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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Additionally, the immunogenicity of biosimilars, which is the ability of the drug to trigger an immune response, can be highly variable and impact the safety and efficacy of the drug. 2016, November 11). Overcoming Regulatory Hurdles in the Development of Biosimilars. link] KBDNA. 2024, May 17). link] Lawless, L. link] Kurki, P.,

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The Febrile Infant: Incorporating the 2021 American Academy of Pediatrics guidelines

ALiEM - Pharm Pearls

2016 Aug; 138(2):e20154381. 2016 Jun 1;170(6):624]. JAMA Pediatr. 2019;173(4):342-351. PMID: 30776077 Gomez B, Mintegi S, Bressan S, et al. Validation of the “Step-by-Step” approach in the management of young febrile infants. The Journal of Pediatrics. PMID: 27382134 Nguyen THP, Young BR, Poggel LE, et al. Hosp Pediatr. JAMA Pediatr.

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German biotech CatalYm raises €50 million for GDF-15 inhibitor immunotherapy

pharmaphorum

Founded in 2016 as a spin-out from Wuerzburg University, CatalYm’s lead molecule CTL-002 is designed to neutralise the tumour-produced protein GDF-15. High concentrations of the GDF-15 in serum and tumour-micro-environment help cancers to evade the immune system and are associated with resistance to current therapies.

Immunity 105
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Indian Immunologicals gets regulatory approval for measles-rubella (MR) vaccine

Express Pharma

This Live Attenuated MR vaccine adds to the list of several other vaccines that IIL supplies to Universal Immunization Programme (UIP) of India. IIL’s collaborative effort will help in the immunization of several million children against Measles and Rubella and thereby saving lives”.

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Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

pharmaphorum

Patients will also receive a dose of tacrolimus, an immune-suppressing drug, to guard against any immune reaction to the transplanted cells. The hope is that the spheroids will help to replenish damaged cardiomyocytes in the heart, restoring some of its ability to pump blood around the body.

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Roche rings Bicycle bell again, grabbing another cancer target

pharmaphorum

In 2016 it started a $1 billion alliance with AstraZeneca to find drug candidates that could be used to treat respiratory diseases, and extended that in 2018 to include cardiovascular and metabolic disorders. The agreement includes another $12 million to Bicycle, per candidate, if Genentech decides to take a peptide further in development.

Immunity 105
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Intratumoural viral delivery improves glioblastoma survival

European Pharmaceutical Review

The viral therapy “aims to awaken the patient’s immune system and trigger a healing from within,” Dr Fueyo commented. After injection, patients that respond well develop inflammation inside the tumour, triggering an immune response that first kills the virus.” This makes it difficult to treat the cancer with immunotherapy.