Cell and gene therapy has evolved into one of the biopharma industry's hottest markets with a major splash of investment and a run of approvals likely in the coming years. To meet what's likely to be massive demand for manufacturing capacity, industry experts are calling for "forward-looking" investments—but as one pointed out, those checks aren't easy to write.

Astellas Pharma, based in Tokyo, released the results from the Phase III DOLOMITES trial comparing its roxadustat with Amgen’s Aranesp (darbepoetin alfa) for anemia in non-dialysis dependent (NDD) adults with stage 3-5 chronic kidney disease (CKD). 

Pfizer and Astellas’ Xtandi is already approved to treat nonmetastatic castration-resistant prostate cancer, thanks to data showing it can stop tumors from spreading. But now it’s adding results that show it can help patients live longer, too.

With COVID-19 still sweeping across the U.S. and daily cases and deaths making for grim reading, biomedical R&D deals are not an easy sell.

But researchers at Harvard University and Japanese pharma Astellas are not letting a major pandemic and lockdown get in the way of science: The pair have announced a new research tie-up focused on “multiple, multi-year research projects initiated by faculty at Harvard, focused on the research and development of innovative therapeutics and technologies of mutual interest.”

Regulatory delays are growing ever more likely as the threat of coronavirus ramps up globally. The US FDA announced earlier this month that it was postponing certain manufacturing facility inspections, and some advisory committee meetings have been cancelled; drug approvals are surely next to be hit.

Vantage took a look at US regulatory decisions remaining for this month and those expected in April − bellwethers for the future regulatory landscape.

With $80 million upfront and up to $1.6 billion in biobucks, Astellas is still ramping up the biotech deals after ending 2019 on a buyout high.

Its latest deal sees it strike a modest upfront but meaty backloaded deal with CytomX and will dig into its so-called Probody drug platform, as well as its bispecific formats and CD3 modules. The plan is to unlock the potential of T-cell engaging bispecifics in the treatment of solid tumors.

Astellas and Seattle Genetics impressed Wall Street last fall when their combination of Padcev and Merck’s Keytruda fought off advanced bladder cancer in previously untreated patients. Friday, the partners presented updated results that look even better.

Two months after Pfizer and Astellas’ Xtandi won regulatory approval for a new indication in prostate cancer, the companies have released positive new data in another type of prostate cancer.

SEATTLE GENETICS AND ASTELLAS ANNOUNCE UPDATED RESULTS FROM PHASE 1B/2 TRIAL OF PADCEV™ (ENFORTUMAB VEDOTIN-EJFV) IN COMBINATION WITH IMMUNE THERAPY PEMBROLIZUMAB AS INVESTIGATIONAL FIRST-LINE TREATMENT FOR ADVANCED BLADDER CANCER

On the heels of a $2.7 billion tie-up with BeiGene in China, Amgen is now on track to take full control of a Japanese joint venture with Astellas, as the Big Biotech bets more on the rapidly growing Asian market. The move comes on the heels of a $2.7 billion BeiGene tie-up and feeds into the company's goal of 25% growth in Asia.