Gilead touts pivotal data for new kind of HIV therapy, opening towards large potential market

November 18, 2020 11:06 AM ESTUpdated 11:20 AM

Gilead touts pivotal data for new kind of HIV therapy, opening towards large potential market

Jason Mast

Editor

Pandemic aside, the last couple years at Gilead have been all about expansions: Moving beyond the HIV and hepatitis C antivirals that made them into a $77 billion company and into the immunology and oncology treatments that have become biotech’s bread and butter.

Still, key HIV projects have continued as the California biotech looks to stay on top of a field that still earns them north of $15 billion per year.

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Data Literacy: The Foundation for Modern Trial Execution

Kristin Mauri

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

January 25, 2021 06:45 AM ESTUpdated 07:07 AM

Coronavirus

Merck scraps Covid-19 vaccine programs after they fail to measure up on efficacy in another major setback in the global fight

John Carroll

Editor & Founder

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Hal Barron, GSK via YouTube

January 22, 2021 08:25 AM EST

R&D

What does $29B buy you in Big Pharma? In GlaxoSmithKline’s case, a whole lot of uncomfortable questions about the pipeline

John Carroll

Editor & Founder

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Matt Gline (L) and Vivek Ramaswamy

January 25, 2021 09:30 AM ESTUpdated 01:19 PM

Bioregnum

Scoop: Vivek Ramaswamy is handing the CEO job to a top lieutenant at Roivant — but he’s not exactly leaving the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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José Baselga, AstraZeneca cancer chief (Brent N. Clarke/FilmMagic via Getty Images)

January 25, 2021 09:23 AM EST

R&D

AstraZeneca's Calquence nabs another win against Imbruvica, but Eli Lilly is on its heels

Jason Mast

Editor

Three years after first launching Calquence as a second generation BTK inhibitor, AstraZeneca continues to tout new data to compete with J&J and AbbVie’s first generation blockbuster Imbruvica.

The British pharma announced on Monday that Calquence passed a head-to-head Phase III study against Imbruvica in chronic lymphocytic leukemia, proving non-inferior — i.e. just as good — as the older drug. Although AstraZeneca did not break down any of the numbers, they said the drug proved superior on safety, triggering fewer cases of atrial fibrillation, an irregular heartbeat that can lead to stroke or heart failure.

Ron Cooper, Albireo CEO

January 25, 2021 08:00 AM EST

Regulatory

Albireo just advanced down to the 10-yard line at the FDA. And Ron Cooper’s team is getting prepped for the next big play

John Carroll

Editor & Founder

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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January 25, 2021 07:04 AM EST

R&D

Roche amps up its bispecific attack on Eylea with more PhIII data — but just how threatening is it?

Amber Tong

Senior Editor

Roche has another stack of data to back up its longer-acting challenger to Eylea — although it’s still far from certain just how much they can threaten Regeneron’s dominance.

The latest Phase III results come from two trials that enrolled 1,329 patients with neovascular age-related macular degeneration. With 45% of people in both studies getting faricimab 16 weeks apart during the first year, the bispecific still induced the same level of gains in visual acuity as Eylea every 8 weeks did, Roche’s Genentech reported.

January 25, 2021 11:05 AM EST

Regulatory

Can struggling Iterum turn the corner to an antibiotic success story? They will know in six months

Amber Tong

Senior Editor

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

January 25, 2021 10:59 AM EST

Startups

Buried in Immunocore's IPO filings? A kickback scheme from a now former employee

Jason Mast

Editor

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.