This morning, Eli Lilly reported positive phase 2 results for its dual GLP-1 and GIP receptor agonist tirzepatide in patients with nonalcoholic steatohepatitis (NASH). In the SYNERGY-NASH trial, the therapy achieved NASH resolution without worsening fibrosis in 61.3% of patients. That is considerably higher than data for semaglutide. Picturing tirzepatide’s NASH resolution in a phase…
Eli Lilly’s Mounjaro sees explosive sales growth, yet demand outpaces supply
Eli Lilly’s diabetes medication Mounjaro (tirzepatide) is seeing explosive sales growth, jumping from $187.3 million in the third quarter of 2022 to $1.4 billion in the same period this year. Conversely, sales of Lilly’s Trulicity, another diabetes drug, have declined, dipping from $1.85 billion in Q3 2022 to $1.67 billion in Q3 2023. Mounjaro is…
Mirikizumab shows continued promise for ulcerative colitis after regulatory hiccup
Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were…
Eli Lilly’s obesity focus helps propel promising 2023
2023 is shaping up to be a blockbuster year for Eli Lilly. With the company’s stock soaring by almost 54% since the beginning of the year, analysts are largely upbeat about Lilly’s expanded focus on obesity and diabetes treatments. While the company has developed insulin for a century, the company is now broadening its horizons…
The weight-loss drug market: overhyped or justified?
The obesity drug market has seen a surge of interest recently, largely thanks to the popularity of glucagon-like peptide-1 (GLP-1) drugs like Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro. The explosion in interest in the drug class has fueled the stock prices of Novo and Lilly, which both have multiple GLP-1 drugs in their portfolios. …
Phase 3 trial shows donanemab reduces Alzheimer’s symptoms by 35%
According to results from the Phase 3 TRAILBLAZER-ALZ 2 study published in JAMA, the monoclonal antibody donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease by approximately 35% at one year compared to placebo. The trial enrolled 1736 patients across 277 research centers in 8 countries. Another monoclonal antibody, Leqembi…
Eli Lilly to acquire cardiometabolic disease treatment maker Versanis for $1.925B
Eli Lilly (NYSE:LLY) announced today that it entered into a definitive agreement to acquire Versanis, a private, clinical stage biopharmaceutical company. Versanis focuses on the development of new medicines for the treatment of cardiometabolic diseases. Its lead asset, bimagumab, is a monoclonal antibody. Bimagumab binds activin type II A and B receptors to block activin…
Lilly gets FDA review for empagliflozin in chronic kidney disease
The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential therapy to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD). Some 37 million people in the U.S. have CKD. Lilly (NYSE:LLY) is developing the drug with Boehringer Ingelheim. The…
Lilly completes acquisition of Akouos
Eli Lilly and Company (NYSE:LLY) announced today that it successfully completed its acquisition of Akouos (Nasdaq:AKUS). Indianpolis-based Eli Lilly’s acquisition expands its efforts in genetic medicines. Akouos offers a portfolio of potential first-in-class adeno-associated viral gene therapies. The gene therapies treat inner ear conditions, including sensorineural hearing loss. The company initially announced the acquisition in…
Analysts are bullish on Eli Lilly with its ‘transformative’ drugs
UBS recently issued a report upgrading Eli Lilly (NYSE:LLY) to a “Buy” rating as its diabetes and Alzheimer’s drugs present lucrative opportunities. According to the report, the pharmaceutical giant’s Mounjaro (tirzepatide) “could be the biggest drug ever.” The type 2 diabetes treatment received FDA approval in May. GlobalData said at the time that tirzepatide could…
FDA approves Olumiant as first systemic therapy for baldness form
The FDA has announced that it has approved Lilly’s Olumiant (baricitinib) oral tablets to treat adults with severe alopecia areata, a form of baldness resulting from the body attacking its hair follicles. Manifesting as patchy baldness, alopecia areata affects more than 300,000 people in the U.S. The incidence of alopecia areata is growing. “Access to…
FDA approves Olumiant for treating some hospitalized COVID-19 patients
The JAK inhibitor Olumiant (baricitinib) from Incyte (Nasdaq:INCY) and Lilly (NYSE:LLY) has scored FDA approval to treat hospitalized COVID-19 patients who need help breathing. In particular, the new indication covers adult patients needing supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation. Olumiant first won FDA approval in 2018 for treating moderately-to-severely active…
10 leading pharma executives you need to know
Given the complexity of the pharmaceutical business and the generally slow pace of new drug development, it can be challenging to identify leading pharma executives. Compensation is not necessarily an accurate barometer of success. That said, CEOs’ annualized return over tenure as CEO over their term can hint at performance. In addition, rating sites like Glassdoor…
15 of the best pharma companies to work for
The pharmaceutical industry continues to see strong growth and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research. The best pharma companies to work for continue to offer a number of advantages to skilled workers. Pharma positions remain in high demand, and…
FDA further limits use of GSK’s and Vir’s SARS-CoV-2 antibody sotrovimab
As the omicron BA.2 subvariant has spread, FDA has announced that it will further constrain the use of the investigational monoclonal antibody sotrovimab. The agency announced that it would limit the use of the antibody in some U.S. regions last week. GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) were initially confident that the antibody could…
Lilly stops Phase 3 Jardiance trial early thanks to clear positive efficacy data
The independent data monitoring committee overseeing the Phase 3 EMPA-KIDNEY trial investigating Lilly’s (NYSE:LLY) Jardiance (empagliflozin) concluded the therapy showed positive efficacy in a formal interim assessment. Boehringer Ingelheim co-developed empagliflozin with Lilly. The EMPA-KIDNEY trial focused on treating adults with chronic kidney disease (CKD). The committee recommended that the Phase 3 study be stopped…
FDA approves Lilly’s Jardiance for heart failure
Eli Lilly and Company (NYSE:LLY) has announced that the FDA has approved Jardiance (empagliflozin) 10 mg to lower the risk of cardiovascular death and hospitalization in adults with heart failure. Lilly developed the drug, an SGLT2 inhibitor, in collaboration with Boehringer Ingelheim. Jardiance is contraindicated in adults with type 1 diabetes, given its potential to…
Lilly invests $700M in Boston Seaport site
Eli Lilly and Company (NYSE:LLY) will spend roughly $700 million to build the Lilly Institute for Genetic Medicine in Boston’s Seaport neighborhood. The facility will focus on RNA- and DNA-based therapeutics and draw resources from Lilly’s 2020 acquisition of Prevail Therapeutics for approximately $1 billion. The new facility will be based in a 334,000 ft2…
FDA authorizes new antibody from Lilly that holds up to omicron
FDA has authorized bebtelovimab, a monoclonal antibody from Eli Lilly and Company (NYSE:LLY), for certain high-risk patients with COVID-19. The emergency use authorization (EUA) for the antibody covers the treatment of mild-to-moderate COVID-19 in individuals at least 12 years of age who weigh at least 40 kg (about 88 pounds). The EUA is constrained to individuals…
Lilly to supply up to 600,000 doses of investigational COVID antibody to U.S. government
Monoclonal antibodies were one of the first weapons to emerge in the battle against COVID-19, but only a single antibody therapy, sotrovimab from Vir Biotechnology and GSK, retains potency against the omicron variant. Two weeks ago, FDA recommended limited use of Eli Lilly’s (NYSE:LLY) bamlanivimab and etesevimab and Regeneron’s (NSDQ:REGN) REGEN-COV (casirivimab and imdevimab), given…
Lily delays timeline for Alzheimer’s candidate donanemab amidst aducanumab chaos
Eli Lilly (NYSE:LLY) announced it planned to complete the application for donanemab, which received FDA’s Breakthrough Therapy designation as a potential Alzheimer’s treatment last summer. Lilly had initially planned on filing the application for donanemab in the first quarter of the year. LLY shares fell 2.40% to $244.81 after announcing the news. Medicare had announced…
Pfizer accuses former employees of trade secret theft
Pfizer (NYSE:PFE) is suing Regor Therapeutics, a China-headquartered company that announced a $1.5 billion diabetes alliance with Eli Lilly (NYSE:LLY) in late 2021. Filed in the U.S. District Court for the District of Delaware, Pfizer’s lawsuit also accuses former employees Xiayang Qiu, Min Zhong and 10 unnamed individuals of using its trade secrets as the…
Lilly pays $50 million upfront to use Entos Pharmaceuticals’ Fusogenix nucleic acid delivery technology
Eli Lilly (NYSE:LLY) has acquired exclusive rights to Entos Pharmaceuticals’ Fusogenix proteolipid vehicle (PLV) drug-delivery technology for central and peripheral nervous system applications. Indianapolis-based Lilly plans on using the platform to discover and develop nucleic acid products. Entos said Fusogenix brings together the best features of viral and lipid-based delivery approaches while avoiding their respective downsides.…
FDA authorizes COVID-19 antibody cocktail for younger children
The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns. The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression. The EUA previously covered children at least 12 years of age who weigh at least…
Early data suggest COVID-19 monoclonal antibodies offer less protection against Omicron variant
The antibody cocktails from Regeneron (NSDQ:REGN) and Eli Lilly (NYSE:LLY) may provide less protection against the Omicron COVID-19 variant than earlier circulating variants. Independent researchers at the Fred Hutchinson Cancer Research Center (Seattle) concluded that bamlanivimab and etesevimab had a decrease in protection against Omicron, according to The Wall Street Journal. Omicron could be more resistant…