Yescarta, or axicabtagene ciloleucel, the second drug in a new class of chimeric antigen receptor T-cell therapy products developed to treat cancer, was approved by the FDA for patients with diffuse large B cell lymphoma. The treatment, originally developed by Kite Pharma, was acquired by Gilead Sciences in August, and a single dose is expected to cost $373,000.
Maryland is partnering with the UK in cybersecurity, recently establishing a London-based office to target cybersecurity investment for the state. The office is being funded by a state Commerce Department grant to the state's new iCyberCenter, a startup program that also aims to bring more international companies to Maryland.
The Maryland Office of Homeland Security must seek expertise from the US government, private sector, academics and other state agencies to develop and submit an updated state cybersecurity plan that ensures that critical statewide protections are in place, per an executive order issued by Gov. Larry Hogan.
Conatus Pharmaceuticals' IDN-7314 was granted orphan drug designation by the European Medicines Agency as a treatment for patients with primary sclerosing cholangitis. The drug, an orally available pan-caspase protease inhibitor, also received orphan drug designation from the FDA in June.
In its audit of the USDA's Food Safety and Inspection Service's foreign equivalency assessments, the HHS Office of Inspector General found "a weakness in the agency's oversight structure for monitoring equivalence," as well as inconsistencies in its performance assessment and lack of management controls over foreign countries' food safety system equivalence evaluations. The OIG said the agency should update its guidance for verifying foreign food safety systems' ongoing equivalence and develop and implement guidance for foreign countries regarding delisting and the reasons for it, among other recommendations.
The Lightning-enabled version of DarioHealth's Dario blood glucose monitoring system was granted CE mark approval by European regulators. The version connects to Apple's iPhone 7 and iPhone 8 smartphones via a 3.5-mm headphone jack or Lightning connector.
A petition for suspension or withdrawal of India's benefits under the Generalized System of Preferences was filed by AdvaMed with the US Trade Representative in hopes of advancing discussions with the country in light of its price controls on coronary stents and knee implants that could be extended to other devices. "We believe a stable and predictable market environment is key to driving investments in R&D, manufacturing, and other services to grow the medical technology industry in India, and meet the current and future needs of all of India's people," AdvaMed President and CEO Scott Whitaker said.
Chiesi Farmaceutici gained ex-US rights to Protalix BioTherapeutics' PRX-102, or pegunigalsidase alfa, which is in late-stage testing for treating patients with Fabry disease. The deal grants Protalix $25 million upfront plus milestones and royalty fees.
German company CureVac and Eli Lilly and Co. will collaborate on developing up to five mRNA cancer vaccines using CureVac's RNActive technology, with Lilly determining the diseases to be targeted, conducting clinical studies and marketing any FDA-approved vaccines. Lilly will pay CureVac $50 million in cash upfront plus up to $1.7 billion in milestones and will also invest about $53.1 million in the company, granting Lilly an approximate 3% share in the biotech firm.
Ugandan scientists expect the initial batch of locally grown, disease-resistant biotech potatoes to be released to the market in 2020. Alex Barekye, director of the Kachwekano Zonal Agriculture Research Institute in Rubanda, said its Victoria biotech potato variety showed good yield and performed well in terms of disease resistance in three trials, but additional field tests will be carried out next month in three different areas in Uganda to determine whether the potato can thrive in different environments.
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