A BMJ investigation has shone a spotlight on the marketing of semaglutide in the U.K., raising questions about the effectiveness of regulatory oversight of materials on the weight loss and diabetes treatment. Novo Nordisk is the marketing authorization holder for semaglutide, the active ingredient in diabetes drug Ozempic and obesity therapy Wegovy, but the results of online searches for the molecule include pharmacy websites unrelated to the drugmaker. The BMJ looked into whether any of those pages break the rules on the advertising of prescription drugs and how authorities in the U.K. respond to allegations of illegal promotion. A complaint filed by academics in the U.K. and Sweden forms the centerpiece of the report. Writing to the U.K. drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), the academics said they were “appalled” to find Pharmadoctor, a provider of clinical services to pharmacists, was marketing Wegovy “directly to the ...
Pfizer already reported its experimental drug for hemophilia A and B met a pivotal study’s goals of reducing bleeding episodes. During the annual meeting of the American Society of Hematology, the company presented a full look at the results, which are expected to support regulatory submissions soon. By FRANK VINLUAN Patients with hemophilia A or B can manage the inherited bleeding disorders with regular infusions of the clotting proteins they lack. This treatment helps—until it doesn’t. One problem with these infused factor replacement therapies is patients can develop inhibitors, which are antibodies that render the clotting proteins ineffective. Experimental Pfizer drug marstacimab takes a different approach to both forms of hemophilia. Results from a pivotal study show the subcutaneously injected drug met the main goals of reducing bleeding episodes. The company also has some additional long-term data showing continuing improvement beyond the initial clinical trial evaluation period. The full Phase ...
By Tyler Patchen Pictured: Sign at Pfizer’s headquarters in New York/iStock, JHVEPhoto Pfizer on Friday said it is scrapping an investigational twice-daily oral Glucagon-like peptide-1 receptor agonist candidate after topline data from a Phase IIb trial of obese patients without type 2 diabetes showed high rates of adverse events. While the trial did reach the primary endpoint of a statistically significant change in body weight, there were high rates of adverse events. According to Pfizer, the adverse events in the obesity trial for the twice-daily dosing of GLP-1 danuglipron were mild and included gastrointestinal symptoms that were “consistent with the mechanism” of the candidate. However, the company noted high rates of these side effects. Up to 73% of patients experienced ...
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 ...
The German manufacturing site is the latest capital infrastructure move for Eli Lilly, which has already made $11 billion in investments in its global manufacturing capabilities in the past three years. The new site will help Lilly meet strong demand for its diabetes and obesity drugs. By FRANK VINLUAN Eli Lilly’s cardiometabolic drug portfolio is expanding with newly approved therapies. To meet demand for those therapies and additional products to come, the company is building a new $2.5 billion manufacturing site in Germany. Construction on the new plant is on track to begin next year. Lilly expects the site will start operations in 2027, becoming its sixth manufacturing site in Europe. The company said it has invested more than $11 billion in its global manufacturing capabilities in the past three years to support the production of medicines across its portfolio. Some of Lilly’s capital investments have been closer to the ...
Eight rapid-, short-, and long-acting insulin products will move to tier one preferred status, which limits out-of-pocket spending to $35 or less for patients with diabetes. Optum Rx, the pharmacy benefit manager unit of UnitedHealth, announced that it is moving eight rapid-, short-, and long-acting insulin products to tier one preferred status, which offers the lowest cash price that consumers pay.1 The move, which goes into effect on January 1, 2024, will limit out-of-pocket spending to $35 or less for insulin product for patients with diabetes. Image credit: Aleksandra Gigowska | stock.adobe.com “I’ve seen firsthand how high prices for insulin and other necessary medications can cause patients to limit or skip doses,” said Patrick Conway, MD, MSc, chief executive officer of Optum Rx, in a press release.1 “Medicine that people can’t afford is useless, and by taking this important next step to change our formulary, we will lower costs and ...
Pictured: AstraZeneca office in Gothenburg, Sweden/iStock, Wirestock AstraZeneca has signed an exclusive license agreement with Shanghai-based biotech Eccogene for ECC5004, an early-stage investigational oral glucagon-like peptide 1 receptor agonist that is being developed for obesity, type 2 diabetes and other cardiometabolic diseases. Under the terms of the deal announced on Thursday, AstraZeneca will make an upfront payment of $185 million with the potential for nearly $1.83 billion in future clinical, regulatory and commercial milestones. Eccogene will also be eligible for tiered royalties on net product sales. In exchange for its investment, AstraZeneca will have the exclusive global rights to develop and commercialize ECC5004—except in China, where the pharma will share these rights with Eccogene. “We believe this oral GLP-1RA molecule could offer alternatives to current injectable therapies both as a potential monotherapy as well as in combination for cardiometabolic diseases such as type-2 diabetes, as well as for obesity,” Sharon ...
Don Tracy, Associate Editor The rise in popularity of GLP-1 weight-loss drugs, such as Ozempic, Wegovy, and Mounjaro, has had a wide-reaching impact across the healthcare industry and beyond. Image Credit: Adobe Stock Images/Dimid The launch of multiple glucagon-like peptide (GLP-1) drugs for weight loss—such as Ozempic, Wegovy, and Mounjaro—is expected to cause a major shakeup in the stock market, as millions of Americans are set to shed hundreds of millions of pounds over the next decade while reshuffling trillions of dollars in the process, according to expert analysis. Not only have these treatments helped patients shed a significant amount of pounds, but they have also shown efficacy treating other conditions as well. A recent drug trial by Novo Nordisk found that semaglutide, the active ingredient in Ozempic and Wegovy, could help people with kidney failure as well. As shares of Novo Nordisk and Mounjaro developer Eli Lilly increase, dialysis ...
As COVID revenues dwindle for pandemic stalwart Pfizer, the company is turning attention to its respiratory syncytial virus (RSV) vaccine launch and a potential entry into the hot obesity market. With only five months of sales under its belt, Pfizer’s RSV vaccine Abrysvo is “doing better than we thought,” Chief Commercial Officer Angela Hwang said on the company’s third-quarter earnings call, touting “very fast uptake” for the new shot. After a pair of approvals in late May and August, Abrysvo pulled in revenues of $375 million during the third quarter, Pfizer said Tuesday. Earlier this year, the shot won FDA nods to immunize older adults and then as a maternal vaccination to protect infants. In both settings, the Pfizer offering is facing off against Big Pharma competition. In the adult RSV vaccine marketplace, Pfizer is challenging GSK and its immunization Arexvy. GSK is set to report its third-quarter results Wednesday. ...
Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.Bayer on Tuesday opened its first Cell Therapy Launch Facility in Berkeley, California, which is expected to create capacity to bring cell therapies to patients worldwide. Bayer has invested $250 million to build the plant, which will initially crank out materials for late-stage clinical trials across 100,000 square feet of space, the drugmaker said in a release. The plant is also equipped to support the potential commercial launch of BlueRock’s experimental cell therapy for Parkinson’s disease, bemdaneprocel. At the moment, BlueRock says planning is underway for its phase 2 study of bemdaneprocel, which is expected to start enrolling patients in the first half of 2024. The plant features flexible, modular space ...
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