Latest news with #Brilinta
Reuters
4 days ago
- Health
- Reuters
Health Rounds: Roche's Tecentriq reduces recurrence, deaths for certain colon cancer patients
June 6 (Reuters) - (This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays. To receive the full newsletter in your inbox for free sign up here.) Adding Roche's (ROG.S), opens new tab immunotherapy drug Tecentriq to chemotherapy after surgery in certain patients whose colon cancer had spread to the lymph nodes led to a 50% reduction in cancer recurrence and death compared to chemotherapy alone, according to trial data presented at recent medical meeting. Patients in the study had tumors with a genetic defect known as deficient DNA mismatch repair, or dMMR. About 15% of colon cancer patients have dMMR tumors, which do not respond well to chemotherapy. "The findings from our study represent a major advance in the adjuvant treatment of dMMR stage 3 colon cancer and will now change the treatment for this type of cancer," study leader Dr. Frank Sinicrope of the Mayo Clinic in Rochester, Minnesota said in a statement. The data, opens new tab were presented at the ASCO meeting that concluded earlier this week. The trial enrolled 712 patients with dMMR stage 3 colon cancer that had been surgically removed and who had cancer cells in their lymph nodes. Half of the study participants received chemotherapy along with Tecentriq, which activates the immune system to attack and kill cancer cells, for six months, followed by the immunotherapy alone for another six months. The other half of the patients received chemotherapy for 12 months. The benefit of Tecentriq was seen even in the oldest patients and those at particularly high-risk. "It's extremely rewarding to be able to offer our patients a new treatment regimen that can reduce the risk of recurrence and improve their chances of survival," Sinicrope said. As patients recover after a minimally invasive heart procedure, they might be better off continuing to take a certain type of blood-thinning drug to help prevent a heart attack or stroke, instead of continuing with the traditional aspirin, a new study suggests. Early after percutaneous coronary intervention (PCI) - a procedure to prop open blocked arteries either after a heart attack, or to prevent one - patients often receive dual anti-clotting therapy with both a P2Y12 inhibitor such as clopidogrel, the generic version of Plavix, or AstraZeneca's (AZN.L), opens new tab Brilinta (ticagrelor), and aspirin. After several months, patients are usually switched from dual therapy to lifelong daily aspirin use. But pooled data looking at patients who took part in five earlier clinical trials found that continuing to prescribe the P2Y12 inhibitors and stopping the aspirin was associated with lower rates of death, heart attack and stroke compared with continuing the aspirin, with no increased risk of major bleeding, researchers reported in The BMJ, opens new tab. Overall, the trials involved 16,117 patients who received either a P2Y12 inhibitor or aspirin after completing dual therapy following PCI. After an average follow-up period of around 4 years, P2Y12 inhibitor therapy was associated with a 23% lower risk of a composite of heart-related death, heart attack, or stroke, compared with aspirin, with no significant difference in major bleeding. That translates into one prevented cardiovascular death, heart attack, or stroke for every 46 patients taking a P2Y12 inhibitor instead of aspirin after dual therapy. Overall, the findings suggest that P2Y12 inhibitor drugs should be preferred over aspirin 'due to reductions in major adverse cardiac and cerebrovascular events without increasing major bleeding in the medium term,' according to an editorial published with the study. But the editorial said that since patients are advised to continue the post-PCI therapy for life, large trials directly comparing the different strategies with longer follow up are needed. Some diabetes and weight-loss drugs from the class known as GLP-1 agonists were linked with a small but elevated risk for an age-related eye disease in patients with diabetes, according to a study published on Thursday in JAMA Ophthalmology, opens new tab. In 139,000 patients with diabetes, including 46,334 who had been using the GLP-1 drugs semaglutide or lixisenatide, researchers identified 181 new cases of neovascular age-related macular degeneration, also known as wet AMD. Wet AMD is a degenerative eye disease marked by the abnormal growth of blood vessels under the retina that leak fluid or blood and can lead to blindness. The risk of developing AMD during up to three years of follow-up was low, at 0.2% in GLP-1 users versus 0.1% in non-users. Still, the researchers point out, after accounting for patients' individual risk factors, the odds of AMD were doubled with at least six months of GLP-1 use and tripled in patients with the longest duration of use. Semaglutide is the active ingredient in the widely used Novo Nordisk ( opens new tab drugs Ozempic and Wegovy, while lixisenatide is the main ingredient in Sanofi's ( opens new tab discontinued Adlyxin. GLP-1 drugs have also been associated with higher risks for an eye condition known as nonarteritic anterior ischemic optic neuropathy, or NAION. Researchers did not have information about the dose, route of administration, or frequency of administration of the medications used in the study. Even with that information, the study could not have proved cause and effect. At least one earlier study with longer follow up reported that GLP-1 use was linked with a lower, rather than higher, risk for AMD. 'Our findings are not directly contradictory' with that earlier report, said study leader Dr. Reut Shor of the University of Toronto. 'Factors such as timing and duration of exposure, disease stage, and patient characteristics may all influence outcomes," Shor said. "Our results add another layer to the emerging understanding of this complex relationship and emphasize the need for further research to clarify these trends.' (To receive the full newsletter in your inbox for free sign up here)
Business Upturn
02-05-2025
- Business
- Business Upturn
Alembic Pharma gets USFDA final nod for Ticagrelor 90 mg, tentative approval for 60 mg
Alembic Pharmaceuticals Limited announced on May 2, 2025, that it has received final approval from the US Food and Drug Administration (USFDA) for its Ticagrelor Tablets, 90 mg, and tentative approval for Ticagrelor Tablets, 60 mg. The 90 mg dosage has been approved as a therapeutically equivalent generic to AstraZeneca's Brilinta, and is indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), stroke, and stent thrombosis in certain high-risk patients. The 60 mg variant has also received tentative approval pending patent expiry or exclusivity clearance. Alembic was among the first ANDA applicants to file for the 90 mg dosage with a Paragraph IV certification, indicating it is contesting the innovator's patent. According to IQVIA data, the estimated market size in the U.S. for the 90 mg Ticagrelor tablets is approximately US$ 1,062 million, and for the 60 mg tablets is around US$ 242 million, for the twelve months ending March 2025. With this development, Alembic's cumulative USFDA approvals now stand at 222 ANDAs, comprising 197 final approvals and 25 tentative approvals. The company reaffirmed its long-standing focus on regulated markets, with robust R&D and vertically integrated manufacturing capabilities. Alembic continues to expand its presence in global generics with a strong pipeline and established regulatory track record. News desk at
Yahoo
24-03-2025
- Business
- Yahoo
Forget the Correction: This Stock Is Defying the Sell-Off, and There Might Be More Upside Ahead
The tech-heavy Nasdaq Composite index recently entered correction territory. Though it was able to climb out of it, equities broadly remain down for the year. Still, some companies are performing well amid the volatility. AstraZeneca (NASDAQ: AZN), a U.K.-based pharmaceutical giant, is one of them; its stock is up by an impressive 16% since January. This performance so far in 2025 is not a fluke. And the stock may deliver strong returns, if not in the next few weeks, but for investors willing to hold onto its shares for years. AstraZeneca's shares fell off a cliff late last year when it announced the arrest of some of its executives in China, including Leon Wang, the drugmaker's president in the country. That's on top of an insurance fraud investigation in China it had been dealing with, and allegations that the company imported illegal pharmaceutical drugs into the country. Though these problems are worth monitoring, AstraZeneca's financial results certainly aren't an issue. Last year, its revenue jumped by 18% year over year to $54.1 billion, an excellent performance for a pharmaceutical giant. Adjusted earnings per share were $8.21, 13% higher than the previous fiscal year. AstraZeneca operates several segments focused on various therapeutic areas, and every one except "other medicines" saw sales move in the right direction in 2024. Even with the challenges that AstraZeneca is dealing with now, last year's decline in its share price may have been overdone, given the company's strong financial results. That's likely why the stock has performed well since December, and has kept that momentum through market volatility this year. If it's found liable for illegal drug importation in China, AstraZeneca could incur a fine. The potential fine in China could amount to 100% to 500% of the unpaid importation taxes of $0.9 million. At worst, AstraZeneca will pay $4.5 million if it's found guilty -- a drop in the bucket for a company that generates tens of billions of dollars in annual revenue. The company will also face two patent cliffs in the U.S. this year. The first is for Soliris, a medicine for a rare blood disease called paroxysmal nocturnal hemoglobinuria. The second is for Brilinta, a treatment used to reduce the risk of heart attacks. Neither of these patent expirations should be a game changer for AstraZeneca. Soliris' sales in 2024 totaled $2.6 billion, but declined 18% year over year due to patients switching to AstraZeneca's newer Ultomiris. Brilinta's revenue in 2024 came in at $1.3 billion, up 1% year over year -- it was already facing generic competition in other countries. Because Soliris and Brilinta contributed little (if anything at all) to the pharmaceutical giant's top-line growth last year, the loss of exclusivity for these medicines won't harm its prospects. AstraZeneca has a lot to offer investors: a vast and diversified lineup of medicines, a deep pipeline, and steady revenue and earnings growth. Its lineup featured 14 medicines that each generated over $1 billion in sales last year. Yes, some will lose patent exclusivity, but others will fill the gap. Breztri, a treatment for chronic obstructive pulmonary disease (COPD), came short of blockbuster status for AstraZeneca last year with sales of $978 million, but they were up by 44% compared to 2023. Several other drugs should also continue to help drive strong top-line growth for the pharmaceutical leader, including the newer cancer therapy Truqap. Meanwhile, AstraZeneca's pipeline will likely unearth more gems. Like other drugmakers, it's now seeking to join the promising weight loss area. The company's investigational oral GLP-1 therapy, AZD5004, is undergoing phase 1 and 2 clinical trials across diabetes, weight management, and several other potential indications. (All currently approved GLP-1 medicines are administered subcutaneously, so there could be a reasonable demand for an oral option.) The company's AZD9550 is another potential GLP-1 medicine in early-stage studies. Beyond that, AstraZeneca is running many clinical trials across various therapeutic areas. The company had over a dozen regulatory approvals or clinical trial readouts in the fourth quarter. You can expect more of the same every period, which should allow its financial results to remain strong over the long run, even as it faces patent cliffs. Investors should see past the headwinds -- many already are, since the stock is performing well right now. But it's still time to think about purchasing shares of AstraZeneca. The drugmaker could deliver excellent returns. Before you buy stock in AstraZeneca Plc, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and AstraZeneca Plc wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $721,394!* Now, it's worth noting Stock Advisor's total average return is 839% — a market-crushing outperformance compared to 164% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of March 18, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool recommends AstraZeneca Plc. The Motley Fool has a disclosure policy. Forget the Correction: This Stock Is Defying the Sell-Off, and There Might Be More Upside Ahead was originally published by The Motley Fool Sign in to access your portfolio
