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FDA rejects Sandoz’s BLA for proposed biosimilar rituximab
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Sandoz’s biologics licensing application (BLA) for its proposed biosimilar rituximab.
Regulatory Affairs > News
OnKure secures financing to support development of epigenetics drug
OnKure, the epigenetics-focused drug discovery and development company, has secured $7m series A financing for its research and development activities.
Drug Research > Drug Discovery & Development > News
Merck signs deal with SFJ on colorectal cancer drug development
Merck has entered into a development agreement with US-based SFJ Pharmaceuticals Group (SFJ) to develop abituzumab in metastatic colorectal cancer.
Contract Research & Services > Clinical Trials > News
Janssen Biotech to buy BeneVir Biopharm in $1bn deal
By PBR Staff Writer
Janssen Biotech has agreed to acquire US-based BeneVir Biopharm, a biopharmaceutical company focused on developing oncolytic immunotherapies for cancer, in a deal worth $1.04bn.
Drug Research > Drug Discovery & Development > News
Vivus to acquire product rights to Pancreaze from Janssen for $135m
Vivus has agreed to acquire all product rights for Pancreaze (pancrelipase) Delayed-Release Capsules in the US and Canada held by Janssen Pharmaceuticals, subject to certain closing conditions, including Hart-Scott-Rodino review.
Drug Research > Drug Delivery > News
C4XD, e-Therapeutics to collaborate on Parkinson’s Disease treatment
C4X Discovery (C4XD) has entered into a joint research collaboration with e-Therapeutics (ETX) to identify novel mechanisms for the treatment of Parkinson’s Disease (PD).
Drug Research > Drug Discovery & Development > News
FDA expands approval of Novartis’ Kymriah CAR-T therapy
By PBR Staff Writer
Novartis has secured a second approval for Kymriah (tisagenlecleucel) in the US for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma who had more than two lines of systemic therapy.
Regulatory Affairs > News
FDA grants priority review for Keytruda, chemotherapy combination in NSCLC
Merck said that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy Keytruda based on the results of the phase 3 KEYNOTE-189 trial.
Regulatory Affairs > News
NXDC announces acquisition by German biotech firm
NX Development (NXDC), a privately-held life sciences company, has announced a merger acquisition under which NXDC became a wholly-owned subsidiary of photonamic GmbH & Co. KG (PHN).
Drug Research > Drug Discovery & Development > News
Karyopharm’s multiple myeloma drug Selinexor succeeds in phase 2b study
By PBR Staff Writer
Karyopharm Therapeutics’ selinexor, an oral selective inhibitor of nuclear export (SINE) compound, has succeeded in a phase 2b study by showing a 25.4% overall response rate (ORR) in heavily pretreated patients with refractory multiple myeloma.
Contract Research & Services > Clinical Trials > News
Ani Pharmaceuticals to buy generic products from Amneal and Impax
By PBR Staff Writer
Ani Pharmaceuticals has agreed to acquire a portfolio of generic products and other assets from Amneal Pharmaceuticals and Impax Laboratories for an undisclosed sum.
Drug Research > Drug Delivery > News
PhoreMost, NeoPhore secure Innovate UK funding for small-molecule cancer immunotherapy program
PhoreMost and NeoPhore are set to receiv £1m of funding to develop a novel small-molecule cancer immunotherapy program following award of a Biomedical Catalyst grant in a recent Innovate UK competition.
Drug Research > Drug Discovery & Development > News
AstraZeneca’s Tagrisso gets positive EU CHMP opinion for first-line treatment of EGFR-mutated NSCLC
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Tagrisso (osimertinib) to include the 1st-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
Allergan’s ubrogepant migraine drug succeeds in second phase 3 trial
By PBR Staff Writer
Allergan’s migraine drug ubrogepant has succeeded in a phase 3 trial by meeting its co-primary endpoints for a 50mg dose.
Contract Research & Services > Clinical Trials > News
Omeros’ OMS721 gets FDA breakthrough therapy designation for HSCT-TMA
By PBR Staff Writer
Omeros’ MASP-2 inhibitor OMS721 has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Regulatory Affairs > News
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