Transcelerate Biopharma Inc., a nonprofit established by 10 of the industry's largest pharmas in 2012, is launching Biocelerate, a new subsidiary that aims to improve efficiencies in preclinical research, first by working to illuminate the relationship between patient response and preclinical toxicology findings.
President Barack Obama's $4.1 trillion final 2017 budget proposal arrived on the Hill Tuesday, requesting an 8 percent rise in FDA funding to $5.1 billion, a $2 billion boost for the National Institutes of Health's (NIH) budget to $33.1 billion and a supplemental request for $1.8 billion in emergency funds to fight the Zika virus.
The FDA placed a partial clinical hold on trials of CTI Biopharma Corp.'s lead candidate, pacritinib, citing fatal and life-threatening safety issues in patients treated with the drug vs. those provided best available therapy other than JAK inhibitors in the control arm of PERSIST-1, a phase III study of primary myelofibrosis (MF). The hold also impacts PERSIST-2, an ongoing study extending pacritinib treatment to patients with post-polycythemia vera MF and post-essential thrombocythemia MF.
Invoking Fifth Amendment protection against self-incrimination during a House hearing on high drug prices, former Turing Pharmaceuticals AG chief Martin Shkreli was excused by U.S. House Committee on Oversight and Government Reform Chairman Jason Chaffetz (R-Utah), leaving Chaffetz and other furious representatives to question Turing's chief commercial officer, Nancy Retzlaff, who fought a losing battle to convince them that patient issues accessing Daraprim (pyrimethamine) had nothing to do with Turing's historic increasing of its price.
Takeda Pharmaceutical Co. Ltd. committed to pay Mersana Therapeutics Inc. $40 million up front, plus up to $750 million in milestone payments plus royalties to gain ex-U.S. and Canada rights to the company's lead candidate, a preclinical antibody-drug conjugate (ADC) targeting HER2-expressing tumors, and to advance a potential new slate of ADCs, one of which Mersana can opt to co-develop following phase I studies.
Rising concern over the spread of the Zika virus, crystallized by Monday's WHO labeling of it as a public health emergency, has jumpstarted efforts at Sanofi SA, Glaxosmithkline plc, Newlink Genetics Corp., Mymetics Corp. and Valneva SE to develop new vaccines against the dengue-related virus.
Exelixis Inc. added increased overall survival vs. Afinitor (everolimus, Novartis AG) to the list of benefits provided by cabozantinib for second-line renal cell carcinoma (RCC) patients, providing what president and CEO Michael Morrissey told BioWorld Today was “the missing piece of the puzzle in terms of the full cabozantinib second line RCC story.”
FDA approval for Merck & Co. Inc.'s once-daily hepatitis C virus (HCV) treatment, Zepatier (elbasvir and grazoprevir), is expected to bring new, but not disruptive, competition to the hot market currently dominated by Gilead Sciences Inc. Zepatier, projected by consensus forecasts to generate $544 million for Merck this year and more than twice that by 2018, according to Thomson Reuters Cortellis, offers a new oral treatment option for patients with genotype 1 and 4 infections (GT1 and GT4).
Unrest sowed by Incyte Corp.'s futility-driven stoppage of a phase II substudy testing Jakafi (ruxolitinib) and Stivarga (regorafenib, Bayer AG) against metastatic colorectal cancer (mCRC) helped drive company shares (NASDAQ:INCY) down 9.6 percent on Thursday, closing at $67.81, as analysts pondered the implications for a phase III test of Jakafi in metastatic pancreatic cancer that is expected to yield results this year.
