Blood Cancer Therapy Successful in 75% of Trial Patients

New data from an ongoing Phase 1/2 clinical trial has revealed an experimental immunotherapy led to successful response rates in 73% of patients suffering from multiple myeloma, a deadly form of blood cancer. Based on this promising data, an application to the US Food and Drug Administration (FDA) has been filed to bring the drug to market.

 

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Sanofi Covid Vaccine Shows 100% Efficacy Against Severe Disease

Sanofi and GlaxoSmithKline Plc, the pharma giants that stumbled in the race to develop a Covid-19 shot, found their vaccine protects against severe disease and hospitalization and will submit data to regulators for clearance. The duo said data from a trial shows that two doses of the Sanofi-GSK vaccine have 100% efficacy against severe Covid-19 and hospitalizations and 58% efficacy against any symptomatic Covid-19 disease. They said the safety of the vaccine was favorable too.

Meanwhile, a separate study showed it could increase neutralizing antibody levels 18- to 30-fold when used as a booster in people who’ve received other types of shots first. Shares in Sanofi rose as much as 1.7% in Paris on Wednesday, while GSK rose as much as 1.6% in London.

The data should allow the vaccine giants to finally play a big role in the pandemic fight, after repeated development delays allowed nimbler competitors like Moderna Inc. and the BioNTech SEPfizer Inc. alliance to rush ahead with messenger-RNA products. Those companies, along with AstraZeneca Plc and Johnson & Johnson, steered highly effective products rapidly to market, helping save millions of lives and earning tens of billions of dollars in revenue.

While the Sanofi-Glaxo product appears to be on par with the mRNA shots when it comes to preventing severe disease and hospitalization, the efficacy may trail somewhat in terms of symptomatic disease, Sam Fazeli, an analyst at Bloomberg Intelligence, said in a note.

The vaccine will find a place among people reticent to take mRNA vaccines and in lower-income countries, making for a modest commercial impact on Sanofi and Glaxo,” Fazeli said.

Source: https://www.bloomberg.com/

Johnson & Johnson One-Shot Coronavirus Vaccine Approved in the U.S.

A Centers for Disease Control advisory panel on Sunday recommended Johnson & Johnson’s one-shot COVID-19 vaccine for people 18 and over, clearing the way for inoculations to begin as soon as this week. The recommendation comes one day after the Food and Drug Administration (FDA) on Saturday authorized Johnson & Johnson‘s COVID-19 vaccine for emergency use.

The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said Saturday.

The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The vaccine is the third to be approved for use in the U.S., and the first that requires only one shot. The FDA‘s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend authorizing the vaccine by Janssen, a division of Johnson & Johnson, on Friday. The committee provides expert advice to the FDA, but does not have final say on approval.

https://www.cbsnews.com/

Emergency Use Authorization of the J&J Covid Vaccine is Imminent

The Johnson & Johnson vaccine is getting a lot of people excited. Not only is it another potential option to protect more people from COVID-19, but their vaccine is only one dose, making it a lot easier to reach a broad swath of the population.

In Orange County, the fourth-highest county in the state for vaccine distribution, more than 82,000 initial doses have gone out. Across the sunshine state, more than 1.6 million Floridians have received at least their first dose with nearly 300,000 having completed their vaccine series. Nationwide, the U.S. is inching closer toward 30 million Americans having received at least one dose of the vaccine to protect them against COVID-19.

Johnson & Johnson’s vaccine isn’t approved just yet but it is expected to become  the third vaccine for roll out across the country. With just a single dose needed, health leaders say this could be a game changer.  Johnson & Johnson’s vaccine is only 66 percent effective compared to the 90 plus efficacy rate of both Pfizer and Moderna’s vaccine. However, health leaders stress that data is still promising. And Johnson & Johnson’s doses can remain stable for two years at -4 degree temperatures or at least three months when stored at 36 to 46 degree (8 degree  Celsius) temperatures.

Johnson & Johnson say they have product ready to ship out immediately pending approvals. They’re expected to file for emergency use authorization for their vaccine early February.

https://www.baynews9.com/

1st Long-acting HIV Drug Combo

U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus. The approval of the two-shot combo called Cabenuva is expected to make it easier for people to stay on track with their HIV medicines and to do so with more privacy. It’s a huge change from not long ago, when patients had to take multiple pills several times a day, carefully timed around meals.

That will enhance quality of life” to need treatment just once a month, said Dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, who has no ties to the drug’s makers. “People don’t want those daily reminders that they’re HIV infected.”

Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug — cabotegravir, from ViiV Healthcare. They’re packaged together and given as separate shots once a month. Dosing every two months also is being tested.

The U.S. Food and Drug Administration approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV medicines and who have not shown signs of viral resistance to the two drugs in Cabenuva. The agency also approved a pill version of cabotegravir to be taken with rilpivarine for a month before switching to the shots to be sure the drugs are well toleratedViiV said the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward. The company said that is “within the range” of what one-a-day pill combos cost now. How much a patient pays depends on insurance, income and other things. Studies found that patients greatly preferred the shots.

Even people who are taking one pill once a day just reported improvement in their quality of life to switch to an injection,” said Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles. She consults for ViiV and wrote a commentary accompanying one study of the drug in the New England Journal of Medicine. Deeks said long-acting shots also give hope of reaching groups that have a hard time sticking to treatment, including people with mental illness or substance abuse problems. “There’s a great unmet need” that the shots may fill, he said.

Source: https://www.pbs.org/