Deploying a robust continuous improvement methodology is especially beneficial in the earliest phases of drug development. It can help ensure the delivery of high-quality, reliable, timely bioanalytical and clinical data to make informed decisions about either moving on to the next drug development milestone or pivoting to another strategy.
A month before 23andMe’s bankruptcy filing, CEO Anne Wojcicki had a fully financed proposal to take the genetic testing company private. The financing fell apart, and a series of alternative proposals by Wojcicki did not result in a deal.
Innovative sterilization cases and trays are instrumental in reducing infection risk in medical settings. Learn notable things about them and their makers.
Novo Nordisk is licensing rights to a United Biotechnology drug that sparks metabolic effects by binding to and activating receptors for GLP-1, GIP, and glucagon. Separately, the pharma giant said its recently announced discounted price for obesity medication Wegovy is now expanding to traditional pharmacies.
Specialty pharmacies must meet complex requirements, introducing administrative requirements that can be challenging for health systems to manage internally. Here some strategies that can be employed.
Novartis’s Fabhalta is the first FDA-approved therapy for C3 glomerulopathy. But Apellis Pharmaceuticals’ Empaveli has superior clinical data, and that drug has been submitted for FDA review in the same rare kidney disease as well as another one that does not yet have an approved therapy.
Creating adequate capacity for any therapeutic can be challenging, and the specialized technologies for manufacturing complex biologics require flexibility and agility in production processes. Here's how contract development and manufacturing organizations (CDMOs) ensure that biopharmaceutical companies have a partner with the speed, flexibility, and expertise necessary for successful drug development and manufacturing.
Leasing allows healthcare facilities more freedom to acquire up-to-date medical equipment without the need for immediate capital investment, opening doors for smaller and newer enterprises.
Sanofi is building on its immunology ambitions by acquiring an early clinical Dren Bio drug candidate that offers a potential first-in-class approach to autoimmune disorders such as lupus. It’s the latest acquisition in what has become an active space for dealmaking.
Ampersand Biomedicines’ map of all tissue in the human body reveals “addresses,” identifying markers on disease targets that are not found on healthy tissue. The company aims to improve the targeting of biologic drugs in order to reduce on-target, off-tissue toxicity.
Labcorp’s latest acquisition brings the oncology testing business of BioReference Health. Opko Health, BioReference’s parent, has been cutting costs to return to profitability.
Beyond the branded products currently sold by Mallinckrodt and Endo, the companies say the combined business will also have a strong foundation in rare and orphan diseases. Generic medicines will be spun out as a separate company.
Choosing the right software translates directly into better client management, operational efficiency and growth for your spa franchise. Discover which tool is best for your business.
Many experts — be they venture capitalists or private equity investors — shared their advice with biotech entrepreneurs navigating a tough funding environment.
Multiple myeloma cell therapy Abecma is the lone remaining asset of 2seventy Bio, which spun out from Bluebird Bio in 2021. 2seventy and Bristol Myers Squibb currently share in U.S. commercialization of Abecma.
Beam Therapeutics’ first clinical data in the rare disease alpha-1 antitrypsin deficiency “set a bar for efficacy in the space,” according to one analyst. But the ongoing market slide poses challenges for biotech companies aiming to raise money by selling stock.
CagriSema, a dual-acting drug in development by Novo Nordisk, met the goal of a Phase 3 test in patients with obesity and type 2 diabetes. But the topline results don’t show an advantage over Eli Lilly’s commercialized obesity medication, Zepbound.
Neurotech Pharmaceuticals’ surgically implanted cell and gene therapy, Encelto, is now FDA approved to treat macular telangectasia type 2 (MacTel). It’s the first therapy for this rare retinal degeneration disorder.