The Pharma Data

JANUARY 21, 2021

Among his earlier leadership roles in the biotech, pharmaceutical and medical device industries, Caggiano directed the divestiture of Allergan’s LAP-BAND to Apollo Endosurgery in 2013. Before Acceleron, Attie held clinical development and medical affairs leadership roles of increasing responsibility at Altus Pharmaceuticals, Insmed, Inc.

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The Pharma Data

MARCH 28, 2022

Based on these results, the BIIB078 clinical development program will be discontinued, including its ongoing open-label extension study. “We Vice President and Head of the Neuromuscular Development Unit at Biogen.

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The Pharma Data

FEBRUARY 25, 2021

Prevention of tick-borne encephalitis by FSME-IMMUN vaccines: review of a clinical development programme. Elsevier Saunders; 2013, Philadelphia, PA. 2013:442-457. Key messages about tick-borne encephalitis and tick-borne diseases. Available from: [link]. Accessed: February 2021. Loew-Baselli A, et al. Ehrlich HJ, et al.

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Metabolite Tales Blog

JULY 5, 2023

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. It’s metabolised to 3 main metabolites by CYP3A with potential additional involvement of CYP2C8 and CYP2C19.

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Metabolite Tales Blog

JULY 5, 2023

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. It’s metabolised to 3 main metabolites by CYP3A with potential additional involvement of CYP2C8 and CYP2C19.

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Metabolic Stability Drugs FDA Approval Treatment 52

LifeSciVC

APRIL 27, 2023

By the time Chapter 1 was nearing its end, Project Troubled Water, then Nimbus Discovery, became Nimbus Therapeutics as we took a further step to forward integrate into clinical development. Our long-time clinical development lead, Bhaskar Srivastava, an M.D. dermatologist, could not contain his excitement.

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The Pharma Data

DECEMBER 15, 2020

Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane ® ) in combination with gemcitabine for first-line treatment in 2013 and Onivyde ® in combination with fluorouracil and leucovorin for second-line treatment in 2015.

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The Pharma Data

NOVEMBER 29, 2020

Available at: [link] 2 Nephrol Dial Transplant (2013) 28: 2908–2918 3 Centers for Disease Control and Prevention. Gilbert C and Boivin G. Human Cytomegalovirus Resistance to Antiviral Drugs. Antimicrobial Agents and Chemotherapy. 2005; 49(3):873-883. About Cytomegalovirus (CMV). Kidney transplant waiting list.

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The Pharma Data

DECEMBER 27, 2020

2013 Feb 7;121(6):893. QARZIBA ® is a registered trademark of EUSA Pharma. i Moreau P, Richardson PG, Cavo M, et al. Proteasome inhibitors in multiple myeloma: 10 years later. 2012 Aug 2;120(5):947-59. ii Kortuem KM and Stewart AK. Carfilzomib. iii Amgen Data on File. View source version on businesswire.com: [link]. Source link.

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Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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