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STAT+: FDA rejects Rocket Pharmaceuticals’ gene therapy for ultra-rare condition, another setback for field

STAT

Rocket Pharmaceuticals said Friday that the Food and Drug Administration rejected its gene therapy for an ultra-rare, sometimes fatal immuno-deficiency syndrome, saying the company needed to submit more information to prove it can safely manufacture the product. Continue to STAT+ to read the full story…

Immunity 308
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STAT+: Drug shortages reached a record high as 2023 drew to a close

STAT

These include oxytocin, which is used during childbirth; Rho(D) immune globulin, which helps some women during pregnancy; standard-of-care chemotherapy, pain and sedation medicines; and ADHD pills. Unresolved shortages have, in fact, been hovering above 300 for more than a year as numerous basic and life-saving medicines are in short supply.

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CDC advisory panel backs changes to Covid vaccination policy

STAT

An expert panel that advises the Centers for Disease Control and Prevention on vaccination policy informally endorsed a plan Wednesday to offer an additional Covid-19 booster shot to people 65 and older as well as people who are immunocompromised, and to simplify the Covid vaccine schedule.

Vaccines 269
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Advancing research on human immune systems in India to develop better vaccines

Express Pharma

The vaccine efforts of the COVID-19 pandemic highlighted our knowledge about gaps in the immune system. Reductionist systems, such as genetically identical inbred mice, have long been the choice for immunology research, which focuses on studying the cells, tissues, and organs that make up the immune system.

Immunity 105
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STAT+: Pharmalittle: We’re reading about drug shortages, what drugmakers didn’t tell Alzheimer’s trial patients and more

STAT

Among the basic and life-saving medicines for which shortages continue to be problematic are Rho(D) immune globulin, pain and sedation medications, and ADHD pills. The second most common reason — at 14% of the reported shortages — was blamed on supply and demand with manufacturing issues and business decisions at 12%.

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Linked Immunization Information System, Claims Data Captured COVID-19 Vaccination Status Better Than Claims Data Alone

Pharmacy Times

Reporting vaccination data to Immunization Information Systems databases can support public health surveillance activities.

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IGBA releases first global Intellectual Property and Competition Report

Express Pharma

Archana Jatkar, Chair of the IGBA International Trade and IP Committee, pointed to the widespread nature of the issue, stating, “This report shows that no region is immune to practices delaying the launch of safe, effective, cost-effective, and quality-assured medicines. Practices previously seen in the U.S.