This years’ Astellas cancer care challenge brought home the realities of the COVID-19 pandemic for cancer patients.
Now in its fifth year, the C3 award submissions included many ideas aimed at alleviating the added burden and anxiety the pandemic created for cancer patients as well as people newly diagnosed during the crisis.
Seagen is riding the wave of two new priority reviews straight to the FDA.
The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.
Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.
Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.
All successful drug franchises must one day fade – the challenge comes in finding replacements. It is encouraging therefore to see that almost all major developers improved on the sales freshness index last year, versus 2019, with a couple of notable exceptions.
Natalie Holles, the chief executive of Audentes Therapeutics, has departed the company as the gene therapy developer's new owner Astellas Pharma fully folds the biotech into its larger organization.
Audentes, which was acquired by Astellas for $3 billion almost a year and a half ago, will now operate under the name Astellas Gene Therapies, the company announced Wednesday.
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Gene therapies that replace a single missing or faulty gene have been successful in treating some disorders, such as spinal muscular atrophy, the target of Novartis’ Zolgensma. But most neurodegenerative disorders are caused by multiple genetic abnormalities, making them difficult to address with gene therapy targeted at single mutations.
Scientists at the University of Cambridge have chosen a different path. Instead of going after the dysfunctional genes, they have developed a gene therapy that expresses two therapeutic proteins that boost nerve development and function. The therapy was the target of Astellas’ acquisition of U.K. gene therapy biotech Quethera in 2018.
Astellas took a flier on women’s health when it bought out Ogeda and nonhormonal menopause candidate fezolinetant in early 2017 and then doubled down during a major restructuring just over a year later. Now, an early peek at late-stage studies bode well for Astellas’ chances — and it could be teeing up a fight with Bayer.
Seagen/Astellas’s bladder cancer drug Padcev is expected to be selling nearly $4bn in five years’ time, according to EvaluatePharma sellside consensus, but its confirmatory EV-301 study has thrown doctors a curveball.
The data, being presented today at the Asco-GU meeting, appear to show that the drug does not work in women. However, the companies can probably shrug off this post hoc subgroup analysis and, even if doctors now shy away from prescribing Padcev to female patients, women comprise a relatively minor portion of this cancer type.
The US FDA’s verdict on Biogen’s aducanumab is one of the biggest events on biopharma’s 2021 calendar. And the Alzheimer’s antibody owns another accolade: of the novel projects slated to reach the market this year, aducanumab attracts the sellside's highest revenue forecasts.
Japanese pharma Astellas and its new biotech buyout Audentes got a Christmas gift from the FDA when the agency lifted a clinical hold on its gene therapy.
It’s been a tough 12 months for Audentes. Soon after the high of one year ago, when Astellas spent $3 billion to snap up the Californian biotech, several patients died in a trial of the company’s leading hope, AT132, a gene therapy for the rare disorder known as X-linked myotubular myopathy (XLMTM).