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ImmuPharma completes phase 3 trial of Lupus drug
ImmuPharma has completed its 52-week, randomised, double-blinded, phase 3 clinical trial of Lupuzor, its lead candidate for the potential breakthrough compound for Lupus.
Contract Research & Services > Clinical Trials > News
Almac to further expand Ireland campus with £30m investment
By PBR Staff Writer
Northern Ireland-based pharmaceutical firm Almac is investing £30m to further expand its European campus in Dundalk, Ireland to cope up with its existing and future client requirements in the European Union market.
Production & Manufacturing > Manufacturing > News
CGT Catapult enters into viral vector manufacturing technology collaboration with Freeline Therapeutics
The Cell and Gene Therapy Catapult (CGT Catapult) has partnered with Freeline Therapeutics to further develop the company’s proprietary manufacturing platform at the CGT Catapult’s large scale GMP manufacturing centre in Stevenage, Hertfordshire, UK.
News
USPTO invalidates J&J’s patent on prostate cancer drug Zytiga
By PBR Staff Writer
The US Patent & Trademark Office (USPTO) has invalidated a Johnson & Johnson (J&J) patent on prostate cancer drug Zytiga (abiraterone acetate).
Regulatory Affairs > News
X-Chem, AstraZeneca expand drug discovery partnership
X-Chem, a small molecule discovery specialist, has expanded its existing global drug discovery and technology transfer collaboration with AstraZeneca.
Drug Research > Drug Discovery & Development > News
Carmot Therapeutics secures funding for type 2 diabetes drug
Carmot Therapeutics, a biotechnology company, has closed a $15m financing to support the development of its type 2 diabetes drug, a dual GLP-1R/GIPR agonist, through early clinical proof of concept.
Drug Research > Drug Discovery & Development > News
Novartis’ Kymriah nabs speedy reviews in US, Europe for lymphoma treatment
By PBR Staff Writer
Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) has been granted fast-tracked reviews in the US and Europe for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
Regulatory Affairs > News
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
Sandoz, a Novartis division, announced that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira.
News
Shire’s haemophilia A drug Adynovi secures approval in Europe
The European Commission (EC) has granted marketing authorization for Shire’s Adynovi [Antihemophilic Factor (Recombinant), PEGylated], an extended half-life recombinant factor VIII (rFVIII) treatment, for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
Regulatory Affairs > News
Merck’s Keytruda regimen succeeds in phase 3 NSCLC trial
By PBR Staff Writer
Merck’s Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) plus platinum chemotherapy has significantly improved overall survival (OS) and progression-free survival (PFS) of certain type of lung cancer patients in a phase 3 trial.
Contract Research & Services > Clinical Trials > News
Midatech gets FDA IND approval to begin trial of brain cancer treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Midatech Pharma’s investigational new drug (IND) application to carry out a study of an investigational nano-inclusion product, MTX110, to treat fatal childhood brain cancer DIPG.
Regulatory Affairs > News
Mundipharma agrees to distribute Grünenthal's pain-relief drug in China
Mundipharma has agreed to market and distribute Grünenthal’s Tramal (tramadol) in China from 1 May 2018.
Drug Research > Drug Delivery > News
e-Therapeutics signs two collaboration deals to enhance AI technology capabilities
By PBR Staff Writer
UK-based drug developer e-Therapeutics has agreed to collaborate with Intellegens and Biorelate to improve and extend its artificial intelligence (AI) technology capabilities.
Drug Research > Drug Delivery > News
Avacta signs licensing deal with Glythera after successful trial
Avacta Group has signed a licensing agreement with Glythera for its Affimer technology after a successful proof-of-concept study.
Drug Research > Drug Discovery & Development > News
Telix Pharmaceuticals establishes Japanese subsidiary
Australian biopharmaceutical firm Telix Pharmaceuticals has established Telix Pharmaceuticals (Japan) (Telix Japan) and appointed first two members of the Japanese leadership team.
Drug Research > Drug Discovery & Development > News
1-15 of 50925 results