Myovant’s relugolix wins a pivotal prostate cancer showdown with an old standard — coming down to the wire on approvals

Lynn Seely, Myovant CEO

May 31, 2020 06:54 PM EDTUpdated June 1, 06:23 AM

Myovant’s relugolix wins a pivotal prostate cancer showdown with an old standard — coming down to the wire on approvals

John Carroll

Editor & Founder

Myovant $MYOV has rounded the final turn in its development race to get relugolix down to the regulatory wire at the FDA. And the biotech joined the virtual crowd at ASCO with the kind of data needed to keep the investor crowd’s attention.

Much of the attention on the drug has been focused on uterine fibroids, where AbbVie just scored a regulatory win for their rival drug Oriahnn (elagolix) as the biotech posted results in prostate cancer at the ASCO meeting.

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July 24, 2021 06:00 AM EDT

Weekly

Novartis reshuffles its wild cards; Tough sell for Biogen? Googling proteins; Ken Frazier's new gig; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

July 23, 2021 11:15 AM EDT

Discovery

Google's DeepMind opens its protein database to science — potentially cracking drug R&D wide open

Jason Mast

Editor

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

July 21, 2021 09:51 AM EDTUpdated July 23, 01:52 PM

R&D

Novartis discards one of its ‘wild card’ drugs after it flops in key study. But it takes one more for the hand

John Carroll

Editor & Founder

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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ENDPOINTS CAREERS

Director-Regulatory

Icosavax, Inc.

Seattle, WA, USA

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July 23, 2021 06:58 AM EDT

R&D

Pharma

6 top drugmakers offer perspectives on FDA's new covariates in RCTs guidance

Zachary Brennan

Senior Editor

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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July 21, 2021 07:17 PM EDTUpdated July 23, 03:30 PM

Pharma

Inside Biogen's scramble to sell Aduhelm: Project 'Javelin' and pressure to ID as many patients as possible

Zachary Brennan

Senior Editor

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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July 23, 2021 09:49 AM EDT

Pharma

FDA+

EMA rejects FDA-approved Parkinson's drug, signs off on Moderna vaccine use in adolescents ahead of FDA

Zachary Brennan

Senior Editor

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

Laurent Fischer, Adverum CEO

July 23, 2021 06:25 AM EDT

R&D

Cell/Gene Tx

Adverum faces murky future after review turns up deeper safety issues for gene therapy

Jason Mast

Editor

Three months after revealing that a patient lost significant vision in one eye after receiving its experimental gene therapy, Adverum announced it found the safety issues were more widespread: Five of 12 patients who received a high dose of the therapy saw “similar clinically-relevant events.”

Three required surgery on their treated eye. And all 12 are being recommended “aggressive immunomodulatory treatments” to prevent further injury.

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ENDPOINTS CAREERS

Director, High-Throughput Screening (HTS) Drug Discovery Group

Pliant Therapeutics

South San Francisco, CA, USA

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Molecular Diagnostics Can Transform Cancer Care. Let’s Make It Happen.

Bonnie H. Anderson

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.

July 21, 2021 08:49 AM EDTUpdated 10:54 AM

R&D

FDA levels clinical hold on Magenta's second lead drug, asking for an additional bioassay before it gets to humans

Kyle Blankenship

Managing Editor

Earlier this summer, Magenta Therapeutics was forced to say goodbye to its head of R&D at a pivotal time as the biotech read out data for its lead stem cell conditioning hopeful. Just weeks later, the company’s second drug is facing a clinical hold from the FDA as the agency demands more info on how the candidate works in humans.

Magenta will be required to submit an additional bioassay to help determine the best path forward on dose escalation for the biotech’s Phase I/II study of MGTA-117, an antibody-drug conjugate used to deplete hematopoietic stem cells prior to a transplant of HSC-based gene therapy, the biotech said Wednesday.

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