Florida-based Cyber Business Technology, NextGen Nutritionals and Strictly Health settled Federal Trade Commission false advertising charges, in which they were said to be marketing and selling dietary supplements with claims of curing a variety of conditions and achieving high levels of weight loss. The five dietary supplements with false claims include BioMazing HCG Full-Potency Weight-Loss Drops, VascuVite, Hoodoba, Immune Strong and Fucoidan Force.
Viiv Healthcare's Juluca, or dolutegravir and rilpivirine, was approved by the FDA as a treatment for adult patients with chronic HIV-1 infection who are virally suppressed on a stable regimen for at least six months, have not previously experienced treatment failure and have no known substitutions related to resistance to either of the component drugs.
The FDA issued regulatory plans on the development of generic versions of approved opioid medications formulated to deter abuse, which include recommendations on the types of studies companies should conduct to show a generic drug has at least the same abuse deterrence as its branded counterpart. The guidance also intends to improve the regulatory process with new tools for evaluation and labeling of abuse-deterrent opioids.
A late-stage trial evaluating tirasemtiv in patients with amyotrophic lateral sclerosis was suspended by Cytokinetics after missing the primary endpoint of demonstrating change from baseline in slow vital capacity after 24 weeks of double-blind, placebo-controlled treatment. The drug also did not achieve various muscle strength and respiratory secondary endpoints that were evaluated at 48 weeks.
A supplemental biologics license application was submitted by Johnson & Johnson to the FDA seeking approval to make its drug Darzalex, or daratumumab, a first-line treatment for multiple myeloma patients ineligible to undergo autologous stem cell transplantation. A Type II variation application was also filed with the European Medicines Agency for the same drug.
Orexo and MundiPharma were granted marketing authorization by the European Medicines Agency for Zubsolv, or buprenorphine and naloxone, indicated to treat patients with opioid dependence. Data from a bioequivalence study comparing the drug with Suboxone supported the submission, as well as data from a study of more than 1,000 opioid-dependent patients.
A development agreement was reached by Dexcom with Eli Lilly and Co. to combine Dexcom's continuous glucose monitor with Eli Lilly's connected insulin delivery devices. The companies aim to promote their combined technologies as a comprehensive solution for patients with diabetes and hope to launch trials by next month.
A previously announced offering of common shares and share purchase warrants was upsized by Titan Medical to raise between $14.1 million and $18 million. The company, which previously aimed to secure between $10.2 million and $11.7 million in the offering, intends to use the proceeds as working capital, as well as for further development of its Sport robotic surgical platform and other general corporate functions.
Fresenius Kabi, which specializes in infusion, clinical nutrition and transfusion technologies and medicines, will invest $150 million in an expansion project in Wilson County, N.C., through which it will create 445 jobs in the next five years, said Gov. Roy Cooper. The company intends to enlarge its current pharmaceutical production facility, which specializes in ready-to-administer syringes, and construct a manufacturing facility on the site.
A 50,600-square-foot regional facility was opened by Varian Medical in Brazil. The facility features a demonstration room, manufacturing and warehousing areas, and two training rooms that include the company's Varian Trilogy linear accelerator platform.
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