J&J shareholders reject proposal to end talc sales worldwide

 Despite facing a mountain of litigation over its talc products and pulling them off shelves in North America two years ago, Johnson & Johnson will continue to sell them in many markets around the world.

The decision was put to a vote of stockholders in J&J’s annual meeting on Thursday and failed (PDF) to receive the majority needed to discontinue sales of the products.

Plaintiffs have brought more than 40,000 lawsuits against the company—with more than 25,000 still outstanding—arguing that the company’s talc products cause cancer. The litigation already has cost J&J nearly $1 billion in legal fees and $3.5 billion on verdicts and settlements. In cases where J&J has lost at trial, the company has pledged to appeal.

In 2019, the FDA discovered traces of asbestos in samples of the company’s iconic baby powder, prompting a recall.

Less than a year later, the company halted sales of its baby powder and other products in North America. J&J said that the move was to allow its manufacturing facilities to produce high-demand medicines and to allow its workers to socially distance.

As the litigation has gained steam, J&J created a company to absorb its talc liabilities and declare for bankrupcty protection. J&J has established a $2 billion trust to resolve the claims.

“JNJ remains vulnerable to further erosion of its reputation as a trusted purveyor of health-related products by continuing to sell and market its talc-based Baby Powder to the rest of the world,” the proposal said.

The company’s board responded to the challenge, defending the product.

“The weight of the science does not support any claim that the talc used in JBP causes cancer,” it wrote.

One shareholder proposal that was passed by shareholders on Thursday was a racial justice audit. The proposal cited J&J’s marketing of baby powder to minority and overweight women which “are troubling,” the proxy read.

https://www.fiercepharma.com/pharma/johnson-johnson-shareholders-reject-proposal-end-sales-talc-products-outside-north-america

Sanofi moves patients out of Ukraine warzone to preserve MS trials

 Sanofi has moved clinical trial patients out of Ukraine, as European pharma companies scramble to maintain their multiple sclerosis studies in the wake of the conflict brought on by the Russian invasion. 

About 11% of Sanofi’s study sites for its MS molecule tolebrutinib are in Ukraine and Russia, John Reed, global head of research and development, said on an April 28 earnings call.

The French pharma company’s teams on the ground have made “really heroic efforts” to move patients from the study out of Ukrainian territories affected by the conflict, and to the relatively safer west of the country or into clinical sites in neighboring countries, Reed said.

“We’ve taken mitigation efforts as well to expand recruitment outside those territories to add extra patients in case we lose some data,” Reed said. “But so far so good, I would say, and we are still on track with the submissions that we’ve shared previously.”

Paul Hudson, CEO of Sanofi, said on the call that it was a “Herculean effort” by everybody involved to make sure patients received the attention they need and the trials were kept on track.

In an earnings release on the same day, Sanofi said it was activating new clinical sites and expanding patient enrollment in geographies not impacted by the war. “This may lead to the planned primary completion dates of pivotal trials in MS and COPD to shift [but] previously communicated submission timelines remain unchanged,” the company said.

Fellow European Big Pharmas Novartis and Roche also revealed in their earnings calls this week that they have taken measures to insulate their MS trials from the conflict.

For the global study of Novartis’ BTK inhibitor remibrutinib, the percentage of patients located in Russia or Ukraine was in the low to mid-teens, Vas Narasimhan, CEO of Novartis, said on an April 26 earnings call.

“At the moment we believe we can fully mitigate the patients required from those two countries,” Narasimhan said. “No patients in our … studies have been enrolled so far, and so we’ll simply reallocate to other markets and we expect to remain on track.”

The previous day, Roche Pharmaceuticals’ CEO Bill Anderson revealed that the company had to open new sites in other countries to continue its late-stage trials of Ocrevus and the investigational BTK inhibitor fenebrutinib.

https://www.fiercebiotech.com/biotech/sanofi-moves-ms-patients-out-ukraine-big-pharma-tries-preserve-trials

AbbVie Taking the Reigns in Migraine Treatment

 Migraine is a common neurological disorder experienced by more than one billion people across the globe. Despite the frequency of occurrence, AbbVie’s Aubrey Adams explains that no two migraine patients are exactly alike, which drives the company’s mission to develop best-in-class therapies to treat the disorder that contributes to a loss of productivity in the global economy.

Adams, U.S. area head for therapeutic neurotoxins & migraine, medical affairs at AbbVie, told BioSpace that the Illinois-based company is committed to addressing the burden of migraine. She noted that AbbVie is the only company that offers three treatments across the full spectrum of migraine.

“Our brands are well-positioned across the migraine spectrum to provide HCPs (health care practitioners) and their patients the ability to optimize care,” Adams said in an email. “Bolstered by the legacy of Allergan, AbbVie has been a long-standing leader in the migraine community, keeping patients at the center of what we do.”

Since its $63 billion acquisition of Allergan in 2019, AbbVie has become one of the leading companies developing therapies for the different types of migraine that affect people. Its product list includes the vaunted Botox (onabotulinumtoxinA), which is widely used as a preventive treatment for adult patients with chronic migraine. The crown jewel of AbbVie’s migraine portfolio, Botox was first approved for migraine by the U.S. food and Drug Administration in 2010. Also included in its portfolio of migraine therapies is Ubrelvy (ubrogepant), which has been approved for the acute (immediate) treatment of migraine with or without aura, a sensory phenomenon or visual disturbance associated with migraine.

Ubrelvy, which AbbVie gained in the Allergan acquisition, was the first drug in the class of oral calcitonin gene-related peptide (CGRP) receptor antagonists to be approved for the acute treatment of migraine. During severe attacks, CGRP is released, and treatment with Ubrelvy blocks the peptide from binding to its receptors. The 2019 FDA approval was based on two pivotal studies showing that Ubrelvy led to significantly greater levels of pain freedom and freedom from the most bothersome migraine-associated symptom (defined as nausea, hypersensitivity to light or hypersensitivity to sound) at two hours when compared with placebo.

Rounding out the portfolio is the more recently-approved Qulipta (atogepant), a once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for the preventive treatment of episodic migraine in adults. Qulipta could see expanded approval following positive late-stage data announced earlier this year that showed the medication demonstrated statistically significant reduction of mean monthly migraine days.

“Based on our nearly 12 years of experience treating migraine, we know that no two migraine patients are alike. It is important for healthcare providers to have a variety of treatment options, including Qulipta, specifically developed to target CGRP, which is believed to be crucially involved in migraine in many patients,” Adams said.

It is estimated that approximately 12% to 14% of people globally are affected by migraine. It is the highest cause of disability worldwide for people under 50 years of age. In a 2018 AJMC article, approximately 1 out of every 7 American adults, including 1 in 5 in the midst of their peak employment years (18 to 54), reported severe headaches or migraine during the preceding three-month period. The direct and indirect impact on the U.S. economy was estimated to be $36 billion in 2016, with sufferers losing time to absenteeism and short and long-term disability.

Adams noted that a key to understanding migraine is that the disorder is much, much more than a headache. While it is accurate that migraine is marked by severe headache, it is a complicated neurological disorder that includes other issues such as vomiting, nausea, phonophobia, which is a fear of loud noises and/or photophobia, a sensitivity to light. Many patients are forced to seek additional treatment options from physicians due to the difficulty of finding adequate relief. That’s why it’s important for treating physicians to be able to recognize the migraine spectrum in order to prescribe the proper treatment.

Severe migraine headaches have a negative impact on quality of life. People who are afflicted with these types of migraines typically remain in bed with the lights out. Even minor movement can be painful. There are also parallel impacts such as anxiety and depression, which are often comorbid with migraine.

Migraine is characterized broadly by attack frequency, Adams said. People living with episodic migraine generally have one to 14 headache days per month. Then, there is chronic migraine, which affects about 4 million people in the U.S. People with chronic migraine experience 15 or more headache days each month, with migraine symptoms on at least eight of those days, each lasting four or more hours.

“Since migraine is different from person to person, and even in the same person from attack to attack, it’s important that healthcare providers have a variety of treatment options available to treat the differing needs of their patients. To that end, we are continuing research to investigate additional uses and benefits of our on-market products,” Adams said.

To be sure, AbbVie is not the only company focused on the development of migraine treatments. Last year BioHaven Pharmaceutical announced positive Phase III data from its second pivotal trial assessing intranasal zavegepant for the treatment of acute migraine in adults. The data will be used to support potential approval in the United States and other countries, the company said. Zavegepant distinguishes itself by coming in both an oral and intranasal formulation – an option many patients may prefer. 

Also last year, Amgen posted data showing that its migraine drug Aimovig (erenumab-aooe) held its ground against topiramate, a nerve pain drug commonly prescribed for migraine. A CGRP inhibitor, Aimovig proved to be more effective and better tolerated in patients. And two years ago, Denmark-based H. Lundbeck A/S won approval for Vyepti, a preventative treatment for migraine. Like Qulipta and Aimovig, Vyeptis is a CGRP inhibitor.

As AbbVie moves forward with studies of migraine-aimed therapies, Adams noted that the company’s mission is patient-centric. She said patients are the “North Star,” meaning the guiding light, in all that the company does. With 39 million people in the U.S. alone impacted by migraine, she said AbbVie researchers are working tirelessly to innovate new treatment options to provide much-needed relief.

That patient-centric idea has allowed AbbVie researchers, including Adams herself, to witness the impact of migraine symptoms on patients first-hand. Many members of AbbVie’s team have either personal experience with migraine or have seen the impact on loved ones, she said. And that has been a driving factor in the company’s commitment.

“With AbbVie’s deep migraine legacy, multiple therapies available and more research underway, AbbVie is committed to supporting the migraine community for years,” Adams said.

https://www.biospace.com/article/abbvie-follows-the-north-star-taking-the-reigns-in-migraine-management/

Horizon Gets EC OK for Neuromyelitis Optica Spectrum Disorder Therapy

 

• NMOSD is a devastating autoimmune disease of severe and recurrent central nervous system attacks which can result in blindness, paralysis and death
• UPLIZNA is indicated as monotherapy for treatment of adult patients with NMOSD who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+), which represents 80% of NMOSD patients
• EC approval was supported by results from N-MOmemtum, the largest pivotal trial ever conducted in NMOSD, which showed 87.6% of AQP4-IgG+ NMOSD patients on UPLIZNA were attack free for 28 weeks, with the vast majority remaining attack free for at least four or more years
• UPLIZNA is the EU’s first and only targeted CD19+ B-cell-depleting monotherapy proven to reduce attacks in adult AQP4-IgG+ NMOSD patients

https://www.biospace.com/article/releases/horizon-therapeutics-plc-receives-european-commission-ec-approval-of-uplizna-inebilizumab-for-the-treatment-of-adults-with-neuromyelitis-optica-spectrum-disorder-nmosd-/

CDC: Half of Vermont’s 14 counties have high COVID-19 levels

 Half of Vermont’s 14 counties have been rated as having high community levels of COVID-19, according to the U.S. Centers for Disease Control and Prevention.

The rankings are based on a handful of factors including new hospital admissions for COVID-19, recent case counts, and the community’s overall hospital capacity.

Washington County reported the highest number of cases per 100,000 individuals, followed by Chittenden County and Bennington County. The other counties with high community levels of the virus are Addison, Franklin, Grand Isle and Orleans.

Windham, Rutland and Essex counties have been given a “low” rating by the CDC, with the remaining counties rated at medium risk.

The agency recommends people in counties with high community levels of COVID-19 take actions to reduce transmission, such as wearing a mask in indoor public spaces.

https://apnews.com/article/covid-health-vermont-rutland-montpelier-358b221e394cde05f2db8a05e62a01bd

String of deaths on Navy aircraft carrier spurs calls for change

 After seven deaths in a year among the crew of a single aircraft carrier, including three suicides in just more than a week, lawmakers and advocates are demanding answers from the Navy.

The USS George Washington, a Nimitz-class nuclear-powered carrier, has been at the Newport News, Va., shipyard since 2017 for a midlife, multiyear refueling and complex overhaul.

Between last year and April, seven sailors assigned to it have died, four of them being apparent or confirmed suicides. After a CBS News report on the deaths, a spokesperson for the Navy told The Hill that there were three additional suicides before 2021 — in November 2019, July 2020 and October 2020.

Sailors on the ship have spoken to outlets including Navy Times and NBC News about conditions aboard, with one saying they also attempted suicide, in large part due to working conditions.

The Navy for its part has acknowledged the issues on the aircraft carrier and says it is investigating the deaths.

But Chrystal Verrengia-Bushnell, the vice president of 22 Until None, a volunteer organization aimed at providing resources for active-duty service members and veterans, says her group has heard from sailors and their families about the harsh conditions on the George Washington and that some fear accessing the resources provided by the military because their commanders could find out.

“There’s a big distrust there,” Verrengia-Bushnell said. “We get emails and messages daily on all three of our social media platforms and through email asking, ‘Are there any — is there anybody that I could talk to you about my command won’t find out?’”

Rep. Elaine Luria (D-Va.), who represents the area where the ship is docked, wrote a letter to Chief of Naval Operations Adm. Michael Gilday questioning the climate aboard the ship.

Luria, a 20-year Navy veteran who retired at the rank of commander, recounted her own experiences working on carriers in long overhauls.

“Being in the shipyard, it’s an industrial environment. It is dirty,” Luria told The Hill. “You don’t have the basic services like hot water, lights, heating and cooling, and the quality of the food.”

Master Chief Petty Officer of the Navy Russell Smith held an all-hands phone call with sailors on the USS George Washington on Monday, during which he fielded multiple questions about mental health and conditions on the ship.

But Smith raised eyebrows when he said that even though circumstances could have been better, “what you’re not doing is sleeping in a foxhole like a Marine might be doing.”

Verrengia-Bushnell said Smith “gaslit everybody on that ship” and “completely disregarded all the concern — the ongoing concerns of the sailors on board that ship.”

“These are concerns that have been continually brought up and ignored. And those who have been suffering in this environment, not only have the concerns been ignored, but their feelings on it or the hardship that it’s causing them has been — like they’ve been derided for it.”

Among other actions implemented, the Navy told The Hill that it mobilized a 13-person Special Psychiatric Rapid Intervention Team to provide onboard services from April 16 through April 19.

Sailors are being provided tele-mental health opportunities via network mental health providers. Also, one clinical psychologist and a licensed clinical social worker have reported to the ship as temporary duty support.

“While the Navy is a resilient force, we are not immune from the same challenges that affect the nation that we serve,” Rear Adm. John Meier, commander of Naval Air Force Atlantic, said in a statement. “As a father of two junior service members, I feel these events deeply.” 

All of this comes as the Pentagon ramps up its efforts to address suicides among active-duty service members.

Defense Secretary Lloyd Austin established a Suicide Prevention and Response Independent Review Committee in March to review how the agency is responding. The panel, which will begin its work by May 14, will visit nine military bases as part of its work.

It also comes as the House and Senate Armed Services committees get to work on drafting the National Defense Authorization Act for fiscal 2023.

House Armed Services Committee Chairman Adam Smith (D-Wash.) told The Hill that his concern is with how services are identifying problems on the carrier before they turn tragic.

“We’ve done some work with the different services. We’ve had families who have called us and said, ‘We’re concerned about our son or daughter who’s serving,'” Smith said. “We need to get a better process for identifying those problems and dealing with them before it happens.”

Virginia Sen. Tim Kaine (D), who serves on the Senate Armed Services Committee, said that he thinks there’s an opportunity to learn from recent events as the defense bill gets drafted.

“I think we have an opportunity to get some information, see whether it’s limited in specific just to the George Washington or whether it’s a more general application,” Kaine said. “We can apply lessons we learned in the defense bill.”

https://thehill.com/policy/defense/3472164-string-of-deaths-on-navy-aircraft-carrier-spurs-calls-for-change/

Biden health official says trans youth being ‘driven to depths of despair’

 Assistant Health Secretary Rachel Levine said trans youth are being “driven to depths of despair” and committing suicide at alarming rates, during a speech on Saturday about the dangers of anti-trans laws being passed in red states across the country.

Levine, the first openly transgender federal official to be confirmed by the U.S. Senate, said in a speech at Texas Christian University in Fort Worth that LGBTQ youth are being “attacked” and have “few places to turn” for help.

“I want to say this very, very clearly: lesbian, gay, bisexual, transgender and queer Americans are committing suicide at a rate that should shock our conscience,” Levine said during the Out For Health Conference.

“Even after decades of progress, the most vulnerable among us continue to suffer … transgender women of color not only continue to be harassed, but are more likely than the population at large to suffer violence and even murder.”

Her remarks come after new laws criticized as anti-trans were enacted in several states this year, including the controversial “Don’t Say Gay” law in Florida, which prohibits the discussion of gender identity and sexual orientation in public schools from kindergarten through third grade.

Arkansas also passed a law prohibiting gender-affirming treatment for trans youth, and several Republican-led states have similar bills in the pipeline. Texas has ordered the investigation of parents who allow their children to undergo gender-affirming care, which the state’s attorney general said amounts to “child abuse.”

Levine, who was a doctor for decades before becoming Pennsylvania’s secretary of health, argued during her speech on Saturday that gender-affirming care is an established medical practice “based on decades of study” and is both safe and legal.

“Gender-affirming care is medical care. It is mental health care. It is suicide prevention care. It improves quality of life, and it saves lives,” she added.

The assistant health secretary herself has faced anti-trans attacks, including when Texas Attorney General Ken Paxton (R) called Levine “a man” after she was named USA Today’s Woman of the Year. Levine identifies with she/her pronouns.

Levine said while the Biden administration pushing for equality and acceptance, it was becoming increasingly clear that “not everyone feels that way.”

“Many politicians and their supporters are describing our LGBTQI+ community, in public, as a blight on our culture. Many of the targets of this kind of speech are driven to kill themselves,” Levine said. “We know as a medical fact that trans youth in particular are being hounded in public and driven to the depths of despair at an alarming rate.”

In 2020, about 40 percent of LGBTQ children reported contemplating suicide, while 46 percent said they needed some form of counseling, according to The Trevor Project.

Levine told LGBTQ children “it was okay to be you,” and asked parents to support their children who identify with the community, saying “one supportive adult” makes a huge difference in saving their lives.

She also called on physicians and others in the medical community to take a stand against “slander, bigotry and gender-baiting hate speech.”

“The language of medicine and science is being used to drive people to suicide. The mantle of concern for children is being claimed to destroy children’s lives,” Levine said.

https://thehill.com/policy/healthcare/3473200-top-biden-health-official-says-trans-youth-being-driven-to-depths-of-despair/