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Home » Authors » Tamra Sami

Articles by Tamra Sami

IAS 2023: Will long-acting treatments be the next game changer for people living with HIV?

Aug. 8, 2023
By Tamra Sami
For people living with HIV, the single greatest achievement to date has been the emergence of antiretroviral treatments (ART) that completely block the virus, resulting in reduced mortality and morbidity and improved quality of life. But taking one pill a day for life cannot be the end of this journey, speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia.
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Doctor examining patient's hand

China’s NMPA accepts Luye’s NDA for long-acting rotigotine to treat Parkinson's disease

Aug. 8, 2023
By Tamra Sami
China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease.
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Stem cells

Mesoblast’s hopes dashed again with second FDA complete response letter for remestemcel-L

Aug. 8, 2023
By Tamra Sami
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
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Stem cells

Mesoblast’s hopes dashed again with second FDA complete response letter for remestemcel-L

Aug. 4, 2023
By Tamra Sami
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
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IAS 2023: Will long-acting treatments be the next game changer for people living with HIV?

Aug. 2, 2023
By Tamra Sami
For people living with HIV, the single greatest achievement to date has been the emergence of antiretroviral treatments (ART) that completely block the virus, resulting in reduced mortality and morbidity and improved quality of life. But taking one pill a day for life cannot be the end of this journey, speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia. Even with the success of ART, drug adherence remains a problem due to pill fatigue or depression and other mental health conditions, as well as drug-drug interactions, said Claudia Cortes, associate professor at the University of Chile in Santiago. New drugs that are longer lasting, more convenient, and affordable are desperately needed, she said.
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Doctor examining patient's hand

China’s NMPA accepts Luye’s NDA for long-acting rotigotine to treat Parkinson's disease

Aug. 2, 2023
By Tamra Sami
China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease. The microsphere formulation delivers the dopamine agonist in a weekly injection. If approved, LY-03003 would be the first long-acting extended-release microsphere formulation for the treatment of Parkinson’s disease (PD). The drug is also being developed in parallel in the U.S. and Japan.
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HIV infected cell

IAS 2023: Broadly neutralizing antibodies bring potential cure for HIV closer (part 2)

Aug. 1, 2023
By Tamra Sami
Broadly neutralizing antibodies (bNAbs) have the potential to prevent HIV, and more researchers are turning to bNAbs as an alternative to antiretroviral therapy (ART), speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia. However, for a cure, the viral reservoir that is formed in the early stages of HIV remains an obstacle, and recent studies suggest that controlling or eliminating the HIV reservoir with bNAbs might be possible.
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HIV-1 virus particle
HIV/AIDS

IAS 2023: Vaccines and broadly neutralizing antibodies bring cure for HIV one step closer

Aug. 1, 2023
By Tamra Sami
Although huge strides have been made with antiretroviral therapy (ART) and prevention since HIV was first reported 42 years ago, there is still not an effective preventive vaccine or a scalable cure for those living with HIV. But broadly neutralizing antibodies (bNAbs) look to be a further step down the pathway to a cure, speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia.
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Sumitomo/Otsuka’s ulotaront misses phase III endpoints in schizophrenia

Aug. 1, 2023
By Tamra Sami
Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia.
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Sumitomo/Otsuka’s ulotaront misses phase III endpoints in schizophrenia

July 31, 2023
By Tamra Sami
Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia.
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