Tag: featured

January 18, 2024

Jaguar Gene Therapy is spinning out a new company to handle the specialized work of manufacturing cell and gene therapies, launching Wednesday a wholly owned subsidiary called Advanced Medicine Partners. The spinout, which is backed by investors Deerfield Management, Arch […]

January 17, 2024

Casgevy (exagamglogene autotemcel or exa-cel) became the first drug based on the CRISPR/Cas9 gene-editing technology to be approved towards the end of last year, when it was cleared by the FDA for sickle cell disease (SCD). The UK was the […]

January 16, 2024

CellVoyant—an artificial intelligence (AI) first biotechnology company spun out of the University of Bristol—has raised £7.6 million in seed funding to speed up the development of novel cell therapies. According to a Jan. 16, 2024 press release, the funding was […]

January 16, 2024

Their novel approach to high-throughput experimentation (HTE) could do away with the current need to run trial-and-error experiments to see how chemicals used to make medicines react with one another, predicting their behaviour virtually, and has been described in a […]

January 11, 2024

The J.P. Morgan Healthcare Conference, a yearly temperature taker for the biotechnology industry, had a different feel in 2024. For the first time in awhile, young drugmakers and their backers were optimistic the sector’s downturn might finally be over. An […]

January 11, 2024

Amid an ongoing shortage of the first-line treatment for syphilis in the United States, the U.S. Food and Drug Administration will allow the importation of a different syphilis drug from a French drugmaker. In a letter from Laboratoires Delbert, the […]

January 10, 2024

The arrival of powerful new drugs for obesity has reshaped the pharmaceutical industry, transforming Eli Lilly and Novo Nordisk into the sector’s most valuable companies and sending others scrambling to catch up. Analysts predict that so-called GLP-1 drugs like Lilly’s […]

January 9, 2024

Prescription drug pricing has been an ongoing issue in the US, which is reportedly spending more than double the average amount spent by other OECD member countries on prescription medicines per capita. Florida’s Canadian Prescription Drug Importation Program, which will […]

January 8, 2024

In 2028, Merck faces the possible loss of market exclusivity for its biggest product, Keytruda, which accounted for nearly half of its pharmaceutical revenue over the first nine months of 2023. Aiming to maintain its market share, Merck has been […]

January 4, 2024

Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while […]

January 3, 2024

Goldman’s foray into the biotech world shows continuing investor appetite in the venture capital arena, even while the public biotech market remains tepid. The last year featured a number of new VC fund launches, including from Dimension, Cure Ventures, Yosemite, […]

January 3, 2024

Hemophilia and other blood disorders like sickle cell disease and beta thalassemia have drawn intense investment from genetic medicine developers. in December, the FDA approved two such treatments for sickle cell, clearing Vertex Pharmaceuticals’ gene editing drug Casgevy and Bluebird […]

January 2, 2024

The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response letters for medicines to treat cancer, low blood sugar and […]

January 2, 2024

Novartis is a leading gene therapy developer. In 2019, its SMA treatment Zolgensma became one of the first genetic medicines cleared for use in the U.S., and so far has been the field’s most lucrative product. Since then, gene therapy […]

December 28, 2023

There has been speculation around what manufacturing platforms, if any, can consolidate sufficient market share to dominate either specific operations (e.g., fill/finish) or more broadly, a full spectrum production suite of integrated operations. For the foreseeable future at least, it […]

December 28, 2023

Treatment with the cardiac myosin inhibitor significantly improved exercise capacity in patients with obstructive hypertrophic cardiomyopathy (HCM), an inherited disorder in which the heart muscle becomes thickened and can obstruct blood flow. It is one of the most common reasons […]

December 27, 2023

On Dec. 18, 2023, Andelyn Biosciences, a contract development and manufacturing organization, announced that Ultragenyx has selected it to perform late-stage process performance qualification (PPQ) manufacturing of UX111, Ultragenyx’s investigational gene therapy under development for the potential treatment of Sanfilippo […]

December 26, 2023

The agreement is the latest in a series of acquisitions and licensing deals aimed at bolstering AZ’s position in cell therapy, an area where it has lagged behind other companies like Novartis, Bristol-Myers Squibb, and Gilead Sciences, and also continues […]

December 21, 2023

The latest complete response letter (CRL) for gefapixant comes even though the drug is already on the market in Europe and Japan under the Lyfnua brand name, and less than two years after the FDA first rejected it in January […]

December 20, 2023

The validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot. CureVac – which is developing mRNA-based vaccines for COVID-19 and […]