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Pharmaceutical Business Review

Rigel's fostamatinib meets main goal in phase 3 study in chronic ITP A phase 3 study assessing Rigel Pharmaceuticals’ fostamatinib to treat chronic/persistent immune thrombocytopenia (ITP) met its primary endpoint. Contract Research & Services > Clinical Trials > News
FDA approves Sandoz’s Enbrel biosimilar for multiple inflammatory diseases By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Sandoz’s Erelzi, a biosimilar to Amgen's Enbrel, to treat several inflammatory diseases.
Regulatory Affairs > News OncoMed completes patient enrollment in phase 2 trial of tarextumab in SCLC OncoMed Pharmaceuticals has completed patient enrollment in the Phase 2 "PINNACLE" clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) for the treatment of small cell lung cancer (SCLC).
Contract Research & Services > Clinical Trials > News ARIAD completes rolling submission of NDA for Brigatinib to FDA ARIAD Pharmaceuticals has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA).
Production & Manufacturing > Process & Production > News
Compugen enhances LINKS computational platform Compugen disclosed that its LINKS computational platform, initially designed for the characterization and differentiation of existing novel drug target candidates, has been enhanced to include the in silico discovery of new immuno-oncology drug targets, with a specific focus on the discovery of myeloid targets within the tumor microenvironment (TME).
Automation > IT & Software > News Rigel's fostamatinib meets main goal in phase 3 study in chronic ITP By PBR Staff Writer
A phase 3 study assessing Rigel Pharmaceuticals’ fostamatinib to treat chronic/persistent immune thrombocytopenia (ITP) met its primary endpoint.
Contract Research & Services > Clinical Trials > News Tonix announces successful end-of-phase 2 meeting with FDA for TNX-102 SL in PTSD Tonix Pharmaceuticals, which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an End-of-Phase 2/Pre-Phase 3 meeting.
Production & Manufacturing > Process & Production > News

Latest News and Insight by Sector

Production & Manufacturing

ARIAD completes rolling submission of NDA for Brigatinib to FDA
ARIAD Pharmaceuticals has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA).
Production & Manufacturing > Process & Production > News
Tonix announces successful end-of-phase 2 meeting with FDA for TNX-102 SL in PTSD
Tonix Pharmaceuticals, which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an End-of-Phase 2/Pre-Phase 3 meeting.
Production & Manufacturing > Process & Production > News

Drug Research

Impax recalls one lot of Lamotrigine Orally Disintegrating Tablet 200 mg
Impax Laboratories has issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg.
Drug Research > Drug Delivery > News
BioLineRx and I-Bridge Capital establish drug development JV in China
BioLineRx has established a joint venture (JV) with I-Bridge Capital, a Chinese venture capital fund focused on developing innovative therapies in China.
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

OncoMed completes patient enrollment in phase 2 trial of tarextumab in SCLC
OncoMed Pharmaceuticals has completed patient enrollment in the Phase 2 "PINNACLE" clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) for the treatment of small cell lung cancer (SCLC).
Contract Research & Services > Clinical Trials > News
Rigel's fostamatinib meets main goal in phase 3 study in chronic ITP
By PBR Staff Writer
A phase 3 study assessing Rigel Pharmaceuticals’ fostamatinib to treat chronic/persistent immune thrombocytopenia (ITP) met its primary endpoint.
Contract Research & Services > Clinical Trials > News

Automation

Compugen enhances LINKS computational platform
Compugen disclosed that its LINKS computational platform, initially designed for the characterization and differentiation of existing novel drug target candidates, has been enhanced to include the in silico discovery of new immuno-oncology drug targets, with a specific focus on the discovery of myeloid targets within the tumor microenvironment (TME).
Automation > IT & Software > News
Daiichi Sankyo chooses Veeva Vault to streamline submissions, eTMF, and quality management
Daiichi Sankyo has selected Veeva Systems' Veeva Vault eTMF, Veeva Vault QualityDocs, and Veeva Vault Submissions to unify content management throughout its research and development (R&D) operations worldwide.
Automation > IT & Software > News

Regulatory Affairs

FDA approves Sandoz’s Enbrel biosimilar for multiple inflammatory diseases
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Sandoz’s Erelzi, a biosimilar to Amgen's Enbrel, to treat several inflammatory diseases.
Regulatory Affairs > News
Perrigo secures tentative FDA approval for generic version of Suprep oral solution
Perrigo has received tentative approval from the U.S. Food and Drug Administration (FDA) for the generic version of Suprep (sodium sulfate/potassium sulfate/magnesium sulfate) oral solution.
Regulatory Affairs > News



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