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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In 2021, the FDA granted Amgen’s (NASDAQ:AMGN) non-small cell lung cancer (NSCLC) drug Lumakras (sotorasib) an expedited approval, making it the first FDA-approved KRAS inhibitor. The demand came amid concerns that the drug causes a slew of side effects such as nausea, diarrhea, and liver issues.

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Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

Pharmaceutical Technology

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. In September 2021, the same study reported a 100% seroconversion rate after a booster was given to the participants.

Medicine 119
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GSK shelves arthritis blockbuster hope otilimab after lacklustre data

pharmaphorum

It’s a disappointing outcome for a programme that GSK said in 2021 could potentially generate £1 to £2 billion in peak sales because of the serious unmet need in RA patients. GSK licensed otilimab from German biotech MorphoSys in 2013 in a deal valued at up to €423 million, including around €23 million upfront. Daprodustat backed.

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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. The specific representation of these events differed between the treatments, highlighting potential differences in side effect profiles that should be explored in further studies. 2021; 27 (2): S1-S21.

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Biogen and Eisai’s Alzheimer’s drug secures support in closely watched AdCom

Pharmaceutical Technology

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Leqembi is the second drug developed by Biogen and Eisai for the treatment of Alzheimer’s disease.

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Expanding ketamine’s horizons to treat rare neurological disorders

Pharmaceutical Technology

“That research led to a substantial amount of evidence suggesting that ketamine can have rapid effects on a host of measures associated with neuroplasticity,” he says. In November 2021, the Michael J. There is not a whole lot of evidence to say these effects are underlying ketamine’s therapeutic action in humans, says Kohtala.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

In the past, obesity medications were often dismissed due to insufficient efficacy data and the fact that they were associated with a high occurrence of side effects. The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021.

Medical 105