Cellprotect Nordic Pharmaceuticals AB, of Stockholm, said its cell therapy candidate, Cellprotect, has received EMA orphan drug status for the treatment of multiple myeloma.
Athenex Inc., of Buffalo, N.Y., started the IND process for its oral formulation of eribulin based on its Orascovery platform that uses the oral P-glycoprotein pump inhibitor molecule HM-30181A.
The FDA issued two draft guidances Friday designed to provide clarity on the agency's recommendations for researching and developing targeted therapies. The first, titled "Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease," proposes an approach for drug developers to enroll patients based on the identification of rare mutations into clinical trials for targeted therapies when reasonable scientific evidence suggests the drug could be effective in patients with those genomic findings.
More than two-thirds of late-stage breast cancer patients have bone metastases. Those metastases tend to be resistant to chemotherapy, and current treatments often improve bone function and bone health, but they do not impact the metastases themselves and do not improve survival.
Trovagene Inc., of San Diego, a precision medicine company, priced a public offering of 15 million shares of common stock (or common stock equivalents) and common warrants to purchase up to an aggregate of 15 million shares, with each share/warrant combo priced at 30 cents apiece.
Asklepios Biopharmaceutical Inc. (Askbio) formed Actus Therapeutics Inc., another in its string of so-called spinout special purpose entities, or SPEs, to pursue therapies for rare genetic diseases, beginning with Pompe disease. Chapel Hill, N.C.-based Actus plans to tap Askbio's prowess in rare diseases, its platform of double-strand adeno-associated virus vectors (AAV) and its manufacturing capabilities – in combination with technology licensed from the lab of Dwight Koeberl, professor of pediatrics and a medical genetics specialist at Duke University – to differentiate its approach in gene therapy.
LONDON - Eight years on from securing the first EMA approval for an autologous cell therapy, Tigenix NV has done it again, getting the nod for the first allogeneic adipose-derived stem cell therapy, Alofisel (Cx601, darvadstrocel), in the treatment of complex anal fistulas caused by Crohn's disease.
DUBLIN – The EMA's Committee for Human Medicinal Products (CHMP) closed out 2017 with recommendations for three new drug approvals and for one new biosimilar, along with positive recommendations for five products approved under the generic, hybrid or informed consent pathways, plus two line extensions.
Jnana Therapeutics Inc., a Boston-based startup building a drug discovery platform targeting a family of proteins that serve as cellular "metabolic gates," has raised a $50 million series A financing backed by Polaris Partners, Avalon Ventures, Versant Ventures, Abbvie Ventures LLC and Pfizer Inc.
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