On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved cell-based gene editing therapy to be used in humans, and was developed in joint partnership between Vertex Pharmaceuticals and CRISPR Therapeutics. Casgevy™ is indicated for the treatment of sickle cell disease in patients 12 years and older with recurrent vaso occlusive crises (VOCs). The second, Lyfgenia™ (lovotibeglogene autotemcel (lovo-cel)), is developed by bluebird bio, and is indicated for the treatment of patients 12 years or older with sickle cell disease and a history of vaso-occlusive events (VOEs).
ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC). The FDA’s Breakthrough Device Program is designed to speed up the development, assessment, review for premarket approval, 510(k) clearance, and de novo marketing authorization of medical devices “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” This program replaces the FDA’s Expedited Access Pathway and Priority Review for medical devices. Clearance of the Eye90 device was supported by ABK Biomedical’s recently initiated Route90 trial, an FDA Investigational Device Exemption-supported multicenter trial. The trial evaluated tumor response rates and the duration of response in patients living with unresectable HCC from treatment with Eye90 microspheres.
The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations, known as the ‘Orange Book.’” The FTC’s stated goal was to notify market participants of the FTC’s intent to scrutinize improper Orange Book listings to determine whether they constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act. On November 7, 2023, the FTC followed through on its warning by sending notice letters to more than 10 companies challenging the Orange Book listing of more than 100 patents covering products including specific asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors.
On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin. Cast21’s device seeks to address limitations in one of orthopedic care’s fundamental treatment methods: the cast. A soggy cast can lead to infections, reduced support, skin infections, and more. But as discussed in Cast21’s white paper, Cast321’s FDA-approved product touts a waterproof and breathable design, allowing patients to shower, swim, or wash their limbs.
On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers.1 The FDA first issued its proposed rule in 2010, which subsequently went through three public comment periods between 2010 and 2012.2 Interestingly, the FDA provided no opportunities for the public to comment on the rule since 2012. The FDA addressed the over 10-year gap between the last comment opportunity and the issuance of the final rule, explaining that it was due in large part to competing demands for limited Agency resources, including repeated natural disasters, the opioid epidemic, and infectious disease outbreaks including Ebola, Zika, and COVID-19.3 The FDA concluded that no material changes have occurred in the fundamental concepts, scientific research, or literature underlying the proposed rule since 2012.4
On October 27th, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZITM (toripalimab-tpzi), developed by Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd., for two indications: 1) in…
CooperCompanies announced on November 1, 2023, the purchase of Cook Medical’s doppler monitoring, gynecology surgery, and obstetrics products for $300 million.
CooperCompanies is a global medical device company that is based in San Ramon, CA. CooperCompanies focuses on two areas within the medical device space, vision and women’s health and fertility. In it’s announcement, Al White, President and CEO of CooperCompanies stated:
In a recent precedential opinion, the Court of Appeals for the Federal Circuit vacated an infringement judgement against Mylan (Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 2022-1889, Fed. Cir. Nov. 6, 2023). This Abbreviated New Drug Application (ANDA) litigation involved Actelion’s patents related to epoprostenol formulations, which cover Actelion’s brand name product, Veletri®, an injectable drug for treatment of severe pulmonary arterial hypertension.
Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety. The clearance was supported by data collected from a Phase III/pivotal clinical trial carried out in the UK and Ireland by Ulster University and in Hong Kong by PolyU University, Medical Device Network reports.
Cleerly, a digital healthcare company offering artificial-intelligence-based software to identify and measure atherosclerosis from Coronary Computed Tomography Angiography (CCTA) imaging tests, was awarded Best in Class for the Best Use of AI in Health Tech at the 2023 Digital Health Hub Foundation Awards.
