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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At the Inflection Point for the Next Generation of Cancer Immunotherapy

Willem Overwijk, Ph.D.

Vice President, Oncology Research, Nektar Therapeutics

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

December 4, 2021 06:00 AM EST

Weekly

All about Omicron; We need more Covid antivirals; GSK snags Pfizer’s vaccine exec; Janet Woodcock’s future at FDA; 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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

December 2, 2021 09:02 AM ESTUpdated 14 hours ago

Pharma

Coronavirus

As Omicron spread looms, oral antivirals appear to be one of the best defenses — now we just need more

Paul Schloesser

Associate Editor

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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ENDPOINTS CAREERS

Lead Manager / Associate Director of Statistical Genetics

Deep Genomics

Boston, MA, USA

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December 3, 2021 10:54 AM EST

R&D

FDA+

Pfizer, Amgen and Janssen seek further clarity on FDA's new benefit-risk guidance

Zachary Brennan

Senior Editor

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Lisa Deschamps, AviadoBio CEO

December 2, 2021 11:07 AM ESTUpdated December 3, 02:00 AM

Financing

Startups

Cell/Gene Tx

Ex-Novartis business head hops over to a gene therapy startup — and she's reeled in $80M for a dash to the clinic

Nicole DeFeudis

Editor

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News.

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

December 2, 2021 10:24 AM EST

R&D

With generic competition heating up, Vas Narasimhan outlines Novartis' growth plans at R&D day

Max Gelman

Editor

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

Incorporating External Data into Clinical Trials: Comparing Digital Twins to External Control Arms

Unlearn.AI

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

ENDPOINTS CAREERS

Executive Director - Data Analysis - Science & Technology

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Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

December 1, 2021 07:30 AM EST

R&D

Battling a lineup of skeptics, Vertex claims another early clinical win — this time in kidney disease

Jason Mast

Editor

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

December 3, 2021 04:55 PM EST

Marketing

AbbVie tacks on a new warning to Rinvoq label as safety frets crimp JAK class

John Carroll

Editor & Founder

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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