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Process & Production

Merck provides regulatory update on bezlotoxumab biologics licensing application Merck said that the US Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab, an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence.
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FDA accepts ApeX Therapeutics’ IND for clinical testing of APX3330 in pancreatic cancer By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted ApeX Therapeutics’ investigational new drug (IND) application for clinical testing of APX3330 in pancreatic cancer.
Production & Manufacturing > Process & Production > News EMA grants orphan drug designation to XOMA 358 to treat congenital hyperinsulinism By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan drug designation to XOMA 358 to treat congenital hyperinsulinism (CHI).
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FDA and EMA accept Bristol-Myers’ filing for expanded Opdivo indications
By PBR Staff Writer
The US Food and Drug Administration (FDA) and the European Medicines Agency have accepted to review Bristol-Myers Squibb’s market applications seeking approval to expand the use of Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
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Synergy Pharmaceuticals provides update on FDA review of Plecanatide CIC NDA
Synergy Pharmaceuticals has reached the Food and Drug Administration (FDA) mid-cycle review milestone for the plecanatide new drug application (NDA) in chronic idiopathic constipation (CIC).
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FDA issues complete response letter for Elite's SequestOx new drug application
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (the “CRL”) regarding Elite Pharmaceuticals' New Drug Application (the “NDA”) for SequestOx (oxycodone hydrochloride and naltrexone hydrochloride) investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
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Amgen to discuss data supporting ABP 501 BLA with FDA
Amgen announced that it will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee.
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US FDA grants orphan drug designation for Mazindol to treat narcolepsy
NLS Pharma Group (NLS) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Mazindol for the treatment of narcolepsy.
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FDA grants AbbVie's ABT-414 rare pediatric disease designation to treat DIPG pediatric brain tumor
By PBR Staff Writer
AbbVie has secured rare pediatric disease designation from the US Food and Drug Administration (FDA) for investigational ABT-414 antibody drug conjugate (ADC) to treat Diffuse Intrinsic Pontine Glioma (DIPG) pediatric brain tumor.
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FDA accepts Revive Therapeutics' IND of Bucillamine to treat cystinuria
The US Food and Drug Administration (FDA) has accepted Revive Therapeutics' Investigational New Drug Application ("IND") for a Phase 2 clinical study in the US of Bucillamine for the treatment of cystinuria.
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FDA accepts Cempra's Solithera NDAs to treat community-acquired bacterial pneumonia
Cempra announced that its New Drug Applications (NDAs) for the approval of Solithera (solithromycin) as a treatment for community-acquired bacterial pneumonia (CABP) have been accepted for filing by the US Food and Drug Administration (FDA).
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AB Science provides updates on marketing authorization application of masitinib
AB Science announced that the Committee for Medicinal Products for Human Use (CHMP) did not recommend at this time the accelerated assessment and therefore the review of the conditional marketing authorization application of masitinib in amyotrophic lateral sclerosis (ALS) will follow the standard timeline of the European Medicines Agency (EMA).
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UK’s NICE recommends Ferring’s Firmagon for men with advanced hormone-dependent prostate cancer
By PBR Staff Writer
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Ferring Pharmaceuticals’ Firmagon (degarelix) for men with advanced-hormone dependent prostate cancer and spinal metastases.
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