Shares of Adamis Pharmaceuticals Corp. (NASDAQ:ADMP) climbed 50 percent to $4.80 on Monday as – more than a year after FDA approval of Symjepi (epinephrine), its competitor for Mylan NV’s Epipen and other emergency epinephrine products – it secured a U.S. distributor and commercial partner for the product. Under terms of the 10-year deal, Adamis and Novartis Group’s generics arm, Sandoz Inc., will equally split net profits from sales of the single-dose pre-filled syringe of epinephrine. Read More
The Government Accountability Office (GAO) is weighing in on the need for more oversight of the 340B Drug Pricing Program. In a report released last week, the GAO said that about one-third of the more than 12,000 hospitals and clinics that get the mandated manufacturer discounts on outpatient drugs contract with outside pharmacies to dispense the drugs on their behalf. Read More
Evonetix Ltd., of Cambridge, U.K., said that Innovate UK, the U.K.'s innovation agency, will co-fund a £1.3 million (US$1.7 million) project to develop an enzymatic approach to DNA synthesis to be undertaken in collaboration with Durham University. Read More
Jumping straight into phase III development, Ocugen Inc. is looking to use the 505(b)(2) regulatory pathway to gain expedited approval for OCU-300. Read More
LONDON – It's now only 270-odd days to go, and the U.K. and EU remain at loggerheads on the terms of Brexit. The prospect of the U.K. crashing out with no deal is increasing and life sciences companies are preparing for the worst. Read More
DUBLIN – European biotechnology firms engaged in drug development raised $3,904 million during the first half of the year, dwarfing the $2,302 million raised during the equivalent period last year and putting the sector on course for a new high-water mark. Read More
This time last year, Athenex Inc. was fresh off its IPO, which grossed $66 million, and embarking on an ambitious strategy to conduct phase III trials of Oraxol, the lead chemotherapeutic from its Orascovery platform, in metastatic breast cancer (MBC) and the phase III program for KX-01, the lead candidate from its Src kinase inhibition platform, to treat actinic keratosis (AK). The Buffalo, N.Y.-based company delivered everything promised in the IPO on time or ahead of schedule, according to CEO Johnson Lau. (See BioWorld Today, June 7, 2017.) Read More
