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Immunotherapy treatment enhances lymphoma survival, landmark study shows
The Phase III findings give evidence for the immunotherapy treatment regimen to become standard of care for advanced Hodgkin lymphoma.
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Bristol-Myers Squibb (BMS)
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First-in-class anaemia therapy granted expanded approval
The expanded authorisation of Reblozyl is based on a Phase III trial which showed that the treatment nearly doubled the percentage of certain transfusion-dependent anaemia patients achieving haemoglobin increase, compared to epoetin alfa.
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First-in-class biologic approved for rare lung disease
The biologic therapy offers a novel therapeutic option that targets a new treatment pathway in pulmonary arterial hypertension (PAH).
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Formulation In-Depth Focus 2023
This in-depth focus features articles on trends in capsule formulation and the evolving role of titanium dioxide in formulation.
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European Commission approves CAR T therapy for lymphoma
CD19-directed CAR T-cell therapy Breyanzi has been approved by the European Commission (EC) based on significant results from a lymphoma Phase III trial.
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Bristol Myers Squibb boosts CAR T therapy manufacturing capabilities
Securing in-house viral vector production capabilities in the US is set to help Bristol Myers Squibb manufacture its two CAR T-cell therapies.
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Bristol Myers Squibb appoints new CEO
Bristol Myers Squibb’s leadership team is set to reshuffle, with Christopher Boerner becoming it’s new CEO in late 2023.
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First-in-class plaque psoriasis oral therapy approved in EU
Bristol Myers Squibb’s Sotyktu is the only TYK2 inhibitor approved for the treatment of any disease in the European Union.
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CD19 CAR-T agents to boost blood cancer market
GlobalData says CD19 CAR-T agents are expected to treat over 13,000 blood cancer patients annually by 2031, driving sales of Breyanzi and Yescarta.
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BMS in-licensed PKC theta inhibitor enters clinical trials
A potentially first-in-class PKC theta inhibitor, in development for immunology and inflammation indications, has entered first-in-human trials in the US.
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France’s ATU reform: early access remains possible, but not all diseases are equal
When France's ATU reform was implemented, some viewed it as restrictive. Here, Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
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New initiative will calculate carbon footprint of clinical trials
The new methodology will assess the carbon impact of clinical trials and recommend ways to reduce it.
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NICE recommends first oral S1P receptor modulator for ulcerative colitis
NICE has recommended the drug Zeposia® (ozanimod) for moderate to severe cases of ulcerative colitis.
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Big Pharma deal-making primed for acceleration
Subin Baral, Global Deals Leader, Life Sciences, Ernst & Young LLP, offers his predictions for M&A activity within industry as we head into the later stages of 2022.
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Lilly to pay more than $180mn for defrauding US Medicaid Program
For allegedly underpaying rebates, Eli Lilly has been ordered to pay more than $61 million in damages, an amount that lawyers say will be trebled for the final judgement.
