lunes, 18 de mayo de 2020

WHO embraces plan for Covid-19 intellectual property pool

WHO embraces plan for Covid-19 intellectual property pool

The Readout

Damian Garde & Meghana Keshavan

A volunteer patent and data pool from WHO

The WHO is building a repository of patent rights, regulatory test data, and other useful tidbits that might be shared to develop drugs, vaccines, and diagnostics for Covid-19. All submissions to this database are voluntary, STAT’s Ed Silverman writes — but the hope is to speed along a cost-effective global recovery from the novel coronavirus.
“This is a call for solidarity and a call for action,” said Costa Rican President Carlos Alvarado, who helped spearhead the initiative — based on concerns that less-developed countries would be hit hardest by the disease.
It remains to be seen whether this will be an effective tool to combat the disease — drug makers have a penchant for  carefully guarding their IP, particularly in the U.S.

How Utah went all-in on hydrochloroquine

When Covid-19 began surging through the U.S., the state of Utah doubled down on hyrdochloroquine. One physician there described the drug’s impact on the novel coronavirus as “equivalent to Lazarus” — the Biblical figure brought back to life by Jesus — despite its unproven and dubious efficacy. 
The state put in an $800,000 order for the antimalarial drug in efforts to stockpile it — and even allowed pharmacies to dole it out to Covid-19 patients without prescription. Utah is now backpedaling, as STAT’s Andrew Joseph reports. 

Pfizer's Duchenne therapy effective, but with adverse reaction

An experimental gene therapy from Pfizer seems to improve muscle function in a study of nine boys with Duchenne muscular dystrophy — but it also carries the threat of serious drug reactions, according to data presented at a virtual session of the American Society of Gene & Cell Therapy. Adverse events aren’t a surprise here: Last June, Pfizer said that two boys out of six had been hospitalized after being treated with the gene therapy. However, it also slowed the decline of the disease progression in all the patients tested.

“We believe we’re now in a place where these safety events are monitorable and manageable in the kind of patient settings where we anticipate a gene therapy would be administered,” Pfizer's rare disease chief told STAT.  

BMS drug combo approved for lung cancer

The FDA has approved two Bristol-Myers Squibb cancer blockbusters to be used in combination to treat a specific form of lung cancer. It’s sanctioned nivolumab, or Opdivo, to be used with ipilimumab, or Yervoy, to treat metastatic non-small cell lung cancer, whose tumors express PD-L1. 
Regulators also approved companion diagnostic from Agilent Technologies, to help determine whether a patient’s cancer expresses the PD-L1 immune protein — and would then likely respond to the drug combination. 
The approval is based on a 793-patient trial, which was randomized to treat participants with either BMS’s monoclonal antibody drugs, or with chemotherapy. 
Median overall survival was 17.1 months for the Yervoy-Opdivo combination, compared to 14.9 with chemotherapy. 

More reads

  • If J&J really wants to support nurses, it should make the TB drug bedaquiline affordable. (STAT)
  • Meet the Harvard professor who became a billionaire thanks to coronavirus. (Forbes)
  • With ADC’s $233 million listing, biotech IPOs keep on rolling. (FierceBiotech)
  • Judge shoots down early release for Martin Shkreli. (TMZ)

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