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FDA approves ViiV Healthcare’s two-drug regimen to treat HIV-1 infection
By PBR Staff Writer
Specialist HIV firm ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its two-drug regimen (2DR) Juluca to treat certain adults with human immunodeficiency virus type 1 (HIV-1).
News
Fresenius Kabi to extend pharmaceutical manufacturing in North Carolina
The State of North Carolina and Fresenius Kabi have announced plans to expand the company's presence in Wilson, North Carolina.
Production & Manufacturing > Manufacturing > News
Janssen seeks EMA approval for Darzalex for newly diagnosed multiple myeloma
Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency (EMA), for its immunotherapy Darzalex (daratumumab).
Production & Manufacturing > Process & Production > News
UK regulator accuses Concordia of overcharging NHS for thyroid drug
By PBR Staff Writer
The UK Competition and Markets Authority (CMA) has accused Canadian pharma company Concordia International of abusing its dominant position by increasing the price of a thyroid drug by about 6,000%.
Regulatory Affairs > News
Novartis gets EC approval for Tasigna to treat Ph+ CML-CP in children
By PBR Staff Writer
Novartis has secured approval from the European Commission (EC) for its Tasigna (nilotinib) to treat pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Regulatory Affairs > News
Hemogenyx, University of Oxford partner to transform blood cancers treatment
Hemogenyx Pharmaceuticals has partnered the University of Oxford to test new means of accelerating and improving the process by which transplanted blood stem cells grow and make healthy blood cells.
Drug Research > Drug Discovery & Development > News
Oxford Pharmascience receives MPA advice on OXPzero Ibuprofen OTC opportunity
Oxford Pharmascience has received scientific advice from the MPA (Swedish regulatory authority) with respect to the development program requirements likely to be required to support a future marketing authorisation application (MAA) in Sweden for an OTC product containing OXPzero Ibuprofen.
News
Summit completes initial dosing trials on Duchenne muscular dystrophy drug
By PBR Staff Writer
Summit Therapeutics has completed the half-way stage of dosing of its Duchenne Muscular Dystrophy (DMD) candidate ezutromid in a 48-week phase 2 trial, dubbed PhaseOut DMD.
Contract Research & Services > Clinical Trials > News
Canadian researchers discover medication to treat amyotrophic lateral sclerosis
By PBR Staff Writer
Canadian researchers have discovered an effective medication for the treatment of individuals with amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease.
Drug Research > Drug Discovery & Development > News
Can-Fite’s former subsidiary OphthaliX merges with Wize Pharma
Can-Fite BioPharma says that its previously majority owned subsidiary OphthaliX has completed a merger with Wize Pharma.
Drug Research > Drug Discovery & Development > News
Cerecor to acquire TRx Pharmaceuticals
Cerecor has entered into an agreement to TRx Pharmaceuticals and its subsidiary Zylera Pharmaceuticals.
Production & Manufacturing > Manufacturing > News
Samsung Bioepis’ trastuzumab biosimilar gets EC approval for breast cancer
By PBR Staff Writer
The European Commission (EC) has approved Samsung Bioepis' Ontruzant, a biosimilar version of Genentech’s Herceptin (trastuzumab), for the treatment of breast cancer in early and metastatic stages and also for metastatic gastric cancer.
Regulatory Affairs > News
Cue Biopharma forms research collaboration and signs license deal with Merck
Immunotherapy company Cue Biopharma has entered into a strategic research collaboration and license agreement with Merck.
Contract Research & Services > Contract Research > News
Ionis licenses antisense drug to Janssen
Ionis Pharmaceuticals has earned $5m license fee from Janssen Biotech for a second orally delivered Generation 2.5 antisense drug.
News
Roche’s Hemlibra secures FDA approval for hemophilia A with inhibitors
By PBR Staff Writer
Roche’s Hemlibra (emicizumab-kxwh) has been approved by the US Food and Drug Administration (FDA) for routine prophylaxis to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have factor VIII inhibitors.
Regulatory Affairs > News
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