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Pharmaceutical Business Review

ViiV’s dolutegravir/lamivudine regimen succeeds in two phase 3 HIV-1 trials ViiV Healthcare reported that two phase 3 trials evaluating the two-drug regimen (2DR) of dolutegravir (Tivicay) and lamivudine (Epivir) in treatment naïve HIV-1 infected adults demonstrated the ability to control HIV. Contract Research & Services > Clinical Trials > News
X4P-001-RD demonstrates promising activity in WHIM syndrome patients By PBR Staff Writer
X4 Pharmaceuticals said that its X4P-001-RD has demonstrated promising activity in the ongoing open-label phase 2 portion of a phase 2/3 study in patients with WHIM syndrome.
Contract Research & Services > Clinical Trials > News Celltrion resubmits aBLA to FDA for proposed Trastuzumab biosimilar South Korea-based Celltrion said that it has completed a re-submission to the US Food and Drug Administration (FDA) seeking approval for CT-P6, a proposed mAb biosimilar to cancer drug Herceptin (trastuzumab).
Production & Manufacturing > Process & Production > News BMS’ elotuzumab / pomalidomide improves progression-free survival in cancer trial Bristol-Myers Squibb (BMS) has announced that the ELOQUENT-3 trial, an international Phase 2 study evaluating the addition of Empliciti (elotuzumab) to pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed/refractory multiple myeloma (RRMM), achieved its primary endpoint.
Contract Research & Services > Clinical Trials > News
Futility forces Teva to halt fremanezumab’s chronic cluster headache study By PBR Staff Writer
Israel-based Teva Pharmaceutical Industries said that it will stop an ongoing phase 3 trial of its migraine drug fremanezumab for the treatment of chronic cluster headache due to futility.
Contract Research & Services > Clinical Trials > News Faron Pharmaceuticals reports inconsistent Traumakine biomarker results Faron Pharmaceuticals has announced preliminary biomarker data from its Phase III INTEREST trial of Traumakine for the treatment of Acute Respiratory Distress Syndrome (ARDS).
Contract Research & Services > Clinical Trials > News Sage, Shionogi to collaborate on MDD drug in three Asian countries Sage Therapeutics and Shionogi & Co. have agreed to collaborate for the clinical development and commercialization of the former’s SAGE-217 for the treatment of major depressive disorder (MDD) and other indications in Japan, Taiwan and South Korea.
Drug Research > Drug Discovery & Development > News

Latest News and Insight by Sector

Production & Manufacturing

Celltrion resubmits aBLA to FDA for proposed Trastuzumab biosimilar
South Korea-based Celltrion said that it has completed a re-submission to the US Food and Drug Administration (FDA) seeking approval for CT-P6, a proposed mAb biosimilar to cancer drug Herceptin (trastuzumab).
Production & Manufacturing > Process & Production > News
UK's MHRA, CHM adopt positive opinion on approval of Alliance Pharma's Diclectin
Alliance Pharma said that the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) have adopted a positive opinion for the approval of Diclectin.
Production & Manufacturing > Process & Production > News

Drug Research

Sage, Shionogi to collaborate on MDD drug in three Asian countries
Sage Therapeutics and Shionogi & Co. have agreed to collaborate for the clinical development and commercialization of the former’s SAGE-217 for the treatment of major depressive disorder (MDD) and other indications in Japan, Taiwan and South Korea.
Drug Research > Drug Discovery & Development > News
Recipharm agrees to acquire Sanofi CMO business in UK
Recipharm has agreed to acquire Sanofi CMO business in the UK for a consideration of £45m, in a bid to expand its inhalation capabilities.
Drug Research > Drug Delivery > 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

X4P-001-RD demonstrates promising activity in WHIM syndrome patients
By PBR Staff Writer
X4 Pharmaceuticals said that its X4P-001-RD has demonstrated promising activity in the ongoing open-label phase 2 portion of a phase 2/3 study in patients with WHIM syndrome.
Contract Research & Services > Clinical Trials > News
BMS’ elotuzumab / pomalidomide improves progression-free survival in cancer trial
Bristol-Myers Squibb (BMS) has announced that the ELOQUENT-3 trial, an international Phase 2 study evaluating the addition of Empliciti (elotuzumab) to pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed/refractory multiple myeloma (RRMM), achieved its primary endpoint.
Contract Research & Services > Clinical Trials > News

Automation

Horizon Discovery out-licenses cell line engineering technology to US firm
Horizon Discovery Group has entered into a non-exclusive out-licensing agreement with an undisclosed US-based immuno-oncology company (the Partner) for its technologies to support the development and manufacture of a biomanufacturing cell line for commercial use.
Automation > IT & Software > News
GE to provide biomanufacturing platform for Clover’s Chinese facility
By PBR Staff Writer
GE Healthcare will provide its biomanufacturing platform for Clover Biopharmaceuticals’ new production facility in China.
Automation > IT & Software > News

Regulatory Affairs

FDA approves Roche's Avastin plus chemotherapy for ovarian cancer after surgery
The US Food and Drug Administration (FDA) has approved Roche’s Avastin (bevacizumab) plus chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for treating women with stage III or IV ovarian cancer following initial surgical resection.
Regulatory Affairs > News
Albireo gets FDA rare pediatric disease designation for rare liver disease treatment A4250
By PBR Staff Writer
Albireo Pharma has secured rare pediatric disease designation from the US Food and Drug Administration for its product candidate, A4250, to treat progressive familial intrahepatic cholestasis (PFIC).
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