The Trump administration is using the Defense Production Act to provide a $765 million loan to support the launch of Kodak Pharmaceuticals. The U.S. International Development Finance Corporation (DFC) signed a letter of interest Tuesday with Eastman Kodak Co. to support the start of its new business unit, which will focus on developing active pharmaceutical ingredients (APIs) that have been identified as essential but have lapsed into chronic shortage. “By leveraging our vast infrastructure, deep expertise in chemicals manufacturing, and heritage of innovation and quality, Kodak will play a critical role in the return of a reliable American pharmaceutical supply chain,” Kodak Executive Chairman Jim Continenza said. The DFC loan is expected to accelerate Kodak’s time to market by supporting startup costs to repurpose and expand the company’s existing facilities in Rochester, N.Y., and St. Paul, Minn., and to incorporate continuous manufacturing and advanced technology capabilities. The letter of intent signifies that Kodak has successfully completed the DFC’s initial screening, but the company must undergo standard due diligence before the financing is formally committed, according to the DFC. Once fully operational, Kodak Pharmaceuticals will have the capacity to produce up to one-fourth of the APIs used in nonantibacterial generics in the U.S. News of Kodak’s plans sent the company’s stock (NYSE:KODK) soaring to a high of $33.20 Tuesday, up more than 318% from Monday’s close of $7.94, with trading volume of about 271 million.
The NIH’s National Cancer Institute (NCI) is proposing the grant of an exclusive worldwide patent license to Cytovia Therapeutics Inc., of New York. The license would cover U.S. and foreign patent applications involving the development of chimeric antigen receptors that recognize the glypican3 cell surface protein, which is expressed on the cell surface of several solid tumors, including liver cancers, certain ovarian cancers and neuroblastomas. Comments on the proposed grant should be submitted to the NCI’s Technology Transfer Center by Aug. 14.
The FDA finalized its August 2017 revised guidance, "Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products." Over the past few decades, hospitals and long-term care facilities have increased their demand for single-dose repackaging of solid oral drugs, leading to questions about stability studies and appropriate expiration dates for the repackaged products. Given its understanding of the risks involved in the repackaging of solid oral drugs into unit-dose containers, the FDA said it generally does not intend to take action regarding nonconformance with requirements to determine expiration dating with stability studies if the products are labeled with an expiration date not exceeding six months from the date of repackaging or 25% of the time between the date of repackaging and the expiration date on the container of the original manufacturer’s product, whichever time period is shorter – provided certain conditions are met. The guidance suggests studies to justify longer expiration periods.
The FDA is releasing a revised draft guidance to help drug and biologic applicants comply with the content and format requirements of the pregnancy, lactation, and “females and males of reproductive potential” labeling subsections. The revisions are in response to comments the FDA has received and its own experience in implementing the 2014 pregnancy and lactation labeling rule. Changes include information on formatting, omitting information and pregnancy registries; clarifications to the Risk Summary heading, risk statements, and human and animal data; information on labeling involving pregnancy testing, contraception and infertility; and procedural information on implementing and submitting draft labeling to the FDA for review. Comments on the draft should be submitted to Docket No. FDA-2014-D-1551 by Sept. 28.
The U.K.’s Medicines and Healthcare Products Agency (MHRA) Wednesday announced the creation of two synthetic datasets to help in the development of medical technologies to fight COVID-19 and cardiovascular disease. The datasets were generated to accurately mirror symptoms, diagnoses and treatments in patients, based on anonymized primary care data that were transformed into artificial data containing no original data from “real” patients, the MHRA said. The synthetic datasets can be used in the development and testing of machine learning and artificial intelligence algorithms in medical devices used for diagnosing diseases and monitoring and improving health conditions.
The U.S. Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria will hold a virtual meeting Sept. 9 and 10 to discuss the impact of COVID-19. Topics to be discussed will include the COVID-19 mortality rate due to secondary acquired infections, antibiotic stewardship practices during a pandemic, and the intersection of antimicrobial resistance and emergency preparedness, according to a notice to be published in Thursday’s Federal Register.
The U.S. Solicitor General (SG) filed an amicus brief with the U.S. Supreme Court to address the constitutionality of appointments to the Patent Trial and Appeal Board (PTAB), a controversy engendered by the Federal Circuit’s October 2019 decision in Arthrex v. Smith & Nephew. The SG’s brief notes that the appeals court had allowed Arthrex Inc., of Naples, Fla., to challenge whether PTAB judges were appropriately appointed under the Appointments Clause even though Arthrex failed to make that argument while the underlying patent case was under inter partes review. This, the brief said, was based on reasoning “that would apply to nearly all separation-of-powers challenges,” creating what Acting SG Jeffrey Wall described as “a constitutional infirmity.” The outcome of the Federal Circuit decision in Arthrex was followed by similar outcomes in another 39 cases. Should the Supreme Court ultimately overturn the Federal Circuit’s decision, the decisions in the other cases would be undermined.