Pharma News
19 May 2024 to 25 May 2024
May 24, 2024
Study funded by Novo Nordisk shows that Ozempic may provide benefits for individuals with chronic kidney disease
Pharmaceutical company Novo Nordisk's diabetes drug Ozempic has shown potential in treating chronic kidney disease, according to a study. The study found that a weekly injection of semaglutide, the active ingredient in Ozempic, reduced the risk of major kidney complications, cardiovascular events, and death by 24% in patients with type 2 diabetes and chronic kidney disease. Novo Nordisk plans to seek FDA approval to expand Ozempic's label to include the treatment of chronic kidney disease. Chronic kidney disease affects an estimated 37 million Americans. This development follows the FDA's recent approval of Novo Nordisk's weight-loss drug Wegovy for expanded use.
May 24, 2024
International agreement will address traditional indigenous medicine and genetic resources in relation to patents, reports Loop St. Lucia.
The United Nations' World Intellectual Property Organization (WIPO) has reached an agreement on a new treaty to protect traditional knowledge about genetic resources. The treaty requires patent applicants to disclose the source of their ideas and inputs, particularly if they are derived from the knowledge of indigenous or local communities. While the treaty does not address compensation to these communities, it is seen as a first step towards protecting their historic expertise. The WIPO Intellectual Property, Genetic Resources and Associated Traditional Knowledge treaty will become international law once 15 countries adopt it.
May 24, 2024
FTC states that inflated drug prices are a result of 'Junk patents' issued by pharmaceutical companies, says The Checkup on WSIU.
The United States Federal Trade Commission (FTC) has sent warning letters to drugmakers, accusing them of filing "junk patents" in order to extend their exclusive rights to certain drugs, preventing generic manufacturers from entering the market. These patents, which do not protect intellectual property or innovation, allow drug companies to keep drug prices high for consumers. The FTC warns that if drug manufacturers do not remove these junk patent listings, they may face antitrust lawsuits.
May 24, 2024
Ozempic continues to impress with trial results suggesting positive outcomes for kidney disease, as reported in Nature.
The diabetes drug Ozempic, also known as Wegovy, has shown promising results in reducing the risk of kidney failure and death for people with type 2 diabetes and chronic kidney disease. The drug, semaglutide, is manufactured by Novo Nordisk and has been found to not only decrease the likelihood of major kidney disease events but also reduce the risk of heart attacks and other cardiovascular incidents. Scientists believe that semaglutide has the potential to benefit a broader population of people with kidney disease.
May 24, 2024
Eli Lilly commits $9 billion to enhance production of popular medications Zepbound and Mounjaro
Eli Lilly is significantly increasing its investment in an Indiana manufacturing site to boost production of ingredients for its weight loss and diabetes drugs. The expansion will raise the project's cost from $3.7 billion to $9 billion, making it the largest manufacturing investment in the company's history and one of the biggest in synthetic medicine API manufacturing in US history. Medicare spending on Eli Lilly's Mounjaro, along with Novo Nordisk's Ozempic and Rybelsus, jumped from $57 million in 2018 to $5.7 billion in 2022.
May 24, 2024
FDA rejects Ipsen's request regarding popular drug Somatuline - Endpoints News
The FDA has rejected Ipsen's request to slow down generic competition for its blockbuster drug Somatuline Depot, used to slow the growth of tumors and treat acromegaly. Ipsen's 2019 petition asking for additional requirements for generic versions of the drug was denied. Somatuline, which generated $1.1 billion in 2023, accounted for 34% of Ipsen's sales but has been facing declining revenue due to the entry of generics in recent years.
May 23, 2024
Fulcrum Therapeutics (NASDAQ:FULC) Prepares Phase 3 Candidate with High Potential for Success
Shares of biopharma Fulcrum Therapeutics (NASDAQ: FULC) have surged over 125% in the past year as investors anticipate the successful conclusion of Phase 3 trials for its lead pipeline candidate, Losmapimod. The drug targets facioscapulohumeral muscular dystrophy (FSHD), a rare disease with no approved treatments. Fulcrum expects to report topline data in Q4 2024 and believes Losmapimod will be ready for market by 2026. The company has engaged in a collaboration with Sanofi (NASDAQ: SNY) to develop and commercialize the drug. Analysts are bullish on Fulcrum, with a price target of $17.00 and expectations for peak sales of $1.1 billion.
May 23, 2024
Two New US Patents in Hypertension and Epilepsy Granted to Lexaria Bioscience (NASDAQ: LEXX)
Lexaria Bioscience has been granted two new patents, bringing its total patent portfolio to 43. The first patent is related to compositions and methods for treating hypertension using Lexaria's DehydraTECH-processed cannabidiol, which has shown the ability to lower blood pressure. The second patent is related to compositions and methods for treating epilepsy, specifically focusing on the potential for DehydraTECH-CBD to mitigate epileptic seizures more effectively than current medication. Both patents are set to expire in 2042.
May 23, 2024
Eli Lilly's Next Potential Blockbuster Drug Is Making Waves, Yahoo Finance Reports
Eli Lilly has reported positive phase 3 results for its once-weekly insulin product called efsitora alfa, which showed non-inferiority to daily insulin in treating type 2 diabetes patients. The drugmaker is set to face a showdown with rival Novo Nordisk, which is awaiting regulatory approval for its own once-weekly insulin option, Awiqli. Despite competition, efsitora alfa has the potential to contribute significantly to Eli Lilly's top line, as an estimated 31% of diabetes patients use insulin therapy.
May 23, 2024
Key victory for GSK and Boehringer Ingelheim in initial Zantac trial, reports Fierce Pharma
Pharma companies GSK and Boehringer Ingelheim have won a victory in the first personal injury case to go to trial over heartburn drug Zantac. The Chicago jury rejected Angela Valadez's claim that the drug caused her colon cancer. This verdict could have broad implications for the thousands of lawsuits yet to be decided. GSK lost patent protection for Zantac in 1997 and has faced numerous claims since then. Both GSK and Boehringer Ingelheim have stated that they will continue to defend themselves against the remaining claims.
May 22, 2024
Major pharmaceutical companies across the world are making significant investments in oncology, however, they are not yet taking on the challenge of cancer prevention.
Mainz Biomed, a molecular genetics diagnostic company from Germany, presented key findings from its eAArly DETECT study at Digestive Disease Week. The study demonstrated the effectiveness of its non-invasive at-home CRC screening test, which combines a Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers and AI algorithms to detect colorectal cancer and advanced precancerous lesions. Mainz Biomed aims to revolutionize cancer prevention and reduce mortality rates with its innovative approach.
May 22, 2024
Welch's goal is to address the issue of 'patent thicketing' in order to decrease the cost of prescription medications - WCAX
Senator Peter Welch and Senate Judiciary Committee members held a hearing to address the issue of rising prescription drug prices. Welch highlighted his bill aimed at combatting "patent thicketing," a practice that limits competition from generic drug alternatives and drives up costs. He emphasized that the cost of healthcare, particularly prescription drugs, is becoming unbearable for many Americans and needs to be addressed. The hearing also mentioned the rising cost of new blockbuster weight loss drug Ozempic.
May 22, 2024
A significant blaze consumes the Danish drug manufacturer Novo Nordisk - from report on Euronews website
Pharmaceutical company Novo Nordisk experienced a major fire at its offices near Copenhagen, the second blaze to occur in a week. The fire, which started outside the Novo Nordisk offices, quickly spread to an adjacent building's roof. The company reassured the public that the situation is under control, and no injuries have been reported. Novo Nordisk is known for producing weight-loss drugs such as Ozempic and Wegovy.
May 22, 2024
If you are using Ozempic, here are four foods you should steer clear of - Source: HealthDay
The diabetes and weight-loss drug, Ozempic (semaglutide), has gained widespread popularity as it mimics a hormone called GLP-1 to regulate appetite. Approved by the FDA for both diabetes and obesity, it has shown great effectiveness. However, patients may experience side effects such as nausea and abdominal pain. Modifying the diet can help manage these symptoms while still maintaining proper nutrition.
May 21, 2024
Understanding the latest regulations on life science patents in China - Law.asia
China's 2021 Patent Law has brought significant changes to life sciences patent protection, including the introduction of a patent linkage system similar to the US model. The law also introduced a unique enforcement mechanism called Major Patent Infringement Dispute Adjudication (Major Case), allowing China's national intellectual property office to handle patent infringement disputes. These reforms aim to strengthen life sciences patent protection in China and align with the country's focus on drug innovation. The article provides updates and insights into these legislative components and discusses the practical implications for pharmaceutical companies.
May 21, 2024
China approves Eli Lilly's weight-loss drug for diabetes treatment only, says Indianapolis Business Journal
China has granted approval to Eli Lilly and Co.'s tirzepatide as a treatment for adult patients with type 2 diabetes. The drug, which is also being reviewed for chronic weight management, will deepen the competition between Lilly and Novo Nordisk in the weight-loss drug market, estimated to reach $100 billion by 2030. Lilly also has plans to launch a similar obesity drug called mazdutide with Chinese partner Innovent Biologics Inc.
May 21, 2024
Senators consider measures to prevent misuse of patents by pharmaceutical companies - MedPage Today
Senators and experts on Tuesday examined the range of tools that brand-name drug manufacturers have used to keep generic and biosimilar competition at bay -- from patent thickets and product hopping to "pay-for-delay" settlements -- and wrestled with how to prevent such abuses. One recent analysis showed that the 10 best-selling drugs in the U.S. in 2021 were tied to 1,429 patents and patent applications, 72% of which were filed after FDA approval, Durbin noted.
May 21, 2024
Hims & Hers is marketing a generic version of Ozempic without the necessary approval from the FDA. Learn more in Quartz.
Telehealth platform Hims & Hers has announced that it will offer customers a compounded version of semaglutide, the active ingredient in popular weight loss drugs Ozempic and Wegovy. The move comes as a response to the limited supply and high cost of these drugs. Hims & Hers customers can obtain a prescription for the medication on the platform for a starting price of $199, significantly cheaper than the brand-name options. Compounded drugs are customised versions of approved medications and are typically used when there is a shortage of commercially available drugs.
May 21, 2024
Samsung Bioepis creates OpuBiz as a biosimilar drug.
Samsung Bioepis' OpuBiz, a biosimilar of Ailia, an ophthalmic disease treatment, has been approved by the US FDA. This marks the first approval of an Eilea biosimilar in the US. The FDA also granted interchangeability status to Ailia, OpuBiz, and Biocon Biologics' Yesapili, allowing cross-prescriptions at pharmacies without doctor intervention. Ailia is a blockbuster drug with global sales of $9.214.8 billion last year. A total of 52 biosimilars, including 11 from Korean companies, have been approved by the FDA.
May 21, 2024
Pfizer awarded $107.5 million in lawsuit over cancer drug patents against AstraZeneca
A Delaware federal jury has ruled that AstraZeneca must pay Pfizer $107.5 million in damages due to the infringement of two patents by AstraZeneca's lung cancer drug, Tagrisso. The patents covered methods for treating cancer with Pfizer's breast-cancer drug, Nerlynx. AstraZeneca plans to vigorously defend its rights and insists on its strong intellectual property position. In a separate case, Moderna has won a victory in its COVID-19 vaccine dispute with Pfizer and BioNTech, as the European Patent Office upheld the validity of Moderna's key patent. Pfizer and BioNTech may appeal the decision.
May 21, 2024
GSK's Extended-Release Asthma Medication Successfully Achieves Main Goal in Phase III Testing, According to BioSpace
GlaxoSmithKline (GSK) has announced positive results from pivotal Phase III trials for its asthma drug candidate, depemokimab. In comparison to a placebo, depemokimab significantly reduced asthma attacks in adults and adolescents with severe asthma. The results align with surveys that found physicians have positive views of the drug, with interest in switching patients to depemokimab and prescribing it to asthma sufferers who have not yet tried a biologic therapy. GSK plans to use the data to seek approval for depemokimab in markets worldwide, with sales forecasts exceeding £3 billion.
May 21, 2024
Whistleblower alleges GSK concealed dangers of discontinued heartburn drug Zantac
Pharmaceutical company GSK has been sued by US laboratory Valisure, accusing the firm of concealing cancer risks associated with its discontinued heartburn drug, Zantac. The lawsuit claims that GSK violated the federal False Claims Act by hiding these risks for decades while health programmes covered billions of dollars in prescriptions. Valisure’s testing in 2019 revealed that Zantac could form a cancer-causing carcinogen called NDMA, making it unfit for human consumption. GSK denies the allegations, stating that Valisure’s tests were scientifically flawed and unreliable.
May 21, 2024
Senators show unity across party lines regarding additional pharmaceutical patent reforms, reports Endpoints News
Both Republicans and Democrats in the Senate Judiciary Committee acknowledge the need for further reforms in pharmaceutical patent review and system functioning. The issue of drug patent reform has brought members from both parties together, as they have received numerous stories from their respective states regarding unaffordable medicines. AbbVie's Humira, a blockbuster drug and example of patent thickets that delay competitor drug entry, was frequently mentioned during the hearing.
May 21, 2024
Earnings to be boosted by strong sales of specialty drugs, increasing contribution from Revlimid, and growth in the domestic market - Report from Moneycontrol
Indian pharma company Sun Pharmaceutical Industries is expected to report a 22% increase in earnings for the January-March quarter, driven by strong sales of its specialty drugs and its generic cancer drug Revlimid. The company's net profit is expected to rise to INR2,412.60 crore ($361m) from INR1,984.50 crore ($296m) in the same period last year, with revenue predicted to grow by almost 12% to INR12,241.25 crore ($1.8bn). The company’s earnings report will be released on 22 May.
May 20, 2024
FDA in the US greenlights two biosimilar drugs for popular eye medication Eylea
The U.S. FDA has approved two biosimilar versions of Regeneron Pharmaceuticals' eye treatment Eylea, marking its first-ever clearance for biosimilar versions. The approved biosimilars are Yesafili by Biocon Biologics and Opuviz by Samsung Bioepis and Biogen. The approval also allows for interchangeability, meaning the drugs can be substituted with biosimilars without a doctor's advice. Regeneron has filed lawsuits against companies like Amgen and Biocon that are attempting to bring Eylea biosimilars to the U.S. market. Eylea is facing competition from rivals such as Roche's Vabysmo and a biosimilar threat.
May 19, 2024
Structure Therapeutics sees significant increase in stock value after early results from new obesity medication exceed predictions
Shares of Structure Therapeutics surged 70% after early data from its oral obesity treatment, GSBR-1290, exceeded expectations. The drug showed promising efficacy in reducing body weight in a small study of 24 participants who lost an average of 4.5 kgs after four weeks of treatment. Analysts described the data as "impressive" and believe Structure's drug has a competitive advantage against rivals Eli Lilly and Pfizer. Structure plans to conduct further studies on GSBR-1290 as a treatment for type 2 diabetes and obesity.
May 19, 2024
Coherus BioSciences introduces biosimilar alternative to AbbVie's popular drug Humira.
Coherus BioSciences has launched a discounted copycat version of AbbVie's arthritis drug Humira in the U.S., joining other pharmaceutical companies who have recently released biosimilars of the popular drug. Coherus will sell its biosimilar, called Yusimry, at a price of $995 per carton, significantly cheaper than Humira's current list price of $6,922 per carton. The company has also partnered with Mark Cuban's pharmaceutical startup to offer the biosimilar at $569.27 plus additional fees. Despite competition, experts predict that prices for Humira biosimilars will remain high as manufacturers vie for leverage with pharmacy benefit managers.
