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Tempus receives FDA Breakthrough Device Designation for its companion diagnostic test

August 16, 2023
Research and Development Diagnostics, FDA, Tempus, breakthrough device designation, diagnostic

Tempus has announced that the US Food and Drug Administration (FDA) has granted it Breakthrough Device Designation for its HLA-LOH …

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FDA grants accelerated approval to Pfizer’s Elrexfio

August 15, 2023
Medical Communications Elrexfio, FDA, Oncology, Pfizer, accelerated approval

Pfizer has that the US Food and Drug Administration (FDA) has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment …

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FDA grants orphan drug designation to Genprex’s Reqorsa

August 15, 2023
Medical Communications FDA, ODD, Oncology, Reqorsa

Gene therapy company Genprex has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) …

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NICE shares draft guidance for AI’s use in radiotherapy treatment planning

August 14, 2023
Research and Development AI, Draft Guidance, NICE, Oncology, radiotherapy

The National Institute for Health and Care Excellence (NICE) has shared draft guidance surrounding nine artificial intelligence (AI) technologies which …

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FDA approved Janssen’s Akeega for prostate cancer treatment

August 14, 2023
Research and Development Akeega, FDA, J&J, Janssen, Oncology, prostate cancer

The Janssen Pharmaceutical companies of Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved …

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Zumutor’s cancer drug trial cleared by FDA

August 14, 2023
Research and Development Cancer, Oncology, clinical trial, pharmaceutical

On 11 August 2023, the biopharmaceutical company Zumutor Biologics announced that the trial of its ZM008 drug for cancer had …

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FDA approves Talvey for the treatment of heavily pretreated multiple myeloma

August 11, 2023
Medical Communications FDA, J&J, Janssen, Oncology, Talvey, multiple myeloma

The Janssen Pharmaceutical companies of Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has granted …

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Regeneron shares two-year PULSAR trial results for wAMD

August 11, 2023
Medical Communications Opthalmology, PULSAR trial, Regeneron, wAMD

Regeneron Pharmaceuticals have announced positive, two-year, topline results from its PULSAR trial assessing aflibercept 8mg for the treatment of patients …

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FDA accepts Astellas’ sNDA for Cresemba in children

August 11, 2023
Research and Development Astella, FDA, Paediatrics, cresemba

The US Food and Drug Administration (FDA) announced it has accepted Astellas Pharma’s supplemental New Drug Application (sNDA) for Cresemba …

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Sosei Heptares and Cancer Research UK announce first patient dosed in phase 1/2a trial

August 10, 2023
Research and Development Cancer Research UK, Oncology, Sosei Heptares, clinical trial, immunology

Sosei Heptares and Cancer Research UK have announced that the first patient has been dosed in their phase 1/2a clinical …

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Sunbird Bio and Glympse Bio merge for development of protein-based diagnostic technology

August 10, 2023
Business Services Glympse Bio, Oncology, Sunbird Bio, merger, oncology

Sunbird Bio has announced that it has completed a merger with Glympse Bio, intending to accelerate the development of both …

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Astellas set to open new life sciences facilities in Cambridge, Massachusetts

August 10, 2023
Business Development Astellas Pharma, Pharmacy, pharmaceutical, science facility

On 9 August 2023, Astellas Pharma announced its plans to open what it has described as a “state-of-the-art life sciences …

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EureKING planning creation of new biotech company through the acquisition of SCTbio

August 9, 2023
Business Services, Research and Development Pharmacy

On 9 August 2023, eureKING announced it is set to acquire the pharmaceutical company SCTbio which specializes in cell and …

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Novo Nordisk’s Wegovy reduces risk of cardiovascular events

August 9, 2023
Research and Development Cardiology, Novo Nordisk, Wegovy, cardiovascular, cvd, semaglutide

Novo Nordisk has shared results from the SELECT cardiovascular outcomes trial, which show that a once weekly subcutaneous dose of …

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Oculis announces positive results from phase 3 OPTIMIZE trial

August 9, 2023
Research and Development Oculis, Opthalmology, clinical trial, eyedrops, ocular surgery

Oculis has announced positive topline results from its phase 3 OPTIMIZE trial for its OCS-01 eyedrops, a once daily, high …

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FDA grants clearance to next phase of Ascentage Pharma’s clinical trial for CLL/SLL treatment

August 8, 2023
Research and Development Ascentage Pharma, CLL/SLL, FDA, Oncology, clinical trial

Ascentage Pharma has announced that the US Food and Drug Administration (FDA) has granted clearance for the phase 3 study …

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Astex expands collaboration with MSD

August 8, 2023
Business Services Astex pharmaceuticals, Merck, Oncology, collaboration, small molecules

Astex Pharmaceuticals has announced an exclusive worldwide research collaboration and license agreement with MSD (known as Merck in the US), …

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Amarin’s Vazkepa accepted by SMC for patients with cardiovascular disease

August 8, 2023
Research and Development Cardiology, Vazkepa, cardiovascular disease, pharmaceutical

On 7 August 2023, the Scottish Medicines Consortium (SMC) announced that they had accepted Amarin’s treatment for people with cardiovascular …

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First oral treatment for women with postpartum depression approved by FDA

August 7, 2023
Research and Development FDA, postpartum depression, treatment, zurzuvae

On 4 August 2023, the US Food and Drug Administration (FDA) approved the use of Zurzuvae for adults with postpartum …

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New vaccine research centre opened to prepare for future pandemics

August 7, 2023
Research and Development Immunology, UKHSA, pandemic, vaccine research centre

Ministers have opened a new vaccine research centre at the UK Health and Security Agency’s (UKHSA) Porton Down campus in …

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