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FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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Pistoia Alliance launches Women in STEM leadership pilot
A new collaborative initiative involving 15 large pharma companies will support diversity in executive roles and cross-company leadership skills development.
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Cilta-cel achieves progression-free survival in multiple myeloma patients
In the Phase Ib/II trial, cilta-cel achieved minimal residual disease negativity in 92 percent of patients and improved survival.
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Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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Oral milvexian reduces risk of postoperative venous thromboembolism
Milvexian showed a 12 percent rate of postoperative venous thromboembolism compared to the benchmark rate of 30 percent in a Phase II study.
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NICE approves first long-acting injectable HIV-1 treatment
NICE has published draft guidance recommending cabotegravir, the first long-acting injectable treatment for HIV-1 infection in adults.
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Crohn’s patients achieve 65 percent clinical remission with Tremfya®
At week 48 of the Phase II trial, 65 percent of patients with Crohn's disease receiving Tremfya® achieved clinical remission.
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Developing drug pipelines
Kris Sterkens, Company Group Chairman of Janssen EMEA and Managing Director of Janssen Pharmaceutica considers how alterations made to COVID-19 vaccine development procedures could benefit future drug development pipelines.
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FDA joins Bespoke Gene Therapy Consortium (BGTC) for rare diseases
The consortium also consists of 10 pharmaceutical companies and five organisations to accelerate gene therapies to treat rare diseases.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, August 2021
The EMA's drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
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Europe approves Ponvory (ponesimod) for multiple sclerosis
The European Commission has approved once daily oral Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis in adult patients.
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Vaccine-induced prothrombotic immune thrombocytopenia: pathogenetic and epidemiological issues of concern
Giovanni Di Guardo, DVM, Dipl. ECVP, retired Veterinary Pathologist, discusses the association between adenoviral vector COVID-19 vaccines and rare blood clots, outlining four areas warranting further research.
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ISPE announces its manufacturing Facility of the Year Awards winners
The awardees, including Takeda, Janssen and Gilead, are recognised for their state-of-the-art facility design, construction and operation projects.
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Further woes for Emergent’s Bayview vaccine production facility
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.