Deaths associated with Astellas Pharma’s gene therapy program for patients with X-linked Myotubular Myopathy underscore some of the risks of developing potential one-and-done treatment options for serious diseases.

Seagen (formerly known as Seattle Genetics) forged an exclusive licensing agreement with China’s RemeGen to develop and commercialize disitamab vedotin, a novel HER2-targeted antibody drug conjugate (ADC).

Two doses of Pfizer or AstraZeneca’s Covid-19 vaccine are nearly as effective against the highly transmissible Delta coronavirus variant as they are against the previously dominant Alpha variant, a study published on July 21 showed.

Placebo response is one of the most significant challenges faced by drug developers who are investigating new pain medications. According to a review of published chronic neuropathic pain trials, placebo responses have increased in magnitude over time, making it even more difficult to definitively demonstrate treatment advantage. Research has also shown that up to 60 percent of study participants may experience placebo-related analgesic responses and that these responses may be persistent.

Novartis said on Tuesday that a large British study of the Swiss drugmaker’s cholesterol-lowering medicine Leqvio is not expected to be completed until 2026, a year later than expected, as Covid-19 infections made participant recruitment difficult.

Pregnant women vaccinated against Covid-19 could pass along protection to their babies, according to a new study in Israel.

Findings from a Phase III long-term extension study show a once-daily therapy consisting of relugolix with estradiol and norethindrone acetate leads to clinically meaningful reductions in menstrual pain and non-menstrual pelvic pain over one year in women with endometriosis.

AstraZeneca and Amgen said their experimental asthma drug tezepelumab failed to meet the main goal of reducing patients’ dependence on steroids, while keeping the respiratory condition in check in a late-stage trial.

The American Society of Hematology (ASH) Annual Meeting & Exposition began December 5 with numerous presentations, abstracts and posters.

We are well into the global pandemic that has disrupted our professional and personal lives. This is a once in a lifetime paradigm shift – we have adjusted much of our day to day BUT where does clinical site contracting and budgeting fall?