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Category: News


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Boehringer backs Brainomix AI software for lung fibrosis

July 18, 2024

Via: Pharmaphorum

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 […]


News

NGM, now private, raises $122M for redrawn research plans

July 17, 2024

Via: Biopharma Dive

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 […]


News

Novo leads $100m financing for Alzheimer’s player Asceneuron

July 16, 2024

Via: Pharmaphorum

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 […]


News

Ligand grows in cancer again with $100m Apeiron takeover

July 9, 2024

Via: Pharmaphorum

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 […]


News

Lilly swoops on Morphic to claim IBD drug candidate

July 8, 2024

Via: Pharmaphorum

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. […]


News

Pieris loses Servier as partner for cancer immunotherapies

July 5, 2024

Via: Pharmaphorum

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 […]


News

AbbVie breaks new ground for IL-23 drug Skyrizi in IBD

June 20, 2024

Via: Pharmaphorum

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 […]


News

Study finds low secondary cancer risk with CAR-Ts

June 17, 2024

Via: Pharmaphorum

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 […]


News

Drug Shortage Reports Emphasize Continuing Problems

June 11, 2024

Via: Biopharm International

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 […]


News

Abbott’s OTC glucose monitor ‘will grow the market’

June 4, 2024

Via: Pharmaphorum

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 […]


News

Lilly’s Retevmo cleared for RET-positive child cancers

May 30, 2024

Via: Pharmaphorum

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 […]


News

New ‘plug and play’ system to offer novel way of delivering vaccines and treatments

May 22, 2024

Via: Pharma Times

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 […]


News

Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges

May 6, 2024

Via: Biopharm International

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 […]


News

FDA Says First Round of Tests Show No Live Virus in Pasteurized Milk

April 29, 2024

Via: Drugs.com

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 […]


News

Carvykti, Abecma move earlier in multiple myeloma treatment

April 8, 2024

Via: Pharmaphorum

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 […]


News

High-Strength Lidocaine Skin Creams Can Cause Seizures, Heart Trouble, FDA Warns

March 29, 2024

Via: Drugs.com

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 […]


News

Ensuring Contractors Perform Good Distribution Practices

March 1, 2024

Via: Biopharm International

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 […]


News

Can a Moderna co-founder change the CRO game?

February 29, 2024

Via: Biopharma Dive

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 […]


News

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

February 28, 2024

Via: PMLiVE

The antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria. UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all […]


News

UK biotech Curve swings £40.5m in Pfizer-backed round

February 27, 2024

Via: Pharmaphorum

The round was led by Pfizer’s investment arm Pfizer Ventures, with Columbus Venture Partners and British Patient Capital joining the round along with prior investors Advent Life Sciences and Epidarex Capita. The proceeds will be used to develop Curve’s Microcycle […]