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Johnson & Johnson said on Wednesday its experimental psoriasis drug has shown superior skin clearance compared to Bristol Myers Squibb's Sotyktu in two late-stage head-to-head trials. J&J has been working on more convenient treatment options for psoriasis as its injectable drug Stelara, which recorded over $10 billion in sales last year, faces stiff competition from cheaper rivals. The drugmaker said its oral pill, icotrokinra, met both main and secondary goals when compared to placebo and Bristol's Sotyktu at weeks 16 and 24 in adult patients in the trials. Icotrokinra also showed similar adverse event rates to placebo with no new safety signals. Bristol's Sotyktu is already approved to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The drug generated $246 million in sales in 2024. J&J had previously said it expected icotrokinra to generate sales of $700 million in 2028. J&J is testing its drug in adult and pediatric patients 12 years of age and older with moderate-to-severe plaque psoriasis, which is an immune-mediated condition characterized by thick, scaly patches or plaques. Over 8 million people in the U.S. have psoriasis, according to the National Psoriasis Foundation. J&J's oral pill is designed to block a protein, IL-23, involved in inflammatory responses and...

Eli Lilly’s Nexperimental GLP-1 pill helped people lose about 12% of their body weight, with weight loss plateauing for most patients in the 72-week trial, according to full study results presented at a medical meeting on Tuesday. Lilly had announced in August that the Phase 3 study of the daily pill, orforglipron, met its main goals, but the weight loss was less robust than previous trial results for Novo Nordisk’s weekly injectable GLP-1 drug Wegovy. That news sent Lilly’s shares down 14%. Year-to-date, the company’s shares have fallen about 1%. Results from a late-stage study of the drug orforglipron were presented at a European medical meeting and published in the New England Journal of Medicine. The trial enrolled over 3,000 non-diabetic participants who were obese or overweight with a weight-related health problem. Lilly said orforglipron showed clinically meaningful improvements across key cardiovascular risk factors, including cholesterol levels and blood pressure. It said the highest dose of the drug reduced a key marker of inflammation by 47.7%. The most commonly reported side effects were mild-to-moderate and gastrointestinal. The rate of nausea for high-dose patients was 33.7%, compared with 10.4% for placebo patients. In the high-dose orforglipron group, 10.3% of patients dropped out of the trial due...

Patients on Eli Lilly & Co.’s experimental diabetes pill lost more weight and had better blood sugar control than those on an older, approved rival from Novo Nordisk A/S in the first head-to-head trial of the two medicines. The highest dose of Lilly’s pill — called orforglipron — led to a 1.9% drop in blood sugar levels and shaved roughly 18 pounds from patients’ frames, significantly more than those getting Novo’s Rybelsus. The initial findings from the Lilly-funded study came as the Indianapolis-based drugmaker released full data about orforglipron’s impact on obesity at the European Association for the Study of Diabetes meeting. The results will help Lilly take the lead in the emerging market for an oral form of the GLP-1 drugs that have surged to blockbuster status in recent years, analysts said. Orforglipron, plus a more potent, experimental version of Novo’s GLP-1 pill, is expected to help drive future demand for a class of medicines that’s become so popular that companies have struggled to maintain enough supply. The study findings “clearly position orforglipron as the preferred oral agent” for patients with type 2 diabetes, Evan David Seigerman, an analyst for BMO Capital Markets, wrote in a note to clients. While blood...

Arvinas announced that it has transferred the commercial rights of its experimental breast cancer drug, vepdegestrant, developed in collaboration with Pfizer, to a third-party partner. The drug is currently under review by the U.S. Food and Drug Administration (FDA) for a type of breast cancer, and a final decision on its approval has not yet been announced. The company also said it will limit additional expenses for preparing the drug for commercialization and will reduce its workforce by 15%. Together with a $100 million share repurchase program, these measures are expected to generate annual savings of more than $100 million compared to 2024. In May, trial results showed that vepdegestrant delayed disease progression in breast cancer patients with a specific genetic mutation by more than three months, compared to Faslodex, a drug developed by AstraZeneca. Arvinas said it has transferred commercial rights for its experimental breast cancer drug vepdegestrant, developed with Pfizer, to a third-party partner. The drug is under review by the U.S. FDA, with a decision on approval still pending. The company will also cut costs, reduce its workforce by 15%, and launch a $100 million share buyback, moves expected to save more than $100 million annually versus 2024. In May, trial...

Roche has agreed to buy U.S. biotech firm 89bio for up to $3.5 billion to strengthen its development pipeline of liver and cardiometabolic disease treatments, the Swiss drugmaker said on Thursday. The deal would help Roche grow in a field related to the booming weight-loss market, where the company has recently made major inroads. In a statement, Roche said the deal was worth about $2.4 billion, or up to $3.5 billion when including a non-tradeable contingent value right. The target company's leading drug pegozafermin, part of a class known as FGF21 analogues, is in the late stages of development to treat metabolic dysfunction-associated steatohepatitis - also known as fatty liver - including advanced stages. Roche said it would tender to buy all 89bio common stock for $14.50 per share in cash and a contingent value right to receive certain milestone payments of up to $6.00 per share. It said the acquisition underscores its dedication to advancing therapies in cardiovascular, renal, and metabolic diseases, especially for patients affected by overweight, obesity, and related health challenges such as fatty liver, also known as MASH. This year, the company acquired rights to an obesity therapy developed by Denmark's Zealand Pharma in a deal worth up to $5.3 billion,...

Novo Nordisk's experimental Wegovy pill showed a 16.6% weight-loss in a late-stage study, according to data published in The New England Journal of Medicine on Wednesday, which is comparable to previous trial results of injectable Wegovy.

Regeneron Pharmaceuticals said on Wednesday its experimental treatment for a rare genetic disorder affecting soft tissue significantly reduced abnormal bone formation, meeting the main goal of a late-stage study. The company was testing its drug, garetosmab, in adults with fibrodysplasia ossificans progressiva — a condition where muscle, tendon and ligament tissue gradually turn into bone, leading to a "second skeleton" that causes progressive loss of mobility and reduced life expectancy. The condition affects about one in 1.14 million people in the United States, according to data from the National Institutes of Health. Its only approved treatment is French drugmaker Ipsen's Sohonos, which gained the U.S. Food and Drug Administration's nod in 2023. Garetosmab works by blocking a protein called activin A, which can trigger abnormal bone formation in muscles and soft tissues in people with the disorder. In a 56-week trial involving 63 participants, garetosmab reduced the development of new bone abnormalities by 94% at a 3 milligram/kilogram dose and by 90% at a 10 mg/kg dose, when compared to placebo. Based on the trial data, a panel of experts, called the independent data monitoring committee, recommended patients who were on placebo to be transitioned to garetosmab as soon as possible. Regeneron said it plans...

Eli Lilly (LLY.N), opens new tab's experimental weight-loss pill could be fast-tracked under a one- to two-month review process recently launched by the U.S. Food and Drug Administration, several Wall Street analysts said. Analysts speculate that the drug, orforglipron, is a viable candidate given the growing cost burden of expensive injectable weight-loss drugs and the fact that Lilly is expanding its U.S. manufacturing - issues the Trump Administration has prioritized. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Lilly, based in Indianapolis, declined to comment. The FDA is reviewing an oral version of Denmark-based rival Novo Nordisk's (NOVOb.CO), opens new tab GLP-1 obesity drug, with a decision expected in the fourth quarter. Goldman Sachs recently estimated that if orforglipron were to launch one quarter earlier than expected, it would bring in another $1 billion in revenue to Lilly. The FDA in July detailed terms of its new "Commissioner's National Priority Voucher, opens new tab," under which an experimental drug meeting certain criteria could be approved within a month or two. The agency's standard review takes 10 months. "FDA policymakers have tried to come up with ideas to speed important products to market. ... It is...

Novo Nordisk, looking to turn around slowing growth of its blockbuster weight-loss drug Wegovy, plans to test whether its next-generation obesity drugs can treat a broader range of related conditions from sleep problems to knee pain. The Danish drugmaker aims to generate evidence across both severe and more common obesity-related conditions that affect patients' daily lives, including knee osteoarthritis and sleep apnea, Martin Holst Lange, Novo's head of research and development, told Reuters in an interview during the European Association for the Study of Diabetes conference in Vienna. "We do know that obesity is actually related to more than 200 different co-morbidities," Lange said. The company is battling to reignite growth and fend off competition from U.S. rival Eli Lilly, with some investors calling for Novo to expand beyond its traditional focus on diabetes and obesity treatments to spur sales. Lange said the treatment needs of obese patients could vary widely, driving the company to develop a range of options. TESTING SEMAGLUTIDE FOR ALZHEIMER'S DISEASE Novo has not disclosed which conditions it plans to study in trials of its experimental therapies CagriSema and amycretin. It has already secured regulatory approval for semaglutide as a treatment to reduce the risk of major cardiovascular events such as...

•Eli Lilly said it will spend $5 billion to build a manufacturing facility in Goochland County, Virginia, to boost production capacity for targeted cancer drugs and other treatments. •The plant is the company’s first of four planned U.S. manufacturing sites, which are expected to begin making medicines within five years. •Eli Lilly said the facility will help increase domestic manufacturing of targeted treatments called antibody drug conjugates and its monoclonal antibody portfolio. Eli Lilly on Tuesday said it will spend $5 billion to build a manufacturing facility in Goochland County, Virginia, to boost production capacity for targeted cancer drugs and other treatments — the first in a string of new planned U.S. investments by the drugmaker. The company announced in February that it would spend at least $27 billion to build four new domestic manufacturing plants, adding to $23 billion in previous investments since 2020. Eli Lilly said it will announce the three remaining U.S. sites this year and expects to begin making medicines at all four facilities within five years. Drugmakers have been scrambling to boost their production in the U.S. as President Donald Trump threatens to clamp down on the industry with tariffs on imported pharmaceuticals. Trump has said those levies will...