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Asklepios BioPharmaceutical launches new portfolio company Actus Therapeutics
Asklepios BioPharmaceutical has formed Actus Therapeutics, a new portfolio company based on AskBio’s industry-leading gene therapy platform.
Drug Research > Drug Discovery & Development > News
FDA approves Pfizer’s Xeljanz and Xeljanz XR to treat active psoriatic arthritis
The US Food and Drug Administration (FDA) has approved Pfizer’s Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
News
Drugmaker Teva to cut 14,000 jobs globally
By PBR Staff Writer
Teva Pharmaceutical Industries said it will lay off 14,000 jobs globally as part of a two-year restructuring plan, aimed at boosting its business and financial performance.
Production & Manufacturing > Manufacturing > News
Flexion Therapeutics to acquire novel and non-opioid asset for osteoarthritis of knee
Flexion Therapeutics has entered into a definitive agreement with GeneQuine Biotherapeutics GmbH to acquire the global rights to GQ-203.
Production & Manufacturing > Manufacturing > News
GW Pharmaceuticals reacquires full rights of develop Sativex in US
GW Pharmaceuticals has terminated its previous license agreement with Otsuka Pharmaceutical in relation to Sativex (nabiximols) in the US.
Drug Research > Drug Discovery & Development > News
Pfizer's biosimilar of J&J's Remicade secures FDA approval
By PBR Staff Writer
Pfizer’s IXIFI (PF-06438179, infliximab-qbtx), a biosimilar to Johnson & Johnson’s rheumatoid arthritis drug Remicade (infliximab), has been approved by the US Food and Drug Administration (FDA) for all indications of the reference product.
News
Allergan acquires Repros Therapeutics
Repros Therapeutics has entered into a definitive agreement under which Allergan, through a subsidiary, will acquire Repros for a cash payment of $0.67 per share.
Production & Manufacturing > Manufacturing > News
Shire gets EC nod for lyophilized Oncaspar to treat acute lymphoblastic leukemia
By PBR Staff Writer
Shire has secured marketing approval from the European Commission (EC) for new formulation of Oncaspar to treat patients with acute lymphoblastic leukemia (ALL).
News
CMC Biologics signs development and manufacturing deal with Harpoon Therapeutics
CMC ICOS Biologics and Harpoon Therapeutics have signed an agreement to develop and manufacture HPN424, HPN536, and HPN217, representing three TriTAC molecules for the treatment of several human cancers.
Drug Research > Drug Discovery & Development > News
Combination of AbbVie's venetoclax and Rituxan succeeds in phase 3 R/R CLL trial
By PBR Staff Writer
AbbVie and Roche’s Venclexta/Venclyxto (venetoclax) in combination with MabThera/Rituxan (rituximab) succeeded in a phase 3 trial in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) by meeting the primary endpoint.
Contract Research & Services > Clinical Trials > News
NIH to provide funding for Alzheimer's advance clinical trials
By PBR Staff Writer
US-based National Institutes of Health (NIH) is set to provide financial assistance to a new clinical trials consortium to enhance studies for therapies in Alzheimer’s disease and related dementias.
Contract Research & Services > Clinical Trials > News
Aeonian Pharmaceuticals secures funding to develop mTORC1 inhibitors
Aeonian Pharmaceuticals, a San Francisco Bay Area-based biopharmaceutical company, has closed a seed financing round led by Apollo Ventures and Life Sciences Company.
Drug Research > Drug Discovery & Development > News
Ardelyx signs license agreement with Fosun Pharma for tenapanor in China
Ardelyx has entered into a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Company (Fosun Pharma) for tenapanor.
Production & Manufacturing > Manufacturing > News
Sanofi’s Admelog (insulin lispro injection) gets FDA approval to treat diabetes
By PBR Staff Writer
Sanofi’s Admelog (insulin lispro injection) has been approved by the US Food and Drug Administration (FDA) to help diabetic patients control their blood sugar levels at mealtime.
Regulatory Affairs > News
Pfizer's breast cancer drug improves progression-free survival in Phase 3 trial
Pfizer announced that talazoparib has improved progression-free survival (PFS) in patients with germline (inherited) BRCA1/2-positive (gBRCA+) locally advanced or metastatic breast cancer (MBC) in the Phase 3 Embraca study.
Contract Research & Services > Clinical Trials > News
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