Moderna woos trial vet Melanie Ivarsson to the senior R&D team; Ex-Roche CMO Sandra Horning joins Gilead board

January 31, 2020 08:37 AM ESTUpdated 12:22 PM

Moderna woos trial vet Melanie Ivarsson to the senior R&D team; Ex-Roche CMO Sandra Horning joins Gilead board

Kathy Wong

Assistant Editor

Moderna was founded 10 years ago and early on grew into a unicorn with grand ambitions for a broad preclinical effort in messenger RNA. Now that it has shifted a large number of those candidates — along with some blockbuster expectations — into clinical development, the biotech has recruited a development chief. And they’ve turned to an experienced hand from Big Pharma to get the job done.

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June 2, 2020 06:00 AM EDTUpdated 07:18 AM

Venture

Pfizer’s Doug Giordano has $500M — and some advice — to offer a certain breed of 'breakthrough' biotech

John Carroll

Editor & Founder

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Platform and the Evolution Toward Off-The-Shelf Immuno-Oncology Approaches

Peter Kufer

Vice President & Innovator of BiTE® Technology, Amgen

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

June 3, 2020 08:57 AM EDT

R&D

Is a powerhouse Merck team preparing to leap past Roche — and leave Gilead and Bristol Myers behind — in the race to TIGIT domination?

John Carroll

Editor & Founder

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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ENDPOINTS CAREERS

Process Development Scientist, Compound Management

Recursion Pharmaceuticals

Salt Lake City, UT

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

June 3, 2020 02:40 PM EDTUpdated 03:50 PM

Coronavirus

White House names finalists for Operation Warp Speed — with 5 expected names and one notable omission

Jason Mast

Associate Editor

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

June 3, 2020 11:12 AM EDTUpdated 01:01 PM

R&D

Pharma

Coronavirus

UPDATED: Estimating a US price tag of $5K per course, remdesivir is set to make billions for Gilead, says key analyst

Natalie Grover

Reporter

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Credit: AP Images

June 3, 2020 07:39 AM EDT

Coronavirus

Covid-19 roundup: BARDA supports Operation Warp Speed with big $628M contract to service America's vaccine production needs

Natalie Grover

Reporter

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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June 3, 2020 07:34 AM EDTUpdated 11:25 AM

R&D

Regulatory

FDA delays decision on Novartis’ potential blockbuster MS drug, wiping away priority review

Jason Mast

Associate Editor

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Senior Drug Discovery Scientist

New York, NY

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Fangliang Zhang (Imaginechina via AP Images)

May 31, 2020 11:57 AM EDTUpdated June 1, 06:56 AM

IPOs

China

The big money: Poised to make drug R&D history, a China biotech unveils unicorn racing ambitions in a bid to raise $350M-plus on Nasdaq

John Carroll

Editor & Founder

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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June 3, 2020 11:07 AM EDT

Pharma

A low-profile biotech bests Regeneron in high-profile patent suit

Jason Mast

Associate Editor

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.