Insmed Inc., of Bridgewater, N.J., said data were published in the American Journal of Respiratory and Critical Care Medicine from a phase II study of Arikayce (liposomal amikacin for inhalation) in patients with nontuberculous mycobacterial lung infections who had been unable to achieve culture conversion to negative despite receiving a multidrug guideline-based regimen for six or more months. Read More
Accurexa Inc., of Walnut Creek, Calif., and Stemimmune Inc., of San Diego, inked a collaboration to develop a stem cell-mediated immunotherapy for the treatment of cancers, such as brain cancer. Stemimmune's immunotherapy uses the stealth anticancer payload-carrying and tumor-seeking capacities of a patient's own readily available stem cells to target the disease. Terms were not disclosed. Read More
Nektar Therapeutics Inc., of San Francisco, commenced an underwritten public offering of $175 million of shares of its common stock. In connection with that offering, Nektar will also grant to the underwriters a 30-day option to purchase up to an additional $26.25 million shares. J.P. Morgan is acting as the sole book-running manager. Nektar said it intends to use the net proceeds for general corporate purposes, including research and development funding and working capital. Read More
The FDA awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of drugs, devices and medical foods to treat patients with rare diseases. Read More
SHANGHAI – Hua Medicine Ltd. released the top-line results from the phase II trial of HMS5552, a fourth-generation glucokinase activator (GKA) used as a single drug to treat type 2 diabetes patients in China. The Shanghai-based biotech said the study shows statistically significant efficacy data, as well as an excellent tolerability and safety profile, with low risk of hypoglycemia or other side effects common in diabetes treatments. Read More
HONG KONG – South Korean drugmaker Celltrion Inc.'s Inflectra (infliximab-dyyb) will begin shipments to the U.S. by late November, making it the first biosimilar monoclonal antibody marketed in the U.S. Read More
Four companies are joining a collaborative research effort – and helping, to an undisclosed extent, with funds – in acute myeloid leukemia (AML) called the Beat AML Master trial, led by the Leukemia & Lymphoma Society (LLS) with participation by other oncology researchers. Read More
DUBLIN – Domain Therapeutics SA and Medixci Ventures have teamed up to form Mavalon Therapeutics SA, a single-asset play with €9 million (US$10 million) funding and a preclinical Parkinson's disease program based on a series of orally available positive allosteric modulators (PAMs) of the metabotropic glutamate receptor 3 (mGluR3). Read More
LONDON – ADC Therapeutics Sarl has raised $105 million in the largest private funding round by any biotech in Europe this year, enabling the company to expand its pipeline of antibody-targeted chemotherapeutics to six programs and move into the treatment of solid tumors for the first time. Read More
When it comes to patient assistance programs (PAPs), the biopharma industry is tenacious. Seeking help with copay assistance or no-cost access to Gilead Sciences Inc.'s medications to treat HIV or hepatitis C virus? Read More
The rise of a complex and lucrative specialty drug market in the U.S. has created not only new opportunities for drugmakers, but also new challenges. With a significant portion of care shifting from in-patient to out-patient settings and insurers tightening the reins on specialty drug coverage, drugmakers have turned to patient assistance programs (PAPs) to help them succeed. Read More
