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The Readout Damian Garde & Meghana Keshavan

Another day, another ethically dubious drug price hike

A medicine that’s been around for decades will see its price spike, from about $1,300 for a 10-pack to more than $10,000, STAT’s Ed Silverman writes. Why?

Belcher Pharmaceuticals developed a version of dehydrated alcohol — an injectable medicine used to treat chronic pain and prevent infections in people who receive nutrients intravenously. Before achieving approval in 2018, however, it applied for and received orphan status for the drug, as it was testing it in a hyper-rare indication. So now, other companies cannot market dehydrated alcohol until 2025. 

A Belcher exec argued that it invested “multiple millions of dollars” in Ablysinol (we at the Readout can’t help but read that each time as “Abysmal”), which justifies the price hike. 

Read more.

Biosimilars can be profitable — but quality matters

Teva Pharmaceuticals can attribute its 10% stock bump in large part to its recent launch of Truxima, a biosimilar for the monoclonal antibody Rituxan. Sales of the lookalike biologic have helped boost revenue for the Israeli generics maker, it said in its fourth-quarter earnings call. 

Biosimilars have been a difficult sector: Though cheaper than their branded biologic counterparts, they’re still quite costly and have struggled to penetrate the American market. That makes Teva’s success with Truxima worthy of note — and we’ll be watching to to see how its Herceptin biosimilar, Herzuma, will perform after it’s launched in March-ish

On that note: The manufacturing rigor required of biologics and their similars is tremendous, particularly when compared to chemically synthesized pharmaceuticals. So there has to be global accountability — and a consensus among drug makers to prioritize that biologic and biosimilar quality, Amgen’s R&D chief writes for STAT. 

Read more.

China’s biopharma sector creaking back to life — but many trials are still on hold

In the wake of coronavirus, life may slowly be coming back to the life sciences industry in China: WuXi AppTec, a major contract research organization, said it has resumed operations throughout China. Everywhere except for its Wuhan site, that is. The coronavirus epicenter still remains largely on lockdown. 

Despite WuXi’s welcome reemergence, the virulent germ has taken quite the toll on various aspects of Chinese biopharma — including disrupting the clinical trials of experimental medicines, Reuters reports. About 20% of global trials now take place in China, with nearly 500 U.S.-based clinical trials in Wuhan itself. And drug testing has taken a backseat to patient care. 

“Hospitals aren’t focused on clinical trials right now,” one China-based drug exec said. “They have plenty of other things to be focused on.”

Doudna reviews CRISPR

CRISPR pioneer Jennifer Doudna sounds off on the promise and limitations of genome editing in a review for Nature — comparing and contrasting the different methodologies for this technology. 

For instance, she indicates how AAVs are the most efficient, clinically established vectors for gene therapy, but cites their high cost and manufacturing challenges, along with their limited cargo size and likelihood to provoke an immune response. That’s one broad assessment, but Doudna addresses the intricacies of the sector — including the ethics around human germline editing. She concludes, however, that therapeutic genome editing will come to fruition over the next decade. 

“The potential impact on patients is too important to wait,” she writes.

More reads

  • The cancer industry: Hype vs. reality (Scientific American)
  • Elizabeth Holmes gets fraud charges narrowed but not dismissed. (Bloomberg)
  • Attacking pancreatic cancer with the help of the virus that causes foot-and-mouth disease in cows. (FierceBiotech)

Thanks for reading! More tomorrow,

Damian

Thursday, February 13, 2020

STAT

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