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European Commission approves new indication for Novartis’ Lucentis eye drug The European Commission has approved the sixth indication for Novartis’ Lucentis, making it the only treatment available for a range of choroidal neovascularization (CNV) conditions. Regulatory Affairs > News
Research shows flickering lights could be used in Alzheimer's treatment By PBR Staff Writer
Researchers at the Massachusetts Institute of Technology (MIT) have discovered a non-invasive visual stimulation technique that can be potentially used for treating Alzheimer’s disease.
News Aclaris starts phase 1 trial for ATI-50001 to treat alopecia totalis and alopecia universalis Aclaris Therapeutics' investigational new drug (IND) application for ATI-50001, an orally administered investigational Janus Kinase (JAK) inhibitor, for the potential treatment of alopecia totalis and alopecia universalis has cleared the 30-day review period by the US Food and Drug Administration, allowing the company to go ahead with its planned Phase 1 clinical trial
Contract Research & Services > Clinical Trials > News Sermonix signs licensing deal to further explore lasofoxifene for breast cancer treatment Sermonix Pharmaceuticals has signed a licensing agreement to gain exclusive rights to Duke University intellectual property related to the use of lasofoxifene, its lead investigational drug, in the treatment of endocrine-resistant breast cancer.
Contract Research & Services > Contract Services > News
Cascadian Therapeutics amends HER2CLIMB phase 2 trial of tucatinib Cascadian Therapeutics announced that after a recent meeting with the US Food and Drug Administration (FDA) and discussions with the Company's external Steering Committee, it has amended the HER2CLIMB Phase 2 clinical trial of tucatinib (also known as ONT-380) by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration.
Production & Manufacturing > Process & Production > News European Commission approves new indication for Novartis’ Lucentis eye drug By PBR Staff Writer
The European Commission has approved the sixth indication for Novartis’ Lucentis, making it the only treatment available for a range of choroidal neovascularization (CNV) conditions.
Regulatory Affairs > News Novartis' Zykadia beats chemotherapy in phase III lung cancer study Novartis has unveiled Zykadia first-line study results demonstrating 16.6 month progression-free survival in patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC).
Contract Research & Services > Clinical Trials > News

Latest News and Insight by Sector

Production & Manufacturing

Cascadian Therapeutics amends HER2CLIMB phase 2 trial of tucatinib
Cascadian Therapeutics announced that after a recent meeting with the US Food and Drug Administration (FDA) and discussions with the Company's external Steering Committee, it has amended the HER2CLIMB Phase 2 clinical trial of tucatinib (also known as ONT-380) by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration.
Production & Manufacturing > Process & Production > News
FDA grants fast track designation for Theravance's Velusetrag for idiopathic and diabetic gastroparesis
Theravance Biopharma has secured fast track designation from the US Food and Drug Administration (FDA) to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis.
Production & Manufacturing > Process & Production > News

Drug Research

Bicycle, AstraZeneca enter into potential $1bn multitarget collaboration
By PBR Staff Writer
Bicycle Therapeutics and AstraZeneca have agreed a $1bn multi-target collaboration across respiratory, cardiovascular and metabolic diseases.
Drug Research > Drug Discovery & Development > News
Evotec, Merck sign deals to partner on target discovery technologies
Evotec and Merck have signed agreements to collaborate on target discovery technologies.
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

Research shows flickering lights could be used in Alzheimer's treatment
By PBR Staff Writer
Researchers at the Massachusetts Institute of Technology (MIT) have discovered a non-invasive visual stimulation technique that can be potentially used for treating Alzheimer’s disease.
News
Aclaris starts phase 1 trial for ATI-50001 to treat alopecia totalis and alopecia universalis
Aclaris Therapeutics' investigational new drug (IND) application for ATI-50001, an orally administered investigational Janus Kinase (JAK) inhibitor, for the potential treatment of alopecia totalis and alopecia universalis has cleared the 30-day review period by the US Food and Drug Administration, allowing the company to go ahead with its planned Phase 1 clinical trial
Contract Research & Services > Clinical Trials > News

Automation

Pfizer, IBM partner to advance immuno-oncology research
By PBR Staff Writer
Pharmaceutical major Pfizer and technology giant IBM have partnered to accelerate immuno-oncology research.
Automation > IT & Software > News
Menarini-Silicon’s DEPArray technology aids researchers in lung cancer study
Menarini-Silicon Biosystems said its DEPArray single-cell isolation technology played an important role in a study carried out by researchers from The University of Manchester to develop a model for predicting whether small-cell lung cancer patients will be sensitive or resistant to initial chemo­therapy treatment.
Automation > IT & Software > News

Regulatory Affairs

European Commission approves new indication for Novartis’ Lucentis eye drug
By PBR Staff Writer
The European Commission has approved the sixth indication for Novartis’ Lucentis, making it the only treatment available for a range of choroidal neovascularization (CNV) conditions.
Regulatory Affairs > News
UK's CMA fines Pfizer and Flynn Pharma for epilepsy drug price hike
By PBR Staff Writer
Pfizer and Flynn Pharma have been fined a record amount for abusing their dominant position in the UK by charging excessive and unfair prices for an anti-epilepsy drug.
Production & Manufacturing > Manufacturing > News



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