Amgen attorneys win a megablockbuster patent case, dealing Novartis a severe setback on biosimilars play

August 10, 2019 08:50 PM EDTUpdated August 12, 05:06 AM

Amgen attorneys win a megablockbuster patent case, dealing Novartis a severe setback on biosimilars play

John Carroll

Editor & Founder

Don’t bet against Amgen attorneys.

That’s what Umer Raffat’s old mentor Mark Schoenbaum told the Evercore ISI analyst when he was prepping for a recent deep dive on Amgen’s Enbrel.

Like other classic remarks about Amgen’s litigious nature, it was dead on.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.

Tal Zaks, Moderna CMO (Moderna via YouTube)

July 14, 2020 05:00 PM EDTUpdated 19 hours ago

R&D

Coronavirus

UPDATED: NIAID and Moderna spell out a 'robust' immune response in PhI coronavirus vaccine test — but big questions remain to be answered

John Carroll

Editor & Founder

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.

Transport Simulation Testing for Your Therapy is the Best Way to Assure FDA Expedited Program Approval

Gary Hutchinson

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Source: Shutterstock

July 15, 2020 09:47 AM EDT

People

Editor's note

Who are the women blazing trails in biopharma R&D and leading the fight against Covid-19? Nominate them for Endpoints' special report

Amber Tong

Editor

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

view job offer post your job now

Jeff Albers, Blueprint CEO

July 14, 2020 06:01 AM EDTUpdated 07:09 AM

Deals

Diagnostic champ Roche buys its way into the RET title fight with Eli Lilly, paying $775M in cash to Blueprint

Amber Tong

Editor

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.

Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

July 15, 2020 10:42 AM EDTUpdated 10:58 AM

R&D

Coronavirus

A day after Moderna vaccine results, rumors swirl of pending AstraZeneca data

Jason Mast

Associate Editor

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet.

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

July 15, 2020 09:48 AM EDTUpdated 10:01 AM

Coronavirus

‘Planning to vaccinate everyone in the US,’ Moderna outlines efforts to supply their Covid-19 vaccine as manufacturing ramps up ahead of PhIII

John Carroll

Editor & Founder

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.

July 15, 2020 07:04 AM EDTUpdated 09:17 AM

Coronavirus

Covid-19 roundup: Vaccine by end of 2020? Ken Frazier warns hype doing 'grave disservice'

Amber Tong

Editor

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.

ENDPOINTS CAREERS

Head of Biology

Orum Therapeutics

Cambridge, MA

view job offer post your job now

Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

July 13, 2020 09:28 AM EDTUpdated July 14, 04:12 AM

Bioregnum

Coronavirus

A top analyst turns the spotlight on Moderna, fueling a fast-and-furious Street race over the future of mRNA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ludwig Hantson, Alexion CEO

July 14, 2020 10:47 AM EDT

R&D

Why pay $4B for a steady diet of disappointment? Porges turns thumbs down on Alexion’s M&A strategy, offers some pointers

John Carroll

Editor & Founder

When Alexion announced recently that it was paying $1.4 billion to bag Portola and its underperforming Factor Xa inhibitor reversal agent, you could hear the head-scratching going on around virtual Wall Street.

Why was Alexion going down the discount lane for new products? And why something like this? Analysts have been urging Alexion to get serious about M&A for years if it was serious about diversifying the company beyond Soliris and its successor drug. But this wasn’t the kind of heavy-impact deal they were looking for.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.