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Pharmaceutical Business Review

EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Production & Manufacturing > Process & Production > News
Proteorex, Corbin partner to discover ubiquitin-specific protease inhibitors Proteorex Therapeutics has commenced its research and development collaboration with Montreal-based Corbin Therapeutics.
Drug Research > Drug Discovery & Development > News Iterum Therapeutics raises $65m in new financing round Ireland-based Iterum Therapeutics, which is focused on the development and commercialization of anti-infectives for patients with infectious diseases and other acute illnesses, has raised $65m in a Series B investment round.
Drug Research > Drug Discovery & Development > News EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
Amgen submits BLA of migraine prevention drug to FDA Amgen has submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab to prevent migraine.
Production & Manufacturing > Process & Production > News FDA places clinical hold on Concert Pharmaceuticals’ hair loss drug The US Food and Drug Administration (FDA) has placed a clinical hold on Concert Pharmaceuticals’ CTP-543 Phase 2a clinical trial for alopecia areata.
Contract Research & Services > Clinical Trials > News Shire’s swelling disorder drug meets primary and secondary endpoints in phase 3 study By PBR Staff Writer
Shire’s swelling disorder treatment, lanadelumab, has met its primary endpoint and all secondary endpoints in a phase 3 study.
Contract Research & Services > Clinical Trials > News

Latest News and Insight by Sector

Production & Manufacturing

EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
Amgen submits BLA of migraine prevention drug to FDA
Amgen has submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab to prevent migraine.
Production & Manufacturing > Process & Production > News

Drug Research

Proteorex, Corbin partner to discover ubiquitin-specific protease inhibitors
Proteorex Therapeutics has commenced its research and development collaboration with Montreal-based Corbin Therapeutics.
Drug Research > Drug Discovery & Development > News
Iterum Therapeutics raises $65m in new financing round
Ireland-based Iterum Therapeutics, which is focused on the development and commercialization of anti-infectives for patients with infectious diseases and other acute illnesses, has raised $65m in a Series B investment round.
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

FDA places clinical hold on Concert Pharmaceuticals’ hair loss drug
The US Food and Drug Administration (FDA) has placed a clinical hold on Concert Pharmaceuticals’ CTP-543 Phase 2a clinical trial for alopecia areata.
Contract Research & Services > Clinical Trials > News
Shire’s swelling disorder drug meets primary and secondary endpoints in phase 3 study
By PBR Staff Writer
Shire’s swelling disorder treatment, lanadelumab, has met its primary endpoint and all secondary endpoints in a phase 3 study.
Contract Research & Services > Clinical Trials > News

Automation

Accenture, BioCelerate partner to advance biopharmaceutical innovation
Accenture and TransCelerate BioPharma's subsidiary BioCelerate have partnered to advance biopharmaceutical innovation through increased insights in research & development.
Automation > IT & Software > News
IBM scientists secure patent on machine learning models for drug discovery
By PBR Staff Writer
Technology giant IBM has secured a patent on machine learning models for drug discovery.
Automation > IT & Software > News

Regulatory Affairs

EC launches probe into Aspen's pricing practices for cancer drugs
The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.
Regulatory Affairs > News
FDA turns down generic version of GSK's asthma/COPD inhaler Advair Diskus
By PBR Staff Writer
Vectura and its partner Hikma Pharmaceuticals announced that the US Food and Drug Administration (FDA) turned down VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus.
Regulatory Affairs > News



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