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2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs #fdaapproval #MSL #FSTP #BoardcertifiedMSL #BCMSLcert “Each year, many scientists and other experts working in the biopharma industry see years of their work culminate in FDA approvals. With the COVID-19 crisis stretching into its third year, the 2021 batch of new drug approvals clearly demonstrates that the sector has learned how to operate in a pandemic. All told, the industry nabbed 55 FDA approvals in 2021. They include the controversial accelerated approval for Biogen's Alzheimer's drug Aduhelm, Pfizer's record-shattering COVID-19 vaccine, Comirnaty, and many others. Not all 2021 approvals commanded as many headlines as Aduhelm and Comirnaty. Aside from those notable companies, also represented in 2021's crop of new approvals were Amgen, Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Regeneron. And among the dozens of new drugs green-lit last year, companies such as BridgeBio, ChemoCentryx and Apellis won their first-ever FDA approvals, setting them up to make their commercial debuts. RELATED: FDA missing more approval target dates as COVID slows inspections Yet, some applications did face pandemic challenges. The FDA struggled to keep up with its inspection duties during the pandemic, leading to regulatory delays for certain drugmakers. In November, the agency reported that 55 new drug applications were facing inspection delays. Avadel Pharmaceuticals and UCB were among those to experience inspection-related delays in 2021. “ 2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs 1. #Verquvo 2. #Cabenuva 3. #Lupkynis 4. #Tepmetko 5. #Ukoniq 6. #Breyanzi 7. #Evkeeza 8. #Cosela 9. Amondys 45 10. #Pepaxto 11. #Nulibry 12. #Azstarys 13. #Fotivda 14. #Ponvory 15.#Zegalogue 16. #Abecma 17. #Qelbree 18. #Nextstellis 19. #Jemperli 20. #Zynlonta 21. #Empaveli 22. #Rybrevant 23. #Lybalvi 24. #Truseltiq 25. #Lumakras … https://lnkd.in/gwV7JXXe https://www.instagram.com/p/CYVaOqVpos3/?utm_medium=tumblr

Vertex, needing research spark, finds promising results in small study of kidney disease drug #Vertex #kidneydisease “ The biotech, which has been stung by recent clinical setbacks, plans to soon advance the medicine into late-stage testing. Vertex Pharmaceuticals will quickly advance an experimental drug for a genetic form of kidney disease into late-stage testing, after results from a small study surpassed the company's expectations. The findings are early evidence for a new way of treating the condition, called focal segmental glomerulosclerosis, by targeting gene variations first identified as significant a little more than a decade ago. They're also a much-needed win for Vertex, which, despite having successfully developed four effective drugs for cystic fibrosis, has struggled to convince investors it can repeat its success in other diseases. Focal segmental glomerulosclerosis, or FSGS, describes scarring of the kidney that impairs the organ's ability to filter blood, resulting in high levels of protein in urine. It has a range of causes, such as viral infections or drug toxicity, and is one of several ways kidney disease can develop. Patients are typically treated with blood pressure medicines and steroids, which offer limited benefit. In 2010, a group of researchers in the U.S. and Belgium discovered that two variants in a gene called APOL1 dramatically increase the risk of kidney disease, including FSGS specifically, and can lead to more aggressive progression. Though Vertex still has much to prove, two of its experimental drug programs have shown signs of promise. In October, the company reported encouraging findings from the first patient given a stem cell-based diabetes treatment. And the study results released by the company Wednesday suggest that it's on the right track with APOL1 and kidney disease as well. #MSL #FSTP #BCMSLcert #BoardCertifiedMSL #medicalscienceliaison medical science liaison #Medicalaffairs https://www.instagram.com/p/CW9HeQmhP7U/?utm_medium=tumblr

BC-MSLcert: Board-Certification for aspiring MSL The BC-MSLcert is recognized globally by recruiters and pharmaceutical companies as the aspiring MSL standard. Start your MSL career today, become Board-certified MSL. Read how the BC-MSLcert helped hundreds of professionals transition as an MSL. https://lnkd.in/erFr9PT Or if you’d like to know more about the MSL role, join our free MSL webinar on “How to become an MSL without industry experience”: https://lnkd.in/etJsiyw #MSL #BCMSLcert #MSLexcellence #MSLTraining #OnlineMSLTraining #AspiringMSL #MedicalAffairs #pharma #MD #PharmD #MSc #Pharmacist #Pharmacists #Postdoc #postdocs #PhD #Medicalscienceliaison #MSLS #MSLsociety #health #PhDs #PhDChat #phDforum #PhDcareer #PhDstudent #PhDLife #careerdevelopment #FSTP https://www.instagram.com/p/CVgjtBHBtW3/?utm_medium=tumblr

EC nod for Astellas, FibroGen’s roxadustat for chronic kidney disease #Astellas #kidneydisease Interested to work in the field of kidney disease as an MSL? Several MSL roles are soon to be advertised on this therapeutic area. Time to reach out to the HR team or the company hiring manager and upskill on your disease knowledge. https://lnkd.in/e6dtadE “The European Commission (EC) has approved Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD). The first orally-administered HIF-PH inhibitor available in the European Union, roxadustat increases haemoglobin (Hb) levels through a different mechanism of action compared to injectable erythropoiesis-stimulating agents (ESAs), which are typically co-administered with intravenous iron.” #MSL #FSTP #BCMSLcert #BoardCertifiedMSL #medicalscienceliaison medical science liaison #Medicalaffairs medical affairs #Pharmacist #PHD https://lnkd.in/eeZPFu3v https://www.instagram.com/p/CS5NTsgB-X0/?utm_medium=tumblr