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Pharmaceutical Business Review

Boehringer's Spiolto Respimat approved in European countries to treat COPD Boehringer Ingelheim has received regulatory authority approvals for Spiolto Respimat (tiotropium/olodaterol) in European countries as a once-daily maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Production & Manufacturing > Process & Production > News
Arrowhead begins dosing patients in Phase I trial of ARC-AAT to treat AATD By PBR Staff Writer
US-based Arrowhead Research has started dosing patients in Part B of a Phase I clinical trial of its RNAi-based drug candidate ARC-AAT to treat liver disease associated with the rare genetic disorder alpha-1 antitrypsin deficiency (AATD).
Contract Research & Services > Clinical Trials > News Adaptimmune gets FDA acceptance for IND application for MAGE-A10 T in NSCLC patients By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted UK-based biopharmaceutical firm Adaptimmune Therapeutics' investigational new drug (IND) application for autologous genetically modified T-cells expressing enhanced T cell receptors (TCRs) specific for its therapeutic candidate MAGE A10 (MAGE-A10 T) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Regulatory Affairs > News FDA accepts to review Pfizer's NDA for rheumatoid arthritis drug Xeljanz By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Pfizer’s new drug application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets to treat moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).
Production & Manufacturing > Process & Production > News
Boehringer's Spiolto Respimat approved in European countries to treat COPD By PBR Staff Writer
Boehringer Ingelheim has received regulatory authority approvals for Spiolto Respimat (tiotropium/olodaterol) in European countries as a once-daily maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Production & Manufacturing > Process & Production > News Biogen and AGTC join forces to develop gene therapies in ophthalmology Biogen (BIIB) and AGTC have established collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases.
Drug Research > Drug Discovery & Development > News Kite Pharma join forces with Leukemia & Lymphoma Society Kite Pharma and the Leukemia & Lymphoma Society (LLS) have entered into a partnership to enhance the development of Kite's lead product candidate, KTE-C19, for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL).
Drug Research > Drug Discovery & Development > News

Latest News and Insight by Sector

Production & Manufacturing

FDA accepts to review Pfizer's NDA for rheumatoid arthritis drug Xeljanz
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Pfizer’s new drug application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets to treat moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).
Production & Manufacturing > Process & Production > News
Boehringer's Spiolto Respimat approved in European countries to treat COPD
By PBR Staff Writer
Boehringer Ingelheim has received regulatory authority approvals for Spiolto Respimat (tiotropium/olodaterol) in European countries as a once-daily maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Production & Manufacturing > Process & Production > News

Drug Research

Biogen and AGTC join forces to develop gene therapies in ophthalmology
Biogen (BIIB) and AGTC have established collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases.
Drug Research > Drug Discovery & Development > News
Kite Pharma join forces with Leukemia & Lymphoma Society
Kite Pharma and the Leukemia & Lymphoma Society (LLS) have entered into a partnership to enhance the development of Kite's lead product candidate, KTE-C19, for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL).
Drug Research > Drug Discovery & Development > News

Inward Investment

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
Merck in talks to acquire Cubist Pharmaceuticals for nearly $8bn
By PBR Staff Writer
New Jersey-based drug giant Merck & Co is, reportedly, in talks over a potential acquisition of antibiotics maker Cubist Pharmaceuticals for more than $8bn.
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

Arrowhead begins dosing patients in Phase I trial of ARC-AAT to treat AATD
By PBR Staff Writer
US-based Arrowhead Research has started dosing patients in Part B of a Phase I clinical trial of its RNAi-based drug candidate ARC-AAT to treat liver disease associated with the rare genetic disorder alpha-1 antitrypsin deficiency (AATD).
Contract Research & Services > Clinical Trials > News
TES Pharma and EPFL establish R&D collaboration
TES Pharma and École Polytechnique Fédérale de Lausanne (EPFL) has formed new research and development collaboration on novel small molecule modulators of the kynurenine pathway as therapies for metabolic disorders and age-related diseases.
Contract Research & Services > Contract Research > News

Automation

Panther Biotechnology agrees to buy Alchemia Oncology
Panther Biotechnology has entered into an agreement to acquire Alchemia Oncology, a wholly owned subsidiary of Alchemia Limited, an Australian biotechnology company listed on the Australian Stock Exchange (ACL).
Automation > IT & Software > News
BSN medical expand lymphoedema therapy solutions with FarrowMed acquisition
BSN medical continues to strengthen its position as a market leading provider of lymphoedema therapy solutions by acquiring FarrowMed and its range of patented FarrowWrap and related compression garment technologies, which focus on the management of lymphoedema and venous disease.
Automation > IT & Software > News

Regulatory Affairs

Adaptimmune gets FDA acceptance for IND application for MAGE-A10 T in NSCLC patients
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted UK-based biopharmaceutical firm Adaptimmune Therapeutics' investigational new drug (IND) application for autologous genetically modified T-cells expressing enhanced T cell receptors (TCRs) specific for its therapeutic candidate MAGE A10 (MAGE-A10 T) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA approves Spriaso's NDA for codeine antitussive with anti-histamine
By PBR Staff Writer
The US food and Drug Administration (FDA) has granted approval for Spriaso's new drug application (NDA) for Tuxarin ER, a high strength long acting Rx cough/cold combination product containing codeine and chlorpheniramine.
Regulatory Affairs > News



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