Category: News

July 26, 2024

First up, Third Arc Bio, seeded at Omega Funds and led by former Johnson & Johnson executives, which pocketed an impressive $165 million in a first round led by Vida Ventures and co-led by Cormorant Asset Management and Hillhouse Investment. Omega […]

July 24, 2024

Republican-controlled states have passed various laws regulating medication abortion in the past, said Daniel Grossman, an OB-GYN and a reproductive health researcher at the University of California-San Francisco. But after the Dobbs v. Jackson Women’s Health Organization decision in 2022, […]

July 18, 2024

The new project will focus on the real-world use of Brainomix’s artificial intelligence-powered Brainomix 360 e-Lung software, which was recently approved by the FDA in May to assist in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from medical […]

July 17, 2024

Since NGM’s founding in 2007, the company’s research has covered a range of therapeutic areas. Its progress led to an initial public offering in 2019, which was initially followed by a run-up in the company’s stock price. But clinical setbacks […]

July 16, 2024

The new funds will be used for mid-stage clinical trials of ASN51, an oral small-molecule inhibitor of O-GlcNAcase (OGA), which has emerged in recent years as a possible target for the treatment of tauopathies, including Alzheimer’s. Studies have shown that […]

July 9, 2024

Qarziba (dinutuximab beta) is on the market in 35 ex-US markets for the treatment of high-risk neuroblastoma in patients aged 12 months and above. It is sold by Recordati in all markets except for China, where BeiGene has rights, with both […]

July 8, 2024

Lilly is launching a tender offer to acquire all outstanding shares of Morphic for a purchase price of $57 per share in cash, prompting shares in the biotech to rocket 77% from $31.84 to $56.40 at the time of writing. […]

July 5, 2024

In a Securities & Exchange Commission (SEC) filing, Pieris said that Servier will exit the agreement between the two companies – first agreed in 2017 and focusing on the development of several Anticalin-based therapeutics for cancer – before the end of the […]

June 20, 2024

Skyrizi (risankizumab) was previously already cleared by the FDA for adults with moderately to severely active Crohn’s disease, active psoriatic arthritis, and moderate to severe plaque psoriasis. The approval in UC is based on the results of a 12-week induction study called […]

June 17, 2024

Last November, the FDA issued a warning about a risk of secondary cancers – particularly T-cell cancers – and earlier this year it requested a change to safety labelling to include a ‘black box’ warning on all six of the […]

June 11, 2024

In early June 2024, FDA and the US Pharmacopeial Convention (USP) both published reports on drug shortages as of the end of 2023. The Center for Drug Evaluation and Research at FDA published its 11th annual report to Congress on […]

June 4, 2024

Abbott hasn’t issued a public statement on the 510k approval, which has just been published on the FDA’s website, but the wearable device has a similar indication to Stelo and can be used in both non-insulin-dependent type 2 diabetics as […]

May 30, 2024

Retevmo (selpercatinib) can now be used to treat RET-positive thyroid cancers and other solid tumours with the mutation, regardless of their type. Specifically, the new indication covers advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, advanced or […]

May 22, 2024

A new technology developed by researchers from King’s College London (KCL) could provide a new way of delivering drugs to advance next-generation treatments to prevent and treat a variety of diseases. Published in the nanotechnology journal Small, the ‘plug and […]

May 6, 2024

Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracetic acid, or ethylene oxide) is preferred, but it is only applicable to drug substances that […]

April 29, 2024

Live bird flu virus has not been found in any of the first batch of retail milk samples tested, federal health officials said Friday. Amid an ongoing outbreak of bird flu in U.S. dairy cows, the early findings should reassure […]

April 8, 2024

The decision came right after the US regulator also cleared Bristol-Myers Squibb and 2seventy bio’s rival CAR-T Abecma as a third-line therapy for relapsed or refractory multiple myeloma, moving the cell therapies much earlier in the treatment pathway from their […]

March 29, 2024

Some pain-relieving skin products contain potentially harmful doses of the numbing agent lidocaine and should be avoided, the U.S. Food and Drug Administration warns. These creams, gels, sprays and soaps are marketed for topical use to relieve the pain of […]

March 1, 2024

The number of contractors and subcontractors involved in the supply chain for finished goods can be high, and their relationships very complex, particularly when goods are shipped by air or sea. Depending on the scope of the activity (e.g., whether […]

February 29, 2024

When you’re looking to make changes to how clinical trials are run, it’s helpful to work with one of the top minds in the industry. By welcoming Robert Langer to its advisory board, that’s exactly what Lindus Health hopes to […]