With sarilumab cruising toward a potential FDA approval this fall or earlier, drug developers Sanofi SA and Regeneron Pharmaceuticals Inc. reported that, at week 24, the interleukin-6 receptor antibody beat Humira (adalimumab, Abbvie Inc.) monotherapy on the study's primary endpoint, improving signs and symptoms in patients with active rheumatoid arthritis (RA).
Aspyrian Therapeutics Inc. said a new $40 million series B financing will help the company complete phase I/II trials of RM-1929, its experimental antibody-drug conjugate (ADC) for recurrent head and neck cancer and potentially for other cancers that have failed standard treatment.
Two major medical centers chasing some of the multi-faceted rewards of genomic sequencing – better informed prescribing decisions and potentially lower medical costs – are making slow but steady strides in rolling out nascent infrastructures for the project, according to key players in the initiatives who spoke at the Molecular Medicine Tri-Con meeting this week.
SAN FRANCISCO – Despite growing appreciation for many benefits of personalized medicine, earning it new attention in health care institutions and Washington, progress in the field continues to be decidedly mixed, according to speakers at the Molecular Medicine Tri-Con meeting this week.
Abbvie Inc. agreed to pay Boehringer Ingelheim GmbH $595 million up front for the opportunity to co-develop and later sell BI 655066, a phase III anti-IL-23 monoclonal antibody for psoriasis that could eventually help the North Chicago-based company replace revenue losses that it will face as its largest product, Humira (adalimumab), begins to lose patent protection and incur competition from biosimilars.
Shares of Vitae Pharmaceuticals Inc. (NASDAQ:VTAE) fell more than 50 percent to hit a record low Friday after the company closed enrollment earlier than expected in the second part of a multiple ascending-dose study of its psoriasis candidate, VTP-43742. Concern over the meaning of the move, for which Vitae provided little explanation, led Stifel analyst Tom Schrader to downgrade company shares and suggest that the firm is “unlikely to report data that are viewed as overall positive for this trial.”
Positive data from a phase I/II trial of Biomarin Pharmaceutical Inc.'s experimental therapy for CLN2, a type of the lysosomal storage disorder Batten disease, has the company cruising toward midyear regulatory filings with an eye to gaining approvals for the drug during the first half of 2017.
Shares of PTC Therapeutics Inc. (NASDAQ:PTCT) hit a record low of $5.29 on Tuesday after the company further detailed the FDA's refusal to accept a new drug application (NDA) for its Duchenne muscular dystrophy (DMD) candidate, Translarna (ataluren), saying that, in the agency's view, "both the phase IIb and (phase III) ACT DMD trials were negative and do not provide substantial evidence of effectiveness."
