News Archive

Pharma major Lupin Limited (Lupin) and Natco announced the final ANDA approval of Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) from the United States Food and Drug Administration (FDA). The product, as the first generic, will be launched shortly.

Natco’s Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are generic equivalents of Shire Development LLC’s Fosrenol Chewable Tablets 500 mg, 750 mg and 1000 mg. Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).

CEL-SCI Corporation (NYSE American: CVM) today announced it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the clinical hold that had been imposed on the Company’s Phase 3 cancer study with Multikine* (Leukocyte Interleukin, Inj.) has been removed and that all clinical trial activities under this Investigational New Drug application (IND) may resume.

Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today announced the publication of results from a Phase 1/2a study of intrathecal administration of VTS-270, a 2-hydoxypropyl-β-cyclodextrin (HPβCD) under investigation for treatment of Niemann-Pick Disease Type C1 (NPC-1). The results of the study were published in the August 10, 2017 issue of The Lancet and can be found at http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(17)31465-4.pdf.

25-year biopharma industry veteran joins the Company to drive further growth of its innovative high-performance cell engineering platform for use in commercial drug development

MaxCyte, a US-based global company dedicated to driving the acceleration of the discovery, development, manufacturing and commercialization of next-generation, cell-based medicines, announced today that it has appointed Brad Calvin, a 25-year veteran within the drug development and biotechnology industries, as Executive Vice President of Global Marketing. In his role, Mr. Calvin is responsible for leading MaxCyte’s marketing function to drive growth of the Company’s drug discovery and cell therapy business.

Doug Doerfler, Chief Executive Officer, said, “We are delighted to have someone of Brad’s caliber join MaxCyte to lead our marketing and market development efforts. Brad’s broad biopharmaceutical industry experience has provided him with an in-depth understanding of working across global markets and supporting all phases of product life cycles. His appointment comes at an opportune time for the Company, as we continue to develop new offerings based on our Flow Electroporation® Technology.”

From companies created to work in best in today’s new value-based healthcare system to precision medicine, data analytics and interoperability, you can count on a healthcare IT landscape that is always in flux, thanks to new approaches driven by entrepreneurs who are adept at shaking things up.

This gallery highlights some of the most promising new companies and the founders and CEOs who are making news in 2017. Healthcare IT News is keeping tabs on the most exciting and promising new ventures.

U.S. Sen. Benjamin L. Cardin, JD ‘67, returned to his alma mater, the University of Maryland, Baltimore (UMB), to tour the UM BioPark and host a roundtable discussion with university leaders and biomedical innovators, highlighting such topics as bipartisan solutions to health care policy and ways to encourage small business innovation.

“I always get excited being here,” said Cardin as he kicked off the discussion Aug. 10. “It does energize me. After what I’ve just gone through this month in the United States Senate, it’s good to be here, to realize there is real life going on in our communities.”

You don’t have to go to Johns Hopkins University to make a lot of money. In fact, you can make more money by going elsewhere in Maryland. The U.S. Department of Education offers a College Scorecard that provides would-be attendees many of the resources they need in deciding where to apply and, ultimately, where to attend.

The Trump administration is pushing for dramatic cutbacks at the National Institutes of Health. The proposed $5.8 billion cut from the agency’s annual $32 billion budget would translate into 5,000 to 8,000 fewer grants per year for basic medical research.

But the impact of such cuts would actually be much broader, totaling $15 billion in lost economic activity and 90,000 jobs lost nationwide.

Women Building Bio: the XX factor is a day long conference to recognize and learn from leading women in the bioscience industry as pioneers paving the path to success. These women have faced their own unique challenges and carved out lasting legacies.

This day will catalyze the formation of a diverse network. It is a convergence of academia and industry, men and women, researchers and innovators, professionals and decision-makers gathering together to build relationships. This day long conference provides extraordinary opportunities to exchange new ideas, highlight areas of bioscience and research opportunities, and find partners for future collaboration.

In a striking advance that helps open the door to organ transplants from animals, researchers have created gene-edited piglets cleansed of viruses that might cause disease in humans.