Category: Industry

February 8, 2024

CRISPR gene editing captured headlines in recent months with the landmark approval of Casgevy, the first medicine made from the Nobel Prize-winning technology. But that milestone was only part of a larger story, of which an emerging generation of drugmakers […]

February 7, 2024

AstraZeneca is ramping up in cell therapy after a late entrance to the field. In 2022, it made its first significant acquisition in the area, buying up privately held Neogene Therapeutics. And the follow year, it formed a partnership with […]

February 6, 2024

When getting vaccines, switching arms for each dose may produce greater immunity than having the jabs delivered into the same arm. That’s the finding from a new study that looked at the first two doses of COVID vaccines. Those who […]

February 5, 2024

On the strength of the results, 4DMT is planning to start a phase 3 trial of the gene therapy by the end of the first quarter of 2025. The data from the phase 2 PRISM study comes from a cohort […]

February 5, 2024

R21, which uses an adjuvant developed by Novavax to boost immune response, became the second malaria vaccine to be prequalified by the World Health Organization’s (WHO) in December 2023, following the organisation’s prequalification of the RTS,S/AS01 vaccine in July 2022. […]

February 2, 2024

Another biotechnology company has hit Wall Street via an initial public offering, the third to do so this year in an uptick of IPO activity that suggests rebounding investor interest in life sciences stocks. Alto Neuroscience raised about $129 million […]

February 2, 2024

Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing. The fund, which would be Arch’s 13th, is being put together less than two years after […]

February 1, 2024

On Jan. 30, 2024, Regeneron Pharmaceuticals (Regeneron) announced the formation of a new R&D unit, Regeneron Cell Medicines, founded on an agreement with 2seventy bio, a US-based immuno-oncology cell therapy company. Under the agreement, Regeneron acquires full development and commercialization […]

February 1, 2024

FDA published final guidance on Jan. 30, 2024 that provides consideration for the development of chimeric antigen receptor (CAR) T-cell products. According to FDA, “[CAR T-cell] products are human gene therapy products in which the T cell specificity is genetically […]

January 31, 2024

FDA published a final guidance document, Human Gene Therapy Products Incorporating Human Genome Editing, on Jan. 30, 2024. The document provides recommendations for developing gene therapy products incorporating genome editing (GE) of human somatic cells. Recommendations include information needed in […]

January 30, 2024

Regeneron Pharmaceuticals is expanding its cell therapy research, announcing a deal Tuesday to acquire the drug pipeline of 2seventy Bio and bring on many of the smaller biotechnology company’s employees. The experimental cell therapies Regeneron acquires will be housed in […]

January 30, 2024

The clue came, as they often do, from an unexpected source. Some sixteen months ago, a small study of five people in Germany pointed to a new direction for the high-profile field of cell therapy. The study showed a cellular […]

January 29, 2024

The Food and Drug Administration could soon decide on whether to make AstraZeneca and Daiichi Sankyo’s drug Enhertu available for any solid tumor with a specific genetic signature. The partners on Monday said the FDA is reviewing their request to […]

January 26, 2024

Wilmington, Delaware-based Synnovation, a specialist in small-molecule therapeutics for cancer, has emerged from the shadows with a $102 million first-round financing led by Third Rock Ventures with participation from Nextech, Lilly Asia Ventures, Sirona Capital and Cormorant Asset Management. The […]

January 26, 2024

If cleared by the European Commission, Abecma would be available for third-line use in the EU’s 27 member countries, a needed boost for a medicine that’s losing ground to Johnson & Johnson’s rival therapy Carvykti. Both medicines are part of […]

January 25, 2024

The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments. At the two-day workshop led […]

January 25, 2024

Five of six Chinese children born deaf due to a rare genetic defect now have the ability to hear, thanks to an experimental gene therapy. The therapy involved a hollowed-out virus loaded with a healthy version of the gene responsible […]

January 24, 2024

An 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on Tuesday. The boy, identified as Aissam Dam by The New York Times, was the first participant treated in a small […]

January 24, 2024

Cancer drug developer CG Oncology has raised $380 million in an initial public offering than was larger than it expected, a positive sign for a sector that’s struggled to generate demand from Wall Street investors recently. The company on Wednesday […]

January 23, 2024

The CAR-T therapies — Abecma and Breyanzi from Bristol Myers Squibb, Carvykti from Johnson & Johnson and Legend Biotech, Kymriah from Novartis, and Tecartus and Yescarta from Gilead — can drive deep and durable responses in patients with lymphoma, leukemia […]