Small biotech Viking slapped with clinical hold after FDA says its PhIb trial is actually PhII

January 24, 2022 10:23 AM EST

Small biotech Viking slapped with clinical hold after FDA says its PhIb trial is actually PhII

Max Gelman

Senior Editor

A microcap biotech looking to develop a new drug for a rare genetic disease will have to slam the brakes on a clinical study after an apparent miscommunication with regulators.

The FDA placed a clinical hold on a Viking Therapeutics study, forcing a halt on trials for the biotech’s X-linked adrenoleukodystrophy (X-ALD) program, Viking announced Monday. While Viking has described the study as a Phase Ib trial, regulators consider it to be a Phase II study, according to the biotech.

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May 28, 2022 06:00 AM EDT

Weekly

Biomarker 'roadmaps' and the future of cancer R&D; Curtain raises on #ASCO22; Pfizer, Novartis tackle drug access; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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May 27, 2022 07:40 AM EDT

R&D

Keeping pressure on Amgen, Mirati draws mixed reviews on latest cut of KRAS data

Amber Tong

Senior Editor

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

May 26, 2022 01:59 PM EDTUpdated 04:16 PM

Pharma

FDA+

HHS finishes off Trump-era rule that would've erased basic FDA regs without frequent reviews

Zachary Brennan

Senior Editor

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

May 27, 2022 12:54 PM EDT

Pharma

Marketing

GSK's ViiV debuts next evolution in HIV med Dovato campaign with new spokespeople and new message

Beth Snyder Bulik

Senior Editor

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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May 27, 2022 12:42 PM EDT

R&D

Transition to new European clinical trials info system starts slowly

Zachary Brennan

Senior Editor

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

May 27, 2022 12:25 PM EDTUpdated 03:47 PM

Pharma

Coronavirus

Manufacturing

Switzerland to destroy over 600,000 expired doses of Moderna Covid vaccine

Tyler Patchen

News Reporter

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

May 27, 2022 12:20 PM EDT

FDA+

Law

Senate unveils its version of accelerated approval reforms as bipartisan duo calls on FDA and PTO to work together

Zachary Brennan

Senior Editor

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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Co-CEOs Chintu and Chirag Patel (Amneal)

May 27, 2022 10:34 AM EDT

Pharma

FDA+

Look out, Neulasta: A 5th biosimilar is coming

Nicole DeFeudis

Editor

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News.

Nassim Usman, Catalyst Biosciences CEO

May 27, 2022 09:51 AM EDTUpdated 10:11 AM

Deals

After $60M Vertex deal, group of Catalyst shareholders claims biotech could’ve sold assets three years ago

Kyle LaHucik

Associate Editor

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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