Gilead fires back in ongoing battle with HHS, suing the government for ‘secretly’ obtaining patents

April 28, 2020 07:20 AM EDT

Gilead fires back in ongoing battle with HHS, suing the government for ‘secretly’ obtaining patents

Jason Mast

Associate Editor

While the world urgently awaits data on their potential coronavirus drug, Gilead continues to duke it out with the government over a life-saving drug for a different plague.

On Friday, the California-based drugmaker filed a lawsuit accusing the CDC of breaking longstanding agreements by “secretly” obtaining patents on Gilead’s pre-exposure prophylaxis HIV drug Truvada and failing to notify the company for nearly a decade. The allegations relate to four material transfer agreements, or MTAs, under which Gilead provided drugs to the CDC for academic research and for clinical trials in Botswana. Those MTAs, Gilead says, required the government to disclose any inventions arising out of that research.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

August 3, 2020 01:40 PM EDTUpdated August 4, 03:38 AM

R&D

Coronavirus

When will it end? Goldman economist gives late-stage vaccines a good shot at targeting 'large shares' of the US by mid-2021 — but the downside is daunting

John Carroll

Editor & Founder

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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August 3, 2020 10:53 AM EDT

R&D

Regulatory

J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about?

John Carroll

Editor & Founder

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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August 4, 2020 04:20 PM EDTUpdated 07:21 PM

Coronavirus

UPDATED: Novavax heralds the latest positive snapshot of early-stage Covid-19 vaccine -- so why did its stock briefly crater?

John Carroll

Editor & Founder

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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August 3, 2020 07:22 AM EDTUpdated 10:25 AM

R&D

Cell/Gene Tx

Regulatory

FDA hands MorphoSys and Incyte a quick OK on their potential blockbuster CAR-T alternative

Jason Mast

Associate Editor

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

August 3, 2020 06:50 AM EDTUpdated 07:34 AM

Bioregnum

R&D

So Covid-19 leader BioNTech has a cancer vaccine in development? Yes, and Regeneron just jumped in for the PhII combo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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August 4, 2020 10:26 AM EDT

R&D

Novartis says Kymriah reaches primary endpoint in new PhII, although numbers still to come

Max Gelman

Associate Editor

The race to develop CAR-T therapies has died down since Novartis’ Kymriah and Gilead’s Yescarta first crossed the finish line, though Tecartus also recently received approval. But the companies continue to expand their drugs’ applications, with Novartis preparing to conclude a new Phase II.

Interim data announced by the Swiss pharma show that Kymriah met its primary endpoint of complete response rate in treating patients with relapsed or refractory follicular lymphoma, the second-most common form of non-Hodgkin lymphoma. Based on preliminary trial findings, Kymriah had received RMAT designation from the FDA in April for r/r follicular lymphoma.

August 4, 2020 09:34 AM EDT

R&D

AbbVie shrugs off $134M cash deals, quitting a neuro R&D pact with Voyager Therapeutics on vectorized antibody treatments

Nicole DeFeudis

Associate Editor

It’s the end of the road for Voyager Therapeutics’ collaboration with AbbVie on tau and alpha-synuclein vectorized antibody development.

In two deals spanning the last two years, AbbVie dropped more than $134 million upfront for Voyager’s preclinical R&D of vectorized antibody treatments for diseases like Alzheimer’s and Parkinson’s. But Voyager says AbbVie is walking away now, without offering an explanation for why.

ENDPOINTS CAREERS

Director of Clinical Operations

Recursion Pharmaceuticals

Salt Lake City, UT

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August 4, 2020 09:20 AM EDT

Deals

R&D

Merck scoops up a PhII J&J discard in a bargain-basement deal. And this time they’re shooting at NASH

John Carroll

Editor & Founder

When J&J turned to South Korea’s Hanmi for a GLP-1/glucagon dual receptor agonist obesity drug, the pharma giant paid $105 million in a cash upfront for the licensing rights and plotted a big clinical trial program to test it. A year ago, like a few of Hanmi’s big partners, J&J reviewed their trial data and walked away, handing it back.

Now Merck is stepping up to grab it for their NASH pipeline — and they got it a lot cheaper than J&J.

Igor Splawski (CureVac)

August 4, 2020 09:05 AM EDT

People

CureVac nabs a top Novartis scientist for CSO slot as mRNA vaccines seize the spotlight

John Carroll

Editor & Founder

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

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