The top 10 pipeline blowups, setbacks and snafus for H1 2021

July 7, 2021 07:30 AM EDT

The top 10 pipeline blowups, setbacks and snafus for H1 2021

John Carroll

Editor & Founder

Once the pandemic hit, it was instantly clear that the industry was going to create an entire pipeline of vaccines and new drugs to fight back against Covid-19. In doing so, it also became instantly clear that we were going to get a crash course on just how bad things can go.

In the backdrop to some spectacular successes, we saw some of the biggest players in biopharma stumble, fall and in some cases never get back up again. You can find some of the most significant setbacks in the list below.

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Tillman Gerngross (Adagio)

November 29, 2021 07:04 AM ESTUpdated 02:20 PM

Tillman Gerngross on Omicron: 'It is a grim situation...we’re going to see a significant drop in vaccine efficacy'

John Carroll

Editor & Founder

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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

Lead Manager / Associate Director of Statistical Genetics

Deep Genomics

Boston, MA, USA

view job offer post your job now

November 29, 2021 10:32 AM EST

R&D

Pharma

FDA+

More manufacturing issues: Fennec preps for second CRL for potential hearing loss drug

Paul Schloesser

Associate Editor

Shares of Fennec Pharmaceuticals stock were cut almost in half early Monday as the company said manufacturing issues caused another FDA rejection of its reformulated version of sodium thiosulfate, which is intended to help kids who lose hearing due to chemo treatment.

The biotech had resubmitted an NDA for the drug to treat platinum-based, chemo-related ototoxicity in young children earlier this year. The first NDA was denied by the FDA last year, with the agency citing manufacturing issues with the biotech’s supplier.

Róbert Wessman, Alvogen CEO

November 29, 2021 10:24 AM ESTUpdated 02:04 PM

R&D

Biotech billionaire Róbert Wessman engineers $450M deal for Alvogen subsidiaries

Paul Schloesser

Associate Editor

Alvogen is handing off two of its subsidiaries to CEO Róbert Wessman and his healthcare investment firm Aztiq — who has now tied the two together in a massive biobucks deal.

In an alliance with Thailand’s PTT Group subsidiary Innobic, the two companies signed an agreement last week to buy a 100% stake in Alvogen Emerging Market Holdings Limited (AEMH) for $475 million from Alvogen, buying out shareholders such as CVC Capital Partners and Singapore’s Temasek. And now, the group is the majority shareholder of Alvogen’s former Asian subsidiary Lotus Pharmaceuticals and the only shareholder of Alvogen Malta, the owner of B2B pharma Adalvo.

November 29, 2021 10:06 AM ESTUpdated 01:19 PM

FDA+

Coronavirus

Like the flu vaccine every year, the FDA could move quickly on a variant-targeted Covid vaccine

Zachary Brennan

Senior Editor

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

November 27, 2021 06:00 AM EST

Weekly

Thanksgiving edition: Top 15 Endpoints stories of 2021; Can you name that vaccine?; Merck's Covid antiviral disappoints; FDA nominee's industry ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

ENDPOINTS CAREERS

Executive Director - Data Analysis - Science & Technology

Alexandria Real Estate Equities

Pasadena, CA

view job offer post your job now

Troy Wilson, Kura CEO

November 24, 2021 07:01 AM ESTUpdated 10:30 AM

R&D

FDA+

UPDATED: FDA hits the red light on an early-stage AML study after a patient dies

John Carroll

Editor & Founder

Max Gelman

Editor

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

November 26, 2021 08:35 AM ESTUpdated 12:53 PM

Bioregnum

Cell/Gene Tx

What were Endpoints readers tuning into this year? Here’s a look at our 15 most popular reports of the year (so far)

John Carroll

Editor & Founder

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.