The Great Pharma Brexit? An Endpoints News snap poll finds most life sciences insiders predicting a debacle for the industry

December 4, 2018 08:39 AM EST

John Carroll

The Great Pharma Brexit? An Endpoints News snap poll finds most life sciences insiders predicting a debacle for the industry

Perceptions matter, especially when opinions about the future are being formed in an industry that holds the key to growth where it’s wanted most. And right now the global biopharma business sees Brexit doing far more harm to biopharma in the UK than good.

By large margins.

Following up on a story we ran late last week on one industry poll regarding Brexit — at a time the UK’s rocky departure from the EU had blown into a full fledged political crisis — we decided it would be fun to run a snap survey of our own among readers and Twitter followers to get a broad look at the industry’s view of Brexit’s impact on drug development work and biotech creation — a key field for the island economy.

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Martin Shkreli [via Getty]

August 22, 2019 07:01 AM EDTUpdated 08:05 AM

John Carroll

R&D

Prisoner #87850-053 does not get to add drug developer to his list of credits

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Hal Barron. GSK

August 23, 2019 02:36 AM EDTUpdated 03:27 AM

John Carroll

R&D

GSK's Hal Barron heralds their second positive PhIII for crucial anti-BCMA therapy, pointing to a push for quick OKs in a crowded field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

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Structural Biologist/Biomolecular NMR Investigator

Skyhawk Therapeutics

Waltham, MA

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August 22, 2019 08:47 AM EDTUpdated 01:25 PM

John Carroll

Pharma

R&D

UPDATED: An emboldened AstraZeneca splurges $95M on a priority review voucher. Where do they need the FDA to hustle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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August 20, 2019 03:53 PM EDT

John Carroll

Regulatory

Webinar: Real World Endpoints — the brave new world coming in building franchise therapies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

August 19, 2019 06:07 PM EDTUpdated August 20, 07:30 AM

John Carroll

People

AveXis scientific founder fires back at Novartis CEO Vas Narasimhan, 'categorically denies any wrongdoing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bioinformatics Software Developer

Skyhawk Therapeutics

Waltham, MA, USA

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Bob Smith, Pfizer

August 21, 2019 10:01 AM EDTUpdated 11:59 AM

John Carroll

R&D

Pfizer is making a $500M statement today: Here’s how you become a lead player in the booming gene therapy sector

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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August 21, 2019 07:12 AM EDT

John Carroll

AI

Video: Putting the AI in R&D — with Badhri Srinivasan, Tony Wood, Rosana Kapeller, Hugo Ceulemans, Saurabh Saha and Shoibal Datta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

August 22, 2019 10:47 AM EDTUpdated 02:06 PM

Natalie Grover

R&D

Amgen, Allergan biosimilar of Roche's blockbuster Rituxan clears another US pivotal study

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

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Recruiting Manager/Sr.Manager/Associate Director

Skyhawk Therapeutics

Waltham, MA, USA

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August 22, 2019 10:35 AM EDT

John Carroll

Protocols

BeiGene and Mustang nail down special FDA status for top drugs; Roche bags added coverage for Hemlibra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.