A biologics license application has been submitted to the FDA by Merck for Acarizax, a sublingual allergy immunotherapy tablet, as a treatment for house dust mite allergy. Data from a 4,400-patient study supported the filing. Acarizax, which is being develop in partnership with ALK, is approved in Europe for the treatment of allergic rhinitis and allergic asthma patients who do not respond sufficiently to other treatments.
Zika virus research data will be shared publicly by research institutions worldwide to develop vaccines and treatments against the virus, a group of 30 funders, research institutions and journals said. Institutions that pledged to share data include the CDC, the UK's Academy of Medical Sciences, the World Health Organization, France's Institut Pasteur and the Wellcome Trust.
The US Department of Agriculture will temporarily provide free blood tests for lead, as well as nutrition programs, to some low-income mothers and children in Flint, Mich., to help them cope with the city's water crisis, said Dr. Kathryn Wilson, the agency's deputy undersecretary for food, nutrition and consumer services. Blood tests will be offered until September 2017 to about 3,800 infants, children, and pregnant and post-partum women on the Women, Infants, and Children program. A Summer Electronic Benefit Transfer program will be available to help children eat healthy during the summer break.
Amarantus BioScience Holdings obtained orphan-drug status from the FDA for eltoprazine, a 5HT 1A/1B receptor agonist, as a treatment for levodopa-induced dyskinesia associated with Parkinson's disease treatment. Amarantus is also developing the drug for the treatment of attention-deficit/hyperactivity disorder in adults.
The presence of soy not listed on the label prompted Giant Eagle and Market District Supermarkets to recall about 420 packages of Giant Eagle brand Japanese Breaded Cod Fillets. Affected products have UPC numbers beginning with 268106 and were sold in supermarkets in Ohio and Pennsylvania through Feb. 4.
The FACSPresto system and CD4/Hb cartridge, developed by Becton Dickinson as an HIV/AIDS diagnostic, has received 510(k) clearance from the FDA. The product is intended to work as an absorbance spectrometer and multicolor fluorescent imaging cytometer to deliver CD4 T lymphocyte and hemoglobin concentration results using blood samples.
A recall initiated by Drager Medical involving 117 units of its Oxylog 2000 plus, Oxylog 3000 and Oxylog 3000 plus emergency transport ventilators has been categorized by the FDA as Class I. The recall was issued over concerns that the ventilators may stop working due to a system error, which may result in death or serious adverse health consequences. The firm has already notified customers about the problem.
The Expression MR400, a technology developed by Royal Philips to monitor magnetic resonance imaging patients, has obtained 510(k) clearance from the FDA. The device, which offers MR suite bedside-quality monitoring, alerts clinicians of severe medical changes in the patient.
Mylan agreed to buy Meda, a Sweden-based company that develops branded, over-the-counter and generic treatments, in a cash-and-stock deal valued at $7.2 billion. The acquisition is expected to be completed in the third quarter of this year.
A Series C funding round has brought in $50 million for Redwood City, Calif.-based Armo BioSciences. The firm is evaluating its lead cancer imunotherapy drug, AM0010, in combination with other therapies, in multiple studies for various cancer indications.
- Page 1