Frustrated by years of study but no FDA rule requiring effective patient medication information (PMI) for prescription drugs, a Senate committee threatened to use the power of the purse to force some changes to protect patients from drug labeling mistakes. Read More
In one of its last votes before adjourning for the year, the House passed a two-year budget agreement Thursday night on a vote of 332-94. The resolution now heads to the Senate, which is expected to vote on it next week. Read More
In day two of the FDA’s Allergenic Products Advisory Committee meeting, it reviewed Alk-Abello A/S and Merck and Co. Inc.’s Grastek sublingual tablet. Members agreed unanimously that available data support efficacy of Grastek for treatment of Timothy grass pollen-induced allergic rhinitis in patients 5 to 65 years and that adrenaline auto-injectors must be made available for patients at home. Read More
Oversized hopes for what the company designed as an exploratory Phase II trial led to Immunocellular Therapeutics Ltd.’s stock plunge, after the company disclosed mixed results with its dendritic cell-based vaccine in glioblastoma multiforme (GBM), said CEO Andrew Gengos. Read More
Justitia, the goddess of justice, famously seeks the truth while blindfolded. Scientists, on the other hand, do not. And Glenn Begley thinks that’s why they so often don’t find it. “If I was king of the world, the one thing I would do is to insist that every study be performed blinded,” he told his audience at the National Press Club on Wednesday. Read More
Mimedx Group Inc., of Marietta, Ga., said it priced an underwritten public offering of 5 million shares of its common stock at $6.80 per share for gross proceeds of $34 million. Read More
Celator Pharmaceuticals Inc., of Ewing, N.J., said independent data and safety monitoring board for the company’s Phase III study comparing CPX-351 (cytarabine/daunorubicin) liposome injection to the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3 ) as first-line therapy in older patients with high-risk (secondary) acute myeloid leukemia should continue as planned without any modifications. Read More
Ico Therapeutics Inc., of Vancouver, British Columbia, said its oral amphotericin B is moving into in vitro testing with study partners in Montreal to examine the role of the formulation in targeting latent HIV reservoirs. Read More
Synta Pharmaceuticals Corp., of Lexington, Mass., presented results from the single-arm, multicenter Phase II proof-of-concept ENCHANT-1 trial evaluating the efficacy and safety of lead candidate ganetespib as monotherapy to treat HER2+ (Cohort A) or triple-negative, or TNBC (Cohort B), patients previously untreated for locally advanced or metastatic disease. Read More
Astellas Pharma U.S. Inc., a subsidiary of Astellas Pharma Inc., of Tokyo, said the Centers for Medicare & Medicaid Services assigned a unique Healthcare Common Procedure Coding System code for Astagraf XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant used with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. Read More
Mallinckrodt Inc., of St. Louis, said the Phase III trial of MNK-155, an extended-release oral formulation of hydrocodone and acetaminophen, met the primary efficacy endpoint of change in pain from baseline over 48 hours compared to placebo in managing moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. Read More
