On December 16th, during the 18th Asia-Pacific Symposium on Hypertension, the National Launching Meeting of Sacubitril Valsartan Sodium Tablets (trade name: Yixintan®), which is exclusively commercialized by Fosun Pharmaceuticals and researched, developed and manufactured by Nanjing Fangshenghe Pharmaceuticals, was held grandly in Shanghai. The approved indications of Yixintan® (sacubitril valsartan sodium tablets) are for use in adult patients with chronic heart failure (NYHA class II-IV, LVEF ≤ 40%) with reduced ejection fraction, to reduce the risk of cardiovascular death and hospitalization for heart failure; and for the treatment of essential hypertension. The product is a first-line drug for the treatment of heart failure and hypertension with an innovative crystalline form with independent intellectual property rights. After the launching ceremony, a press conference on the national launching of Yixintan® was held, in which experts appeared and answered questions from the media about the current situation of cardiovascular prevention and treatment, the ...
BY SEAN WHOOLEY Edwards Lifesciences (NYSE: EW)+ announced today that it intends to spin off its critical care business by the end of 2024. The company shared a number of key plans going forward as it outlined its plans for future growth. Among its plans, Edwards expects to spin off the critical care unit and its full range of smart monitoring technologies next year. “During 2024, Edwards plans to support the growth and leadership of innovations in advanced patient monitoring, with the goal of improving the quality of care for millions of patients annually,” Edwards wrote in a news release. Analysts expect shares of Edwards to move up on the news today. Shares of EW rose 1% at $70.17 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remained even. Edwards intends to complete the spin-off tax-free. The ...
Pharmaceutical Executive Editorial Staff Patients with obesity are now able to access Zepbound (tirzepatide) with a prescription at retail and mail-order pharmacies across six dose strengths. Eli Lilly and Company announced today that its obesity treatment Zepbound (tirzepatide) is now commercially available at pharmacies in the United States.1 Last month, the FDA approved Zepbound injection as the first and only approved treatment for obesity that activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) hormone receptors.2 Image credit: Kurhan | stock.adobe.com Patients with obesity are now able to access Zepbound with a prescription at retail and mail-order pharmacies across six dose strengths—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg. “Today opens another chapter for adults living with obesity who have been looking for a new treatment option like Zepbound,” said Rhonda Pacheco, group vice president, Lilly Diabetes and Obesity, US, in a press release.1 The ...
By Tristan Manalac Pictured: Roche’s building in California Roche on Monday announced it has entered into a definitive merger agreement with Berkeley, California-based Carmot Therapeutics, a move that could place it in the thick of the lucrative and increasingly competitive weight-loss market. As per the terms of the acquisition, Roche will make an upfront payment of $2.7 billion at the transaction’s close, which the companies anticipate will occur in the first quarter of 2024, pending regulatory and anti-trust clearance. Carmot’s equity holders will also be eligible for up to $400 million in additional payments, contingent on the achievement of certain milestones. In return, Roche will gain access to Carmot’s portfolio of preclinical and clinical assets, including three GLP-1 receptor agonists, which have “best-in-class potential to treat obesity,” according to Monday’s news release. Carmot’s lead asset is CT-388, a dual agonist of both the GLP-1 and GIP receptors that is ready ...
Culmination Bio has secured $10m in investment from the Merck Global Health Innovation Fund (venture capital arm of MSD) and Amgen Ventures to develop an intelligence platform to facilitate diagnostic and therapeutic development. The US-based company has a library of multimodal and longitudinal data along with the accompanying biospecimens, Culmination Bio’s CEO Lincoln Nadauld told Pharmaceutical Technology. The data for Culmination’s library consists of de-identified HIPPA-compliant data from Intermountain Health. This allows the company to “identify specific patient cohorts and proactively or prospective rapidly recruit them”, which can accelerate drug discovery and clinical trial recruitment. Nadauld said that having biospecimens is instrumental in validating diagnostic devices, adding: “An example would be a liquid biopsy company validating their novel technology in the liquid biopsy space, for cancer. They often need fresh samples from patients with defined diseases, and we can deliver not only the biospecimens but the accompanying multimodal data that ...
By Kate Goodwin Pictured: Bristol Myers Squibb building in Munich/iStock, Tati Campelo Bristol Myers Squibb is upping the ante in its partnership with Avidity Biosciences. The San Diego-based biopharma announced Tuesday an expansion of its previous collaboration with BMS, with the latter paying $100 million upfront and adding up to five cardiovascular targets. With potential cumulative payments of up to $2.3 billion plus low double-digit royalties, the partnership could be a lucrative one for the RNA biopharma. The deal expansion sent Avidity’s suffering stock soaring around 35% in premarket trading. A welcome reprieve to the 72% tumble it took earlier this year. Avidity will get a $60 million upfront cash payment in addition to BMS scooping up $40 million of its stock to deliver new cardiovascular treatments utilizing the former’s antibody oligonucleotide conjugates (AOCs). Avidity’s AOCs combine the targeting specificity of monoclonal antibodies with the precision of oligonucleotide therapies to ...
Nicholas Saraceno IQVIA report explores why these shortages are increasing, and how they can be mitigated. Image Credit: Adobe Stock Images/Julia Drug shortages are an issue that continue to grow in news coverage, due to their impact on patient care and public health. Data suggests that the amount of drug shortages in the US is increasing as more shortages continue to be reported than resolved. As a report by IQVIA titled Drug Shortages in the US 2023: A Closer Look at Volume and Price Dynamics1suggests, stakeholders have suggested various tactics to mitigate shortages, including prioritizing essential medicines, stockpiling, and making changes to reimbursement or statutory rebates. Shortages appear to be driven by a variety of causes that need to be better understood, as they may impact which solutions will best address them. This aforementioned report assesses shortages reported by the FDA, alongside sales and volume data of these medicines in ...
By Tristan Manalac Pictured: NASDAQ Stock Exchange headquarters Carmot Therapeutics on Friday filed for an initial public offering (IPO), banking on its pipeline of GLP-1 agonists and the multibillion-dollar potential of the obesity market. Carmot did not disclose how many shares of its common stock will be put up for sale or its projected earnings from the planned offering. The company expects to wrap up its IPO before the year closes, after which it will trade on Nasdaq under the proposed ticker CRMO, according to a Nov. 17 SEC filing. The California-based biotech is advancing a pipeline of “life-changing therapeutics for people living with metabolic diseases,” particularly obesity and diabetes, per the SEC filing. One of its most mature candidates is CT-868, a dual agonist of both the GLP-1 and GIP receptors, both of which play crucial roles in the regulation of insulin secretion, appetite and weight. CT-868 is being ...
By Tristan Manalac Pictured: Bayer’s office in New Jersey Bayer on Sunday announced it was stopping the Phase III OCEANIC-AF study ahead of schedule due to the disappointing performance of its investigational factor XIa inhibitor asundexian. The decision to end OCEANIC-AF early is in line with the recommendation of an Independent Data Monitoring Committee, which during the ongoing surveillance of the study found that asundexian had “inferior efficacy” versus Bristol Myers Squibb’s and Pfizer’s Eliquis (apixaban). Bayer will take “appropriate measures” to close the study and will work with investigators to determine the next steps for patients. Bayer did not provide specific data from OCEANIC-AF in its news release, but said it will continue to analyze its results and publish the findings. Asundexian is an investigational inhibitor of the blood protein factor XIa, which is a key player in the coagulation cascade. The drug candidate is designed to be orally ...
By Tristan Manalac Data from an early-stage study showed that Eli Lilly’s investigational RNA silencing therapeutic lepodisiran can induce sharp and durable reductions in serum lipoprotein(a) levels, the company revealed in a read-out presented over the weekend at the 2023 Scientific Sessions of the American Heart Association. These findings come nearly three months after the Indianapolis-based pharma notched another Phase I victory, this time for its oral drug candidate muvalaplin, which strongly decreased lipoprotein(a) levels in healthy participants within 24 hours. Lipoprotein(a), also known as Lp(a), is a form of cholesterol that can cause plaques to form in arteries and block blood flow and is often tied to the risk of developing cardiovascular diseases. The first-in-human trial of lepodisiran enrolled 48 patients who were given ascending doses of the investigational therapy—from 4 mg up to 608 mg—or a placebo. At the highest dose level, lepodisiran was able to elicit a ...
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