Pharmaceutical Business Review
Return to: PBR Home

News

View news from other Pharmaceutical sectors:
16-30 of 51311 results
Grünenthal begins phase III trials in Complex Regional Pain Syndrome
Grünenthal has recruited first patients in two trials of pivotal phase III program to investigate neridronate for the treatment of Complex Regional Pain Syndrome (CRPS).
Contract Research & Services > Clinical Trials > News
Ascletis' Ganovo gets CFDA approval for treatment of viral hepatitis C
The China Food and Drug Administration (CFDA) has approved Ascletis' Category 1 new drug, Ganovo (Danoprevir or ASC08), for the treatment of viral hepatitis C.
Regulatory Affairs > News
Merck's Keytruda secures FDA approval for advanced cervical cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has expanded the approval of Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of recurrent or metastatic cervical cancer in patients whose disease had progressed on or after chemotherapy.
Regulatory Affairs > News
AstraZeneca, Eli Lilly terminate clinical trials of Alzheimer's disease treatment lanabecestat
By PBR Staff Writer
AstraZeneca and Eli Lilly have announced the termination of global phase 3 clinical trials of Alzheimer's disease treatment, lanabecestat, which is an oral beta secretase cleaving enzyme (BACE) inhibitor.
Contract Research & Services > Clinical Trials > News
BridgeBio Pharma to acquire late stage therapy for ultra-rare disorder from Alexion
BridgeBio Pharma has entered into an agreement with Alexion Pharmaceuticals to acquire cyclic pyranopterin monophosphate (cPMP; ALXN1101), a synthetic enzyme co-factor therapy for patients with the ultra-rare disease caused by molybdenum cofactor deficiency (MoCD) Type A.
Drug Research > Drug Discovery & Development > News
Advaxis doses first patient with ADXS-NEO cancer immunotherapy
Advaxis has started a phase 1 trial with the dosing of the first patient with ADXS-NEO, an investigational personalized immunotherapy candidate targeting personal neoantigens found by sequencing a patient’s own cancer cells.
Contract Research & Services > Clinical Trials > News
Sanofi Pasteur to buy license of Translate's mRNA technology in $805m deal
By PBR Staff Writer
Sanofi Pasteur, the vaccines business of French pharma firm Sanofi, has agreed to acquire exclusive license of Translate Bio’s mRNA technology to develop messenger RNA (mRNA) vaccines in a deal that could be worth up to $805m.
Drug Research > Drug Discovery & Development > News
AstraZeneca gets EC nod for Tagrisso as first-line treatment for EGFR-mutated NSCLC
By PBR Staff Writer
The European Commission (EC) has approved AstraZeneca's Tagrisso (osimertinib) as monotherapy for first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Regulatory Affairs > News
FDA accepts Cellenkos’ IND to begin clinical trial of CK0801 for bone marrow failure syndromes
The US Food and Drug Administration (FDA) has cleared Cellenkos’ investigational new drug (IND) application to proceed with a phase I clinical trial of CK0801, third party cord blood derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis.
Contract Research & Services > Clinical Trials > News
Alnylam's Lumasiran yields positive results in phase 1/2 Hyperoxaluria study
Alnylam Pharmaceuticals said that lumasiran, its investigational RNAi therapeutic targeting glycolate oxidase (GO) has yielded positive results from a phase 1/2 study in patients with Primary Hyperoxaluria Type 1 (PH1).
Contract Research & Services > Clinical Trials > News
FDA approves AbbVie and Roche's Venclexta-rituximab combo for CLL
By PBR Staff Writer
AbbVie has secured approval from the US Food and Drug Administration (FDA) for the combination of Venclexta (venetoclax tablets) and rituximab for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Regulatory Affairs > News
Oncologie commences operations in Boston and Shanghai
Oncologie is launching operations in both Boston and Shanghai with $16.5m seed financing led by Pivotal bioVenture Partners China.
Drug Research > Drug Discovery & Development > News
UK's MHRA, CHM adopt positive opinion on approval of Alliance Pharma's Diclectin
Alliance Pharma said that the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) have adopted a positive opinion for the approval of Diclectin.
Production & Manufacturing > Process & Production > News
Genentech’s Rituxan gets FDA approval to treat pemphigus vulgaris
By PBR Staff Writer
Genentech, a subsidiary of Roche, has secured approval from the US Food and Drug Administration (FDA) for its antibody therapy Rituxan (rituximab) to treat adults with moderate to severe pemphigus vulgaris (PV).
Regulatory Affairs > News
Axovant, Oxford BioMedica sign $842.5m Parkinson’s disease deal
By PBR Staff Writer
Axovant Sciences has signed an exclusive worldwide licensing agreement with Oxford BioMedica to develop and commercialise, OXB-10, to treat Parkinson’s disease.
Drug Research > Drug Discovery & Development > News
16-30 of 51311 results