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. J&J will have […]
Pharmaceuticals
Samsung Biologics slides on South Korean regulatory probe
News that Samsung Biologics (KRX:207940) 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 […]
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 […]
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 […]
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 […]
3D model of female reproductive system could help test drugs for efficacy, safety
In January last year, the National Institutes of Health issued a new requirement for grant funding in basic science: Researchers must discuss how gender as a biological variable will impact their research. Teresa Woodruff, director of the Women’s Health Research Institute at Northwestern University, told Drug Delivery Business News that this helped support their effort to develop a model that […]
EU regulators: We should suspend drugs at suspect Indian facility
This week, the European Medicines Agency recommended the suspension of more than 300 generic drug approvals and applications, after they uncovered “unreliable” tests conducted by Micro Therapeutic Research Labs. The India-based contract research firm is part of the country’s drug-testing industry, which has faced problems with international regulators in recent years. European officials have reportedly […]
Researchers tout preclinical results for one-shot vaccination method
Researchers from Boston Children’s Hospital said today that they achieved strong vaccine responses in preclinical models by adding adjuvants to boost the immune response. The team’s work was published the Journal of Clinical Investigation-Insight and the Journal of Allergy and Clinical Immunology. Vaccines have the potential to drastically reduce infant mortality, the researchers said, but newborns often don’t […]