Insmed’s PhII smokes and sputters, but researchers herald enough surprisingly positive data to roar on Wall Street

February 4, 2020 05:59 AM ESTUpdated 07:24 AM

Insmed’s PhII smokes and sputters, but researchers herald enough surprisingly positive data to roar on Wall Street

John Carroll

Editor & Founder

There was plenty not to like in Insmed’s Phase II readout of an anti-inflammatory drug dubbed INS1007.

The dose response didn’t pan out and in fact, the high dose missed on a key endpoint that could be the pivotal goal needed for an approval. But with several analysts expecting the whole thing to be a bust, investors cheered on evidence of positive efficacy in treating non-cystic fibrosis bronchiectasis and ran up the stock price $INSM by 40%.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.

Biotech investors and CEOs see two paths to growth, but are they equally viable?

Noël Brown

Head of US Biotechnology Investment Banking, RBC Capital Markets

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

October 4, 2022 06:00 AM EDTUpdated 11:21 AM

People

Pharma

In Focus

Father starts lab after intellectual property issues stymie rare disease drug development

Jared Whitlock

Features Editor

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.

Fireside chat between Hal Barron and John Carroll, UKBIO19

October 5, 2022 07:38 AM EDT

Bioregnum

It’s time we talked about biopharma — live in London next week

John Carroll

Editor & Founder

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

ENDPOINTS CAREERS

Senior Quality Assurance Compliance Specialist

Lonza

Houston, TX, USA

view job offer post your job now

October 4, 2022 10:00 AM EDTUpdated 9 hours ago

Manufacturing

Takeda to pull key hypoparathyroidism drug from the market after years of manufacturing woes

Zachary Brennan

Senior Editor

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

October 5, 2022 02:23 PM EDT

Pharma

Marketing

Pfizer, BioNTech partner with Marvel for Avengers and Covid-fighting comic book

Beth Snyder Bulik

Senior Editor

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.

Kaile Zagger, Infinant Health CEO

October 5, 2022 02:00 PM EDT

R&D

Pharma

UC Davis microbiome spinout rebrands infant supplement business with nature focus

Nicole DeFeudis

Editor

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

October 5, 2022 11:28 AM EDTUpdated 12:57 PM

FDA+

FDA+ roundup: Adcomm date set for Cytokinetics heart drug; New generic drug guidance to reduce facility delays

Zachary Brennan

Senior Editor

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.

ENDPOINTS CAREERS

Head of Quality Systems

Lonza

Lexington, MA, USA

view job offer post your job now

Bob Azelby, Eliem Therapeutics CEO

October 5, 2022 10:48 AM EDT

R&D

Eliem says earlier drug exposure issues have been resolved, drops one epilepsy indication

Max Gelman

Senior Editor

After being forced to delay two Phase IIa trials and blaming CMC issues on a Phase Ib miss, Eliem Therapeutics believes it’s now in the clear.

The Seattle and UK-based biotech put out word Wednesday morning about how it conducted new early-stage studies to confirm why low exposure issues arose during the Phase Ib. After researchers compared the results of the studies, Eliem found “no meaningful difference” between them and ruled out CMC as the reason for the foiled Phase Ib study, the company said in a press release.

October 5, 2022 07:43 AM EDT

R&D

GSK touts topline win for PD-1 in head-to-head with Keytruda — while steering next big checkpoint drug into PhIII

Amber Tong

Senior Editor

GSK is claiming a win for what it calls the largest head-to-head trial pitting a PD-1 against Merck’s best-selling Keytruda in a type of lung cancer, as its Jemperli met the primary endpoint of objective response rate.

In a separate positive move, GSK says it’s moving both arms of the COSTAR Lung trial into Phase III to test Jemperli as well as the TIM-3 inhibitor cobolimab.

Hesham Abdullah, GSK’s global head of oncology development, said in a statement that the two trials “support the ambition for dostarlimab to become the backbone of our ongoing immuno-oncology-based research and development programme when used alone and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options.”

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.