Abeona Therapeutics received an FDA rare pediatric disease designation for ABO-202, which is being developed to treat CLN1 disease, an infantile- and late-infantile-onset Batten disease.
The FDA granted ADDMEDICA approval to market Siklos, its hydroxyurea tablets used to treat sickle cell patients ages 2 years and older, in the US. The drug, which has been on the market in Europe since 2007, will be sold in the US by Medunik USA.
Johnson & Johnson unit Janssen Pharmaceutica's late-stage erdafitinib has been granted breakthrough therapy status by the FDA as a treatment for patients with metastatic urothelial cancer.
The FDA has granted fast-track status to Ovid Therapeutics' OV101, which is in development to treat fragile X syndrome. This year, the company will start a midstage study of the drug in males ages 13 to 22.
A safety review will be conducted by Health Canada for Fibristal, or ulipristal acetate, a uterine fibroid treatment, after reports of serious liver injury or impairment requiring transplant in women taking the drug. Fibristal's label was updated in Canada in January to reflect the risks of liver injury, and Health Canada said it will review new scientific literature and injury cases, taking action as needed to optimize the benefits of Fibristal and lessen the risk associated with using it.
A voluntary nationwide recall was issued by Johnsonville for approximately 109,603 pounds of Jalapeno Cheddar Smoked Sausage after three consumer complaints about the presence of hard, green plastic pieces in the product. The recalled products bear the establishment number EST. 34224 and best-by date of April 4 of this year, and were distributed to retail locations across the country.
Industry groups and vendors flooded the FDA with comments regarding a draft guidance on clinical and patient decision support software, with AdvaMed saying that the concept of transparency "should remain focused on the information underlying the recommendation within an artificial intelligence and/or machine learning process, rather than the algorithm itself." Commenters also expressed concern about the lack of a risk-based framework that would ensure clarity of the agency's scope of regulation and enforcement discretion for CDS software, with the Clinical Decision Support Coalition warning that fewer products would make it to the market if the draft guidance were enacted without changes.
Akcea Therapeutics has acquired an exclusive global license to develop and commercialize Ionis Pharmaceuticals' hereditary transthyretin amyloidosis drug candidate inotersen and IONIS-TTR-Lrx for hereditary and wild-type forms of ATTR. Under the terms of the deal, Ionis will receive a $150 million licensing fee and is eligible for milestone payments of $50 million and $40 million upon FDA and European approval of inotersen and IONIS-TTR-Lrx.
An initial public offering brought in $120 million for cancer immunotherapy developer Arcus Biosciences. The funds will be used to continue development of Arcus' two lead drugs, with the company slated to report on initial clinical data later this year.
Novo Nordisk continues to highlight the cardiovascular benefits of its diabetes drug Victoza in two new TV ads. "There still remains an important need to educate around the link between type 2 diabetes and cardiovascular disease and this campaign brings a fresh creative approach to this very crowded category but keeps the same educational message," says Novo's Ed Cinca.
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