ACIP Update

After a review, CDC’s ACIP agreed with the FDA that Pfizer’s Covid-19 vaccine is appropriate for adolescents. The panel also reiterated its belief in the safety of the Johnson & Johnson vaccine, despite blood clots that are not seen with the mRNA vaccines, and reviewed the status of variants.

ACIP tells FDA/CDC: Continue the Pause on the J&J Covid-19 Vaccine

One day after the CDC and the FDA recommended a voluntary “pause” in the use of Johnson & Johnson/Janssen’s Ad26.COV2.S (JNJ-78436735), a Covid-19 vaccine, the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) met and said it needs more data, additional risk refinement, and a benefit:risk assessment before it can make a decision on what should be done ab out the vaccine. That meeting is now scheduled for April 23, 2021.

Use of J&J's Covid-19 Vaccine "Paused"

The Centers for Disease Control and Prevention (CDC) and the FDA recommended a “pause” in the use of Johnson & Johnson/Janssen’s Covid-19 vaccine, Ad26.COV2.S (JNJ-78436735), after six reported cases in the U.S. of a “severe stroke-like illness” linked to a rare type of blood clot. One patient died. Here is what you need to know.

ENDO 2021

Rare endocrine diseases, often manifesting in childhood or even infancy – but even extending into adulthood for some conditions – are getting attention from researchers who are developing targeted therapies in hopes of correcting or reversing the endocrine abnormalities created by congenital or inherited genetic conditions. At the virtual 2021 meeting of the Endocrine Society, researchers reported on ongoing treatments that could make big differences in the lives of these patients, including new agents for hypoparathyroidism, obesity, growth hormone deficiency, achondroplasia, and acromegaly.

ESMO-TAT Congress -- Drugs to Watch

ESMO’s TAT Congress offered a glimpse into three early-stage targeted therapies: Spectrum Pharmaceuticals’ poziotinib – efficacy still a question and BID dosing only marginally improves tolerability; Black Diamond Therapeutics’ BDTX – much too early to know much but an interesting idea; and Bristol-Myers Squibb’s CC-90010 – a hint of efficacy and no significant food effect.

What was Learned in the CDC Review of the J&J Covid-19 Vaccine

Johnson & Johnson’s Ad26.COV2.S is the latest Covid-19 vaccine to become available in the U.S. CDC’s ACIP review of the vaccine brought out a number of points, raised some questions, and provided a few answers that you may not have heard before about that vaccine.

FDA Advisory Committee Recommends EUA for J&J Covid-19 Vaccine

An FDA Advisory Committee voted unanimously to recommend the FDA issue an emergency use authorization (EUA) for Johnson & Johnson’s one-dose Covid-19 vaccine. While the vaccine doesn’t look quite as efficacious in seniors, the panel agreed it is safe and effective. The acting panel chair summed it up: “In this environment, whatever [vaccine] you can get, get.”

Preview of FDA Panel Review of J&J Covid-19 Vaccine

An FDA advisory committee will review a third Covid-19 vaccine on February 26, Johnson & Johnson/Janssen’s Ad26.COV2.S. The panel is likely to recommend approval, but there are several questions about the vaccine that should make for an interesting discussion.

World Conference on Lung Cancer

What happens to lung cancer patients when osimertinib doesn’t work or stops working? There are next-generation EGFR inhibitors in development that target the multiple mutations that allow cancers to evade osimertinib. Here is a look at three: Spectrum Pharmaceuticals’ poziotinib, Johnson & Johnson’s amivantamab, and Takeda’s mobocertinib (TAK-788) – plus new data on AstraZeneca’s Tagrisso (osimertinib).

Bascom Palmer Eye Institute's Angiogenesis, Exudation, and Degeneration 2021

Drug development for age-related eye diseases is an active area, and it is not just a race among me-too agents – at least not among the drugs reviewed at this meeting. Among five drugs in development to treat geographic atrophy, there were four different approaches reviewed. Among five drugs in development to treat wet age-related macular degeneration, there were four new agents and one new delivery method. On top of that, three gene therapies were discussed.

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