Achaogen’s bankruptcy and going-out-of-business sale offer a grim cautionary tale for the future of antibiotic development

April 16, 2019 08:48 AM EDT

Achaogen’s bankruptcy and going-out-of-business sale offer a grim cautionary tale for the future of antibiotic development

John Carroll

Editor & Founder

The lights are winking out at Achaogen, offering another cautionary tale that will make it even less likely we’ll see new companies come along to develop antibiotics — even as drug-resistant strains of bacteria pose a rising threat to the world’s population.

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Biotech Halftime Report: After a bumpy year, is biotech ready to rebound?

Brian Abrahams

Co-Head of Biotechnology Research

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

October 22, 2021 08:46 AM EDTUpdated 09:47 AM

R&D

No, scientists are not any closer to pig-to-human transplants than they were last week

Jason Mast

Editor

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

October 22, 2021 08:00 AM EDTUpdated 03:32 PM

FDA+

UPDATED: Agenus calls out FDA for playing favorites with Merck, pulls cervical cancer BLA at agency's request

Zachary Brennan

Senior Editor

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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October 21, 2021 11:09 AM EDTUpdated 2 hours ago

FDA+

How to collect and submit RWD to win approval for a new drug indication: FDA spells it out in a long-awaited guidance

Zachary Brennan

Senior Editor

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

October 21, 2021 08:13 AM EDTUpdated 13 hours ago

Financing

Cell/Gene Tx

Pfizer throws its weight behind LNP player eyeing mRNA treatments for CF, PCD

Amber Tong

Senior Editor

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Luc Boblet, Egle Therapeutics CEO

October 22, 2021 10:49 AM EDTUpdated 04:46 PM

Financing

Startups

A new Treg player emerges with $46M and backing from Takeda

Nicole DeFeudis

Editor

In recent years, the chorus of biotechs and Big Pharma backers targeting regulatory T cells — also known as “Tregs” — for cancer and autoimmune diseases has only grown louder.

The newest voice is from Egle Therapeutics, which sang out a $46.4 million Series A round on Friday led by LSP and Bpifrance through their InnoBio 2 fund. Takeda’s venture arm also chipped in, about a year after the pharma struck a research pact with the Paris-based upstart.

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René Russo, Xilio CEO (Alicia Petitti for Xilio)

October 22, 2021 10:52 AM EDT

Financing

Xilio Therapeutics goes public as biopharma IPOs rumble forward in Q4

Paul Schloesser

Editorial Intern

It’s been a busy fall on Wall Street — and this week, we’ve got another biotech going public after Ventyx yesterday.

Massachusetts solid-tumor biotech Xilio Therapeutics made its public debut today, joining 149 other biotechs that have gone public so far this year.

Back on October 1st, Xilio filed its S-1 with the SEC to make its IPO debut for $100 million — the next step in financing after completing a $95 million Series C back in February.

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Marty Duvall, Oncopeptides CEO

October 22, 2021 10:44 AM EDT

Pharma

FDA+

Oncopeptides stock craters as it pulls cancer drug Pepaxto from the market

Zachary Brennan

Senior Editor

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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October 22, 2021 10:39 AM EDT

FDA+

Coronavirus

Pfizer pitches its Covid-19 vaccine for younger children ahead of adcomm next week

Zachary Brennan

Senior Editor

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.