Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. By Frank Vinluan Hair loss caused by alopecia areata now has a new FDA-approved treatment, a third-in-class drug from Sun Pharmaceutical Industries that will compete against commercialized medicines from Eli Lilly and Pfizer. The regulatory decision announced Friday for the drug, deuruxolitinib, covers the treatment of adults with severe alopecia areata. Mumbai, India-based Sun Pharma, which has U.S. operations in Princeton, New Jersey, will market the twice-daily pill under the brand name Leqselvi. Alopecia areata is a condition in which the immune system attacks hair follicles, causing sudden hair loss. The disorder affects both males and females. While the hair loss mainly happens on the scalp, the condition can affect other parts of the body. Sun Pharma cites studies estimating that 700,000 ...
By Tracy Duberman, PhD Insights from Takeda, Jazz, Nestlé Health Sciences, Humana, and other healthcare executives Milestones such as major acquisitions, FDA approvals for new therapies, or obtaining Series C funding are transformative events for pharmaceutical organizations. These triumphs come with nuanced challenges including how to integrate new teams while retaining core talent and how to sustain morale during rapid scaling. Pharma leaders managing talent post milestones need to focus on assessing future talent needs, implementing strategic talent acquisition, onboarding new hires to the company’s culture, leveraging internal talent mobility, prioritizing DE&I initiatives, recognizing employee performance, and focusing on employee well-being. Below are talent management strategies to consider for post-milestone growth. Projecting talent needs for future success: It is important to assess the impact of any large-scale change on both current and future talent and to have a data-informed approach to effectively manage talent during transformative phases. Understanding current talent ...
Drugdu.com expert’s response: The qualifications required for foreign trade enterprises to act as agents for pharmaceutical exports primarily encompass the following aspects: I. Basic Qualifications 1.Foreign Trade Management Right: Foreign trade companies must possess general foreign trade import and export management rights, which serve as the fundamental prerequisite for acting as agents for pharmaceutical exports. This right permits the company to engage in or act as an agent for the import and export of various goods and technologies, except for those commodities and technologies whose import and export are restricted or prohibited by the state. 2.Registration: Foreign trade companies need to register with relevant government departments. For instance, they must register with the Ministry of Foreign Trade and Economic Cooperation to obtain import and export qualifications and with the Entry-Exit Inspection and Quarantine Bureau to acquire a quarantine registration code. These registrations are crucial steps to ensure compliance with regulations ...
Not long after pulling a last-minute plug on a $232m initial public offering (IPO) on Nasdaq, Telix Pharmaceuticals has raised $398m (A$600m) via the issue of convertible bonds. The bonds, which are convertible into ordinary shares, will yield a 2% – 2.75% interest, the radiopharmaceutical specialist said in a 23 July press release. The maturity date is set for five years from now, at the end of July 2029. Australia-based Telix said it intends to list the convertible bonds on the Official List of Singapore Exchange Securities Trading Limited (SGX-ST). While Telix had been planning on going public on Nasdaq earlier this year, the company U-turned on the IPO citing market conditions at the time. Telix had been on course to raise $232m in the listing, though the company maintained that the decision was not “predicated on the need to raise capital”. Instead, the convertible bonds bring low-cost financing to ...
Meitheal Pharmaceuticals has expanded its biopharmaceutical portfolio through the acquisition of rights to CONTEPO (fosfomycin for injection) from Nabriva Therapeutics for the North American region. Meitheal gains access to the rights to CONTEPO, including development and regulatory works, intellectual property rights, technology and related know-how. Nabriva will receive payment upon the agreement closing in addition to royalties on net sales of the injection in the US. An intravenous broad-spectrum antibiotic, CONTEPO has shown activity against multi-drug resistant strains causing complicated urinary tract infections (cUTI). Fosfomycin for intravenous administration is already marketed outside the US and has been approved for nine indications, including cUTI and other serious bacterial infections. CONTEPO’s new dosing approach aims to optimise the compound’s pharmacokinetics and pharmacodynamics. It met the primary endpoint in the ZEUS trial enrolling patients with cUTI. Nabriva filed a new drug application with the US Food and Drug Administration (FDA) seeking approval for ...
Roche reported its oral GLP-1 agonist led to an average 6.1% weight loss at four weeks, according to preliminary results from part of a Phase 1 study. The small molecule comes from Roche’s $2.7 billion acquisition of Carmot Therapeutics last year. By Frank VinluanRoche is a relative latecomer to GLP-1 metabolic disorder drugs, but an oral drug candidate that came as part of a $2.7 billion acquisition last year now has preliminary early-stage clinical data that keep the pharmaceutical giant in contention to bring patients a pill to tap into this increasingly popular mechanism for weight loss. The results reported Wednesday are from a Phase 1 test of CT-996, a once-daily pill designed to activate the GLP-1 receptor to treat type 2 diabetes and obesity. Roche said treatment of patients who are obese and do not have type 2 diabetes lost a placebo-adjusted average of 6.1% of body weight within ...
The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
Unlike GLP-1 agonist drugs marketed for weight loss, new Amylyx Pharmaceuticals drug avexitide blocks its target receptor. Amylyx plans to advance this GLP-1 antagonist into Phase 3 testing for post-bariatric hypoglycemia, a rare condition in which blood sugar levels drop precipitously. By Frank VinluanBefore GLP-1 drugs became a wildly popular pharmacologic way to treat obesity, bariatric surgery was a top option for those seeking a medical intervention for losing weight. While this procedure is effective for weight loss, it turns out that changing the structure of the gut can lead to a debilitating disorder in some patients. Amylyx Pharmaceuticals, months removed from a clinical trial failure that shattered its prospects in neurodegeneration, is now planting a flag in metabolic disease with the acquisition of a Phase 3-ready drug for this rare disorder with no FDA-approved therapies. The drug comes from Eiger BioPharmaceuticals, which last month sold off its assets in ...
Eli Lilly’s Morphic acquisition brings an oral small molecule that blocks the same target as Entvyio, an injectable inflammatory bowel disease drug from Takeda Pharmaceutical. The Morphic deal follows Lilly’s 2023 acquisition of Dice Therapeutics, another company developing oral immunology medications. By Frank VinluanEli Lilly has immunology and inflammation products administered by injection, but the pharmaceutical giant is among the companies interested in bringing patients more convenient pill formulations. Its $3.2 billion acquisition of Morphic comes with a lead drug candidate that’s an oral small molecule in mid-stage development for inflammatory bowel disease. According to deal terms announced Monday, Lilly is paying $57 in cash for each share of Waltham, Massachusetts-based Morphic. That price represents a 79% premium to Morphic’s closing stock price on Friday. The deal, which has been approved by the boards of directors of both companies, is expected to close in the third quarter of this year. ...
Drugdu.com expert’s response: In the medical device industry, there are numerous reports worthy of attention, typically issued by industry research institutions, consulting firms, or relevant government departments. These reports aim to provide comprehensive insights into the current state of the industry, market size, development trends, competitive landscape, and more. Below are some of the most noteworthy medical device industry reports: 1.Global and China Medical Device Market Research Reports Issued by: Reputable global consulting firms such as McKinsey, Boston Consulting Group , Deloitte, among others. Content Overview: These reports comprehensively cover the overall size, growth rates, market segments (including diagnostic equipment, therapeutic devices, consumables, etc.), key market drivers, regional market analyses, competitive landscapes, and future trend forecasts for both the global and Chinese medical device markets. Value: Provide industry players with a holistic view of both global and Chinese markets, facilitating the formulation of internationalization and localization strategies. 2.Medical Device Technology ...
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