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Eli Lilly

Lilly’s LOXO-292 shrinks tumours in lung cancer trial

Eli Lilly has announced its experimental cancer drug LOXO-292, acquired in January, shrank tumours in almost 70% of advanced lung cancer  patients.

LOXO-292 (selpercatinib) treatment resulted in a 68% objective response in patients who had been previously heavily pre-treated with at least 48% of those having received at least one multikinase inhibitor. Additionally in 11 patients whose cancer had spread to the brain, 91% saw tumour shrinkage by 30% or more.

Mylan gets provisional FDA greenlight for generic version of Lilly's blockbuster cancer drug Alimta

Mylan has scored a preliminary approval in the US from the FDA for its generic version of Eli Lilly’s blockbuster therapy Alimta (permetrexed) for the treatment of non-squamous non-small cell lung cancer (NSCLC) and mesothelioma.

This tentative approval means that Mylan will be cleared to market its product in the US, but only once Lilly’s patent on the originator medicine expires in the country. This means that Mylan will need to wait until May 2022, when the patent on low-cost generic competition is due to run out.  

Lilly's Taltz beats Janssen's Tremfya at Phase 4 in plaque psoriasis

Eli Lilly has unveiled new Phase 4 data supporting the efficacy and safety of Taltz (ixekizumab) when compared to Janssen’s Tremfya (guselkumab), showing that the former met all primary and secondary endpoints in the treatment of moderate to severe plaque psoriasis (PsO).

The 1,027-participant trial is the first to directly compare an IL-17A inhibitor to an IL-23/p19 inhibitor using the Psoriasis Area Severity Index (PASI) 100 score as a primary endpoint to assess their efficacy.

Top Ten most popular articles on Pharmafile.com this week!

This week’s top story covered the scandal surrounding Novartis over its covering up of faulty data from the FDA. The Swiss firm’s integrity was called into question after it waited until it’s $2.1 million gene therapy had been approved before informing the US regulator of inaccuracies in its data.

Lilly's Emgality smashes all Phase 3 endpoints in migraine sub-population

New Phase 3 data have been revealed on Eli Lilly’s Emgality (galcanezumab-gnlm), detailing its success in meeting all of its primary and secondary endpoints as a preventive treatment for chronic and episodic migraine in patients who have previously failed to control their condition with other migraine medications.

Specifically, the indicated patient population refers to those who have found inadequate relief with two to four different standard-of-care migraine preventive medication categories, either because of efficacy or safety and tolerability reasons.

Lilly's Verzenio combo shows additional breast cancer survival benefit in new Phase 3 data

Eli Lilly has revealed new Phase 3 data on its CDK4 & 6 inhibitor Verzenio (abemaciclib), demonstrating its efficacy in extending overall survival when combined with AstraZeneca’s Faslodex (fulvestrant) in the treatment of breast cancer.

The study of 669 participants from which the data was drawn focused on the efficacy of the drug combo in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine therapy.

Lilly's Baqsimi nasal powder gains FDA approval after proving non-inferior to injection

Eli Lilly has been awarded approval from the FDA for its Baqsimi nasal powder in the treatment of severe hypoglycaemia, it has emerged, marking the authorisation of the first glucagon therapy in this indication in the US that can be administered without an injection.

Differing from the traditional injectable glucagon treatments which have been approved for decades, the therapy takes the form of a powder which is administered nasally via a single-use dispenser.

US Judge blocks Trump administration law requiring pharma to include prices in TV ads

A judge has blocked the Trump administration from enacting a law that would require pharmaceutical companies to include the prices of their drugs in TV ads.

On 8 July 2019, District Judge Amit Mehta in Washington, DC ruled in favour of pharma giants Amgen, Eli Lilly and MSD in preventing the Department of Health and Human Services (HHS) new law from taking effect.

Drugmakers sue Trump over prices in TV ads

Amgen, Eli Lilly and MSD have sued the Trump administration to try and block measures to force pharma companies to include prices in TV ads.

Three of America’s biggest drugmakers filed a lawsuit against the Trump administration over the Department of Health and Human Services (HHS) ruling to force pharmaceutical companies to list the prices of their drugs in adverts on TV.

Eli Lilly's heart drug underwhelms with REWIND trial

Eli Lilly’s Trulicity (dulaglutide) reduced major cardiovascular events (MACE) by 12% versus placebo in adults with type 2 diabetes, according to the results of the REWIND trial.

The study of 9901 adults with type 2 diabetes looked at the glucagon-like peptide 1 receptor agonist Trulicity in combination with standard of care treatment in comparison to standard of care treatment combined with placebo.

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