Home / Business News (page 105)

Business News

FDA Grants Orphan Drug Designation to Selten Pharma’s Pulmonary Arterial Hypertension Candidate

Today, privately-held, rare disease focused Selten Pharma, Inc. announced that US health regulators granted its investigational pulmonary arterial hypertension (PAH) drug orphan drug designation. The company said that its lead compound tacrolimus (SPI-026) has been granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the …

Read More »

Galapagos and Janssen End Inflammation Alliance

Galapagos NV and Janssen Pharmaceutica NV of Johnson & Johnson have ended their eight-year alliance to develop anti-inflammatory drugs. The companies originally entered into a worldwide multi-target alliance in October 2007, to discover and develop novel small-molecule therapeutics for the treatment of rheumatoid arthritis (RA), a deal which provided Galapagos …

Read More »

CSL Behring’s Kcentra Shows Superiority to Plasma in Late-Stage Study

Results from CSL Behring’s late-stage study showing Kcentra’s superiority to plasma for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, warfarin) therapy in adult patients needing an urgent surgery or invasive procedure were published in The Lancet. CSL’s Kcentra is the first and …

Read More »

Respiratory Biotech Pulmatrix to Merge with Ruthigen

Respiratory biotech Pulmatrix announced an agreement to merge with publicly traded, biopharmaceutical company Ruthigen. The companies have entered into a definitive merger agreement, under which Pulmatrix will become a wholly-owned subsidiary of Ruthigen – which would take the Pulmatrix name and continue Pulmatrix’s work of advancing a new generation of …

Read More »

European Commission Approves Novartis’ Jakavi for Treatment of Patients with a Rare Blood Cancer

Today, Novartis announced that the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients with a rare blood cancer. The company said that the drug is now approved in Europe for the treatment of adults with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. …

Read More »

Biosimilars 20/20: A Market Analysis of the Growth and Implications of Biosimilars Over the Next Five Years

TAMPA, FL, March 16, 2015 — The biosimilars event of the year – Biosimilars 20/20 – is scheduled for June 3-4, 2015 at The Hub in Philadelphia, PA. The event promises to provide an in-depth look into the future of the biosimilars market and address challenges of implementation. Biosimilars 20/20 …

Read More »

Samsung Submits Application to the EMA for its Remicade Biosimilar Candidate, SB2

South Korea’s Samsung Bioepis Co., Ltd. recently announced that it has submitted a marketing authorization application (MAA) for SB2, its Remicade (infliximab) biosimilar candidate to European health regulators. The company said that it has submitted the MAA to the European Medicines Agency (EMA). The MAA for SB2 is the second …

Read More »

Valeant Raises its Offer to Acquire Salix

After Endo International offered a rival bid, Valeant Pharmaceuticals International announced that it has raised its offer for gastrointestinal drugmaker Salix Pharmaceuticals. The companies announced that they have entered into an amendment to their agreement and plan merger. Valeant has increased its offer price to acquire all the outstanding common …

Read More »