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Showing posts with the label USFDA

Pickings by Pharma Veterans Newsletter #29 – August 17, 2025

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Pickings by Pharma Veterans Newsletter #29 – August 17, 2025 This newsletter is the offering from Asrar Qureshi, Founder of Pharma Veterans. It will bring to you a selection of Pharma Industry news and developments from Pakistan, region, and the world. It will be published fortnightly on alternate Sundays. For queries and sending information, please send email to pharmaveterans2017@gmail.com. SPECIAL NOTE The objective of this newsletter is to share important news from the US and Europe, where exciting new research and development in drugs is going on. News from India, Bangladesh, and Pakistan are included to show where Pakistan stands vis-à-vis the region. This is done in order that Pharma Industry in Pakistan may take necessary actions for course setting and long-term strategy making. PAKISTAN • Highnoon Laboratories Limited has entered into a strategic partnership with Beximco Pharmaceuticals Limited, a leading pharmaceutical manufacturer based in Bangladesh. This alliance marks a...

New Drugs Approvals – Asrar Qureshi’s Blog Post #929

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New Drugs Approvals – Asrar Qureshi’s Blog Post #929 Dear Colleagues! This is Asrar Qureshi’s Blog Post #929 for Pharma Veterans. Pharma Veterans Blogs are published by Asrar Qureshi on its dedicated site https://pharmaveterans.com. Please email to aq.pharmaveterans@gmail.com for publishing your contributions here. Credit: Mikhail Nilov Credit: Pavel Danilyuk Credit: Polina Tankilevitch Periodically, I gather information and write a blog post about approval of new drugs in the USA, because it leads in the research, discovery, and commercialization of new, research products. Even if a pharmaceutical product is first registered in Europe, it is inevitably applied to USFDA for approval. USA also leads because it is the single largest market in the global pharma market. US accounts for about 47% of the world pharmaceutical market which is currently estimated to be about US$ 1.2 trillion. You can have an idea of the size.  The list of new drugs/ newer uses of existing drugs is given bel...

Two Landmark New Drug Approvals – Asrar Qureshi’s Blog Post #897

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Two Landmark New Drug Approvals – Asrar Qureshi’s Blog Post #897 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #897 for Pharma Veterans. Pharma Veterans  aims to share knowledge and wisdom from Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Credit: Google Images Credit: Google Images Credit: Google Images In December 2023, US Food and Drug Administration approved two gene therapy-based drugs for sickle cell disease treatment.  CASGEVY (exagamglogene autotemcel) is the first approved CRISPR/Cas9 genome-edited cell therapy for the treatment of Sickle Cell Disease – SCD, in patients 12 years or older with frequent vaso-occlusive crises (VOCs). CASGEVY has been developed by Vertex Pharmaceuticals and CRISPR Therapeutics and has been shown to reduce or eliminate vaso-occlusive crises for SCD patients....

Drug Development Update – Asrar Qureshi’s Blog Post #837

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 Drug Development Update – Asrar Qureshi’s Blog Post #837 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #837 for Pharma Veterans. Pharma Veterans aims to share knowledge and wisdom from Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Photo Credit: Pavel Danilyuk Photo Credit: Pixabay Photo Credit: RF._. studio Periodically, I bring to you the update on new registrations by the USFDA. USFDA approval is most relevant because most research is happening in the US, and USFDA is mostly the first regulatory authority to approve new drugs, line extensions, new combinations, and expansion of indications. Some drugs are first applied to EMA – European Medicines Agency, but these are relatively few.  A look at new approvals is not just academic; it shows where the research is going, and where most investment is...

New Pill Promises Relief From Constipation Without Drug – Asrar Qureshi’s Blog Post #756

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New Pill Promises Relief From Constipation Without Drug – Asrar Qureshi’s Blog Post #756 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #756 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Photo Credit: Bess Hamiti Photo Credit: cottonbro studio Photo Credit: Pixabay US Food & Drug Administration has approved a new pill for relief from chronic constipation. The pill is called VIBRANT, and has been developed by the company Vibrant Gastro Inc. The pill was approved by USFDA in August last year but has become available to patients now. The patients will take the pill at bedtime daily. The pill should pass through stomach and small intestine and finally reach large intestine in about 14 hours. It will stimulate the nerve cells in th...

More Facts About Pfizer-BioNTech Covid Vaccine – Last Part – Asrar Qureshi’s Blog Post #755

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More Facts About Pfizer-BioNTech Covid Vaccine – Last Part – Asrar Qureshi’s Blog Post #755 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #755 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Photo Credit: EVG Kowalievska Photo Credit: Ketut Subiyanto Photo Credit: Max Fischer An excerpt from a study published on 5th January 2023 in BMC Infectious Diseases Journal. The study was conducted in the Palestinian territory.  [Quote] Approximately one-third of participants reported no adverse effects after receiving the first, second, or third dose of the Pfizer vaccine, with 34%, 33.6%, and 32.5%, respectively. Participants who received more than one dose experienced more side effects. The most commonly reported adverse effects were ...

More Facts About Pfizer-BioNTech Covid Vaccine – Part 4 – Asrar Qureshi’s Blog Post #754

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More Facts About Pfizer-BioNTech Covid Vaccine – Part 3 – Asrar Qureshi’s Blog Post #754 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #754 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Photo Credit: Anna Shvets Photo Credit: August de Richelieu Photo Credit: Nataliya Vaitkevich NINE PAGES REFERENCE There is much talk about 9 pages of side effects. This comes from Pfizer/FDA document titled ‘BNT 162b2 – 5.3.6 – Cumulative Analysis of Adverse Events Reports. The 9-pages are Appendi1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST. It is a lot of medical terminology which is not relevant for non-medical people. You may follow the link to see these adverse events. In all, it is a 38-page document (including 9 pages). I shall give some o...

More Facts About Pfizer BioNTech Covid Vaccine – Part 3 – Asrar Qureshi’s Blog Post #754

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More Facts About Pfizer BioNTech Covid Vaccine – Part 3 – Asrar Qureshi’s Blog Post #754 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #754 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Photo Credit: Artem Podrez Photo Credit: Nandhu Kumar USFDA maintains that currently available data for Pfizer-BioNTech and Moderna vaccines shows that the vaccines are safe by and large. A CDC study published in Lancet Infectious Diseases says that self-reported data was reviewed by the researchers. Patients were advised to report adverse events on two systems: VAERS – Vaccine Adverse Event Reporting System, and v-safe tracker. Of the 340,522 reports made to VAERS, 92% were non-serious, 6.6% were serious, and 1.3% were deaths. The most common adv...

More Facts About Pfizer BioNTech Covid Vaccine – Pat 1 – Asrar Qureshi’s Blog Post #752

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More Facts About Pfizer BioNTech Covid Vaccine – Pat 1 – Asrar Qureshi’s Blog Post #752 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #752 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Photo Credit: Anna Shvets Photo Credit: Google Images When COVID19 started from Wuhan, China and rapidly gripped the world, the talk of vaccine started immediately. Pfizer-BioNTech vaccine took the lead in introducing its mRNA-based vaccine. It was closely followed by Moderna, and Johnson & Johnson. China and Russia also delivered their conventional vaccines. The vaccines were administered worldwide, despite the initial inequality when the developed nations kept most of the stock for their own population. Some statistics are staggering. • 13....