Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit that alleged the company overpriced its insulin. As part of the settlement, which was recorded (PDF) in a federal district court in New Jersey, Lilly has agreed to cap out-of-pocket costs for its insulin at $35 per month for four years. The deal comes three months after the company said it would slash price of the type 1 diabetes treatment to the same level to “make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system.” Lilly’s initial move had come a month after President Joe Biden, in his State of the Union address, called on Congress to limit insulin costs for all patients to $35 per month. The Inflation Reduction Act already had limited insulin costs for patients on Medicare at $35 per month. The lawsuit was ...
After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the U.S.’ drug regulator is making concerns about the facilities public. In Form 483 filings posted this week, the FDA flagged Lilly’s site in Indianapolis for three manufacturing-related shortfalls and Rentschler’s Baden-Wurttemberg, Germany, site for five deficiencies. At Lilly’s site, the regulator said the company’s aseptic technique for an undisclosed drug’s filling operation was “deficient.” Specifically, operators “handled unprotected sterile components” in a way that “may introduce contaminants onto sterile surfaces” in certain areas, the FDA said. Aside from that observation, the FDA flagged “processing areas” for two filling lines as substandard. Again, the FDA flagged sanitization procedures as not meeting its standards. Inspectors visited Lilly’s Indianapolis site from Oct. 17-21, 2022. In parallel to the Indianapolis site inspection and filing, the FDA in April rejected Eli Lilly’s ulcerative colitis prospect mirikizumab over manufacturing-related shortfalls. It isn’t immediately clear whether the ...
Eli Lilly’s experimental Alzheimer’s drug, donanemab, has been shown to significantly slow cognitive and functional decline in patients with early-stage disease. The phase 3 TRAILBLAZER-ALZ 2 study met its primary endpoint, with the drug slowing the progression of the disease by 35% compared to placebo in 1,182 patients with early symptomatic Alzheimer’s disease and intermediate levels of tau protein. All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits, the company said. Results from the trial demonstrated that 47% of patients who received donanemab showed no disease progression a year after starting treatment, compared with 29% on placebo. Additionally, 52% of patients completed their course of treatment by one year, and 72% completed by 18 months as a result of achieving amyloid plaque clearance. Patients receiving donanemab also experienced a 39% lower risk of progressing to the next stage of disease, and ...
The drug is available in 27 markets, with worldwide sales totalling over $139m in 2022. Eli Lilly will sell its low blood sugar drug Baqsimi to Amphastar Pharmaceuticals in a deal worth over $1bn, the two companies announced. Under the terms of the definitive agreement, Amphastar will pay Lilly $500m at closing and an additional $125m after one year, with Lilly also eligible to receive sales-based milestone payments of up to $450m. Baqsimi is the first and only nasally administered glucagon to treat severe hypoglycaemia – very low blood sugar – in diabetes patients aged four years and above. Classed as a diabetic emergency, severe hypoglycaemia is a complication that can occur in diabetes patients who take insulin and certain anti-diabetic tablets. The condition is characterised by altered mental or physical functioning, including confusion and disorientation, convulsions, loss of consciousness and coma. Lilly launched Baqsimi ...
The stakes are getting even higher for the fight between Eli Lilly and Novo Nordisk for supremacy in the multibillion-dollar obesity market. Lilly on Friday quietly registered a new phase 3b trial on clinicaltrials.gov. The study, coded SURMOUNT-5, will pit Lilly’s Mounjaro against Novo’s Wegovy in patients with obesity or overweight with weight-related health conditions. The trial aims to enroll 700 participants from 61 sites in the U.S., Canada, South America and several European countries, according to the post. The study is currently expected to officially start next Friday and last for about 78 weeks, with an estimated primary completion date in February 2025. On the study’s primary endpoint, investigators will compare the percentage weight changes between the two drugs by week 72 from baseline. However, it’s not immediately clear whether Lilly is designing SURMOUNT-5 as a superiority study to show Mounjaro is better than Wegovy or just to show ...
Genentech recently won the patent for a psoriasis drug. Unfortunately, Roche’s Genentech unit prosecuted Eli Lilly for violation by claiming their psoriasis drugTalz, infringes on one of their patents.
Eli Lilly’s one-time blockbuster hopeful baricitinib $LLY is back and on track and ready to run a gamut of outside experts at the FDA.
Amgen is confident its injectable obesity drug would have a differentiated profile compared to medications now on the market from Novo Nordisk and Eli Lilly and it’s now preparing for Phase 3 testing. But an oral obesity drug in Amgen’s pipeline will not advance beyond Phase 1. By Frank Vinluan Amgen aims to challenge the Novo Nordisk and Eli Lilly duopoly in the market for injectable obesity medications, and the company is now preparing for Phase 3 testing of an injectable drug candidate that would introduce new competition. While executives are not yet sharing specific details of the clinical data that support these plans, Amgen’s drug candidate could have dosing and manufacturing advantages. The update for the drug, maridebart cafraglutide or MariTide (known in earlier stages of development as AMG 133), came with Amgen’s report of financial results for the first quarter of 2024. CEO Robert Bradway said the company ...
Don Tracy, Associate Editor Deal includes a number of radioligand therapies targeting solid tumors, such as breast, prostate, and lung cancers. Novartis announced that it has acquired Mariana Oncology, a biotech specializing in developing radioligand therapies (RLTs) for cancer treatment. According to the company, the acquisition is expected to enhance Novartis’ existing RLT pipeline and add major research capabilities. These programs target breast, prostate, and lung cancers, and features a leading developmental candidate, MC-339, for small cell lung cancer. As per terms of the agreement, Novartis is expected to make an upfront payment of $1 billion, with further potential payments of up to $750 million upon the completion of pre-specified milestones.1 “The acquisition of Mariana Oncology reflects our commitment to radioligand therapy as one of our company’s key technology platforms and strengthens our leadership in this field,” said Fiona Marshall, president, biomedical research, Novartis, in a press release. “We are ...
Don Tracy, Associate Editor First of its kind study reported major improvements in skin clarity and itch relief in over two-thirds of participants. New trial data show that 68% of participants with skin of color suffering from moderate-to-severe atopic dermatitis who were administered Eli Lilly’s lebrikizumab experienced at least a 75% reduction in disease severity, including skin clearance and itch relief. The study notes that people with skin of color have faced a lack of representation in previous clinical trials and are more likely to experience severe symptoms of atopic dermatitis and face delays in diagnosis and treatment.1 “People with skin of color are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, a delay in diagnosis and a lengthier timeframe to find appropriate treatment. They also have been historically underrepresented in clinical trials, which means we have lacked data pertaining to the treatment of patients with skin of ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.