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Amneal to acquire Impax to expand generics business in US
By PBR Staff Writer
Amneal Pharmaceuticals has agreed to buy Impax Laboratories in an all-stock deal to create a diversified pharmaceutical firm that is expected to become the fifth largest generics business in the US.
Production & Manufacturing > Manufacturing > News
Exelixis’ liver cancer drug cabozantinib meets primary end point in phase 3 trial
By PBR Staff Writer
Exelixis’ liver cancer drug cabozantinib (Cabometyx) has met its primary end point in the global phase 3 Celestial trial.
Contract Research & Services > Clinical Trials > News
Pfizer’s lung cancer drug lorlatinib succeeds in phase 2 trial
Pfizer says that its investigational, next-generation tyrosine kinase inhibitor lorlatinib showed clinically meaningful activity against lung tumors and brain metastases in a phase 2 trial in patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC).
Contract Research & Services > Clinical Trials > News
US FDA accepts BMS’ application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma
Bristol-Myers Squibb (BMS) announced that the US Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
News
US federal judge invalidates Allergan patents on Restasis
By PBR Staff Writer
A US federal judge has ruled four of Allergan’s patents over its dry eye medicine Restasis (Cyclosporine Ophthalmic Emulsion) 0.05% to be invalid for covering obvious ideas.
Regulatory Affairs > News
miRagen Therapeutics reports positive clinical data of MRG-106 in patients with mycosis fungoides form of cutaneous T-cell lymphoma
miRagen Therapeutics has announced new interim results from its ongoing phase 1 clinical trial evaluating the safety, efficacy and pharmacokinetics of MRG-106 in patients with the mycosis fungoides (MF) form of cutaneous T-cell lymphoma (CTCL).
Contract Research & Services > Clinical Trials > News
UK’s NICE makes Nivolumab available for head and neck cancer patients
UK’s National Institute for Health and Care Excellence (NICE) has made nivolumab (Opdivo) made by Bristol-Myers Squibb available for patients with head and neck cancer who did not respond to chemotherapy within six months, and the cancer has spread to other parts of the body.
Drug Research > Drug Delivery > News
FDA panel backs approval of Aerie’s Rhopressa for glaucoma treatment
By PBR Staff Writer
Aerie Pharmaceuticals’ Rhopressa (netarsudil ophthalmic solution) 0.02% has been recommended for approval by an advisory panel of the US Food and Drug Administration (FDA) for the treatment of glaucoma and ocular hypertension.
Production & Manufacturing > Process & Production > News
Moleculin to collaborate with University of Bergen for immune stimulation drug
Moleculin Biotech has entered into an agreement to collaborate with the University of Bergen to expand research on inhibition of brain metastasis by its pre-clinical drug WP1066 and its ability to increase immune system response to cancer and suppression of tumor cell proliferation and survival.
Drug Research > Drug Discovery & Development > News
Human clinical trial commences for first leprosy vaccine candidate
The Infectious Disease Research Institute (IDRI) and American Leprosy Missions have started a Phase 1 clinical trial in humans for leprosy vaccine candidate, the first vaccine developed specifically for leprosy.
News
FDA panel supports Spark Therapeutics gene therapy approval for rare form of blindness
By PBR Staff Writer
Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec) has been recommended for approval by an advisory panel of the US Food and Drug Administration (FDA) for the treatment of blindness caused by an inherited retinal disease (IRD).
Production & Manufacturing > Process & Production > News
Ardelyx's phase 3 study of Tenapanor for IBS-C meets primary endpoint
Ardelyx has released positive results from its second Phase 3 study of tenapanor, dubbed T3MPO-2, for irritable bowel syndrome with constipation (IBS-C).
Contract Research & Services > Clinical Trials > News
Janssen submits NDA to FDA for apalutamide to treat non-metastatic castration-resistant prostate cancer
Janssen Biotech has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC).
Regulatory Affairs > News
Lupin buys Symbiomix to expand women’s health specialty business
By PBR Staff Writer
Mumbai-based Lupin’s US subsidiary has acquired Symbiomix Therapeutics for $150m in an all-cash deal to expand its branded women’s health specialty business.
Production & Manufacturing > Manufacturing > News
Sanofi to invest €170m for expansion of French vaccine manufacturing facility
By PBR Staff Writer
Sanofi is set to invest around €170m to expand its vaccine manufacturing facility in Val de Reuil, France.
Production & Manufacturing > Manufacturing > News
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