The pill form of the drug semaglutide is worth pursuing as a way to control blood sugar in patients with type 2 diabetes, say researchers.
Boston-based Intarcia Therapeutics became the latest casualty of the FDA’s manufacturing standards. The agency has rejected Intarcia’s implanted diabetes drug/device, which company execs have long insisted is on a straight path to blockbuster sales.
Nemaura Medical Inc. (NMRD), a medical technology company focused on the development and commercialization of sugarBEAT®, a wireless adhesive skin-patch for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system announced today that it has completed development of a medical grade app prepared and verified in accordance with ISO13485 quality systems and the appropriate medical devices directives, and designed to be used with the sugarBEAT® device or with glucose meters and strips to display glucose levels on users android mobile devices.
Growth in prescriptions for diabetes medicines is exceeding the rise in overall prescribing, according to new figures from NHS Digital.
The US Food and Drug Administration has given a tentative green light to Merck & Co’s follow-on biologic basal insulin Lusduna Nexvue.
Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
Tong Hua Dong Bao Pharmaceutical Co., Ltd (hereinafter referred to as the “Company”) has initiated the Phase I clinical trial in China after receiving the notification of approval for the clinical trial of Degu Insulin Liraglutide Injection from the State Drug Administration and has recently successfully completed the first case of patient dosing. The completion of Phase I clinical trial of Degu Insulin Liraglutide Injection is another significant progress in the development of GLP-1RA compound formulation of insulin analog, which will further enhance the competitiveness of the Company in the field of endocrine therapy. In the future, the Company is expected to accelerate the process of clinical trials and speed up the approval and listing of its products by virtue of its R&D advantages accumulated in the field of diabetes treatment over the years, so as to provide richer and better choices for clinical medication. Degu Insulin Liraglutide Injection has ...
RAPT Therapeutics has announced plans to terminate two Phase II trials for its lead candidate, zelnecirnon (RPT193), three months after the US Food and Drug Administration (FDA) placed a clinical hold on them. In February, the US regulatory agency placed a clinical hold on the Phase IIa (NCT05935332) and Phase IIb trials (NCT05399368) that evaluated zelnecirnon in atopic dermatitis and moderate to severe asthma, respectively. The hold was placed after a patient in the atopic dermatitis trial suffered liver failure possibly caused by zelnecirnon. Following the trial termination news, RAPT’s stock was down by 41.7% at market close on 9 May, compared to market close on the previous day. Since the clinical hold was announced on 20 February, the company’s stock has dropped by over 82% compared to its peak before the news. RAPT ended Q1 with $141.6m in cash reserves and a net loss of $30.5m. Rapt’s market cap ...
Recently, Tong Hua Dong Bao Pharmaceutical Company Limited (“Tong Hua Dong Bao” or the “Company”) signed a Commercialization License and MAH Cooperation Agreement (“Commercialization License and MAH Cooperation Agreement”) on the GLP-1 product simelglutide injection (“Simelglutide Injection”) with Beijing Quality Peptide Bio-pharmaceutical Technology Co. (hereinafter referred to as “QPBio”) entered into the Commercialization License and MAH Cooperation Agreement (hereinafter referred to as the “Agreement”) in relation to the GLP-1 product, Simeglutide Injection. Pursuant to the Agreement, the Company will obtain the exclusive commercialization rights and interests in Mainland China for ZT001 Simeglutide Injection (indication: blood glucose control in adults with type 2 diabetes mellitus) (the “Collaboration Product”), which is a clinical product under development by Plasmapeptide Biologics, as well as the right to co-develop the overseas market. The Cooperative Product has completed the Phase I clinical trial for the indication of type 2 diabetes mellitus in Mainland China and has ...
Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.Novo Holdings’ planned acquisition of Catalent is facing another delay. Just weeks after Novo Holdings decided to resubmit its application to the Federal Trade Commission, the agency is seeking more information about the deal. The transaction was originally expected to close by the end of this year, but this timeline may not be as solid given the repeated delays in the FTC’s review process. The acquisition was announced in early February when Novo Holdings — the investment arm of the foundation that owns a controlling stake in Danish pharma giant Novo Nordisk — disclosed its plans to acquire New Jersey-based contract development manufacturing organization Catalent ...
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