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FDA approves Kite’s Car T therapy Yescarta for B-Cell Lymphoma Kite Pharma’s chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) has been approved by the US Food and Drug Administration for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who had at least two lines of systemic therapy. Regulatory Affairs > News
Boehringer Ingelheim partners with TARGET to progress NASH research TARGET PharmaSolutions announced that Boehringer Ingelheim International has entered into a multi-year strategic partnership for TARGET-NASH.
News Alnylam, Vir to jointly advance RNAi therapeutics for infectious diseases Alnylam Pharmaceuticals has announced an exclusive licensing agreement with Vir Biotechnology for the development and commercialization of RNAi therapeutics for infectious diseases, including chronic hepatitis B virus (HBV) infection.
Drug Research > Drug Discovery & Development > News FDA approves Kite’s Car T therapy Yescarta for B-Cell Lymphoma By PBR Staff Writer
Kite Pharma’s chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) has been approved by the US Food and Drug Administration for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who had at least two lines of systemic therapy.
Regulatory Affairs > News
Teva seeks FDA approval for migraine drug fremanezumab By PBR Staff Writer
Israel-based Teva Pharmaceutical Industries is seeking approval of its migraine drug fremanezumab in the US having filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA).
Production & Manufacturing > Manufacturing > News Takeda, HemoShear collaborate to develop drugs for liver diseases By PBR Staff Writer
Takeda has collaborated with HemoShear Therapeutics to discover and develop novel therapeutics for liver diseases such as nonalcoholic steatohepatitis (NASH).
Drug Research > Drug Discovery & Development > News Ignyta’s Entrectinib gets EMA prime designation for NTRK fusion-positive solid tumors Ignyta’s entrectinib has been granted Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy.
Production & Manufacturing > Process & Production > News

Latest News and Insight by Sector

Production & Manufacturing

Teva seeks FDA approval for migraine drug fremanezumab
By PBR Staff Writer
Israel-based Teva Pharmaceutical Industries is seeking approval of its migraine drug fremanezumab in the US having filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA).
Production & Manufacturing > Manufacturing > News
Ignyta’s Entrectinib gets EMA prime designation for NTRK fusion-positive solid tumors
Ignyta’s entrectinib has been granted Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy.
Production & Manufacturing > Process & Production > News

Drug Research

Boehringer Ingelheim partners with TARGET to progress NASH research
TARGET PharmaSolutions announced that Boehringer Ingelheim International has entered into a multi-year strategic partnership for TARGET-NASH.
News
Alnylam, Vir to jointly advance RNAi therapeutics for infectious diseases
Alnylam Pharmaceuticals has announced an exclusive licensing agreement with Vir Biotechnology for the development and commercialization of RNAi therapeutics for infectious diseases, including chronic hepatitis B virus (HBV) infection.
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
http://inwardinvestment.pharmaceutical-business-review.com/news/ppf-group-acquires-minority-stake-in-cytune-pharma-060215-4506503" class="title2"> 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

FDA approves Kite’s Car T therapy Yescarta for B-Cell Lymphoma
By PBR Staff Writer
Kite Pharma’s chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) has been approved by the US Food and Drug Administration for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who had at least two lines of systemic therapy.
Regulatory Affairs > News
US FDA accepts sBLA for Imfinzi in locally advanced and unresectable NSCLC
AstraZeneca and MedImmune announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
Regulatory Affairs > News



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