Most Popular News Stories on OBR Daily

    (STAT) Jan 22, 2019 - Nina Kjellson was just two years out of college, working as a research associate at Oracle Partners, a hedge fund in New York, when a cabbie gave her a stock tip. There was a company in New Jersey, he told her, trying to resurrect thalidomide, a drug that was infamous for causing severe birth defects, as a treatment for cancer. Kjellson was born in Finland, where the memory of thalidomide, which was given to mothers to treat morning sickness but led to babies born without arms or legs, was particularly raw because the drug hit Northern Europe hard. But she was on the hunt for new cancer drugs, and her interest was piqued. She ended up investing a small amount of her own money in Celgene. That was 1999. Since then, Celgene shares have risen more than 100-fold; the company became one of the largest biotechnology firms in the world. Earlier this month, rival Bristol-Myers Squibb announced plans to purchase Celgene for $74 billion in cash and stock.

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    (Reuters) Feb 5, 2019 - GlaxoSmithKline bolstered its cancer drug development pipeline on Tuesday, agreeing to pay up to 3.7 billion euros ($4.2 billion) to Germany's Merck KGaA for the rights to a next-generation immunotherapy. Merck will receive an upfront payment of 300 million euros for the drug - known as M7824, or bintrafusp alfa - and is eligible for potential payments of up to 500 million euros depending on development milestones in lung cancer, the two companies said in statements on Tuesday. Merck could also get up to a further 2.9 billion euros, depending on commercial milestones, for a total deal value of as much as 3.7 billion euros.

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    (Vantage) Feb 11, 2019 - In the Keynote-426 study Merck & Co’s Keytruda looks to have blasted Opdivo out of the water, showing a 47% reduction in risk of death versus Sutent. Bristol-Myers Squibb is probably getting tired of this, but it’s happened again. Another oncology setting in which Opdivo had seized an early foothold, in this case renal cell carcinoma, looks soon to fall to its arch-rival, Merck & Co’s Keytruda. The first-line Keynote-426 study, in which Keytruda was combined with Pfizer's Inlyta, was already known to have hit overall and progression-free survival endpoints, but full data had been kept back until today’s abstract reveal at the Asco-Genitourinary Cancers symposium. The result looks likely also to clip the wings of Pfizer/Merck KGaA’s Bavencio, whose Inlyta combo impressed at Esmo last year.

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    (Fred Hutch News Service) Feb 6, 2019 - More than two-thirds of people with an advanced form of a rare skin cancer are on track to survive at least two years after starting an immunotherapy drug on a landmark clinical trial, researchers reported Wednesday in the Journal of Clinical Oncology. That’s a profound shift for this deadly cancer, Merkel cell carcinoma, or MCC. Just a few years ago, patients with advanced MCC would invariably receive chemotherapy, the previous standard of care. As many as three-quarters of them would die within that two-year timeframe, previous studies have shown. The investigators are “thrilled” that so many of the trial participants are doing so well compared to what historical data would predict, said Dr. Martin “Mac” Cheever of Fred Hutchinson Cancer Research Center, one of the leaders of this first-of-its-kind study.

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    (Xconomy New York) Jan 24, 2019 - Bristol-Myers Squibb has lost yet more ground in its ongoing cancer immunotherapy battle with rival Merck. Along with its earnings, the pharma firm reported Thursday that it has pulled a key approval application to use a combo regimen of its already approved immunotherapies, nivolumab (Opdivo) and ipilimumab (Yervoy), in a portion of patients with newly diagnosed, advanced non-small cell lung cancer (NSCLC). Specifically, Bristol said that, upon discussions with the FDA, it needs more data to support the approval filing. The problem: Bristol needs to provide additional evidence for “the relationship between [tumor mutational burden] and PD-L1”—two biomarkers meant to help identify patients who might respond to immunotherapy—to really tell if the Bristol regimen is helping patients live longer.

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    (BioSpace) Feb 12, 2019 - The American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium (ASCO GU) is being held in San Francisco from February 14-16. Ahead of the conference, several companies have announced presentations. Here’s a look at just a few. Merck & Company. Merck plans to present survival data from its pivotal Phase III KEYNOTE-426 clinical trial of its checkpoint inhibitor Keytruda in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced or metastatic renal cell carcinoma (RCC). The company had announced in October 2018 that the trial met both primary endpoints of overall survival (OS) and progression-free survival (PFS), as well as the key secondary endpoint of objective response rate (ORR).

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    (Forbes) Jan 29, 2019 - It doesn't seem possible. But they say it's true. A small team of Israeli scientists is telling the world they will have the first “complete cure” for cancer within a year, The Jerusalem Post reported on Monday. And not only that, but they claim it will be brief, cheap and effective and will have no or minimal side-effects. “We believe we will offer in a year’s time a complete cure for cancer,” said Dan Aridor, chairman of the board of Accelerated Evolution Biotechnologies Ltd. (AEBi), a company founded in 2000 in the ITEK incubator in the Kiryat Weizmann Science Park in Ness Ziona, Israel, just north of the Weizmann Institute of Science in Rehovot, Israel. A development-stage biopharmaceutical company engaged in discovery and development of therapeutic peptides, AEBi developed the SoAP platform, a combinatorial biology screening platform technology, which provides functional leads—agonist, antagonist, inhibitor, etc.—to very difficult targets.

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    (Bloomberg) Jan 24, 2019 - Eli Lilly & Co.’s cancer drug Lartruvo shouldn’t be started in new patients and those already taking it should ask their doctors if they should continue, U.S. regulators said, following a key study that failed to show the medicine prolonged lives. The drug for soft tissue sarcoma, a relatively rare and hard-to-treat type of tumor, was given accelerated approval by the U.S. Food and Drug Administration in 2016 based on promising data from an early-stage study. The company was required to complete a larger trial to confirm the benefits.

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    (MSN.com/Wall Street Journal) Jan 27, 2019 - Twenty years ago, Pfizer Inc. didn’t sell any drugs treating cancer. Now, it sells 17, including four that were approved in the U.S. at the end of last year, more than any other pharmaceutical company. The new lineup is projected to generate $8.3 billion in sales this year, according to EvaluatePharma. For the first time, Pfizer in 2019 expects oncology products to outsell the heart and other primary-care medicines the company was long known for. Pfizer is throwing in with other big drug companies trying to expand their footprint in cancer or gain a toehold, even as many startups hunt for new therapies, too. Driving the attraction: new insights about the disease’s biology that have paved the way for discovery of treatments, combined with major commercial potential if those therapies reach the market.

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    (CNBC) Jan 29, 2019 - An Israeli biotech company said preliminary research on mice gives it hope of developing a cancer cure "within a year's time" — but it still has years of testing ahead of it before it could get U.S. approval — even if it works for humans. Accelerated Evolution Biotechnologies (AEBi) told the Jerusalem Post it used peptides, which are a chain of amino acids, to target and kill cancer cells in mice. "We believe we will offer in a year's time a complete cure for cancer," the company's chairman of the board of directors, Dan Aridor, told the Jerusalem Post in an article published Monday.

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