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Pharmaceutical Business Review

FDA approves label expansion for Shire’s HAE drug Cinryze Shire has secured a label expansion from the US Food and Drug Administration (FDA) for its hereditary angioedema (HAE) therapy Cinryze to help prevent angioedema attacks in HAE-affected children, aged 6 years and older. Regulatory Affairs > News
Ironwood Pharmaceuticals starts phase III program for IW-3718 in persistent gastroesophageal reflux disease Ironwood Pharmaceuticals has initiated two Phase III clinical trials to assess the safety and efficacy of IW-3718 in patients with persistent gastroesophageal reflux disease (GERD).
Drug Research > Drug Discovery & Development > News AdoRx raises $10m funding to discover new cancer therapeutics UK-based AdoRx Therapeutics, which is focused on discovering new cancer therapeutics, has secured an initial $10m investment round financed by Epidarex Capital and CRT Pioneer Fund (CPF).
Drug Research > Drug Discovery & Development > News FDA approves label expansion for Shire’s HAE drug Cinryze By PBR Staff Writer
Shire has secured a label expansion from the US Food and Drug Administration (FDA) for its hereditary angioedema (HAE) therapy Cinryze to help prevent angioedema attacks in HAE-affected children, aged 6 years and older.
Regulatory Affairs > News
Report says smart pills will gain grounds in diagnostics and health monitoring applications A report from Persistence Market Research has revealed that increasing uptake for indigestible medical devices will drive global demand for smart pills during 2017 to 2026.
Drug Research > Drug Discovery & Development > News Novacap to acquire US-based CDMO PCI Synthesis Novacap has agreed to acquire Boston-based PCI Synthesis, a pharmaceutical contract development and manufacturing organization (CDMO), for an undisclosed price.
Drug Research > Drug Delivery > News Novo Nordisk’s semaglutide succeeds in two phase 3a type 2 diabetes trials By PBR Staff Writer
Novo Nordisk said that oral semaglutide succeeded in two phase 3a trials by registering statistically significantly greater reductions in HbA1c and weight in adults with type 2 diabetes.
Contract Research & Services > Clinical Trials > News

Latest News and Insight by Sector

Production & Manufacturing

Novacap to acquire US-based CDMO PCI Synthesis
Novacap has agreed to acquire Boston-based PCI Synthesis, a pharmaceutical contract development and manufacturing organization (CDMO), for an undisclosed price.
Drug Research > Drug Delivery > News
Alexion seeks approval from FDA for PNH drug ALXN1210
Alexion Pharmaceuticals said that it has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA), seeking approval for its C5 complement inhibitor ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
Production & Manufacturing > Process & Production > News

Drug Research

Ironwood Pharmaceuticals starts phase III program for IW-3718 in persistent gastroesophageal reflux disease
Ironwood Pharmaceuticals has initiated two Phase III clinical trials to assess the safety and efficacy of IW-3718 in patients with persistent gastroesophageal reflux disease (GERD).
Drug Research > Drug Discovery & Development > News
AdoRx raises $10m funding to discover new cancer therapeutics
UK-based AdoRx Therapeutics, which is focused on discovering new cancer therapeutics, has secured an initial $10m investment round financed by Epidarex Capital and CRT Pioneer Fund (CPF).
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

Novo Nordisk’s semaglutide succeeds in two phase 3a type 2 diabetes trials
By PBR Staff Writer
Novo Nordisk said that oral semaglutide succeeded in two phase 3a trials by registering statistically significantly greater reductions in HbA1c and weight in adults with type 2 diabetes.
Contract Research & Services > Clinical Trials > News
Can-Fite delays phase 2 trial of liver cancer drug Namodenoson
By PBR Staff Writer
Israeli biotechnology company Can-Fite BioPharma revealed that the results of its phase 2 trial of its liver cancer drug Namodenoson (CF102) will be delayed longer than originally estimated.
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 label expansion for Shire’s HAE drug Cinryze
By PBR Staff Writer
Shire has secured a label expansion from the US Food and Drug Administration (FDA) for its hereditary angioedema (HAE) therapy Cinryze to help prevent angioedema attacks in HAE-affected children, aged 6 years and older.
Regulatory Affairs > News
ImmunoGen gets FDA fast track status for mirvetuximab soravtansine to treat platinum-resistant ovarian cancer
ImmunoGen has secured fast track designation from the US Food and Drug Administration (FDA) for its lead program, mirvetuximab soravtansine.
Regulatory Affairs > News



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