasm, TP53 gene, United States Food and Drug Administration

PMV Pharmaceuticals; rezatapopt; p53; ovarian cancer; clinical trial; response rate; FDA filing; funding; cash runway

Trump Administration Weighs Severe Restrictions on US Pharmas Licensing Chinese Medicines

5 days ago talkbio0Tagged AstraZeneca, chinese medicine, Drug Industry, drug manufacturing, executive order, licensing restrictions, lobbying, National Security, Pfizer, Transplant Registry Unified Management Program, United States Food and Drug Administration

Trump administration; Chinese medicines; executive order; pharmaceutical industry; licensing restrictions; national security; lobbying; Pfizer; AstraZeneca; biotech; drug manufacturing; FDA review

Second MAHA Report Emphasizes Chronic Disease, Tilts at Vaccine Reform

5 days ago talkbio0Tagged childhood health, childhood vaccine schedule, Chronic disease, Commission, federal directives, Food Policy, MAHA, Prescription Drug Overuse, public health medicine (field), Robert F. Kennedy Jr., Vaccine Reform

MAHA Commission; chronic disease; vaccine reform; Robert F. Kennedy Jr.; childhood health; food policy; medication overuse; public health; federal directives; childhood vaccine schedule

Amgen, Kyowa Kirin Bolster Safety Profile for Atopic Dermatitis Drug Rocatinlimab

5 days ago talkbio0Tagged amgen, ASCEND trial, Dermatitis, Atopic, Eczema, Kyowa Kirin, Long-term, OX40 receptor, Programs - Publication Format, Rocatinlimab, Rocket, Safety

Amgen; Kyowa Kirin; rocatinlimab; atopic dermatitis; OX40 receptor; ASCEND trial; ROCKET program; long-term safety; eczema

Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy

6 days ago talkbio0Tagged Capricor Therapeutics, Cell Therapy, Clinical Trials, data misinterpretation, deramiocel, Effectiveness, Endpoints, HOPE-2 trial, Muscular Dystrophy, Duchenne, Non-Parametric Test, Rejection, Statistical Significance, United States Food and Drug Administration

Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy

Daiichi and Merck’s Lung Cancer ADC Achieves 48% Response Rate in Pivotal Trial

1 week ago talkbio0Tagged Accelerated, Antibody-Drug Conjugates, Approved, Breakthrough Therapy, CD276 gene, Co., Daiichi, Deruxtecan, Frequency of Responses, IDeate-Lung01, Identifier, ifinatamab, Overall Survival, Progression-Free Survival, Sankyo, Small cell carcinoma of lung, therapeutic autologous dendritic cells, United States Food and Drug Administration

Daiichi Sankyo; Merck & Co.; ifinatamab deruxtecan; I-DXd; B7-H3; antibody-drug conjugate; ADC; small cell lung cancer; SCLC; IDeate-Lung01; objective response rate; accelerated approval; progression-free survival; overall survival; FDA Breakthrough Therapy Designation