The 21st Century Cures Act, which would speed up the regulatory process for medical devices and drugs, cleared the Senate by a vote of 94-5 on Wednesday and was sent to President Barack Obama for his signature. BIO President and CEO Jim Greenwood said the bill "is an important victory for medical innovation that will help expedite the development of the next generation of breakthrough medicines to save lives and reduce suffering for millions of patients, while helping to lower other health care costs."
The Gladstone Institutes' entrepreneurial initiative BioFulcrum has launched Tenaya Therapeutics, a biopharmaceutical company that will focus on drug discovery and regenerative medicine for cardiovascular diseases through cellular reprogramming. The new firm is funded through $50 million in Series A financing.
The FDA and Panther Biotechnology met about the firm's plan to submit an investigational new drug application for TRF-DOX next year and shared guidance on Panther's open-label Phase IIa study. The drug is a transferrin-doxorubicin conjugate being developed to treat platinum-resistant ovarian cancer.
A Series A financing round has brought in $44.5 million for Cambridge, Mass.-based TCR2 Therapeutics. The immuno-oncology firm intends to develop T-cell therapies using its T-cell receptor fusion construct platform for potential use in treating solid and hematological cancers.
The development of herbicide-tolerant biotech crops has reduced farmers' reliance on tillage, thus preventing erosion, improving soil health and reducing greenhouse gas emissions, writes Council for Biotechnology Information Managing Director Kate Hall. The Conservation Technology Information Center says "biotechnology has played a significant role in influencing the shift of millions of acres of US cropland to conservation tillage systems, which in turn has reduced topsoil loss, energy consumption, pesticide use, labor, water pollution and air pollution," Hall writes.
A draft guidance has been submitted to the FDA by the Amyloidosis Research Consortium on developing drugs for amyloid light chain amyloidosis. The guidance presented suggestions for clinical trial designs to take impaired cardiac and renal function in patients into consideration and also suggests using as an endpoint free light chains or N-terminal pro-brain natriuretic peptide measurements.
Sandoz has launched a generic version of Allergan's Latisse, or bimatoprost ophthalmic solution, which will be available in a 4-mL bottle with 70 applicators and in an 8-mL with 140 applicators. The solution is designed to treat hypotrichosis of the eyelashes.
Snow Monkey Subzero Superfood branded pods in Cacao and Goji Berry flavors are being recalled by FMIF Holdings due to potential listeria contamination. The products being recalled were packed in 8-ounce plastic pods and were sold online in 17 states and the District of Columbia between May and June.
The FDA has given Voluntis clearance to market its Insulia Diabetes Management Companion, a prescription-only device that comes with companion software to provide type 2 diabetes patients with coaching messages and insulin dose suggestions based on diabetes-related data, such as blood glucose values. The device, which is expected to be launched in the first half of next year, has also received CE mark approval from regulators in Europe.
The FDA has given Abiomed an expanded indication for its Impella CP heart pump for use in high-risk percutaneous coronary interventions for up to six hours. The device previously received premarket approval from the agency for up to four hours of use in treating cardiogenic shock after a heart attack or heart surgery.
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