Bristol Myers backs a European VC’s record-setting biotech venture fund, which tops out at $600M

March 10, 2020 06:52 AM EDTUpdated 07:25 AM

Bristol Myers backs a European VC's record-setting biotech venture fund, which tops out at $600M

John Carroll

Editor & Founder

A European biotech venture group with a yen for transatlantic deals will face whatever is coming on the investment side of the business with a new fund that claims boasting rights as the largest life sciences fund ever raised on the continent.

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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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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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George Yancopoulos (Regeneron)

July 1, 2020 08:28 AM EDTUpdated 13 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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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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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.)

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.

ENDPOINTS CAREERS

Manager of Vivo Pharmacology

Caribou Biosciences, Inc.

Berkeley, CA

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July 1, 2020 06:37 AM EDTUpdated July 2, 02:40 AM

Deals

R&D

Pharma

An experienced biotech is stitched together from transpacific parts, with 265 staffers and a focus on ‘new biology’

John Carroll

Editor & Founder

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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July 1, 2020 09:37 AM EDTUpdated 09:53 AM

R&D

Coronavirus

Pfizer shares surge on positive impact of their mRNA Covid-19 vaccine — partnered with BioNTech — in an early-stage study

John Carroll

Editor & Founder

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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