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Draft regulatory guidance on personalised cancer therapies published
The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
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Anti-Cancer Therapeutics
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MHRA approves SARCLISA for newly diagnosed multiple myeloma
SARCLISA (isaxtuximab) provides a new first-line treatment option for patients with multiple myeloma, offering significant improvements in progression-free survival.
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CHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
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New analysis asserts survival benefit for Roche breast cancer therapy
The new data highlights the potential of the ItovebiTM (inavolisib)-based regimen as a new standard of care in advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer.
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GSK acquisition to advance potential best-in-class GI tumour treatment
The new acquisition by GSK could enable major advancement in the standard of care for gastrointestinal stromal tumours (GIST) after nearly two decades.
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Potential blockbuster drugs to watch in 2025
Eleven drugs are poised to make waves in the pharmaceutical industry in 2025, according to the annual report.
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AstraZeneca’s PARP inhibitor newly recommended by NICE
The regulatory recommendation provides a targeted therapy option for eligible patients with the most common cancer in the UK.
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Could novel gel therapeutic set new standard of care in oncology?
Findings from the interim clinical study showed that the gel formulation enhanced quality of life in over half of cancer patients.
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Roche to advance potentially best-in-class antibody drug conjugate
As part of the collaboration and license agreement, Innovent Biologics, Inc. could receive up to $1 billion, subject to developmental success of the biologic candidate.
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Targeting ovarian cancer with a novel antibody therapeutic
Christina Pelizon, International Medical Affairs Head for Oncology at AbbVie discusses the significance and impact of the European Commission’s approval last month of Elahere® (mirvetuximab soravtansine) to treat ovarian cancer.
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ASH 2024: CAR T-cell therapy demonstrates durable benefit in lymphoma
The cell therapy could increase survival in certain lymphomas without requiring patients to undertake subsequent therapy, the new analysis suggests.
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Early promise for novel breast cancer immunotherapy
With potential “groundbreaking” results, the immunotherapy could alter the need for breast cancer patients to undertake chemotherapy, trial investigators suggest.
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Novartis and Ratio to progress next-gen radiotherapeutic
The collaboration between Novartis Pharma AG and Ratio Therapeutics aims to advance a potential best-in-class therapeutic candidate as a treatment for a difficult-to-treat cancer.
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BeiGene proposes new name, reaffirming oncology mission
The new name and logo represent BeiGene’s vision to eliminate cancer through global collaborations to widen its reach for patients.
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Major immunotherapy trial sees survival benefit in solid tumours
A key barrier in delivering this type of therapy to patients was overcome in the first-of-a-kind T cell therapy trial, data shows.
