Shifting focus to oncology, GSK recruits a cancer vet as new chief of US pharmaceuticals — adding another woman to the top ranks of biopharma

Maya Martinez-Davis via Linkedin

August 12, 2019 10:42 AM EDT

People

Shifting focus to oncology, GSK recruits a cancer vet as new chief of US pharmaceuticals — adding another woman to the top ranks of biopharma

John Carroll

Editor & Founder

Jack Bailey GSK

The slow-moving overhaul of the leadership and strategy at GSK is taking a fresh turn today, and bringing another woman to the top ranks of the industry.

GlaxoSmithKline said today that US pharmaceuticals president Jack Bailey “has decided to step down” at the end of the year.

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

July 2, 2020 06:30 AM EDTUpdated 10:07 AM

People

Coronavirus

Tesla chief Elon Musk teams up with Covid-19 player CureVac to build 'RNA microfactories'

John Carroll

Editor & Founder

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

July 1, 2020 08:28 AM EDTUpdated 7 hours ago

People

UPDATED: Regeneron co-founder George Yancopoulos offers a combative defense of the police at a high school commencement. It didn’t go well

John Carroll

Editor & Founder

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

June 30, 2020 09:39 AM EDT

People

R&D

Pharma

Elias Zerhouni discusses ‘amateur hour’ in DC, the destruction of infectious disease R&D and how we need to prep for the next time

John Carroll

Editor & Founder

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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ENDPOINTS CAREERS

Senior Scientist,Fibrosis

Recursion Pharmaceuticals

Salt Lake City, UT

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June 29, 2020 05:59 AM EDTUpdated 10:34 AM

R&D

Cell/Gene Tx

Second death triggers hold on Astellas' $3B gene therapy biotech's lead program, raising fresh concerns about AAV

John Carroll

Editor & Founder

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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July 2, 2020 10:37 AM EDTUpdated 11:00 AM

China

Looking for 'external innovation,' Boehringer Ingelheim reserves $500M+ for new Shanghai hub

Amber Tong

Editor

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/EPA-EFE/Shutterstock)

July 2, 2020 10:31 AM EDTUpdated 11:26 AM

Pharma

Novartis pays $678M for kickback scheme as Vas Narasimhan tries to distance pharma giant from shady behavior

Jason Mast

Associate Editor

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all. (“Nobody presented slides on the fishing trips,” the complaint says.)

July 2, 2020 08:48 AM EDT

Peer Review

Novavax snags Ben Machielse for CMC and promotes a trio of staffers; Marty Duvall lands another CEO post at Oncopeptides

Alex Hoffman

Assistant Editor

Kathy Wong

Assistant Editor

→ Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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ENDPOINTS CAREERS

Manager of Vivo Pharmacology

Caribou Biosciences, Inc.

Berkeley, CA

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Dan Gold, MEI Pharma CEO

July 2, 2020 08:30 AM EDT

R&D

Development partners at MEI, Helsinn dump a high-risk PhIII AML study after concluding it would fail survival goal

John Carroll

Editor & Founder

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

July 2, 2020 07:08 AM EDTUpdated 09:59 AM

Pharma

Regulatory

Novartis loses biosimilar appeal as court upholds a 31-year monopoly by Amgen's Enbrel

Amber Tong

Editor

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.