Yeah sex is cool and all but have you ever seen “her” turn into “hero” in the Captain Marvel trailer?

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Historically, federal dollars inadvertently flowed to medical research with a disproportionate focus on men’s health. There are several reasons for this. Decades ago, many scientists concluded men were easier to study because they weren’t subject to frequent hormonal changes that could complicate a study’s design or the interpretation of its results. Also, safety concerns for pregnant women once resulted in broad exclusions of women with “child-bearing potential” from many clinical studies.

The last quarter-century has brought a greater focus on the opportunity cost of uneven representation in clinical studies. When it comes to gender, in particular, we now know unequivocally that a person’s sex can influence disease presentation, diagnosis, severity and treatment.

For example, certain chemotherapy drugs have more side effects on women than men. Women may need lower dosages of certain medications due to differences in body weight compared to men. Research suggests that women may be 20 to 70 percent more likely to develop lung cancer than men who smoke the same number of cigarettes. Meanwhile, colon cancers are frequently misdiagnosed because the disease can present differently in women than men.

In 1993, Congress passed the National Institutes of Health (NIH) Revitalization Act – a federal rethinking of the participation levels of women and minorities in clinical research. The legislation was a much-needed breakthrough, but not a cure.

Today, the NIH review process treats inclusion of women and minority subjects as an indicator of a proposal’s scientific merit, and NIH staff tracks these metrics for consideration in making grant awards. Additionally, the U.S. Food and Drug Administration (FDA) has made significant strides in diversifying clinical trials conducted in the United States. The FDA launched an Office of Women’s Health Research focused on advancing the science of women’s health as well as an Office of Minority Health charged with increasing clinical trial data available on racial and ethnic minorities.

These federal efforts have helped the biopharmaceutical industry achieve substantial progress in diversifying trials, yet gaps persist. An FDA study published in July 2017 found that women represent 43 percent of trial subjects globally (and 49 percent in the United States) despite the fact that women make up more than half of the population. A cardiology study published this April, for example, found women to be under-represented in clinical trials for new medicines to treat artery disease, acute coronary syndrome and heart failure.

One way we can close the gender gap in clinical research is by promoting greater collaboration between drug developers and researchers who specialize in women’s health. Last month, I sat down with Nicole Oshurak, director of corporate partnerships at the Magee-Women’s Research Institute and Foundation (MWRI) – a Pittsburgh-based organization whose mission is to “change the world’s thinking on women’s health.”

With $40 million in NIH grants last year, MWRI is the country’s largest research institute devoted exclusively to women’s health research. Its researchers are making discoveries in reproductive biology, breast cancer genomics, fertility, and HIV immunization and prevention.

MWRI investigators conduct research studies with major institutions, universities and medical centers around the world. Now, the group is exploring industry partnerships beyond NIH funding with the hope of getting breakthroughs to more patients. This June in Boston, the institute participated in its first BIO International Convention, and Oshurak told me she was flooded with requests for business meetings by potential industry partners.

The growing appetite of drug developers to partner with women’s health researchers is a real trend – and, I believe, a harbinger of further strides to come. Companies interested in exploring women’s health collaborations should consider attending the Magee-Women’s Research Summit Oct. 9-10 in Pittsburgh, where MWRI will award the $1 million Magee Prize – the world’s largest for a scientific collaboration to advance women’s health.

One of MWRI’s most enduring contributions to medical research is its maintenance of the world’s largest maternal infant database containing information from more than 200,000 births spanning two decades. That project is part of its 9-90 research, which focuses on how human life in the womb for the first nine months can predict and change the course of a person’s health over the next 90 years.

Women may be 51 percent of the world’s population, but they carry to term 100 percent of our collective future. Patients of every age, gender and background stand to benefit significantly from medical research better calibrated to reflect this reality.

Greenwood, who represented Pennsylvania’s 8^th district in the U.S. House of Representatives from 1993 to 2005, is CEO of BIO, the world’s largest trade association representing the biotechnology industry.

Point72 Asset Management L.P. lessened its holdings in shares of Puma Biotechnology Inc (NASDAQ:PBYI) by 28.2% during the second quarter, …

Last week, the House Judiciary Committee unanimously reported the bipartisan SUCCESS Act. Co-sponsored by Representatives Adams, Chabot, Comstock, Goodlatte, Handel, Jeffries, Johnson, Nadler, Velazquez and Wagner, the bill brings together important legislative efforts long supported by BIO.

First, it directs the establishment of a joint study by the United States Patent and Trademark Office (PTO) and Small Business Administration on ways to identify best practices for increasing patenting rates for women, minorities and veterans. Secondly, the bill extends the soon-to-expire authority for the PTO to adjust the fees it relies on for funding.

Women and persons of color apply for and hold far fewer patents than white men, which is contributing to an imbalance in entrepreneurial and startup success rates and missed opportunities for American innovation and competitiveness.

To directly address this disparity, BIO’s member companies, as part of our Workforce Development, Diversity, & Inclusion (WDDI) Initiatives, have set as a goal “as an industry, [to] achieve significant increase in racial diversity, increase LGBTQ representation and achieve 50 percent representation of women at functional leader and C-Suite by 2025, (gender diversity improving from ~25 percent currently).”

We believe these goals are achievable if we all work together. BIO is hopeful that the full House will take up and pass the SUCCESS Act soon and urges the Senate to do the same.

The Global Food Biotechnology Market report provides deep analysis of market.It define,describe and forecast the market by product type and key …

Today marks the last day of the Global Climate Action Summit  in San Francisco, California. The annual event convenes leaders, policymakers and people from around the world to celebrate, and share, the extraordinary achievements of states, regions, cities, companies, investors and citizens with respect to stopping global warming and taking climate action.

As part of this week’s festivities, BIO hosted an event along with below50 and the Low Carbon Fuels Coalition to discuss how states can implement low carbon fuel standards to reduce their transportation sector’s impact on the environment. Moreover, the event, Driving Decarbonization: How Low Carbon Fuel Standards are Transforming Transportation, Saving Lives, and Igniting Innovation, explored how these types of carbon-cutting policies can benefit more than the environment by also strengthening economies and reducing human health impacts.

Here at BIO we support initiatives that leverage low carbon and renewable fuels to reduce transportation’s impact on all things. As part of our efforts to advocate for such policies, BIO hosts events year-round, including the BIO International Convention and BIO World Congress, to help our members network and partner to DRIVE growth in the renewable fuels industry. BIO’s co-hosting of the Driving Decarbonization event is a continuation of our advocacy efforts.

Bryan Sherbacow, Chief Commercial Officer with World Energy, and panelist at the Driving Decarbonization discussion, authored the following piece illustrating the widespread positive impacts that can be gained from low carbon fuel standards. The piece hones in on California’s low carbon standard, which was implemented in 2011.

Read the full piece below, or read on BiofuelsDigest.com by clicking here.

As 2018 has made all too clear, climate change is real and it’s impacting all of our lives. July 2018 was the hottest month ever recorded in California. We have dealt with the state’s largest wildfire this summer, just one year after the state’s costliest, most destructive, wildfire season.

Across the U.S., the Northeast experienced record warm overnight low temperatures and unprecedented high humidity. Europe has been blistering this summer, marked by droughts, melting glaciers, and decreased food and grain production. Japan has also experienced record heat and deadly floods throughout the summer.

Despite the impacts of climate change appearing all around us and the broad agreement from the scientific community that greenhouse gas emissions are the cause, the federal government has withdrawn the United States from our commitments in the Paris Agreement.

As a result, it is critical for states to take the lead by implementing climate policies such as low carbon fuel standards (LCFS) to reduce the environmental impact of America’s transportation sector. Moreover, such carbon cutting policies at the state level benefit human health and grow the biobased economy.

To understand a low carbon fuel standard, it’s best to look at California as an example. California is one of two states (neighboring state, Oregon, is the other) to enact a low carbon fuel standard. Typically, these state policies set a limit to the amount of carbon that can be emitted from fuel per unit of energy, which decreases annually. To comply with the rule, fuel companies must reduce the average carbon intensity level of the fuel they sell or buy credits from low carbon fuel suppliers.

California’s LCFS considers the full life cycle of fuel when setting carbon intensity standards. The Air Resources Board calculates carbon emissions not just from combustion on the roadways, but also from production and distribution of the fuel as well.

As a result, California’s LCFS reduces the environmental impact of transportation.

Since 2011, California’s LCFS has prevented more than 13.7 billion gallons of petroleum from being combusted on the state’s roadways. This equates to avoiding 38 million tons of carbon pollution. And as we have already met our 2020 target, we look to make even more gains in the next decade by increasing the carbon reduction targets even further for 2030 and 2050.

The benefits of a low carbon fuel standard, however, extend beyond environmental impact. According to California’s American Lung Association, the state’s low carbon fuel standard has helped Californians avoid $1.84 million in public health costs and averted more than 200 premature deaths from pollution. And as the carbon intensity standards become more stringent, the health benefits stemming from the rule will increase. The state’s lung association, along with the Environmental Defense Fund, reports that by 2025 California’s LCFS, along with cap and trade, will save $8.3 billion in pollution-related health costs and prevent 600 heart attacks, an additional 680 premature deaths, 38,000 asthma attacks and almost 75,000 lost work days.

And more available work days means more capital that can be gained and invested into the economy. Furthermore, low carbon fuel standards increase investment in companies working on new, innovative renewable fuel sources that emit less carbon.

Since its implementation, California’s program has increased the value of the clean fuels market by an estimated $2.8 billion. And as investment in low-carbon fuels increases, the biobased economy – an economy that spans from the farmers in rural America growing corn and other feedstocks to the researchers identifying new processes for creating low carbon fuel to the biorefineries where the fuel is produced and distributed from – strengthens.

With the lack of concrete federal policies to reduce our environmental impact from fuel, it’s now up to the states to take the wheel and drive towards decarbonization.

States should introduce their own low carbon fuel program to reduce their transportation sector’s environmental impact, save lives, and strengthen America’s biobased economy.

At the Global Climate Action Summit this week in San Francisco, I’ll be joined by policymakers and other leaders at an event co-hosted by below50, the Biotechnology Innovation Organization and the Low Carbon Fuels Coalition to explore California’s LCFS as a model for other states and the benefits these type of fuel policies can have. Already, California, Oregon and British Columbia are reaping the benefits of such carbon-cutting policies. If more states implement a LCFS we can strategically reduce our nation’s carbon footprint in a manner that will benefit our nation’s economy, our citizens’ health and the global environment.

Bloomberg has authored an investigative piece exposing drug cost middlemen, better known as pharmacy benefit managers (PBMs), for their role in marking up prices for common drugs and pocketing the difference.

At issue is a little-known tactic called “spread pricing”, a strategy designed to pad the pockets of PBMs at the expense of the client, who in this particular case were Iowa taxpayers funding the state’s Medicaid program. As pharmacist Mark Frahm learned firsthand, what one PBM charged the pharmacy, and what the PBM then billed the state for a common prescription differed dramatically.

“For years, Frahm’s South Side Drug bought pills from distributors, and dispensed prescriptions to the Wapello County jail. In turn, the pharmacy got reimbursed for the drugs by CVS Health Corp., which managed the county’s drug benefits plan.

“As he compared the newspaper notice with his own records, and then with the county’s, Frahm saw that for a bottle of generic antipsychotic pills, CVS had billed Wapello County $198.22. But South Side Drug was reimbursed just $5.73.”

So where did the $192.00 difference go? To the bottom line of the middlemen.

“’Middlemen have to make some money, but we didn’t expect it to be this extreme,’ said Frahm, who said his pharmacy lost money in the jail account last year because CVS paid so little. ‘We figured everyone was playing fair.’”

Frahm’s case, however, is not isolated. Bloomberg analyzed the data of PBM markups in Medicaid plans around the country, finding massive spreads on dozens of drugs. For example, of “the 90 drugs analyzed, which includes more than 500 dosages and formulations, PBMs and pharmacies siphoned off $1.3 billion of the $4.2 billion Medicaid insurers spent on the drugs in 2017.”

But middlemen working behind the scenes to protect their profit margins is nothing new. In a state-commissioned report, Ohio officials found that PBMs billed taxpayers roughly $220 million more for prescription drugs than they reimbursed pharmacies to fill those prescriptions over the course of a year.

Source: Bloomberg News

Similarly, private Medicaid plans in Indiana spent more than $800 for a 30-day supply of a hepatitis B pill that cost pharmacies less than $140 to buy.

Source: Bloomberg News

As we explain in our “Follow the Pill” video, the drug cost ecosystem is more complex than most people think. Insurers and PBMs largely decide how much people pay out of pocket for the medicines they need. As Bloomberg and others have shown, the decisions these middlemen make can have costly consequences for both patients and taxpayers.

Read the full Bloomberg story here, and learn more about how the drug cost ecosystem works here.

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The numbers are staggering. The opioid epidemic is costing our nation more than $500 billion annually in health and social costs. What’s more, 1 in 5 deaths among young adults in 2016 were opioid related. This crisis is plaguing communities across the country, leaving in its wake countless victims, devastated families and economic ruin.

Jim Greenwood, BIO’s President and CEO, has been on the air describing for radio listeners across the country the urgent need to spur access to, and greater innovation of, novel therapies to help treat both pain and addiction.

Don’t miss Jim’s recent radio interviews:

• The Steve Gruber Show
• The Lars Larson Show
• Jimmy Lakey Show
• The Bill Meyer Show
• WSGO Ringside Politics

And for more information about the biopharmaceutical industry’s commitment to combating the opioid crisis, please visit www.bio.org/opioid.