Peregrine Pharmaceuticals Starts Phase III Lung Cancer Trial

barbara.lempert Peregrine Pharmaceuticals Initiates Sunrise Pivotal Phase III Clinical Trial of Bavituximab in Second-Line Non-Small Cell Lung Cancer Company Launches www.SunriseTrial.com ...

Argos swings for a $60M IPO in the shadow of Dendreon’s struggles

Damian Garde North Carolina's Argos Therapeutics believes it can succeed where Dendreon has faltered, pitching a $ 60 million IPO that would help the biotech get its personalized ...

China suspends imports of Pfizer’s AIDS-related drug on a paperwork problem

Carly Helfand Foreign drugmakers have had their fair share of struggles in China this year as the country looked to cut down on healthcare spending and root out bribery. But neither ...

Karolinska’s Axelar comes up short in Phase II with lung cancer drug

Damian Garde Swedish biotech Axelar's lung cancer drug failed to beat out standard docetaxel in a mid-stage trial, but bankroller Karolinska Development isn't giving up, planning ...

FDA says nada to Lemtrada; will Sanofi be willing to invest in additional trials?

Eric Palmer Sanofi intends to appeal the FDA's denial of Lemtrada, its multiple sclerosis drug that was a key reason it paid $ 20.1 billion to buy Genzyme two years ago. But will ...

Threshold Pharmaceuticals Achieves Target Enrollment in Phase III Sarcoma Trial

barbara.lempert Threshold Pharmaceuticals Announces Target Enrollment of 620 Patients Achieved in Pivotal Phase 3 Trial of TH-302 in Advanced Soft Tissue Sarcoma $ 12.5 Million USD ...

Astellas, Immuno-Biological Laboratories in Silkworm Deal

barbara.lempert Astellas and IBL Concludes Co-Research Agreement Regarding Pharmaceutical Applications of Recombinant Human Proteins Made Using transgenic Silkworms Tokyo, December ...

Novo nabs FDA approval of a new drug for rare blood clotting disorder

John Carroll Novo Nordisk is ending the year with an approval from the FDA. The agency announced yesterday that it is giving the green light to a new therapy dubbed Tretten to treat ...

FDA smacks Hospira with nearly 2 dozen observations at India plant

Eric Palmer Hospira is getting on top of its manufacturing issues in the U.S. But the company continues to face issues at a plant in India that received a warning letter in ...

FDA Advisory Committee to Review Ragweed Sublingual AIT Tablet

barbara.lempert ALK announces FDA Advisory Committee to review ragweed  sublingual AIT tablet Allergenic Products Advisory Committee meeting scheduled for 28 January 2014.   COPENHAGEN, ...

TiGenix snags $13.7M for Phase III cell therapy

Damian Garde Belgium's TiGenix has hauled in about $ 13.7 million in debt financing, piling up cash as it works through Phase III with a stem cell treatment. FierceBiotech News

Owners and insurers agree to a $100M fund for victims of NECC’s tainted drugs

Eric Palmer The fungal meningitis outbreak tied to New England Compounding Center led to the bankruptcy of the company and new authority for the FDA to oversee this niche of the drug ...
Page 1 of 612345...Last »
© 2017 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS