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Pharmaceutical Business Review

Roche's emicizumab shows substantial reduction in bleeds in phase III studies Roche’s haemophilia A drug emicizumab has showed a significant effect in the phase III Haven 1 and Haven 2 studies. Contract Research & Services > Clinical Trials > News
bluebird unveils topline interim data from Starbeam study of Lenti-D in CALD bluebird bio has released topline interim data from the initial cohort of 17 patients in the ongoing Phase 2/3 Starbeam Study (ALD-102) evaluating its investigational gene therapy Lenti-D in under-18 boys with cerebral adrenoleukodystrophy (CALD).
Contract Research & Services > Clinical Trials > News FDA accepts for filing Icon’s NDA for Dexycu drug therapy The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
Production & Manufacturing > Process & Production > News Roche's emicizumab shows substantial reduction in bleeds in phase III studies By PBR Staff Writer
Roche’s haemophilia A drug emicizumab has showed a significant effect in the phase III Haven 1 and Haven 2 studies.
Contract Research & Services > Clinical Trials > News
European Medicines Agency recommends approval of Humira biosimilar Imraldi By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis' Imraldi for approval, which is a biosimilar candidate referencing Humira (adalimumab).
Regulatory Affairs > News Pfizer gets CRL on Epogen biosimilar from FDA By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News Cancer frim Repare Therapeutics announces $68m Series A financing Repare Therapeutics has secured $68m in a Series A financing round which it will use to advance its platform and pipeline of novel medicines that target genetically defined weaknesses of cancers.
Drug Research > Drug Discovery & Development > News

Latest News and Insight by Sector

Production & Manufacturing

FDA accepts for filing Icon’s NDA for Dexycu drug therapy
The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
Production & Manufacturing > Process & Production > News
Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News

Drug Research

FDA accepts for filing Icon’s NDA for Dexycu drug therapy
The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
Production & Manufacturing > Process & Production > News
Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > 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

bluebird unveils topline interim data from Starbeam study of Lenti-D in CALD
bluebird bio has released topline interim data from the initial cohort of 17 patients in the ongoing Phase 2/3 Starbeam Study (ALD-102) evaluating its investigational gene therapy Lenti-D in under-18 boys with cerebral adrenoleukodystrophy (CALD).
Contract Research & Services > Clinical Trials > News
Roche's emicizumab shows substantial reduction in bleeds in phase III studies
By PBR Staff Writer
Roche’s haemophilia A drug emicizumab has showed a significant effect in the phase III Haven 1 and Haven 2 studies.
Contract Research & Services > Clinical Trials > News

Automation

Numerate, Takeda partner to generate clinical candidates using AI-driven drug discovery
Numerate has entered into a multi-year agreement with Takeda Pharmaceutical under which it will identify and deliver multiple clinical candidates by applying artificial intelligence (AI) at cloud scale.
Automation > IT & Software > News
Novartis, IBM partner to optimize cancer care and improve patient outcomes
By PBR Staff Writer
Novartis has partnered with IBM Watson Health to explore the development of a cognitive solution, aimed at enhancing outcomes in advanced breast cancer.
Automation > IT & Software > News

Regulatory Affairs

European Medicines Agency recommends approval of Humira biosimilar Imraldi
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis' Imraldi for approval, which is a biosimilar candidate referencing Humira (adalimumab).
Regulatory Affairs > News
Shire gets FDA approval for ADHD drug Mydayis
By PBR Staff Writer
Shire has secured approval from the US Food and Drug Administration (FDA) for its Mydayis (mixed salts of a single-entity amphetamine product) to control attention deficit hyperactivity disorder (ADHD) in patients 13 years and older.
Regulatory Affairs > News



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