FDA Turns Down TransCon PTH; Black Market Hormones; Pandemic Thyroid Tumors
(MedPage Today) -- Denmark's Ascendis Pharma announced that the FDA declined to approve the company's new drug application for the hypoparathyroidism drug palopegteriparatide (TransCon PTH) due to manufacturing concerns. Workdays missed because... (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - May 2, 2023 Category: Endocrinology Source Type: news

FDA Approves Abilify Asimtufii (aripiprazole) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults
April 28, 2023 -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Abilify Asimtufii® (aripiprazole)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 28, 2023 Category: Drugs & Pharmacology Source Type: news

Arbutus Biopharma shares decline as FDA puts hold on drug study application
The Bucks County company's investigational new drug application is for an experimental therapy to treat hepatitis B infections. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 26, 2023 Category: American Health Authors: John George Source Type: news

bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events
SOMERVILLE, Mass.--(BUSINESS WIRE)--Apr. 24, 2023-- bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 24, 2023 Category: Drugs & Pharmacology Source Type: news

Janssen Marks First Approval Worldwide for AKEEGA ® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations
BEERSE, Belgium, 21 April 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.2Prostate cancer is the most common cancer in men in Europe, and the sixth-highest cause of cancer-related death worldwide.1...
Source: Johnson and Johnson - April 21, 2023 Category: Pharmaceuticals Tags: Innovation Source Type: news

Industry Resources
Information to assist the drug manufacturing industry in the development of generic drugs and the completion of abbreviated new drug applications (ANDAs) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 21, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA
TOKYO& BASKING RIDGE, N.J.--(BUSINESS WIRE)-- April 21, 2023 -- Daiichi Sankyo (TSE: 4568) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 21, 2023 Category: Drugs & Pharmacology Source Type: news

Johnson & Johnson Reports Q1 2023 Results
New Brunswick, N.J. (April 18, 2023) – Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2023. “Our first quarter results demonstrate strong performance across all three segments of our business and reflect the dedication of Johnson & Johnson colleagues around the world,” said Joaquin Duato, Chairman of the Board and Chief Executive Officer. “With this momentum, I look forward to the remainder of the year, one filled with exciting catalysts that will create both near- and long-term value for patients and all of our stakeholders.”OVERALL FINANCIAL RESULTSQ1($ in Millions, except EPS)2...
Source: Johnson and Johnson - April 18, 2023 Category: Pharmaceuticals Tags: Financial Source Type: news

Ardelyx Resubmits New Drug Application to U.S. Food and Drug Administration for Xphozah (tenapanor)
WALTHAM, Mass., April 18, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 18, 2023 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab
INDIANAPOLIS, April 13, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 13, 2023 Category: Drugs & Pharmacology Source Type: news

Pharma CMOs may feel heat as USFDA approves fewer new drugs, GlobalData report says
Inflation and declining FDA drug approvals will pose challenges for pharma contract manufacturers in 2023, stated GlobalData in its latest report - ‘New Drug Approvals and Their Contract Manufacture – 2023 Edition’. The report said that USFDA’s new molecular entity approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop, which meant fewer commercial-scale production contracts for the most i nnovative products. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 6, 2023 Category: Pharmaceuticals Source Type: news

Parathyroid Drug on Hold; FreeStyle Libre Safety Note; Levothyroxine Overprescribed?
(MedPage Today) -- The FDA "identified deficiencies" in Ascendis Pharma's new drug application for its hypoparathyroidism drug palopegteriparatide (TransCon PTH), putting new labeling and post-marketing discussions on hold for now, the developer... (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - April 5, 2023 Category: Endocrinology Source Type: news

FDA accepts Pfizer's Supplemental New Drug Applications for BRAFTOVI + MEKTOVI
Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. (Source: World Pharma News)
Source: World Pharma News - April 5, 2023 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Thyroid Drug on Hold; FreeStyle Libre Safety Note; Levothyroxine Overprescribed?
(MedPage Today) -- The FDA "identified deficiencies" in Ascendis Pharma's new drug application for its hypoparathyroidism drug palopegteriparatide (TransCon PTH), putting new labeling and post-marketing discussions on hold for now, the developer... (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - April 5, 2023 Category: Endocrinology Source Type: news

HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer
Hong Kong, Shanghai& Florham Park, NJ— Friday March 31, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: ​HCM, HKEX:​13) today announces that it completed the rolling submission of a New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 31, 2023 Category: Drugs & Pharmacology Source Type: news