Pfiz­er took a Phase III shot at re­pur­pos­ing its old drug silde­nafil as a new com­bi­na­tion ther­a­py for per­sis­tent pul­monary hy­per­ten­sion in in­fants. And failed.

Ap­proved in pill form for erec­tile dys­func­tion (Vi­a­gra) and PAH (Re­va­tio), re­searchers took an IV for­mu­la­tion added to in­haled ni­tric ox­ide in­to a piv­otal tri­al in PPHN for new­borns. The study proved that it was no bet­ter at re­duc­ing treat­ment fail­ure or time on ni­tric ox­ide than ni­tric ox­ide alone.

Pul­monary hy­per­ten­sion in­volves the con­stric­tion of pul­monary ar­ter­ies, which forces the heart to work hard­er to pump blood to the lungs. It’s called per­sis­tent pul­monary hy­per­ten­sion in new­borns, a rare and some­times fa­tal con­di­tion that de­creas­es the flow of oxy­gen as the nor­mal change­up in blood flow at birth fails to oc­cur.

Re­va­tio was ap­proved for PAH 14 years ago and has been wide­ly dis­trib­uted around the globe. That came 7 years af­ter the same ac­tive in­gre­di­ent was ap­proved as Vi­a­gra, now 21 years old in mar­ket­ing years. A com­pa­ny called Novi­tium ob­tained a gener­ic ap­proval for PAH just days ago.

So­cial im­age: Kristof­fer Trip­plaar, AP Im­ages

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.