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Контент предоставлен Emma Nichols, PhD and Emma Hitt Nichols. Весь контент подкастов, включая эпизоды, графику и описания подкастов, загружается и предоставляется непосредственно компанией Emma Nichols, PhD and Emma Hitt Nichols или ее партнером по платформе подкастов. Если вы считаете, что кто-то использует вашу работу, защищенную авторским правом, без вашего разрешения, вы можете выполнить процедуру, описанную здесь https://ru.player.fm/legal.
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Tirzepatide for Obesity, Ixchiq Chikungunya Vaccine, fruquintinib for mCRC, Adzynma (ADAMTS13, recombinant-krhn) for cTTP
MP4•Главная эпизода
Manage episode 407556899 series 3561458
Контент предоставлен Emma Nichols, PhD and Emma Hitt Nichols. Весь контент подкастов, включая эпизоды, графику и описания подкастов, загружается и предоставляется непосредственно компанией Emma Nichols, PhD and Emma Hitt Nichols или ее партнером по платформе подкастов. Если вы считаете, что кто-то использует вашу работу, защищенную авторским правом, без вашего разрешения, вы можете выполнить процедуру, описанную здесь https://ru.player.fm/legal.
Check out our free downloads at nascentmc.com:
- Implementing AMA Style – 8 Things to Get Right in Your Next Project
- Needs Assessments – 7 Essentials for Getting Funded
- Working With Your Medical Writer – 8 Ways to Get the Most out of Them
See the full write ups for today's episode at nascentmc.com/podcast
Here are the highlights:
- The FDA has approved Zepbound (tirzepatide) for adults with obesity, allowing its use in individuals with a body mass index (BMI) of 30 or more, as well as overweight individuals (BMI of 27 or greater) with at least one weight-related condition. Tirzepatide, an agonist of GLP-1 and GIP, was shown to significantly reduce body weight when used in combination with a reduced-calorie diet and increased physical activity in clinical trials, but it may have adverse effects, including gastrointestinal issues and a potential link to medullary thyroid cancer.
- Ixchiq has become the first FDA-approved chikungunya vaccine for individuals aged 18 and older at increased risk of exposure to the chikungunya virus, which is primarily transmitted by mosquitoes. Chikungunya is a global health threat with symptoms including fever, joint pain, and rash, and severe joint pain that can last for months. The vaccine, while effective, may cause severe or prolonged chikungunya-like adverse reactions, and the manufacturer, Valneva, is required to conduct a postmarketing study to assess these risks.
- Fruzaqla (fruquintinib) has received FDA approval for patients with metastatic colorectal cancer (mCRC) who have undergone previous treatments, including various chemotherapy and targeted therapies. Fruquintinib, a kinase inhibitor of VEGFRs, demonstrated improvements in overall survival and progression-free survival in clinical trials, with consistent safety profiles. The approval was granted to Takeda, and the drug is also under review for marketing authorization in Europe.
- Adzynma (ADAMTS13, recombinant-krhn) has been approved by the FDA for congenital thrombotic thrombocytopenic purpura (cTTP), making it the first FDA-approved recombinant ADAMTS13 protein for this rare condition. cTTP results from a deficiency in ADAMTS13, leading to blood clot formation and severe bleeding episodes. Adzynma serves as prophylactic and on-demand treatment, with promising results in a phase 3 study, and its approval was granted to Takeda.
Intro and outro music
60 эпизодов
MP4•Главная эпизода
Manage episode 407556899 series 3561458
Контент предоставлен Emma Nichols, PhD and Emma Hitt Nichols. Весь контент подкастов, включая эпизоды, графику и описания подкастов, загружается и предоставляется непосредственно компанией Emma Nichols, PhD and Emma Hitt Nichols или ее партнером по платформе подкастов. Если вы считаете, что кто-то использует вашу работу, защищенную авторским правом, без вашего разрешения, вы можете выполнить процедуру, описанную здесь https://ru.player.fm/legal.
Check out our free downloads at nascentmc.com:
- Implementing AMA Style – 8 Things to Get Right in Your Next Project
- Needs Assessments – 7 Essentials for Getting Funded
- Working With Your Medical Writer – 8 Ways to Get the Most out of Them
See the full write ups for today's episode at nascentmc.com/podcast
Here are the highlights:
- The FDA has approved Zepbound (tirzepatide) for adults with obesity, allowing its use in individuals with a body mass index (BMI) of 30 or more, as well as overweight individuals (BMI of 27 or greater) with at least one weight-related condition. Tirzepatide, an agonist of GLP-1 and GIP, was shown to significantly reduce body weight when used in combination with a reduced-calorie diet and increased physical activity in clinical trials, but it may have adverse effects, including gastrointestinal issues and a potential link to medullary thyroid cancer.
- Ixchiq has become the first FDA-approved chikungunya vaccine for individuals aged 18 and older at increased risk of exposure to the chikungunya virus, which is primarily transmitted by mosquitoes. Chikungunya is a global health threat with symptoms including fever, joint pain, and rash, and severe joint pain that can last for months. The vaccine, while effective, may cause severe or prolonged chikungunya-like adverse reactions, and the manufacturer, Valneva, is required to conduct a postmarketing study to assess these risks.
- Fruzaqla (fruquintinib) has received FDA approval for patients with metastatic colorectal cancer (mCRC) who have undergone previous treatments, including various chemotherapy and targeted therapies. Fruquintinib, a kinase inhibitor of VEGFRs, demonstrated improvements in overall survival and progression-free survival in clinical trials, with consistent safety profiles. The approval was granted to Takeda, and the drug is also under review for marketing authorization in Europe.
- Adzynma (ADAMTS13, recombinant-krhn) has been approved by the FDA for congenital thrombotic thrombocytopenic purpura (cTTP), making it the first FDA-approved recombinant ADAMTS13 protein for this rare condition. cTTP results from a deficiency in ADAMTS13, leading to blood clot formation and severe bleeding episodes. Adzynma serves as prophylactic and on-demand treatment, with promising results in a phase 3 study, and its approval was granted to Takeda.
Intro and outro music
60 эпизодов
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