06Jun

Women with ovarian cancer who take statins to lower their cholesterol have a 40% lower death rate.

“These drugs are appealing as they are widely used, inexpensive, and well tolerated in most patients. The associated reduction in ovarian cancer mortality is promising,” said Dr. Kala Visvanathan, lead researcher of a new study presented last week during the American Association for Cancer Research Virtual Annual Meeting II.

Dr. Visvanathan, professor of epidemiology and oncology at Johns Hopkins Bloomberg School of Public Health and Sidney Kimmel Comprehensive Cancer Center in Baltimore, said all statins reduced the risk of dying, with lipophilic statins such as simvastatin and lovastatin, decreasing the likelihood by an average 43%. The most significant reductions occurred in those with high-grade serous carcinoma (40% reduction in mortality) and endometrioid ovarian cancer (50% reduction.)

The findings are the most comprehensive to date and add support to other, smaller studies showing similar improvements in ovarian cancer mortality from statins.

Most recently, a team of researchers at Australia’s QIMR Berghofer Medical Research Institute, analyzed 36 studies of several common medications taken by ovarian cancer patient. They concluded statin use showed the most promise. “Statin use is associated with better ovarian cancer survival,” they wrote in an article this month in Gynecologic Oncology, cautioning that, “Further study, preferably a clinical trial, is required.”

At the AACR meeting, Visvanathan said her team reviewed data on 10,062 ovarian cancer patients from the Finnish national cancer registry. 2,621 used statins, and 80% of those used lipophilic statins.

“Our results provide further evidence in support of the clinical evaluation of lipophilic statins as part of the treatment of ovarian cancer,” Visvanathan said.

Ovarian cancer is a rare cancer type, accounting for only about 1.2% of cancer cases diagnosed in the United States each year. Its five year survival rate is less than 50% because of the difficulty of diagnosing it until it has progressed to an advanced stage.

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Jun 6, 2023

As Pharma Transforms, Drug Stocks Poised for Comeback

Big Pharma is poised for a financial comeback this year, even as both industry leaders and ambitious upstarts will navigate through choppy waters.

J.P. Morgan analyst Chris Schott wrote in mid-December that 2020 will be a recovery year for the stocks of major pharmaceutical companies. After a year in which the S&P 500 was up 25%, the S&P 500 Pharmaceuticals grew not even half that.

Schott basis his forecast on several new drug launches and significant growth for the category of cancer drugs known as PD-1 inhibitors. He also discounts the possibility of drug pricing legislation, suggesting “there appears to be more headline risk than fundamental risk.”

Meanwhile, a CPHi outlook article discusses 10 trends pharma leaders expect the industry to confront during the year. Artificial intelligence and its application in developing, not drugs or clinical outcomes surprisingly, but in predicting timelines and in compliance and regulatory matters.

Cell and gene therapies (CGT) will likely continue to be one of the focus areas in 2020, while the importance of biologicals will continue to grow. Pharma will increasingly turn to CDMOs to take their research from clinical development through regulatory approval.

Peter Bigelow, president of xCel Strategic Consulting, sees more “transformational partnerships between CDMOs and big pharma” in 2020, as the major companies refocus their traditional methods of operation.

“Whereas in the past Big Pharma has been very transactional and has put driving product costs down as a priority, they are instead looking now at partnerships on baskets of products. This means the CDMOs must operate differently, be longer-term in the way they envision these relationships and they must commit to very high degrees of operational and quality improvement.”

Another prediction, this from Jim Miller, founder and former president of Pharmsource, is that CDMOs will continue to be the targets of acquisition. He expects some of the bigger private equity firms to be attracted to the mid-size CDMOs as will larger, public firms.

Morgan analyst Schott agrees. Rather than more mega-mergers, “We see biz dev pivoting towards bolt-on deals in 2020 with focus on building out existing therapeutic verticals and adding potential mid-2020s launch opportunities.”

Jun 6, 2023

COVID Has Forever Changed How Vaccines Are Developed

The vaccine rollout may be progressing too slowly, but that there’s a vaccine so soon at all is a tribute to the single-focus of scientists and the biotech industry.

The way the Pfizer and Moderna vaccines were developed “are revolutionary,” says Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization.

In a wide-ranging interview with Steve Forbes and published on Forbes online, she said, “The platforms that have shown success — for example, the MRNA platform that has been used in both the Pfizer and Moderna vaccine — are revolutionary in that they will forever change how we think about developing new vaccines.”

Because of what scientists have learned, “When it comes to preventing the next pandemic — when it comes to even preventing the next iteration of Covid, because we know it’s constantly mutating and evolving — we are incredibly prepared.”

The breakdown in getting a vaccine, she says, is not the development. “We have seen that the science is not our barrier; that often it’s the bureaucracy, it’s the miscommunication and misalignment, and it’s the lack of resources.”

McMurry-Heath laments the lack of effective planning for the distribution of the vaccines and the therapeutics that have been shown effective in treating patients. “There’s no excuse for this. This is not rocket science. We’ve done mass vaccination programs before,” she said.

Michelle Mcmurry Heath.jpg

The pandemic and how the nation responded to it have shown us, she says, that, “The things I think we’ve learned that are most impactful don’t even have to do with infectious diseases.”

Looking ahead, she told Forbes, it’s important the “high-touch-and-rapid-response approach” of the Food & Drug Administration continues. Another lesson is “that we need a new approach to clinical trials.”

“We need to look at our national clinical trial networks and ask ourselves, why are they not more easily mobilized for these massive public health concerns? And why is it so hard to get diverse patient populations through them?”

Says McMurry-Heath, “These are critically important questions that we are just starting to ask. But they’ll be very important, not just for infectious diseases, but for every disease out there that’s awaiting a cure.”

Photo by Macau Photo Agency

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