Here we go again. Biotech stocks led Monday's market selloff, with the Nasdaq Biotech Index falling 4.1 percent following disappointing news from a pair of companies. Amgen Inc. led the stampede after FDA briefing documents posted Monday suggested its cancer immunotherapy drug, talimogene laherparepvec (T-vec), will face strong headwinds at Wednesday's joint meeting of the Cellular, Tissue and Gene Therapies and Oncologic Drugs Advisory Committee. Read More
Royalty investors backing a matchstick-sized implantable drug pump in late-stage testing by Intarcia Therapeutics Inc. invested $225 million in the company to carry the first version of the device, delivering exenatide to type 2 diabetics, through potential approval and early launch in 2017. Read More
DUBLIN – Galapagos NV piled on the good news for investors Tuesday, unveiling 12-week phase IIb rheumatoid arthritis (RA) data for its selective Janus kinase 1 (JAK1) inhibitor filgotinib as a monotherapy, which could eventually help to line it up as a potential contender in first-line therapy but in the short term confirms the strong efficacy signal it recently reported from a phase IIb trial of the drug administered in combination with methotrexate. Read More
More than a month after approving Sandoz Inc.'s Zarxio as the nation's first biosimilar, the FDA Tuesday issued final versions of the first three draft guidances it released on biosimilars in 2012. Read More
On schedule, Biomarin Pharmaceutical Inc. this week finished off the rolling new drug application (NDA) for exon 51-skipping drisapersen to treat Duchenne muscular dystrophy (DMD), situating the firm a few months ahead of Sarepta Therapeutics Inc. with eteplirsen, another exon 51 DMD therapy. Read More
In an ongoing quest to find ways to reduce the cost and time of getting innovative drugs and devices from conception to patients, the Senate Health, Education, Labor and Pensions (HELP) Committee Tuesday asked the FDA and NIH for practical suggestions. Read More
United Therapeutics Corp., of Silver Spring, Md., reported total revenues of $327.5 million for the first quarter, missing analyst estimates of $354 million. Revenue from its pulmonary arterial hypertension franchise included sales of $146.3 million for Remodulin (treprostinil injectable), $113.4 million for Tyvaso (treprostinil inhaled), $20.9 million for Orenitram (treprostinil extended-release tablets) and $45.4 million for PDE5 inhibitor Adcirca (tadalafil). Read More
Paratek Pharmaceuticals Inc., of Boston, said it planned to offer $60 million of its common stock in an underwritten public offering to support ongoing and planned trials of omadacycline, an oral and intravenous once-daily antibiotic with activity against gram-positive, gram-negative, atypical and anaerobic bacteria, as well as to advance its pipeline and preclinical candidates. Read More
Dandrit Biotech USA Inc., of Copenhagen, Denmark, signed a collaboration agreement with GISCAD Foundation, an Italian group with a focus on digestive tract cancer studies. Read More
Aeterna Zentaris Inc., of Quebec City, said the independent data safety monitoring board completed an initial pre-specified interim futility analysis for the pivotal phase III ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin (AEZS-108) in women with advanced, recurrent or metastatic endometrial cancer and recommended that the trial continue as planned. Read More
Merck & Co. Inc., of Kenilworth, N.J., said The Lancet and Clinical Infectious Diseases have published online the results from the pivotal phase III studies of Zerbaxa (ceftolozane/tazobactam) for injection (1 g/0.5 g) in complicated urinary tract infections and complicated intra-abdominal infections, respectively. Read More
