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Pharma News

FDA Will Retain Some Guidances After End to COVID Emergency
FDA Will Retain Some Guidances After End to COVID Emergency
The FDA has decided the postpandemic fate of 72 final guidances published over the past three years to address COVID-19 issues, choosing to withdraw about one-third, phase out another one-third and...
Gilead Awarded $175.2 Million Over HIV Drug Fraud Scheme
Gilead Awarded $175.2 Million Over HIV Drug Fraud Scheme
A federal judge in Florida has awarded Gilead Sciences $175.2 million in damages over charges that the defendants fraudulently enrolled individuals in Gilead’s Medication Assistance Program then ...
US FDA approves Acadia Pharmaceuticals’ Rett syndrome therapy
US FDA approves Acadia Pharmaceuticals’ Rett syndrome therapy
The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. ...
Solanezumab Fails to Halt Amyloid and Cognitive Decline in Preclinical Alzheimer’s
Solanezumab Fails to Halt Amyloid and Cognitive Decline in Preclinical Alzheimer’s
Eli Lilly’s antiamyloid antibody solanezumab struck out in a highly anticipated phase 3 preclinical treatment study, failing to alter disease progression in people who had amyloid brain plaques b...
FDA Approves Pfizer’s Zavzpret in Acute Treatment of Migraine
FDA Approves Pfizer’s Zavzpret in Acute Treatment of Migraine

The FDA has approved Pfizer’s Zavzpret (zavegepant), a nasal spray for acute treatment of adults with migraine, with or without aura.

Despite FDA doubts, advisors back first-line Polivy use
Despite FDA doubts, advisors back first-line Polivy use
The FDA had reservations about the efficacy of Roche’s Polivy as a first-line regimen alongside chemotherapy for diffuse large B-cell lymphoma (DLBCL), but its advisors feel the data is strong e...
InnoCare Announces First Subject Dosed in Clinical Trial of BCL2 Inhibitor ICP-248 in China
InnoCare Announces First Subject Dosed in Clinical Trial of BCL2 Inhibitor ICP-248 in China
InnoCare Pharma, a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first subject has been dosed in clinical trial of the Com...
Gilead Prevails in Antiviral Patent Challenge
Gilead Prevails in Antiviral Patent Challenge
A federal appeals court has ruled in favor of Gilead Sciences, rejecting the Regents of the University of Minnesota’s claim the drugmaker violated the university’s patent protections for sofosb...
Tagrisso demonstrated strong overall survival benefit in the ADAURA Phase III trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
Tagrisso demonstrated strong overall survival benefit in the ADAURA Phase III trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
Positive high-level results from the ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall ...
Many Accelerated Approval Drug Labels Lack Required Marketing Information
Many Accelerated Approval Drug Labels Lack Required Marketing Information

More than 10 percent of drugs marketed with an Accelerated Approval (AA) failed to include mention of the AA on the label, a new study has found.

FDA Accepts Ionis NDA for Eplontersen in Rare Hereditary Disease
FDA Accepts Ionis NDA for Eplontersen in Rare Hereditary Disease
The FDA has accepted Ionis Pharmaceuticals’ new drug application (NDA) for eplontersen to treat patients with hereditary transthyretin-mediated amyloid polyneuropathy, a rare inherited genetic condi...
J&J-backed Rapport Therapeutics snags $100M for precision approach to neurological diseases
J&J-backed Rapport Therapeutics snags $100M for precision approach to neurological diseases
Rapport Therapeutics, a clinical-stage biotech aiming to develop precision medicines for neurological disorders, launched Tuesday with $100 million in Series A financing from Third Rock Ventures, A...
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