PTC Therapeutics Inc., of South Plainfield, N.J., reported revenues of $56.1 million for the first quarter, with net product revenues of Duchenne muscular dystrophy drugs Translarna (ataluren) and Emflaza (deflazacort) totaling $36.8 million and $19.2 million, respectively. First-quarter net loss was $19.3 million. Read More
Sunshine Biopharma Inc., of Montreal, said it signed an agreement with Jitney Trade Inc., extending the equity financing previously announced of up to C$10 million (US$7.8 million) until Aug. 31. Terms and conditioned remained at 400 million shares of company stock priced at C2.5 cents per share. Read More
The FDA filed two complaints in federal court seeking permanent injunctions against two stem cell clinics – US Stem Cell Clinic LLC, of Sunrise, Fla., and California Stem Cell Treatment Center Inc., in Rancho Mirage and Beverly Hills, Calif. – to stop them from marketing stem cell products without FDA approval. Read More
Celldex Therapeutics Inc., of Hampton, N.J., said in its first-quarter earnings that it is discontinuing development of CDX-014, an antibody-drug conjugate (ADC) in early phase I development in renal cell and clear cell ovarian carcinomas, and CDX-1401, an NY-ESO-1 antibody fusion protein being explored in investigator-sponsored and collaborative studies. Read More
BOSTON – The most highly anticipated clinical study for this year's edition of the Heart Rhythm Society annual meeting, the Cabana (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial, came up short on a couple of important statistical measures, including total mortality and disabling stroke. Still, the study was close enough to a home run to suggest more widespread use of this technology, a proposal undergirded by patients' unwillingness to deal with the side effects of antiarrhythmic drugs and a significant improvement in patient quality of life. Read More
Exelixis Inc.'s pivotal phase III blowup in colorectal cancer (CRC) may have little read-through to an ongoing melanoma study trying the same two drugs plus a third, and investors still have plenty to cheer about in the strong-selling renal carcinoma (RCC) therapy Cabometyx (cabozantinib). Read More
Looking for a preview of President Donald Trump's plan to bring down prescription drug prices, lawmakers pressed Health and Human Services (HHS) Secretary Alex Azar for details at an HHS budget hearing Thursday. Read More
Eli Lilly and Co. said it will buy Armo Biosciences Inc. for about $1.6 billion, in an all-cash transaction intended to bolster its immuno-oncology program through the addition of Armo's lead candidate, pegilodecakin, a pegylated interleukin-10. The $50-per-share offer, coming just months after Armo's upsized January IPO, represents a 68 percent premium to Wednesday's close. Read More
In weighing presentations from Akcea Therapeutics Inc. and the FDA on the risk/benefit profile of the antisense oligonucleotide (ASO) volanesorsen (Waylivra) in familial chylomicronemia syndrome (FCS), members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) came down on the side of the drug in a 12-8 vote, with no abstentions. In comments following the vote late Thursday, several EMDAC members said they gave more weight to the unmet need in FCS, an orphan disease with no approved treatments, than to concerns about adequate characterization of the patient population and the number and severity of adverse events (AEs). A few openly acknowledged they were swayed by comments during the open public hearing, when 13 individuals – patients, family caregivers and physicians – all spoke in favor of approval. Read More
