Although the buyout of Therakos Inc. for about $1.3 billion is the second drug-device acquisition by Mallinckrodt plc this year, it's because of the synergies between the two firms involved in the deals rather than a preference for such technology per se. Read More
Genome-editing start-up Editas Medicine Inc. has raised $120 million in an oversubscribed series B financing to advance its discovery-stage programs and platform in one of the year's biggest private financings. Read More
Last week, Astrazeneca plc tapped Mirati Therapeutics Inc. for a partnership that will explore a pairing of the spectrum-selective histone deacetylase, or HDAC, blocker mocetinostat with the anti-programmed death-ligand 1 (PD-L1) candidate durvalumab (MEDI4736). Read More
A federal district judge shot down the FDA's attempts to marginalize the Second Circuit's Caronia ruling in justifying its continued censorship of drugmakers' truthful comments about off-label uses of their products. Read More
LONDON – Ocata Therapeutics Inc. is poised to start phase II trials of its human embryonic stem cell-derived retinal pigment epithelium (RPE) cells in the treatment of macular degeneration, which the company said will be the first such ophthalmic studies to feature placebo-controlled arms. Read More
A phase II trial of an experimental respiratory syncytial virus (RSV) vaccine created by Novavax Inc. prevented symptoms of the common and sometimes deadly virus in as many as 46 percent of older adults, giving the company a strong foundation ahead of a planned pivotal phase III trial that could start as early as the fourth quarter and boding well for another program testing the vaccine to protect infants via maternal immunization scheduled to report data in September. Read More
HONG KONG – Two stem cell labs in China have independently reported the successful transformation of fibroblasts into functional neurons using only chemicals, with one group using human cells from healthy individuals and Alzheimer's patients, while the other used mouse cells, potentially providing other sources of neuronal cells for drug discovery and regenerative medicine. Read More
Shares of Karyopharm Therapeutics Inc. hit a new 52-week low Monday on news that a higher-than-expected rate of sepsis prompted the Newton, Mass.-based firm to reduce the dose in an ongoing phase IIb study testing selinexor in elderly patients with acute myeloid leukemia (AML). Read More
Zynerba Pharmaceuticals Inc., of Devon, Pa., said it closed its IPO of 3.45 million shares priced at $14 each, including the exercise in full by underwriters to purchase up to 450,000 additional shares, resulting in gross proceeds of $48.3 million. Read More
Anavex Life Sciences Corp., of New York, said it received a research grant from the Michael J. Fox Foundation for Parkinson's Research for Anavex 2-73, which is being studied for Parkinson's disease. Read More
Gamida Cell Ltd., of Jerusalem, reached agreements with the FDA and European regulators regarding the phase III study design outline of Nicord. Read More