U.S. Health and Human Services (HHS) Secretary Alex Azar kicked off his congressional budget tour Tuesday with the announcement that Norman "Ned" Sharpless, director of the National Cancer Institute (NCI), will step in as the acting FDA commissioner when Scott Gottlieb leaves the post. Read More
DUBLIN – Shares in Geneuro SA rose as much as 35 percent Tuesday on news that its multiple sclerosis (MS) candidate, temelimab, showed hints of efficacy on several measures of disease progression and neuroprotection in patients in a phase IIb extension study. Read More
Zafgen Inc. CEO Jeffrey Hatfield said the firm has backup compounds for ZGN-1258 to treat Prader-Willi syndrome (PWS) and "remains committed" to the condition. "We're going to evaluate all of our options to try and unlock potential value we see in methionine aminopeptidase 2 [MetAP2] inhibition for this terrible disease." Read More
Akebia Therapeutics Inc. said two pivotal Japanese studies of its anemia drug, vadadustat, each with active controls, met their primary endpoints by helping people with chronic kidney disease (CKD) achieve mean hemoglobin levels noninferior to Aranesp (darbepoetin alfa). The results will support Akebia's commercial partner, Mitsubishi Tanabe Pharma Corp. (MTPC), in readying a new drug application seeking Japanese regulatory approval this year. Read More
Osiris Therapeutics Inc. is slated to be acquired by orthopedics player Smith & Nephew plc for about $660 million in cash. The deal is focused on skin substitutes – particularly allografts made of donor tissue that the London-based company expects will help to ramp up its wound management business. Read More
TOKYO – An ongoing downturn in global trade may turn out to be unexpectedly severe, but in the midst of the ongoing difficulties there may be opportunities for biotech companies. That was the opinion of industry executives speaking at the Bio Asia International Conference last week, as they generally agreed that this year should be a good one for biotech stocks, in no small part thanks to an expected recovery from the sharp correction during the last quarter of 2018. Read More
Apellis Pharmaceuticals Inc., of Waltham, Mass., closed its public offering of 6.9 million shares, including 900,000 shares to fulfill the underwriters' option to purchase additional shares, at $17 per share, which grossed the company $117.3 million. Citigroup, J.P. Morgan and Cowen acted as joint book-running managers for the offering. Cantor Fitzgerald & Co. acted as lead manager for the offering. Read More
Pfizer Inc. agreed to a $975,000 settlement with the Oregon Department of Justice to resolve allegations that the New York drug company distributed misleading marketing materials and coupons to Oregon consumers. Read More
Secura Bio Inc., of Henderson, Nev., said it acquired global rights to histone deacetylase inhibitor Farydak (panobinostat) from Novartis AG, of Basel, Switzerland. In 2015, Farydak received FDA accelerated approval and EMA approval to treat multiple myeloma. Financial terms were not disclosed. Read More
