Astellas’ AML drug wins over CHMP — strengthening lead on Daiichi Sankyo

September 20, 2019 11:24 AM EDT

Astellas' AML drug wins over CHMP — strengthening lead on Daiichi Sankyo

Amber Tong

Senior Editor

Less than a year after scoring a fast FDA OK for its pioneering acute myeloid leukemia drug gilteritinib, Astellas has snapped up a positive recommendation from European regulators following an accelerated assessment.

The CHMP thumbs up widens the gap between Astellas and Daiichi Sankyo, which has run into a roadblock at the FDA when trying to field its own FLT3 targeted therapy after being green-lighted in Japan.

Daiichi’s drug, quizartinib, has also nabbed speedy review at the EMA.

Up to 30% of AML patients have an FLT3 mutation, which stimulates the growth of abnormal leukemia cells. Novartis’ Rydapt is approved on both sides of the Atlantic to treat the same group in combination with chemotherapy.

The marketing authorization for gilteritinib — branded Xospata — will cover relapsed or refractory cases in adults.

Social image: Astellas, AP Images

AUTHOR

Amber Tong

Senior Editor

amber@endpointsnews.com @AmberTongPW

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Data Literacy: The Foundation for Modern Trial Execution

Kristin Mauri

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

January 25, 2021 06:45 AM ESTUpdated 07:07 AM

Coronavirus

Merck scraps Covid-19 vaccine programs after they fail to measure up on efficacy in another major setback in the global fight

John Carroll

Editor & Founder

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

January 25, 2021 04:54 PM ESTUpdated 3 hours ago

In Focus

After 3 deaths rock the field, gene therapy researchers contemplate AAV's future

Jason Mast

Editor

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

January 26, 2021 04:55 PM ESTUpdated 05:23 PM

R&D

Agios scores its second positive round of data for its lead pipeline drug — but that won't answer the stubborn questions that surround this program

John Carroll

Editor & Founder

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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January 26, 2021 11:13 AM EST

Pharma

Drugmakers 'inching ahead' in increasing access to drugs worldwide, with GlaxoSmithKline leading the pack

Nicole DeFeudis

Associate Editor

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.

January 26, 2021 10:58 AM ESTUpdated 06:09 PM

Manufacturing

Vir's CMO says he's surprised that a low dose of their hepatitis B drug appears promising in early slice of data — shares soar

Conner Mitchell

Associate Editor

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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January 26, 2021 10:30 AM ESTUpdated 11:18 AM

Coronavirus

Eli Lilly demonstrates that 2 antibodies beat 1 for guarding against severe Covid-19. But can that solve the first antibody’s problem amid slow uptake?

Jason Mast

Editor

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

January 26, 2021 07:35 AM ESTUpdated 07:48 AM

R&D

Coronavirus

Regeneron touts positive preliminary impact of its Covid antibody cocktail, preventing symptomatic infections in high-risk group

John Carroll

Editor & Founder

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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January 26, 2021 11:03 AM EST

News Briefing

News briefing: Nestlé whips up research collaboration with newly-unveiled Flagship upstart; Marianne De Backer joins Kronos board

John Carroll

Editor & Founder

Max Gelman

Associate Editor

Flagship Pioneering tapped into a variety of trendy R&D themes when it officially debuted Senda Biosciences a few months ago, most prominently its focus on the microbiome, computational biology and cellular interactions. And while it’s all still in its infancy, the founders clearly elicited some high-profile attention from a major player which straddles the line between food and medicine.

Nestlé Health Science has partnered with Senda on one of its initial slate of R&D focuses, aligning itself with the biotech on metabolics, with a focus on some big targets, including obesity and glycemia.