Decades of demands for clinical trials to be more representative of the real world appear to have gone unheeded as trials still tend to reflect a Goldilocks population that's predominantly white, not too old, not too young and not too sick. Read More
LONDON – Bergenbio A/S raised NOK187.5 million (US$24 million) in a private placement of new shares, lengthening the cash runway as it awaits data from six ongoing phase II cancer trials and enabling the company to extend the applications of its Axl kinase inhibitor bemcentinib (BGB-324) to the treatment of fibrotic disorders. Read More
With a phase III candidate that CEO Matthew Pauls said could be positioned as "the first-line, first-choice medicinal therapy for Cushing's syndrome [CS]," Strongbridge Pharma plc kicked off a second late-stage trial to test Recorlev (levoketoconazole), an oral cortisol synthesis inhibitor. Read More
KARACHI, Pakistan – Marking a significant step for Pakistan's reborn pharmaceutical industry, a domestic manufacturer received pre-qualification from the World Health Organization (WHO) for the sale of one of its products, moxifloxacin hydrochloride, for use in treating pulmonary infections as part of its tuberculosis program. Read More
HONG KONG – South Korean company Daewoong Pharmaceutical Co. Ltd. is partnering with Universitas Indonesia (UI), a state university in Jakarta, to jointly develop new biological medicines. The collaboration – the first of its kind in Indonesia – is expected to help Daewoong expand its global manufacturing and R&D network. Read More
LONDON – The industry is calling for pragmatism as it fights back against the EMA's decision to enforce a hard Brexit and expel the U.K. from its system by March 2019. Read More
Dicerna Pharmaceuticals Inc. has agreed to $25 million worth of cash and stock to settle a long-running legal spat with competitor Alnylam Pharmaceuticals Inc., which had sought damages in excess of $100 million against it. News of the settlement sent Dicerna's shares (NASDAQ:DRNA) briefly more than 40 percent higher Friday, before ending the day at $12.01, up $1.82. Read More
Hemispherx Biopharma Inc., of Orlando, Fla., entered a securities purchase agreement with certain accredited institutional investors to purchase about $2.57 million shares of its common stock in a registered direct offering and concurrent private placement at a premium to market. Read More
Shire plc, of Dublin, confirmed Friday that it received a fourth proposal from Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, regarding a possible offer for the company. Read More
Tumors with a high mutational burden, such as lung tumors, present a good news-bad news conundrum for targeted therapies. The many mutations in their genomes make finding an actionable driver mutation akin to finding a needle in a haystack, though those many mutations also make it likely that there is a needle in the haystack in the first place. Researchers from the University of Texas Southwestern Medical Center and the South Korean Yonsei University College of Medicine have now developed an analysis method to identify "therapeutic triads" consisting of a target mutation, an enrollment biomarker, and a tool compound effective against the target mutation. Read More
Biogen Inc. didn't have to look far beyond the revenue stream for its spinal muscular atrophy (SMA) blockbuster, Spinraza (nusinersen), to conclude that keeping partner Ionis Pharmaceuticals Inc. close at hand was in its best interest. With the five-year neuroscience deal that spawned Spinraza set to expire in the next year, Biogen sweetened the pot by paying $1 billion for a 10-year extension. Read More
