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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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 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…

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…

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 (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…

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.…

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…

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…

South San Francisco–based biopharma Fountain Therapeutics has pulled in $15 million in Series A-2 financing, bringing its total Series A funding to $26 million. The company focuses on drug development for chronic degenerative diseases. Eli Lilly and Company (NYSE:LLY), Alexandria Venture Investments and R42 Group joined as new investors in the funding round. Prior investors…

Eli Lilly (NYSE:LLY) has announced that it has approved Verzenio (abemaciclib) for certain patients with HR+ HER2– high-risk early breast cancer. The drug will become the first inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6) to hit the U.S. market. “Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated…

Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. Just one example: the mortality rate for Black women with breast cancer is 40% higher than…

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…

Reyvow (lasmiditan) is an FDA-approved treatment from Lilly for the acute treatment of migraine with or without aura in adults. FDA has not approved it as a preventive treatment of migraine. In October, Lilly announced that the drug showed superior pain freedom after two hours of ingestion in two-thirds of migraine attacks in a Phase…

FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares. But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist. Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021…

Eli Lilly (NYSE:LLY) has announced that its investigational drug tirzepatide led to more substantial blood glucose and body weight improvements in a Phase 3 trial than semaglutide, a diabetes drug from Novo Nordisk (NYSE:NVO) that recently scored FDA approval for weight loss in early June. Lilly’s SURPASS-2 results published in The New England Journal of Medicine show tirzepatide…