Biotronik touted data today from its Magnesium 1,000 program, which provided doctors with an early post-market opportunity to evaluate the company’s new resorbable Magmaris magnesium scaffold. More than 98% of physicians reported that the scaffolds successfully deployed, according to the data, and that it performed well compared to the leading polymeric scaffold, Biotronik said. The program […]
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SteadyMed reels in losses with Q4 earnings
Shares in SteadyMed (NSDQ:STDY) rose yesterday after the pharmaceutical company reported its 4th quarter results. The San Ramon, Calif.-based company posted losses of -$2.4 million, or -12¢ per share, on sales of $400,000 for the 3 months ended Dec. 31, for bottom-line growth of 63.1% on sales loss of -25.6% compared with the same period last year. […]
Capsugel expands into late-stage inhalation delivery
Capsugel said today that it expanded its late-stage inhalation formulation capabilities to move dry powder inhalation concepts through late-stage clinical trial and into commercial production. The company installed a new Harro Hofliger Modu-C MS encapsulation unit at its Oregon-based facility. The machinery features specialized drum-dosing tech for use in dry powder inhalation development projects with […]
Aura Biosciences wins fast track designation for light-activated nanoparticle therapy
Aura Biosciences said today that it enrolled and dosed the 1st patient in the Phase Ib trial of its light-activated AU-011 viral nanoparticle conjugate therapy for the treatment of ocular melanoma. The company also said that the FDA granted fast track designation to its targeted treatment, which will give priority review for the company’s New Drug […]
Acorda plans NDA for inhaled Parkinson’s drug after touting long-term safety data
Acorda Therapeutics (NSDQ:ACOR) touted data from 2 ongoing, long-term safety studies of its inhaled Parkinson’s therapy. The trials showed no difference in pulmonary function between the group receiving CVT-301, the inhaled formulation of Parkinson’s drug levodopa, and the control group. The investigational drug is being studied as a therapy for people with Parkinson’s disease experiencing “off” […]
Mylan shares down -3% after FDA rejects Advair generic
Shares in Mylan (NSDQ:MYL) dropped -3% to $40.46 apiece today after the FDA rejected its Abbreviated New Drug Application for the generic version of GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus. The Canonsburg, Penn.-based company said it is “in the process of reviewing this response and will provide an update on its application as soon as practicable once it has […]
Pulmatrix jumps 8% on rumors of potential Mylan takeover bid
Shares in Pulmatrix (NSDQ:PULM) jumped more than 8% today on rumors that the company’s collaboration partner Mylan (NSDQ:MYL) may be interested in a takeover bid. In 2015, the 2 companies inked an ex-U.S. development deal for PUR0200, Pulmatrix’s investigational bronchodilator for the treatment of chronic obstructive pulmonary disease. Mylan had an option on the rights […]
Trump FDA pick to recuse himself from agency decisions involving 20 companies
Donald Trump’s nominee to head the FDA, Dr. Scott Gottlieb, reportedly told ethics officials at the Office of Government Ethics he plans to recuse himself for 1 year from agency decisions on more than 20 companies, including GlaxoSmithKline (NYSE:GSK) and Bristol-Myers Squibb (NYSE:BMY). Gottlieb has received millions of dollars for his roles as advisor, paid speaker […]
NuTech Medical acquired by Organogenesis
Organogenesis said today that it acquired NuTech Medical for an undisclosed price. The combined company plans to feature a portfolio of wound care products and surgical biologics. Birmingham, Alabama-based NuTech Medical will keep it’s non-biologics product line as a separate company called NuTech Spine. “This is an important transaction for the regenerative medicine field. It unites […]
Cardiologists: $6B NIH cut a ‘catastrophe’
Top heart doctors and researchers reportedly described President Donald Trump’s proposed 20% cut to the National Institutes of Health budget as “chilling” and a “catastrophe” at the American College of Cardiology meeting this month. Many expressed fears that as drug companies shift their focus to oncology and rare diseases, NIH-funded research will become more important to […]
