Certain manufacturers will be allowed by the FDA to distribute blood pressure drug losartan that contains N-Nitroso-N-methyl-4-aminobutyric acid levels above acceptable limits until it can be eliminated. The agency anticipates firms to be able to manufacture losartan without the impurity and replenish the US supply in about six months.
Final guidance was issued by the FDA for drug developers of therapies that treat severely debilitating or life-threatening hematologic disorders, including sickle cell disease and hemophilia. Goals include speeding drug development while protecting patients and reducing use of animal studies, Commissioner Scott Gottlieb said.
Nutra Pharma received a warning letter from the FDA for distributing unapproved homeopathic products online with claims they can treat chronic pain and addiction. The products lack "Rx only" on their labels, the website featured the FDA logo in multiple places, and the statement "FDA Registered" appeared on the site's shopping cart page.
The FDA has given Siemens Healthineers clearance to market its Mobilett Elara Max mobile X-ray system, which comes with fully integrated cables, antimicrobial coating and improved IT security. The system enables patient information to be directly accessed at the bedside.
Abbott Laboratories' Alinity m diagnostics assays and system to test for sexually transmitted and infectious diseases has received the CE mark. The assays test for HIV-1, hepatitis B and C viruses and STDs such as chlamydia and gonorrhea.
Alexion and Affibody Medical agreed to work together to develop ABY-039 for rare immunoglobulin G-mediated autoimmune diseases in a deal that could mean more than $650 million for Affibody. A separate deal by Alexion potentially worth $695 million for Zealand Pharma involves peptide therapies for complement-mediated diseases.
Swiss biotech Lonza announced that Sheba Medical Center in Israel will use its Cocoon manufacturing platform for the development of point-of-care cell-therapy manufacturing. Sheba uses chimeric antigen receptor T-cell therapy and other immunotherapies to treat cancer patients.
A framework that allows exports of biotech crops without nontariff barriers remains a goal in talks with China, Agriculture Secretary Sonny Perdue said at a meeting of the National Grain and Feed Association. "China has laid on the table some very attractive numbers regarding ag purchases, but there again, we are still in the negotiation phase, and I don't want to raise expectations if we are not able to come to an agreement," Perdue said.
Some of the 39 small refineries seeking Renewable Fuel Standard exemptions are expected to receive partial waivers from the Environmental Protection Agency. In 2017, at least 34 full exemptions were granted for small refineries, but only one partial exemption had been granted previously.
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