article thumbnail

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.

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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.

article thumbnail

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.

article thumbnail

Adherence to Treatment: Making the Most of the First 30 Days

PM360

Indeed, in research from the 2021 PURE Report, 3 50% of the patients responding found the therapy discussion to be a highly stressful period in their treatment journey. Hospital Admissions Associated with Medication Non-Adherence: A Systematic Review of Prospective Observational Studies.” Start Patient Support Immediately.

article thumbnail

Telehealth in the 2022 Medicare Physician Fee Schedule: Audio-Only Telehealth for Mental Health Made Permanent, and CMS Punts on Remote Direct Supervision

Nixon Gwilt Law

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) finalized the Medicare Physician Fee Schedule for Calendar Year 2022 (the “Final 2022 MPFS” or the “Final Rule”). We predict that the PHE will be extended beyond 2021, and that remote direct supervision will be permissible until at least December 31, 2022.

article thumbnail

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.

FDA 115