Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)
As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.
GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.
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Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs
Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.
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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.
Joan Perelló, Sanifit CEO
Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.
Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.
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Most people know if they’re ‘Team Pfizer’ or ‘Team Moderna,’ but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.
And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novovax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as ‘Covid-19 Vaccine Janssen.’
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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)
Back in June, Sanofi unveiled a big project to reshape its R&D around the future of mRNA, and followed that up Monday by taking a step toward achieving that goal.
The French drugmaker signed a deal with Chinese tech giant Baidu to access its AI algorithm for mRNA-based therapeutics, Baidu said Monday morning. It’s for an undisclosed sum, but Baidu noted its platforms will be used to ‘contribute to the optimization of mRNA sequences’ in Sanofi’s drug development processes.
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Ronald Lorijn, NeuExcell CEO
Pennsylvania’s already well-established biotech scene got word of a boost last week with several announcements, including the building of a massive life sciences manufacturing center in Pittsburgh thanks to some funding from an area nonprofit and a local university. But those jawns in Philadelphia aren’t letting go of its stranglehold on the state easily.
NeuExcell Therapeutics, a preclinical gene therapy biotech that focuses on neurodegenerative diseases, announced that it signed a deal with The Discovery Labs in King of Prussia, about 25 miles northwest of downtown Philly.
Ameet Mallik, Rafael Holdings CEO
Ameet Mallik left Novartis to claim the CEO spot at Rafael Holdings back in May, taking the reins from founder Howard Jonas. Now — one month after a stock-crushing pivotal failure in pancreatic cancer that sent Rafael’s team back to the drawing board — Mallik is taking off for greener pastures.
Mallik will hand his chief executive responsibilities back to Jonas on Feb. 1 as part of an overhaul that’s set to shake up the highest rungs of the company, Rafael announced Monday.
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Bluebird bio may, at long last, get a gene therapy approved in the US.
The Cambridge, MA biotech announced Monday that the FDA had accepted and given priority review for Zynteglo, its gene therapy for the rare blood disorder beta-thalassemia. The announcement sets up an expedited FDA decision by May 20, 2022.
A priority review doesn’t guarantee approval, and more than a few recent biotechs have been spurned after receiving the designation, including Incyte, Sesen, and Provention. But it represents a substantial step forward for a therapy that has seen repeated setbacks and an application that was slapped down with a refuse-to-file letter.
Kevin Gorman, Neurocrine CEO
Eight months after Neurocrine $NBIX chronicled a flop for a mid-stage schizophrenia drug, the biotech is headed right back into Phase II armed with a new drug candidate from Sosei Heptares.
Neurocrine outlined a deal that provides Sosei Heptares $100 million upfront, R&D expenses and a motherlode of milestones worth up to $2.6 billion if successful. That starting figure closely resembles what the biotech paid Takeda to land 3 programs, including the schizophrenia drug TAK-831, which failed to measure up in the clinic.
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Emily Leproust, Twist CEO
Twist Bioscience has come a long way since dipping its toes into the antibody discovery space a couple years ago, spinning out its first company just last week to take a Covid-19 antibody into the clinic. There’s plenty more where that came from, CEO Emily Leproust says — and she thinks a small biotech’s mice are the key to getting there.
Leproust is putting down up to $10 million in cash and another $140 million in stock to buy out Massachusetts-based Abveris (formally known as AbX Biologics) and its family of hyperimmune mouse models, she announced on Monday morning. If Abveris hits an internal revenue target next year, it’s eligible for up to another $40 million in Twist shares.
https://endpts.com/glaxosmithkline-places-a-risky-bet-on-arrowheads-rna-drug-in-the-failure-strewn-nash-field/
