Cadence Health, Inc.

As President Joe Biden mulls the declaration of a public health emergency following the U.S. Supreme Court’s decision to overturn Roe v. Wade, HRA Pharma, a Perrigo company, has submitted an application to the U.S. Food and Drug Administration seeking approval for the country’s first-ever over the counter (OTC) birth control pill. The application requests a prescription to OTC switch for Opill, which HRA Pharma acquired from Pfizer in 2014. Opill is a progestin-only daily birth control bill that prevents pregnancy by thickening the mucus in the cervix, preventing sperm from entering the uterus. As with all applications of this nature to the FDA, a decision is expected within ten months. “This historic application marks a groundbreaking moment in contraceptive access and reproductive equity,” Frédérique Welgryn, chief of strategic operations and innovation officer at HRA Pharma, said in a press release. “More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.” Normally, an application request to switch from prescription to OTC wouldn’t garner much attention. However, this application arrives swiftly after the Supreme Court voted to overturn Roe v. Wade, ending the federally protected right to abortion. On Sunday, Biden stated that he is considering declaring a public health emergency to free up federal resources to promote abortion access. Reportedly, White House officials have questioned the legality and effectiveness of this action, leading others to think of different ways to increase access to reproductive health care. Leaders Weigh in on how the Fall of Roe Will Affect Biopharma This is not the first time that HRA Pharma has discussed OTC birth control with the FDA. As reported by The New York Times, since 2016, both HRA and Cadence Health have held discussions with the regulatory agency to bring OTC birth control to the market. Cadence Health is currently in the process of seeking approval for its oral contraceptive Zena with the company reporting that it is currently testing new OTC labels and packaging with consumers. Cadence has faced setbacks with the FDA, including a halt on its actual-use trial in which the FDA asked for repeated tests on OTC use and for the company to reconsider adding new warnings on its drug safety label. Adverse events are a primary concern for those hesitant to advocate for OTC birth control. Birth control pills have decades of evidence to support their efficacy and safety, but it is true that the medication can increase the risk of heart attack, stroke and blood clots and interact with certain medications. Opposers to OTC birth control believe that unsupervised use of the medication could cause serious side effects. However, many are quick to point out that pregnancy itself can cause the same risks. Additionally, many people take birth control to manage other health conditions that are equally risk-posing such as extremely heavy menstrual cycles and endometriosis. OTC birth control has also received overwhelming support from the Pro-Choice Caucus, which recently penned a letter to FDA Commissioner Robert M. Califf urging that the FDA approach applications to OTC birth control in a swift manner and defend against political interference during review. Beyond OTC birth control, activists are also calling for OTC access to abortion medication, specifically Mifeprex produced by Danco Laboratories. The FDA stated that the company would have to present data showing the Mifeprex was safe for use in miscarriage. The company reportedly did not have any plans to provide such data. Activists Call for Over-the-Counter Access to Abortion Meds

The company intends to use the financing to support the expansion and commercialisation of its Dayspring active compression system Koya Medical will use the funding to advance its active compression therapy. (Credit: PublicDomainPictures from Pixabay.) Koya Medical has raised $26m in a Series B financing round to advance its portfolio of active compression therapies for lymphedema and venous disorders. The California-based healthcare technology company provides a portfolio of advanced, people-centric platforms for lymphatic and venous care. Led by 3×5 Partners, the funding round has also seen participation from new investors Asahi Kasei Ventures, Cadence Healthcare Ventures. Existing investors including Arboretum Ventures and Scientific Health Development, along with others, have also participated in the Series B round. 3×5 Partners managing director Joe Biller said: “Koya Medical is an innovative company that has the leadership, insights, and capabilities to bring ground-breaking treatment options that provide greater freedom and more mobility to patients with lymphedema and venous disorders.” Koya intends to use the financing to support the expansion and commercialisation of its Dayspring active compression system. In addition, the company will continue to advance the Dayspring platform research programmes to pursue additional indications for lymphedema and venous disorders. Dayspring is a wearable active compression system, approved by the US Food and Drug Administration (FDA) to treat of lymphedema and other similar conditions. The system includes an active garment, a soft, breathable mesh produced using Koya’s unique Flexframe technology, a rechargeable hand-held controller, and a mobile app. It is the first and only compression therapy option that enables movement, mobility, and personalised care, that cannot be achieved with traditional therapy, said Koya. Koya Medical founder, president, and CEO Andy Doraiswamy said: “Welcoming new investors alongside our existing investors further validates our progress and commitment to developing innovative patient-centric solutions. “We are proud to have the support of experienced medtech investors who believe in our vision to reimagine treatment options that transform lymphatic and vein care and impact the lives of millions of patients. “The financing strengthens our ability to provide a comprehensive suite of active compression solutions that enable natural movement and muscle use to promote healthy fluid flow and help improve the quality of daily life for people living with lymphedema, venous insufficiency, and other chronic swelling disorders.”