Bad news last week from the FDA for cash-strapped Vion Pharmaceuticals Inc. regarding Onrigin pointed up the need for a better therapy against acute myeloid leukemia in the elderly as well as the difficulty in developing one that works and can pass muster with regulators.
An eye-opening overall response rate of 32.7 percent in Phase II trials with antibody-drug conjugate TDM-1 in last-resort breast cancer patients left investors in ImmunoGen Inc. with well-founded hope that partner Roche Holdings AG will file for approval in the first half of next year and get an accelerated nod from the FDA. (BioWorld Today)
Allos Therapeutics Inc.'s stock drop last week after Celgene Corp. disclosed its plan to buy out competitor Gloucester Pharmaceuticals Inc. seemed to signal investor nail-biting over the market chances for Allos' recently approved peripheral T-cell lymphoma drug Folotyn, due to fully launch in the first quarter of next year. (BioWorld Insight)