Researchers from the Institute for Research in Biomedicine in Barcelona, Spain said yesterday that they have shown in preclinical tests that a bee-venom peptide, apamin, can be used to ferry medications across the blood-brain barrier. Although the blood-brain barrier prevents most things from getting in and flooding the brain, certain peptides in animal venoms can travel […]
Pharmaceutical
Sanofi boasts observational hypoglycemia rates for Toujeo insulin injection
Sanofi (NYSE:SNY) touted real-world clinical data for its Toujeo insulin glargine injection from a new observational study. The data from Deliver 2 showed that patients with Type II diabetes who switched to Toujeo from other basal insulins had significantly lower risk of hypoglycemia without compromising blood sugar control. The Deliver 2 study analyzed electronic medical […]
United delays Remosynch launch until 2018
Shares in United Therapeutics (NSDQ:UTHR) fell -7% this morning to $126.17 apiece after the company said that the U.S. commercial launch of Remosynch, Medtronic‘s (NYSE:MDT) implantable infusion pump for Remodulin, will be delayed until 2018. “United Therapeutics’ commitment to bringing better therapies to patients transcends temporary delays or setbacks,” United chairman & CEO Martine Rothblatt said in […]
Johnson & Johnson’s tender offer for Actelion snares 78% stake
Johnson & Johnson (NYSE:JNJ) said today that it controls nearly 78% of voting rights in its $30 billion acquisition of Swiss biotech firm Actelion (VTX:ATLN). Janssen, J&J’s Swiss subsidiary, declared the tender offer successful. The company added that based on regulatory approval proceedings, the offer is expected to settle in the 2nd quarter of this year. Get the full […]
Samsung Biologics slides on South Korean regulatory probe
News that Samsung Biologics is facing a probe by South Korean regulators over its valuation ahead of an initial public offering last year sent its share price down this week in Seoul. South Korea’s Financial Supervisory Service is running a special audit of the drugs contract manufacturer, prompted by a Korean Institute of Certified Public Accountants review that found “unclear […]
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 […]
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 […]