With new approaches coming down the pike and Hemlibra (emicizumab, Roche Holdings AG) due for a potentially wider label in a month or so, Bayer AG's win with longer half-life Jivi (antihemophilic factor [recombinant] pegylated-aucl) makes for an even more competitive hemophilia A space. Read More
HONG KONG – Following a priority review, Astrazeneca plc won approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Tagrisso (osimertinib). The drug is now greenlighted as a first-line treatment in patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Read More
DUBLIN – Genomics plc raised £25 million (US$32.5 million) in a series B round, led by Vertex Pharmaceuticals Inc., which also signed up for a three- to five-year collaboration in which the Oxford, U.K.-based data science firm will hunt for new drug targets and seek new disease insights by analyzing extensive repositories of human genetic data that are linked to phenotypes and clinical outcomes. Read More
Not all that long ago, many first-in-class drugs approved in the U.S. could face competition within five years as more drugs in that class poured from the pipeline. Not so much these days. FDA Commissioner Scott Gottlieb chalks the difference up to the growing complexity and cost of clinical trials, for both drugs and devices. The cause and effect of the cost of trials and the lack of ready competition is contributing to high prices for therapies and cures, he said. Read More
Pfizer Inc. is quitting a pair of phase II studies testing its experimental Duchenne muscular dystrophy (DMD) drug domagrozumab after finding the anti-myostatin candidate offered boys with DMD no more benefit than a placebo during a stair-climbing test. The candidate was one of the 15 programs the company had identified as potential blockbuster medicines. The company's early stage gene therapy candidate for DMD remains in development. Read More
Changes in the manufacturing process may have led to the formation of N-nitrosodimethylamine (NDMA), a potential carcinogen, in valsartan manufactured by Zhejiang Huahai Pharmaceutical Co. Read More
Fit Biotech Oy, of Tampere, Finland, said that, under its convertible note and warrant programs established with Alpha Blue Ocean (ABO), the company's board has approved ABO's request to convert €30,000 (US$34,984) worth of convertible capital notes into the company's K shares. It says it will transfer 75 million new K shares to ABO. Read More
Ixico plc, a London-based provider of specialty data analytics services, said that it has expanded its contract with an unidentified biopharma company to May 2021, adding €0.5 million (US$583,300) to the Alzheimer's disease-focused contract. The total contract value is now €1.3 million (US$1.5 million) Read More
