Brand Beat: Juul Fights FDA Ban

Shortly after banning Juul from selling its products, the FDA placed a hold on its decision in order to review the company’s case more closely. At this time, Juul can continue sales in the U.S., however, the company is required to prove to the FDA that their e-cigarettes in fact benefit the public. Juul’s claim is that adults who choose their products are more likely to quit or reduce smoking and teens are unlikely to become addicted to their products.

The FDA backed their initial decision by saying there were unanswered questions about the chemical formulas used in the company’s vape and their potential health risks, but Juul claims its data addresses all the agency’s questions. In a brief filed in support of a longer-term appeal in the U.S. appeals court in Washington, D.C., Juul said that it only received one opportunity to respond to the FDA’s concerns prior to being denied approval while other companies have been known to submit up to 14 amendments to their applications. Should the review of Juul’s marketing application result in another product ban, the company has another 30-day period to appeal.

Doctor Docs: Oncologists React to ASCO Educational Material

Following the annual American Society of Clinical Oncology (ASCO) conference, oncologists were asked how the data presented would impact their care of patients. Sermo, a physician-first online community, found the tracks at ASCO that oncologists felt were the most transformative to be breast cancer (58%), lung cancer (34%), and developmental therapeutics—molecularly targeted agents and tumor biology (32%).

Breast cancer tracks were some of the most highly attended presentations at ASCO and, particularly, 43% of attendees to the DESTINY-Breast04 abstract found its data to be meaningful to their treatment decisions. In terms of other treatment data, 59% of oncologists found the data on tumor-targeting antibodies to be the most interesting, followed by adoptive cell therapies (58%), ​​immune effector cell modulators co-inhibitory antagonists (54%), and immunogenic cell death inducers or radiotherapy and chemotherapy (45%).

When asked about driving diversity in clinical trials, 31% of surveyed oncologists felt the best solution is to create a network of clinical trial sites in underserved communities. Another 17% recommended mandating patient recruitment requirements and 14% would like to see the development of a diverse pool of investigators and staff.

DC Dispatch: PFAS Are More Harmful Than Originally Stated

EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS.

The Environmental Protection Agency (EPA) announced that perfluoroalkyl and polyfluoroalkyl substances (PFAS), the “forever chemicals” from non-stick pans and other products, are dangerous even when at undetectable levels in our drinking water. Since the 1940s, PFAS were used in the manufacturing of numerous consumer products. Even though common PFAS compounds such as perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) have been phased out voluntarily by companies, they last indeterminate amounts of time in the environment, hence the moniker “forever chemicals.”

Since 2016, the EPA put health advisories on PFAS levels of more than 70 parts per trillion, but now the EPA warns that the chemicals are in fact dangerous even at levels near zero. PFAS contaminants can be found in our drinking water as a manufacturing byproduct and are also present in household items such as cardboard, water-repellent sports gear, cosmetics, and carpeting. National drinking water regulations for PFOA and PFOS are expected later this year, with the EPA offering grants to states to invest in testing and treatment of water.

The “forever chemicals” are linked to cancer and birth defects among other serious health complications. They pose an extreme risk as they stay in the bloodstream indefinitely and fail to break down even in the environment. While some compounds in the PFAS family have been advertised as safe alternatives by manufacturers, the EPA recognizes that the entire family of chemical compounds have severe health and disease risks.

“People on the front-lines of PFAS contamination have suffered for far too long,” EPA Administrator Michael Regan said in a statement. “That’s why EPA is taking aggressive action as part of a whole-of-government approach to prevent these chemicals from entering the environment and to help protect concerned families from this pervasive challenge.” The FDA also determines that PFAS is undoubtedly in our water, soil, and air and therefore contaminates our food. Food tested for PFAS have been found in low levels, but with the EPA’s recent guidelines, it has become clear that these levels are dangerous as well.

Patient Pages: Stigma Stands in the Way of Migraine Treatment

The stigma still attached to migraine can cause additional hardships on sufferers, according to the lasted OVERCOME survey from Eli Lilly.

Migraine sufferers know that besides the blinding pain, nausea, and other physical symptoms of migraines, the stigma around the condition makes it extremely hard to bear. Eli Lilly’s fourth international-population-based OVERCOME survey sought to understand the impact of stigma on the quality of life of migraine patients.

It might come as no surprise that 31% of frequent migraine sufferers experience stigma “very often,” but even those with infrequent bouts deal with stigma “often” and “very often” (25%). The types of stigma experienced include “secondary gain,” or belief that claiming a migraine is used for a patient’s own gain such as missing work or other obligations, and “minimizing the burden,” which is when others believe that migraine is not burdensome to a patient or their family. Additionally, migraine sufferers reported dealing with “interictal burden,” or the fear or stress of another attack.

“They worry about when the next attack is coming,” Eric Pearlman, Associate Vice President, Global and U.S. Medical Affairs, Eli Lilly, told FiercePharma. “They find it difficult to plan because of the unpredictable nature of the migraine attacks and that leads to a significant amount of disability. He further explained that if the person experienced both types of stigma “often” and “very often,” even if they only had one migraine headache day a month, they reported more disability than someone with 15 migraine headache days a month who didn’t experience stigma.

While pharma has seen a serious uptick in recent migraine treatment and services, this type of stigma can be an obstacle in patients’ treatment and well-being.

FDA Update

Drug Approvals

The FDA has approved expansion of Genentech’s CellCept (mycophenolate mofetil), which is now indicated for organ rejection in pediatric recipients of allogenic heart and allogeneic liver transplants aged 3 months and older. Originally, the drug was approved for treatment with other immunosuppressants for adult kidney transplant, adult heart transplant, adult liver transplant, and pediatric kidney transplant patients.

The Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), has received emergency use authorization (EUA) from the FDA. The vaccine is administered in two doses and can be given to individuals 18 years of age and over.

The FDA revised the EUA for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to authorize state-licensed pharmacists to prescribe the oral anti-viral COVID-19 treatment to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.

Med Device Approvals

Spectral Medical Inc. received FDA Breakthrough Device designation for Toraymyxin, a therapeutic hemoperfusion device that removes endotoxin, which can cause septic shock.

The FDA approved the LungFit PH system from Beyond Air to treat term and near-term neonates with hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN).

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