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Pharmaceutical Business Review

US federal judge invalidates Allergan patents on Restasis 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
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

Latest News and Insight by Sector

Production & Manufacturing

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
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

Drug Research

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
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

Inward Investment

New WuXi Life Science to acquire WuXi PharmaTech for $3.3bn
Shanghai-based WuXi PharmaTech has entered into a merger agreement with New WuXi Life Science and its wholly owned subsidiary WuXi Merger, worth a total cash consideration of $3.3bn.
Inward Investment > News
PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
Inward Investment > News

Packaging

Catalent completes acquisition of Australia's Pharmapak
By PBR Staff Writer
US-based Catalent Pharma Solutions has strengthened its ability to provide integrated solutions to customers with the acquisition of Pharmapak Technologies, an Australian pharmaceutical packaging business.
Production & Manufacturing > OTC > News
MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
Packaging > News

Contract Research & Services

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

Automation

Broad Institute of MIT and Harvard joins discussions to create global CRISPR-Cas9 licensing pool
The Broad Institute of MIT and Harvard has joined discussions to form a non-exclusive CRISPR-Cas9 joint licensing pool coordinated by MPEG LA, an organization that operates patent pool licensing programs in various institutions and countries.
Automation > IT & Software > News
Servier, Transgene to apply viral vectorization technology to engineering of allogenic CAR-T
Servier and Transgene have signed a research agreement on the application of viral vectorization technology for the production of allogenic CAR-T cell therapies.
Automation > IT & Software > News

Regulatory Affairs

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



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