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KATHERINE supports filings for earlier use of Kadyla in adjuvant setting of metastastic breast cancer.
While Chugai’s satralizumab may not be odds on to win the race for approval, it may beat Alexion’s Soliris on ease of use with a regimen of subcutaneous application once a month versus Soliris’ fortnightly IV.
Opdivo failed to meet an overall survival endpoint in a Phase III confirmatory study in small-cell lung cancer. But several analysts think Bristol will keep the SCLC labeling obtained in August due to lack of treatment options for these patients.
German Merck tells Scrip its quest to find a partner for its Bruton’s tyrosine kinase inhibitor evobrutinib should be helped by positive 24-week Phase IIb data in relapsing multiple sclerosis.
October has been a very good month for Ionis. Following US approval of Tegredi, it has now signed a potentially lucrative deal with existing partner Roche for another antisense drug, this time to tackle advanced dry AMD.
Big pharma and little biotechs are getting ready to pack their bags for Germany where over 2,000 abstracts will be presented at ESMO and the fine details on some major oncology studies will be closely watched.
Promising drugs from Tetraphase, ContraFect, Spero and Entasis get a platform at the Infectious Diseases Society of America’s IDWeek.
Celgene estimates 80% of moderate-to-severe plaque psoriasis patients experience the disease in their scalps, meaning positive data in this indication could broaden the market opportunity for Otezla substantially. Novartis’ Cosentyx got scalp psoriasis added to its US label in February.
Analysts shrugged off mixed topline data from a Phase II study showing Xencor’s lead compound XmAb5871 missed its primary endpoint in systemic lupus erythematosus (SLE), blaming the miss on the number of patients dropping out of the placebo arm of the trial.
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