Grail kicks off its first study to provide doctors with real-world results from its multi-cancer blood test

Grail kicks off its first study to provide doctors with real-world results from its multi-cancer blood test

After gathering tens of thousands of people to participate in its clinical research studies, Grail says it’s got at least one more to do—an interventional trial of its multi-cancer blood test, where it will be used for the first time by oncologists to help guide a patient’s care. The FDA has given Grail a green light to conduct the study, dubbed Pathfinder, and it has already begun enrolling participants through the company’s health system partners at the Dana-Farber Cancer Institute, Intermountain…

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Bristol-Myers finds FDA receptive to speedy review of key cell therapy

Bristol-Myers finds FDA receptive to speedy review of key cell therapy

Dive Brief: Former shareholders in Celgene, bought by Bristol-Myers Squibb last year for $74 billion, can rest easier knowing the Food and Drug Administration will quickly review a cancer cell therapy that was one of three experimental drugs critical to the merger.  On Thursday, Bristol-Myers announced the FDA granted the CAR-T treatment, called liso-cel, priority review, setting up a decision by Aug. 17, 2020. An on-time approval, if secured, would be well ahead of the year-end deadline set out by Bristol-Myers…

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Federal prosecutors snare 3rd generics exec in price-fixing investigation

Federal prosecutors snare 3rd generics exec in price-fixing investigation

In a long-running price-fixing probe into some of the generics industry’s biggest players, federal prosecutors have seen modest returns so far for their efforts. But now, a third generics exec is facing charges, and more could be on the way as a massive lawsuit moves through the courts. Pennsylvania federal prosecutors on Tuesday charged Ara Aprahamian, a former sales executive at Taro Pharma, on three counts of conspiring to fix prices for the company’s generic drugs and lying to investigators, the Department of Justice said in…

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Cervical Cancer Could All But Disappear in North America by 2040

Cervical Cancer Could All But Disappear in North America by 2040

Vaccination and screening could nearly wipe out cervical cancerin North America in the next 20 years and rid the world of the disease within the next century, researchers say. In a new study, the researchers assessed the potential impacts of the World Health Organization’s (WHO) draft strategy for cervical cancer elimination, which calls for 90% of girls to be vaccinated against human papillomavirus(HPV) by 2030. HPV causes most cervical cancer cases. The WHO plan also calls for 70% of women to be…

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HIV Drug Costs Soaring, Jeopardizing Effort to End Epidemic

HIV Drug Costs Soaring, Jeopardizing Effort to End Epidemic

The U.S. government aims to end the HIV epidemic by 2030, but skyrocketing medication costs may make that a pipe dream, a new study suggests. Since 2012, the cost of antiviral treatment for HIV, the virus that causes AIDS, has jumped 34%. That’s nearly four times the inflation rate. Even with new generic options, initial treatments now top $36,000 per patient per year, according to the study. In 2012, the average annual cost of initial treatment was $25,000 to $35,000. By 2018,…

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New sickle cell drugs from Novartis, GBT need big discounts: ICER draft

New sickle cell drugs from Novartis, GBT need big discounts: ICER draft

When Global Blood Therapeutics won approval for its new sickle cell disease drug Oxbryta last year, execs predicted a “paradigm shift” in the way patients are treated. Now, the company is running into a common hurdle in today’s U.S. launch paradigm—pushback from cost watchdog ICER. In a draft report, ICER concluded that sickle cell disease drugs from GBT, Novartis and Emmaus Medical are too expensive to meet traditional cost-effectiveness measures. To fall within one measure of cost-effectiveness—below $150,000 per quality-adjusted life year—the companies would have to dramatically cut their prices, ICER…

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Systemic option for squamous cell carcinoma

Systemic option for squamous cell carcinoma

A new systemic medication option offers promising results for patients with high-risk squamous cell carcinoma for whom surgery has not worked, according to Chrysalyne Schmults, M.D., associate professor of dermatology at Harvard Medical School and vice chair of surgical oncology at Brigham and Women’s Hospital dermatology department, Boston. An intravenous, programmed death receptor-1 inhibitor drug called cemiplimab (Libtayo, Sanofi and Regeneron Pharmaceuticals) could offer a long-term halt of disease for a significant number of patients with this disease. “We’ve gone for so many years, in fact, the entire history of…

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Remarkable New T-Cell Discovery Can Kill Several Cancer Types in The Lab

Remarkable New T-Cell Discovery Can Kill Several Cancer Types in The Lab

The discovery of a new kind of immune cell receptor could pave the way for a new type of T-cell cancer therapy that can attack a diverse range of cancers in human patients without requiring tailored treatment. The researchers behind the discovery emphasise that testing is still at an early stage, having been conducted only in mice and in human cells in the lab, not yet in living patients. But the preliminary results are promising, and suggest we could be on the…

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America is about to get a powerful tool in the war against cancer

America is about to get a powerful tool in the war against cancer

KEY POINTS The country’s first carbon ion therapy center to treat cancer is being built in collaboration with Hitachi on the campus of the Mayo Clinic in Jacksonville, Florida. An alternative to surgery, this new treatment is viewed as the next horizon of cancer care. It has the capability of killing cancer cells that are resistant to traditional radiation therapy, many experts say. America’s war on cancer is about to get another tool in its arsenal. The country’s first carbon…

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All in the Timing: Many Get Knee Replacement Too Late or Too Soon

All in the Timing: Many Get Knee Replacement Too Late or Too Soon

It’s a question many aging Americans face: Is it time to replace my aching knee, or should I wait? New research suggests that for far too many patients, the procedure is done either too late or too soon. Much of the success of knee replacement surgery for knee osteoarthritis depends on timing, but a team at Northwestern University’s Feinberg School of Medicine in Chicago found that 90% of patients who could benefit from the procedure waited too long to have…

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