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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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.
Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here.
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.
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.
Following news last week that Biogen received ‘a negative trend vote’ in Europe for its controversial Alzheimer’s drug aducanumab, the company has officially pulled out of the EU’s priority medicines scheme, known as PRIME.
First granted entry into the PRIME program back in May 2016, the EMA said recently that aducanumab’s PRIME eligibility was withdrawn at the request of Biogen. The EMA also noted that Biogen’s Phase III trials have been discontinued, likely lessening the odds that Biogen would re-submit its application in Europe.
Ugur Sahin (L) and Özlem Türeci (Bernd von Jutrczenka/picture-alliance/dpa/AP Images)
Pfizer and BioNTech are planning to file for full approval of their Covid-19 vaccine for all of those over the age of 12 after they said longer-term analysis of the vaccine in teens continued to show strong protection against symptomatic cases of Covid-19 more than four months after the second dose.
With no serious safety concerns at least 6 months after the second dose for those ages 12 through 15, the companies said the data will form the basis for a planned upgrade from EUA to supplemental Biologics License Application (sBLA).
German biotech Affimed caught some attention earlier this year with a pair of complete responses in an early study of its NK cell regimen for lymphoma. The biotech is back with more data from that study, and the results look promising — but will durability hold up?
A combination regimen of donor NK cells and Affimed’s CD30-targeting innate cell engager AFM13 spurred responses in 16 of 18 patients with relapsed or refractory Hodgkin and non-Hodgkin lymphomas, including seven complete responses, as part of the first of two rounds of treatment in a Phase I/II study, the biotech said Monday.
https://endpts.com/rafael-holdings-guts-its-top-leadership-including-its-short-tenured-ceo-as-cancer-fiasco-spurs-a-shakeup/
