PERTH, Australia – Australia's Neuclone Pharmaceuticals Ltd. is developing a broad pipeline of biosimilars, and it plans on being a big disrupter to the global pharma market. Read More
President Donald Trump said Friday he will sign a deal that will reopen the federal government for three weeks, an announcement seconded by FDA Commissioner Scott Gottlieb via Twitter. Gottlieb said he is "delighted by the announcement" by the president "of a deal to re-open the federal government," lauding FDA employees who worked without pay as well as those who had been furloughed. Read More
Geovax Labs Inc., of Atlanta, said an article published in the open-access Atlas of Science reported that testing in a challenge model showed that its vaccine candidate, GEO-ZM02, provided full protection to mice infected with a lethal dose of Zika virus delivered directly into the brain. The study was funded by a grant from the CDC, which also provided technical assistance. Read More
Nicox SA, of Sophia Antipolis, France, said it entered a tranched bond financing of up to €20 million (US$22.8 million) with Kreos Capital, expected to extend its cash runway into 2021. Nicox expects to draw down the first tranche of €8 million by Feb. 1, with the option to draw up to €7 million on Aug. 1 and the remainder on Nov 1. Read More
Abbvie Inc., of North Chicago, reported net revenues of $8.3 billion in the fourth quarter, a gain of 7.3 percent year-over-year, and 2018 net revenues of $32.75 billion, an increase of 15.2 percent on an operational basis. Abbvie said global sales of Humira (adalimumab) increased 0.5 percent in the fourth quarter based on growth of 9.1 percent in the U.S. and a decline of 14.8 percent operationally outside the U.S., where the therapy faced growing competition from biosimilars. Read More
In every type of financing, from IPOs and follow-on public offerings to private placements and venture capital rounds, the med-tech industry produced more money and completed more financings in 2018 than the prior year, reflecting the same significant jump in activity seen with its biopharma counterpart. Read More
Investors and others in the field of Parkinson's disease (PD) are weighing the odds of two major players in treating "off" episodes: Sunovion Pharmaceuticals Inc. with apomorphine sublingual film (APL-130277), for which the FDA set Tuesday as the PDUFA date; and Acorda Therapeutics Inc., of Ardsley, N.Y., preparing to launch Inbrija (levodopa inhalation powder) this quarter. Off periods are times when PD symptoms return because of low dopamine levels between doses of oral carbidopa/levodopa. Read More
About four years after starting up as part of the Y Combinator accelerator, Notable Labs Inc. has its first drug, ND-1000, ready to enter the clinic. Read More
Patent protection for drugs hinges on protecting the molecules themselves in composition-of-matter patents. But its structure is only one aspect of a drug that can be protected by patents. Another possibility is to patent the chemical pathway to that structure via composition patents. Pathways, plural, actually – pretty much any compound can be synthesized via multiple routes. The patents around Merck & Co. Inc.'s Januvia (sitagliptin), for example, include more than 400 intermediates, and more than 450 unique reactions. Read More
Researchers from the Roswell Park Comprehensive Cancer Center have demonstrated that a normally intracellular peptidase, when administered systemically, bound to the extracellular domain of both HER2 and EGFR, and was effective at killing tumor cells in mouse models of HER2-driven breast cancers. Read More
