Sidekick Health and Eli Lilly partner on digital therapeutics for breast cancer

Sidekick Health today announced a collaboration on an integrated digital therapeutics solution in conjunction with Eli Lilly (NYSE:LLY).

The collaboration between the companies will mark the first phase of a relationship between Sidekick and Lilly, which starts with a digital therapeutic offering for patients battling breast cancer.

According to a news release, the first phase will consist of the integrated digital therapeutic offering rollout in Germany. Reykjavik, Iceland-based Sidekick said the further expansion of its portfolio of digital therapeutics into the treatment of breast cancer will be tailored to support the needs of patients within Lilly’s oncology treatment programs.

“We are extremely excited to be announcing our collaboration with Lilly,” Sidekick CEO and co-founder Dr. Tryggvi Thorgeirsson said in the release. “Cancer is one of the leading causes of death worldwide and is sadly a disease that will likely affect e…

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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 safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Dr. Kendall Marcus, director of the division of dermatology and dentistry in the FDA’s Center for Drug Evaluation and Research, in a news release. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

FDA first approved Olumiant in 2018 for rheumatoid arthritis. In 2022, the drug won an indication for COVID-19 in some hospitalized COVID-19 patients.

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Lilly says proposed $2.1B facility investment could create up to 500 jobs 

Eli Lilly and Company (NYSE: LLY) has announced plans to build two new factories in Indiana. The plants will bolster its supply of active ingredients and new therapeutic modalities.

The plants will be based in LEAP Lebanon Innovation and Research District in Boone County, Indiana.

The proposal could ultimately create as many as 500 new jobs.

The company notes in a press release that the investment is “contingent upon local zoning and annexation approvals.”

Lilly CEO David A. Ricks, who has called for the state to become more competitive, stressed that the company is “committed to investing and innovating in Indiana.”

Eli Lilly was founded in 1876 in Indianapolis, where the company remains headquartered.

“These new sites will add capacity in support of our growing pipeline of innovative medicines, while also creating more high-tech jobs for Hoosiers,” Ricks said in a news release. “We are plea…

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FDA approves Olumiant for treating some hospitalized COVID-19 patients

[Olumiant image courtesy of Lilly]

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 rheumatoid arthritis.

Lilly began testing the drug in hospitalized COVID-19 patients in June 2020. It won emergency use authorization (EUA) for such patients in November of that same year when used with remdesivir.

FDA broadened the EUA in July 2021 to allow its use with or without remdesivir.

Olumiant is the first immunomodulatory therapy to score FDA approval for a COVID-19 indication.

The drug continues to be avail…

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Glooko adds former Eli Lilly exec to its board of directors

Diabetes management technology developer Glooko announced today that it appointed Alfonso “Chito” Zulueta to its board of directors.

Zulueta joins Palo Alto, California-based Glooko’s board having spent more than 30 years with Eli Lilly and Company, serving as a senior executive across an array of global business and commercial units.

Get the full story at our sister site, Drug Delivery Business News.

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10 leading pharma executives you need to know

Pfizer CEO Dr. Albert Bourla [Image courtesy of Pfizer/Business Roundtable]Given the complexity of the pharmaceutical business, it can be challenging to gauge the performance of any chief executive in the space.

That said, CEOs’ annualized return over tenure as CEO over their term can hint at performance. In addition, rating sites like Glassdoor also indicate CEOs’ popularity.

Here, we parsed a range of metrics, including CEOs’ approval ratings, their ability to navigate the pandemic and their firms’ stock performance over time, to identify ten leading pharma executives.

Get the full story from our sister site, Drug Discovery & Development. 

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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 hold up to the first omicron subvariant, but the companies have concluded that it is probably ineffective against the BA.2 subvariant. 

The FDA has announced that sotrovimab is not currently authorized in areas where the BA.2 subvariant makes up the majority of COVID-19 infections. These areas include the Northeast, much of the Western part of the country and a portion of the Midwest. 

The FDA has also withdrawn authorization for sotrovimab in Alaska and major U.S. territories, including Puerto Rico. 

Last year, FDA similarly limited the use of Lilly’s bamlanivimab (LY-CoV555)…

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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 early, given clearly positive data.

Earlier, the Medical Research Council (MRC) Population Health Research Unit at the University of Oxford, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), concluded Jardiance met the prespecified positive efficacy criteria.

Jardiance was first FDA approved as a treatment for type 2 diabetes in 2014. An indication followed for reducing the risk of cardiovascular death in adults with type 2 diabetes in 2016.

Approvals followed in 2021 and 2022 for heart failure with r…

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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 elevate the risk of ketoacidosis in such patients.

It is also contraindicated in patients who are hypersensitive to empagliflozin or the excipients in Jardiance.

FDA first approved Jardiance as a treatment for type 2 diabetes in 2014.

In 2016, it won an indication for reducing the risk of cardiovascular death in adults with type 2 diabetes.

Lilly also notes that the drug is not recommended for improving glycemic control in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) under 30 mL/min/1.73 m2.

The company notes that the treatment …

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Lilly invests $700M in Boston Seaport site

15 Necco Street, Seaport Innovation District, Greater Boston. Image courtesy of Alexandria Real Estate Equities, Inc.

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 site in a 12-story building.

Lilly plans on occupying the site in 2024.

Before the acquisition, Prevail focused on developing disease-modifying AAV9-based gene therapies for neurodegenerative diseases.

“Establishing the Lilly Institute for Genetic Medicine will allow us to pair cutting-edge technologies with our deep biological expertise in several areas, including neuroscience and diabetes,R…

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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 who are not good candidates for existing approved or authorized alternative COVID-19 therapies.

The authorization covers a single 175-mg intravenous dose of bebtelovimab is 175 mg administered over at least 30 seconds.

Lilly began developing bebtelovimab early in 2021 and confirmed its potency against omicron in pseudovirus and authentic virus testing.

Dr. Daniel Skovronsky

The broadly neutralizing antibody “could be used to fight a highly mutated variant, should one emerge,” said Dr. Daniel Skovronsky, Lill…

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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 their diminished protection against omicron.

Eli Lilly, however, said it has found its investigational antibody bebtelovimab retains full neutralizing activity against the variant based on pseudovirus and authentic virus testing.

Lilly also noted that the antibody retains neutralization against the BA.2 subvariant.

Now, the company has reached an agreement with the U.S. government to supply up to 600,000 doses for a price tag of at least $720 million. The supply agreement asks for delivery of that number of doses by March 31. The U.S. has the option of purchasing an additio…

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