Pharma News
20 Oct 2024 to 26 Oct 2024
Oct 26, 2024
Pharmaceutical company in France sees significant growth in the third quarter - Report by The Brussels Times
French pharmaceutical group Sanofi reported a 12% increase in net profit to €2.844 billion in Q3, driven by the popularity of its drug Dupixent and vaccines. Sales exceeded analyst projections, with new pharmaceutical launches and vaccine sales contributing to the boost. Sanofi remains confident in its target sales of around €13 billion for Dupixent by 2024.
Oct 25, 2024
Ozempic's potential connection to Alzheimer's, 23andMe facing a crisis, Novo Nordisk taking action: Latest updates in the pharmaceutical industry
Novo Nordisk's drug Ozempic shows promise in reducing the risk of Alzheimer's disease, according to a recent study. 23andMe, known for consumer genetic testing, may face delisting from Nasdaq. Novo Nordisk seeks FDA intervention to prevent compounding pharmacies from producing generic versions of its weight loss and diabetes medications containing semaglutide. These are some of the highlights from the pharmaceutical industry this week.
Oct 25, 2024
Spravato from J&J on track for significant success, poised to become a blockbuster drug - PharmaVoice
Johnson & Johnson's esketamine nasal spray, Spravato, has seen a significant increase in sales, reaching $780 million in the first nine months of 2024, a 62% increase from the previous year. The growth can be attributed to increased marketing efforts and the accumulation of safety and efficacy data over time. Spravato, currently approved as an adjunctive therapy, may become a blockbuster drug with forecasts estimating peak sales of $1 billion to $5 billion. J&J's plans to become a neuroscience powerhouse rely on the continued success of Spravato.
Oct 25, 2024
Sanofi reports $5 billion in core profit for Q3, driven by strong sales of Dupixent and vaccines, and increases 2024 forecast.
French drugmaker Sanofi has reported a third-quarter revenue of €13.44bn ($14.79bn), beating consensus expectations of $13.97bn. Sales were boosted by Dupixent, with the blockbuster eczema drug generating revenues of €3.48bn, a 23.8% increase. Sanofi's adjusted EPS also rose by 12.2% to €2.86, driven by the strong performance of Dupixent, pharma launches, and vaccines. The company reaffirmed its expectation that Dupixent will deliver around €13bn in sales by 2024.
Oct 25, 2024
Tremfya, a drug from Johnson & Johnson, effectively treats plaque psoriasis with lesions...
Johnson & Johnson announced that its drug Tremfya successfully cleared or nearly cleared skin in adults with low body surface area moderate plaque psoriasis who had failed topical treatment. The Phase 3b SPECTREM study showed that a significantly greater proportion of patients who received Tremfya achieved clear or minimal disease compared to those who received a placebo. Tremfya generated global sales of $1.01 billion in the third quarter. The drug was recently approved by the FDA for adults with ulcerative colitis and is under review for Crohn's disease.
Oct 25, 2024
Congress Still Needs to Address Pending Matters Regarding Drug Patents and Competition - Mondaq
Congress left unfinished proposals with ramifications for generic and biosimilar drug competition before recess. The "Affordable Prescriptions for Patients Act of 2023" aims to limit the number of patents a biologic drug sponsor can assert in a patent infringement lawsuit against a potential biosimilar competitor. Another bill, the "Biosimilar Red Tape Elimination Act," seeks to simplify the process for approving biosimilar products as interchangeable with their reference products. Additionally, legislation requires FDA to notify generic drug applicants about the qualitative and quantitative sameness of inactive ingredients in a generic drug application.
Oct 24, 2024
Manufacturer of Zantac agrees to a settlement of $2.2 billion
Pharmaceutical company GSK has agreed to pay up to $2.2 billion to settle about 80,000 lawsuits related to the heartburn drug Zantac. The drug was withdrawn from the market in 2020 due to the presence of a probable cancer-causing chemical, N-nitroso dimethylamine (NDMA). GSK has not admitted wrongdoing but agreed to the settlements to avoid further litigation. Other companies involved, including Pfizer and Sanofi, have also reached settlements. The agreement comes after a Delaware judge's ruling allowed plaintiffs' scientists to testify that Zantac caused cancer, increasing the risk of future trials for the company.
Oct 24, 2024
Observational study finds possible connection between use of Ozempic and reduced risk of Alzheimer's diagnosis - STAT News
Novo Nordisk's drug Ozempic, known scientifically as semaglutide, has been found to be associated with a lower risk of being diagnosed with Alzheimer's disease among individuals with type 2 diabetes. A study analyzing medical records of over 1 million people with diabetes revealed a 40-70% decrease in the risk of developing Alzheimer's over three years when compared to other diabetes treatments. These findings support further research into the potential benefits of Ozempic in treating neurodegenerative diseases. The study was conducted by researchers from Case Western Reserve University and published in the journal Alzheimer's & Dementia.
Oct 24, 2024
Preview of Cipla's Second Quarter: Anticipated absence of significant US drug introductions and a strong prior year performance might limit profit growth
Indian drug manufacturer Cipla is set to release its Q2 earnings on October 29. The absence of major drug launches in the US market and regulatory challenges impacting two key upcoming launches are expected to result in tepid earnings growth for the company. Cipla's net profit is predicted to grow by just 5% in Q2 FY25, with revenue projected to increase by 5% as well. The decline in earning growth is likely to be due to slower drug launches and muted margin growth.
Oct 24, 2024
Viking Therapeutics jumps 21%: Could this new obesity drug be a game-changing weight loss remedy?
Viking Therapeutics saw a 21.3% jump in its stock after reporting strong Q3 results, which included a doubling of its cash reserves to $930 million. The company plans to use the funds to accelerate its plans for VK2735, an obesity drug candidate that could disrupt the weight loss market. Viking is set to unveil fresh data on VK2735 at the upcoming ObesityWeek conference in November, which could pave the way for a blockbuster obesity treatment. With strong clinical data and a strengthened balance sheet, Viking is poised for growth in major therapeutic markets.
Oct 24, 2024
Viking Therapeutics experiences 21% increase in stock value: Could this new obesity medication become a top contender? - GuruFocus
Viking Therapeutics' strong Q3 results, which include a doubling of cash reserves to $930 million, position the company to accelerate its plans for obesity drug candidate VK2735. The company's R&D spending has reached $22.8 million this quarter, and the VENTURE Phase 2 trial has shown VK2735 delivering up to 14.7% weight loss in 13 weeks. The upcoming end-of-Phase 2 FDA meeting could pave the way for Phase 3 trials. Viking is also progressing in other programs such as VK2809 for NASH/MASH and VK0214 for X-linked adrenoleukodystrophy.
Oct 23, 2024
Amgen to introduce Eylea biosimilar following legal decision - BioPharma Dive
Amgen is preparing to launch its biosimilar version of Regeneron's blockbuster drug Eylea after winning a victory in an ongoing legal battle. The U.S. Court of Appeals for the Federal Circuit lifted a temporary injunction that barred Amgen from introducing the medicine, but granted Regeneron's request to speed up legal proceedings. Amgen plans to launch its Pavblu biosimilar "as quickly as possible," while Regeneron expressed disappointment and said it will continue to fight. The move surprised analysts, as Amgen is launching "at risk" and could face extensive damages if found guilty of patent infringement.
Oct 23, 2024
Regeneron's attempt to prevent Amgen from launching Eylea biosimilar in the US unsuccessful, according to Westlaw Today.
Oct 23, 2024
Novo seeks FDA action to prevent compounders from producing counterfeit versions of Ozempic
Novo Nordisk has requested the FDA to prevent compounding pharmacies from producing generic versions of its weight loss drug semaglutide, citing concerns over safety. The company believes that semaglutide is too complex for these pharmacies to safely manufacture. semaglutide-patent-expiration" style="color: #F36C42; font-weight:600";>Semaglutide, marketed as Ozempic and Wegovy, has been in shortage for over two years. Novo Nordisk is urging the FDA to include semaglutide on the "Demonstrable Difficulties for Compounding Lists," which prohibits the production of complex medications by compounding pharmacies, regardless of shortages. The FDA's decision is pending.
Oct 23, 2024
Is Eli Lilly a Leading Healthcare Stock Following the Approval of Its Successful New Drug? - StockNews
Eli Lilly and Company's shares have surged by nearly 56% in 2024, driven by the success of its blockbuster drugs Mounjaro and Zepbound in the diabetes and obesity markets, as well as the FDA approval of its eczema drug Ebglyss. The company's expansion into the weight-loss market with tirzepatide and its introduction of a lower-cost version of the drug, Zepbound, have also contributed to its strong financial performance. Analysts are optimistic about the company's future prospects, with revenue and earnings expected to increase significantly in the coming years.
Oct 23, 2024
An executive from Roche expresses confidence that Vabysmo will surpass biosimilar competition from Eylea, according to a report from Fierce Pharma.
Roche's eye disease drug Vabysmo continues to drive sales growth, recording a 56% YoY increase in Q3 sales to exceed 1 billion Swiss francs ($1.2 billion). Vabysmo's market share in various indications has also grown, with Teresa Graham, CEO of Roche Pharmaceuticals, expressing confidence that the imminent launch of a biosimilar to its competitor Eylea would not hinder Vabysmo's momentum. Roche also reported success with its subcutaneous versions of multiple sclerosis drug Ocrevus and cancer immunotherapy Tecentriq. Additionally, Roche's Duchenne muscular dystrophy gene therapy Elevidys exceeded sales estimates in Q3.
Oct 23, 2024
The company behind Ozempic is seeking to prevent the production of generic versions of its popular medication.
Danish pharmaceutical company Novo Nordisk is seeking to curb the production of compounded versions of its weight-loss drugs Ozempic and Wegovy by lobbying the US Food and Drug Administration (FDA) to add semaglutide, the active ingredient in the drugs, to the agency's Demonstrable Difficulties for Compounding (DDC) lists. Novo Nordisk argues that compounded semaglutide presents safety risks and patients should receive only FDA-approved products. Compounded drugs are not subject to FDA approval, and there have been reports of adverse side effects related to compounded semaglutide.
Oct 23, 2024
Challenges in the supply chain and access to Semaglutide faced by the pharmaceutical industry, as reported by Pharmaceutical Executive.
The CEO and Chief Advocacy Officer of the Alliance for Pharmacy Compounding, Scott Brunner and Tenille Davis, discuss the challenges posed by drug shortages, particularly for semaglutide and other medications. They emphasize the role of compounding pharmacies in addressing shortages and stress the importance of differentiating legitimate compounding pharmacies from illegal entities. The conversation underscores the need for collaboration among pharmaceutical manufacturers, healthcare providers, and regulatory agencies to improve the drug supply chain and ensure patient access to essential medications. No drug or company names mentioned.
Oct 23, 2024
Novo focuses on obesity drugs that are compounded; Amgen's launch is in jeopardy, STAT News reports.
Pharmaceutical company Novo Nordisk has requested that the US FDA prohibit compounding pharmacies from producing copies of its weight loss drug semaglutide, arguing that it is too complex to be safely made by these pharmacies. Novo Nordisk also urged the FDA to include semaglutide on the "Demonstrable Difficulties for Compounding Lists." In separate news, Amgen will launch its biosimilar version of Regeneron's eye disease drug Eylea following a US appeals court ruling in its favor. Eylea generated $5.89 billion in US sales last year.
Oct 22, 2024
Amgen plans to introduce Eylea biosimilar in the US following court decision on Regeneron's patent case, TradingView reports.
Amgen has announced the launch of its biosimilar version of Regeneron's blockbuster drug Eylea, following a favorable ruling by the U.S. appeals court. The court rejected Regeneron's request to block the launch temporarily, while it appeals a related decision in a patent case. Eylea generated $5.89 billion in U.S. sales for Regeneron in 2023.
Oct 22, 2024
Lilly and Novo Nordisk face increased competition from generic versions of weight-loss medications, raising safety concerns
Eli Lilly is taking legal action against three medical spas and online vendors for selling products containing tirzepatide, the active ingredient in its weight-loss drug Zepbound. Meanwhile, Novo Nordisk is also pursuing legal action to protect its semaglutide-based drugs from unauthorized competition and potentially unsafe copycat products. The company has filed a lawsuit against Canadian firm Apotex to block the production of a generic version of its oral semaglutide medication Rybelsus. Novo Nordisk has previously found impurities and lack of the drug in some copycat products. In related news, a late-stage trial showed that the oral version of semaglutide reduced cardiovascular events by 14%. The company plans to file for a label expansion in the US and EU.
Oct 22, 2024
Prozac to be substituted with generic alternative in Taiwan | Report from Taiwan | Oct. 22, 2024 16:28
Eli Lilly, the local manufacturer of Prozac, announced it will stop producing the drug in Taiwan at the end of this year. However, the health ministry has stated that there are several generic drugs with the same ingredients that can be substituted for Prozac. These generic drugs are already available under the National Health Insurance and have the same content as Prozac. The use of generic drugs is considered a norm internationally after the expiration of patents, and it helps save money for healthcare systems.
Oct 22, 2024
A new television advertisement from AstraZeneca showcases the COPD medication Breztri as it takes to the airwaves.
Pharmaceutical company AstraZeneca has launched a new TV advertisement for its drug Breztri, emphasizing the product's ability to improve the lives of chronic obstructive pulmonary disease (COPD) patients. The ad features a woman discussing how Breztri improved her lung function and reduced flare-ups, ultimately allowing her to enjoy more good days. The advertisement showcases various activities the woman can now partake in, including dancing and touring a bustling town. Breztri has been a significant product for AstraZeneca, with a 51% sales increase in the second quarter.
Oct 22, 2024
Amgen plans to release its Eylea biosimilar in the United States following a decision in the Regeneron patent lawsuit.
Amgen will soon release its biosimilar version of Regeneron's Eylea after a U.S. appeals court ruling favored Amgen. The ruling denies Regeneron's request to temporarily block the launch while they appeal a related decision in a patent case. Eylea brought in $5.89 billion in U.S. sales for Regeneron in 2023.
Oct 21, 2024
Head of Catalent to continue leading company following acquisition by Novo Holdings
Catalent CEO Alessandro Maselli has assured customers that the company will continue to operate independently after being acquired by Novo Holdings, the controlling shareholder of Novo Nordisk. Maselli's statement comes in response to criticism over the $16.5 billion deal, with concerns raised about potential competition issues and the impact on weight-loss drugs and gene therapies. Despite requests for the US Federal Trade Commission to block the acquisition, the deal has received regulatory approval in Brazil but still requires clearance in Europe and the US.
Oct 21, 2024
The pill form of Ozempic, known as Rybelsus, reduces the likelihood of heart attacks - Quartz
The pill form of Novo Nordisk's drug Ozempic, containing the active ingredient semaglutide, has been found to reduce the risk of heart attacks and strokes in a late-stage clinical trial. The study showed a 14% reduction in major adverse heart events among patients with Type 2 diabetes and cardiovascular disease and/or chronic kidney disease, compared to those who received a placebo. Novo Nordisk plans to seek FDA approval to expand the use of the oral semaglutide to include reducing the risk of adverse heart events.
