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Celgene

Celgene and Acceleron's Reblozyl secures FDA approval for anaemia in beta thalassaemia

The FDA has moved to authorise Celgene and Acceleron Pharma’s Reblozyl (luspatercept-aamt) in the treatment of anaemia associated with the rare hereditary blood disorder beta thalassaemia, it has emerged.

The decision relates specifically to adult patients who require regular red blood cell (RBC) transfusions and makes Reblozyl the first and only erythroid maturation agent approved by the US regulator to treat the condition. However, the authorisation does not cover the therapy’s use as a substitute for RBC transfusions in patients who require immediate correction of anaemia.

Celgene signs $1.5bn partnership with Immatics to fight cancer with engineered T-cell therapies

Celgene and biopharma firm Immatics Biotechnologies have announced that they have entered a partnership valued at a potential $1.5 billion to pursue the development of T-cell receptor-engineered T-cell therapies (TCR-T) for a range of cancer types.

The pair will leverage Immatics’ XPRESIDENT technology and XCEPTOR TCR discovery and engineering platform to develop immunotherapies based on the method of engineering T-cells of patients to express a specific receptor.

Celgene's Otezla becomes first and only FDA-approved therapy for oral ulcers in Behçet’s Disease

Celgene has revealed the US approval of Otezla (apremilast), confirming that the FDA awarded marketing authorisation for the treatment of with oral ulcers in adult patients with the rare and chronic inflammatory condition Behçet’s Disease, making it the first and only therapy approved in this indication by the US regulator.

Just around five in 100,000 people are affected by the condition, with painful oral ulcers occurring in 98% of these cases.

Bristol-Myers Squibb to sell off Celgene's Otezla ahead of $74 billion merger

Bristol-Myers Squibb has agreed to sell off Celgene’s psoriasis treatment Otezla, to appease antitrust regulators.

BMS will divest one of Celgene’s most lucrative drugs as the two companies prepare for their $74 billion merger. Otezla generated $1.86 billion in sales last year and was previously seen as an important driver of future growth.

However, in light of discussions with the US Federal Trade Commission (FTC), BMS will sell off the psoriasis drug as quickly as possible. BMS expects this date to be in late 2019 or early 2020.

FDA first as agency expands label on Celgene's Revlimid in previously treated follicular or marginal zone lymphoma

Celgene has revealed that the FDA has expanded its authorised indications of Revlimid (lenalidomide) to include combination with a rituximab product (R²) as a therapy for previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL), marking the first approval for the US regulator in these indolent forms of non-Hodgkin’s lymphoma (NHL) that does not include chemotherapy.

Phase 3 data submitted in support of the application showed that the combo therapy demonstrated a “statistically significant” improvement in median progression-free survival (PFS) compared to rituxima

NICE recommends Celgene's Revlimid in treatment-naive multiple myeloma

Celgene’s Revlimid (lenalidomide) has been recommended by NICE for use on the NHS in England and Wales in combination with dexamethasone in the treatment of previously untreated multiple myeloma, the company has announced. The expanded indication relates specifically to adult patients who are not eligible for stem cell transplant and only where thalidomide cannot be tolerated or is contraindicted.

Sorrento Therapeutics seek $1 billion from billionaire biotech investor Patrick Soon-Shiong

Image Credit: NHS Confederation

Sorrento Therapeutics is seeking $1 billion in damages from billionaire biotech investor Patrick Soon-Shiong, owner of US newspaper the LA Times.  

The legal action comes after Sorrento accused Soon-Shiong of “catching and killing” a generic version of a cancer drug, which would have acted as competition to one owned by Celgene, a company in which he was the largest shareholder.

Sorrento claim Soon-Shiong acquired Cynviloq, a generic version of Celgene’s Abraxane, with the intention of stopping its progression to market.

Celgene inks drug discovery deal worth at least £25m with AI firm Exscientia

Celgene has entered into a new three-year partnership with British artificial intelligence and drug discovery firm Exscientia to the value of at least $25 million, it has emerged, in a bid to galvanise small molecule drug discovery in oncology and autoimmunity.

Transactions stemming from the deal include this initial upfront payment in addition to “substantial” milestone payments subject to future regulatory and commercial successes.

Celgene's Abraxane combo flops in phase 3 cancer trials

Celgene’s Abraxane, in combination gemcitabine, has failed to meet its primary endpoint in a pivotal Phase 3 trial of patients with pancreatic cancer.

Celgene’s drug failed to achieve its primary endpoint of improvement in disease-free survival in patients with surgically resected pancreatic adenocarcinoma, as confirmed by independent radiological review, compared to gemcitabine alone.

Disapproval from top shareholder throws $74bn BMS/Celgene merger into doubt

The news kicked off 2009 with a bang when Bristol-Myers Squibb announced it intended to acquire Celgene for $74 billion, but what could potentially be the biggest pharmaceutical industry merger of all time has been thrown into doubt thanks to a key BMS shareholder.

Top shareholder Wellington Management, which owns around 8% of BMS shares, has announced, in a rare move, that it does not support the prospective deal on the basis that it is a risky and expensive move.

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