The U.S. Patent and Trademark Office (PTO) is seeking feedback on artificial intelligence (AI), posing questions on whether the regulations or even the statute will have to be amended to allow the agency to issue patents for items invented in part or in whole by AI. Read More
Artificial intelligence (AI) has helped the med-tech industry in numerous ways. From genomics, to screening, to diagnostics, AI has made things easier for clinicians. And that has caught the eye of investors. According to Mercom Capital Group LLC, as a whole, digital health venture capital funding in the second quarter 2019 jumped from the previous quarter ($3.1 billion raised in 169 deals vs. $2 billion raised in 149 deals). Read More
The next wave of drug discovery is being enabled by powerful computers dining on complex algorithms to uncover potential new scientific approaches for the development of innovative therapeutics. This fact has not been lost on venture capital firms specializing in the health care space that are beginning to support emerging biopharma companies that are using artificial intelligence (AI) and machine learning (ML) to supercharge their drug discovery and development activities. Read More
DUBLIN – Amgen Inc. is picking up Celgene Corp.'s oral phosphodiesterase 4 (PDE4) inhibitor Otezla (apremilast) for $13.4 billion, in a move that strengthens its hand in inflammatory disease, while paving the way for Bristol-Myers Squibb Co. to complete its $74 billion cash-and-shares acquisition of Summit, N.J.-based Celgene. Read More
Top-line results from The Medicines Co.'s first pivotal phase III trial of the cholesterol-lowering candidate inclisiran met all primary and secondary efficacy endpoints, with safety "at least as favorable" as in two recent studies, the company said, addressing a top concern for investors tracking the program. Though final results of the study, Orion-11, won't be made public until next week's European Society of Cardiology Congress (ESC) in Paris, excitement about what Evercore ISI analyst Umer Raffat said could be the "first 'vaccine' for cholesterol management," dosed twice-yearly, lifted Medco shares (NASDAQ:MDCO) 13.8% to $39.85 on Monday. Read More
BEIJING – Fibrogen Inc. said its first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor roxadustat (previously FG-4592) won a second approval in China to include more patients with anemia caused by chronic kidney disease (CKD). China, again, is the first market to grant the company the nod to treat patients who are not dialysis-dependent. Read More
BOGOTA, Colombia – The Mexican health surveillance agency Cofepris issued an alert about the presence in the country of counterfeited batches of Herceptin (trastuzumab, Roche Holding AG). The alert followed an investigation conducted by the agency after the Swiss drug maker filed a complaint and warned the federal authorities of the counterfeited product in the market. Read More
The FDA issued a draft guidance Monday encouraging the inclusion of male patients in breast cancer clinical trials. The draft provides clarity on how additional data to support efficacy and safety for male patients can be generated through a variety of trial designs using different data sources, including studies that use real-world data. Read More
Clarus Therapeutics Inc., of Northbrook, Ill., said that Lipocine Inc., of Salt Lake City, has confirmed that it will not seek preliminary injunctive relief against the company in a lawsuit that asserts its product Jatenzo infringes certain Lipocine patents, even in the event that the product, an oral testosterone undecanoate capsule for the treatment of appropriate men with testosterone deficiency, is launched. A trial date in the dispute has been set for August 24, 2020, in the U.S. District Court for the District of Delaware. Read More
Veloxis Pharmaceuticals A/S, of Copenhagen, said the company's capital has been increased by 6.48 million new shares with a nominal value of DKK 0.10 each corresponding to DKK 648,606 (US$96,700) as a result of the exercise of warrants by current and former employees of the company. The new shares will be listed on Nasdaq Copenhagen following registration of the capital increase with the Danish Business Authority. Read More
Johnson & Johnson's "misleading marketing and promotion" of opioids created a nuisance that compromised the health and safety of thousands of Oklahomans, an Oklahoma judge ruled Monday. In a first-of-its-kind case, Judge Thad Balkman ordered J&J to pay more than $572 million to immediately abate the nuisance he said the company and its subsidiary, Janssen Pharmaceuticals Inc., caused. "The opioid crisis is an imminent danger and menace to Oklahomans ... This is a temporary public nuisance that can be abated," Balkman said. Read More
