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Home » Newsletters » BioWorld

BioWorld

March 13, 2019

View Archived Issues

Azar opens congressional budget tour by naming acting FDA commissioner

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

Temelimab extension data keep Geneuro's MS hopes alive

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

Assay can you see? Effort in diabetes active, Zafgen discloses holdup in PWS

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's vadadustat succeeds in Japanese pivotal anemia studies

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

Smith & Nephew nabs Osiris in $660M deal; regen med firm adds to wound healing business

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

Despite downturn, drug execs mostly positive about 2019, with a few caveats

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

Financings

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

Regulatory front

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

Other news to note

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

Clinical data for March 12, 2019

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Regulatory actions for March 12, 2019

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