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Biothera signs cancer immunotherapy clinical trial collaboration deal with Genentech
Biothera Pharmaceuticals has entered into a clinical trial collaboration agreement with Genentech to assess the safety and efficacy of Biothera’s Imprime PGG in combination with Genentech’s atezolizumab (TECENTRIQ), an anti-PD-L1 antibody, and bevacizumab (AVASTIN), an anti-VEGF antibody, to treat patients with metastatic colorectal cancer.
Contract Research & Services > Clinical Trials > News
Regeneron’s eye-drug combination fails in two Phase 2 studies
By PBR Staff Writer
Regeneron Pharmaceuticals announced that results from two Phase 2 studies that added the angiopoietin2 (Ang2) antibody nesvacumab to EYLEA (aflibercept) Injection did not provide enough differentiation to warrant phase 3 development.
Contract Research & Services > Clinical Trials > News
ViiV Healthcare begins third phase III HIV trial of cabotegravir/rilpivirine regimen
ViiV Healthcare, a joint venture of GSK, Pfizer and Shionogi, has commenced a phase III study with a two-drug regimen of its long-acting, injectable cabotegravir and Janssen Sciences Ireland’s long-acting injectable rilpivirine in virally suppressed adults with HIV-1 infection.
Contract Research & Services > Clinical Trials > News
Biogen, Alkermes to develop and commercialize ALKS 8700 to treat multiple sclerosis
Biogen and Alkermes have entered into a global license and collaboration agreement to develop and commercialize ALKS 8700, a novel, oral, monomethyl fumarate (MMF) small drug molecule in phase 3 development for the treatment of relapsing forms of multiple sclerosis (MS).
Drug Research > Drug Discovery & Development > News
MSD to establish life sciences discovery research facility in London
By PBR Staff Writer
MSD, known as Merck and co. in North America, has unveiled plans to establish a life sciences discovery research facility in London, UK, creating around 950 jobs.
Drug Research > Drug Discovery & Development > News
AstraZeneca submits sNDA for Tagrisso to treat EGFRm NSCLC
By PBR Staff Writer
AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan’s pharmaceuticals and medical devices agency seeking approval for Tagrisso (osimertinib) as a first line treatment for patients with inoperable or recurrent EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
Pharming submits supplemental BLA to FDA for Ruconest for prophylaxis of hereditary angioedema attacks
Pharming Group has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).
Production & Manufacturing > Process & Production > News
Microbial contamination forces Sun Pharma to recall two lots of diabetes drug in US
By PBR Staff Writer
Sun Pharmaceutical Industries is voluntarily recalling two lots of diabetes drug Riomet in the US due to microbial contamination.
Production & Manufacturing > Manufacturing > News
PhoenixBio invests in KMT Hepatech
KMT Hepatech has reached an agreement to join efforts with PhoenixBio. Together the companies will advance the use of the cDNA-uPA/SCID mouse model with highly humanized liver to support researchers across a range of drug development fields.
Drug Research > Drug Discovery & Development > News
European Commission approves Tremfya to treat moderate to severe plaque psoriasis
Janssen-Cilag International announced that the European Commission (EC) has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Regulatory Affairs > News
Cancer Research UK to use Astra Zeneca’s AZD1775 in head and neck cancer trial
By PBR Staff Writer
UK researchers are all set to launch an early-stage trial to evaluate an experimental drug from Astra Zeneca’s for improving the treatment of head and neck cancer.
Contract Research & Services > Clinical Trials > News
Cytokinetics’ ALS treatment tirasemtiv fails to meet primary endpoint in phase 3 study
Cytokinetics has announced that international phase 3 clinical trial of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS) has did not meet the primary endpoint.
Contract Research & Services > Clinical Trials > News
Midatech secures manufacturing certification from Spanish regulatory authority
Midatech Pharma has received manufacturing certification from Spanish regulatory authority AEMPS.
Production & Manufacturing > Manufacturing > News
Research finds gastric acid suppressant lansoprazole could target tuberculosis
By PBR Staff Writer
A new research in the UK suggests that a cheap and commonly used drug to treat heartburn, gastritis and ulcers has the potential to target Mycobacterium tuberculosis, the bacteria that causes tuberculosis (TB).
Drug Research > Drug Discovery & Development > News
European Prevention of Alzheimer’s Dementia Consortium opens six new study sites
The European Prevention of Alzheimer’s Dementia Consortium (EPAD) is enrolling research participants at six new sites, which takes the total to ten centers across six European countries.
Contract Research & Services > Clinical Trials > News
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