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MARKET INTEL by PharmaCompass
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By PharmaCompass
2024-12-19
Impressions: 230
As the year draws to a close, the US Food and Drug Administration (FDA) has been approving drugs at a feverish pace. It approved two significant treatments for atopic dermatitis — Organon’s Vtama cream and Galderma’s Nemluvio injection. It also approved Mesoblast’s cell therapy — Ryoncil — that treats a complication that can occur after a cell transplant.
Neurocrine Biosciences achieved a historic milestone with the approval of Crenessity, the first new med in seven decades to treat classic congenital adrenal hyperplasia (CAH), a rare disorder affecting the production of hormones. Checkpoint Therapeutics marked its transition to a commercial-stage company with the FDA approval of Unloxcyt, the first PD-L1 inhibitor for treating advanced cutaneous squamous cell carcinoma.
Among drugmakers, Novo Nordisk made much news. First, it announced plans to establish a US$ 1.2 billion production facility in Odense, Denmark, focused on manufacturing rare disease drugs including hemophilia treatments. Second, its parent company, Novo Holdings, cleared a significant hurdle in its US$ 16.5 billion acquisition of Catalent, with the US Federal Trade Commission (FTC) okaying the deal. And third, its popular diabetes drug Ozempic came under scrutiny when two studies suggested that it can more than double the risk of a rare eye condition that can cause sudden vision loss. The European Medicines Agency (EMA) is reviewing the two studies.
Meanwhile, Merck entered the race for weight loss drugs by signing a global licensing deal worth up to US$ 2 billion with Chinese biotech Hansoh Pharma.
Novo Nordisk invests US$ 1.2 bn to build new rare disease drugs plant in Denmark
Novo Nordisk is investing US$ 1.2 billion to establish a new production facility in Odense, Denmark. This facility will focus on manufacturing drugs for rare diseases, including treatments for hemophilia. The new plant, spanning 40,000 square meters, is expected to create 400 permanent jobs upon its completion in 2027. This investment marks the Danish drugmaker’s first new factory in the country this century.
Ozempic linked to sudden vision loss: Novo’s Ozempic (semaglutide) has come under scrutiny due to potential links to a rare eye condition known as non-arteritic anterior ischemic optic neuropathy (NAION). This condition can cause sudden and irreversible vision loss. Two studies conducted by the University of Southern Denmark found that Ozempic more than doubles the risk of developing NAION in type 2 diabetes patients. The European Medicines Agency has said it will review the two Danish studies. The agency has said that to this point, evidence has not supported a connection between the GLP-1 and NAION.
After intense scrutiny, FTC okays Novo Holdings’ US$ 16.5 bn buyout of Catalent
Novo Holdings is set to finalize its US$ 16.5 billion acquisition of Catalent after getting the FTC greenlight. This deal, which has been under intense scrutiny, also includes Novo Nordisk's plan to purchase three of Catalent’s fill-finish sites for US$ 11 billion, which will bolster its production capacity for injectable drugs like Wegovy (semaglutide).
Last week, the buyout also received the go-ahead from EU regulators. The deal has faced criticism from lawmakers and consumer groups concerned about potential anti-competitive effects, particularly in the GLP-1 drug market, where Novo Nordisk and Eli Lilly are major players.
Merck enters race for obesity drugs via US$ 2 bn licensing deal with Chinese biotech
Merck has signed a global licensing deal worth up to US$ 2 billion with Chinese biotech Hansoh Pharma for its experimental oral drug to treat obesity. Merck will develop, manufacture and potentially sell the drug — HS-10535 — which is an investigational preclinical oral small molecule GLP-1 receptor agonist.
Merck is a late entrant in the GLP-1 space, as several players (including Amgen and Pfizer) are already testing their candidates. Merck will pay Hansoh US$ 112 million upfront, and US$ 1.9 billion in various milestone payments. Hansoh will also be eligible for royalties on net sales.
Meanwhile, Merck is discontinuing the development of two cancer candidates, vibostolimab and favezelimab, after receiving underwhelming data from phase 3 trials.
FDA okays Organon’s Vtama cream, Galderma’s Nemluvio shot for atopic dermatitis
FDA has approved two treatments for atopic dermatitis (AD), one a cream and the other an injection. Organon’s Vtama (tapinarof) cream was approved for the treatment of AD in adults and children as young as two years. This approval came months ahead of its adjusted PDUFA date of March 12, 2025.
The nod came three months after New Jersey-based Organon acquired the product in a US$ 1.2 billion takeover of Dermavant. This could help spark stagnant sales of Vtama, which has not lived up to analyst expectations as a novel, steroid-free treatment.
Galderma’s Nemluvio (nemolizumab-ilto), a subcutaneous injection, was approved for patients aged 12 years and older with moderate-to-severe AD. Nemluvio is designed to be used alongside topical corticosteroids and/or calcineurin inhibitors. It is the first humanized IgG2 monoclonal antibody that targets the IL-31 receptor. It achieved significant improvements in skin clearance, itch relief, and reduced sleep disturbances compared to placebo in a phase 3 trial of over 1,700 patients. Galderma anticipates Nemluvio to achieve blockbuster status by the end of 2027 with peak sales exceeding US$ 2 billion.
Mesoblast’s cell therapy okayed: FDA has approved Mesoblast’s cell therapy — Ryoncil — that treats graft-versus-host disease (GVHD), a complication that can occur after a cell transplant, where the donated stem cells attack the recipient’s cells, viewing them as an unfamiliar threat. Ryoncil is the first such therapy approved to treat pediatric patients aged two months and older whose GVHD symptoms have not responded to standard steroid therapy.
FDA approves Neurocrine’s Crenessity — first med for CAH in seven decades
FDA has approved Neurocrine Biosciences’ new drug, Crenessity (crinecerfont), calling it an “important advance” for treating classic congenital adrenal hyperplasia (CAH) in both children and adults. CAH is a rare genetic disorder that affects the adrenal glands, leading to an overproduction of androgens and a deficiency in cortisol. This can lead to symptoms such as dehydration, vomiting, and in extreme cases, life-threatening salt loss. Crenessity is the first new treatment for CAH in seven decades.
Checkpoint’s skin cancer drug bags FDA nod: FDA has approved Checkpoint Therapeutics’ Unloxcyt (cosibelimab-ipdl) for treating cutaneous squamous cell carcinoma (cSCC), a type of cancer that affects the outer layer of the skin. This approval is for cases where the cancer is locally advanced or has spread to other parts of the body, making surgery and radiation unviable.
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