Stressed caregivers could use a boost from pharma. Think mental health and financial help, survey says

Remember the sandwich generation? That’s the group of middle-aged people who are caring for both children and aging parents.

It’s a group that pharma companies often market to directly as parents who are making decisions about vaccinations, routine visits or rare conditions, but less often in their roles as caregivers who are making healthcare decisions for older family members.

But maybe they should.

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Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.

Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).

Richard Pazdur (via AACR)

There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.

‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.

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A Chrysalis Initiative and Intouch Solutions campaign features art depictions of Black women with a white not-equal sign drawn over to point out disparity in breast cancer care.

Jamil Rivers went from metastatic breast cancer patient to advocate to non-profit founder – all in her pursuit of breast cancer healthcare equity for Black women. Her mission began a few years ago when at age 39, she was diagnosed with metastatic breast cancer. As she navigated her care and the health system, she was shocked to find out that Black women die from breast cancer at a 40% higher rate than white women.

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The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.

The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.

American children under the age of five may not be vaccinated until mid-2022, as Pfizer said Friday that it’s going to now test a third dose of its Covid-19 vaccine in the trial.

The decision comes as Pfizer announced non-inferiority was not met for children between the ages of two and five when compared to older teenagers in the current trial.

Pfizer previously said it might apply for an EUA in this youngest population by the end of December or early next year, but now says that if the three-dose study proves successful, Pfizer and BioNTech expect to submit data to regulators to support an EUA ‘in the first half of 2022.’

Well, Purdue Pharma’s multi-billion dollar opioid settlement is now in jeopardy — a federal judge just said no.

Colleen McMahon, a judge on the US District Court for the Southern District of New York, said that the settlement, which would dissolve Purdue Pharma and was approved in September by a bankruptcy judge, should not go forward because it releases the company’s owners, members of the billionaire Sackler family, from liability in civil opioid-related cases.

Stigma around lung cancer likely isn’t going away — the ‘you did it to yourself’ critics continue no matter the statistics or circumstances presented. So instead Novartis is encouraging people with lung cancer to self-advocate and have meaningful conversations where it matters.

Its ‘Sound Up for Lung Cancer’ campaign focuses on the power patients do have. In videos that center on patients’ voices, for instance, people talk about how they felt blamed or isolated after diagnosis and how they dealt with it. As one woman says, ‘Connecting with other people going through it and focusing on what’s important. That’s what helped me find my normal again.’

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Robert Califf (Graeme Sloan/Sipa via AP Images)

As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.

The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.

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Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)

Well, see you in January 2023.

In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.

The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.
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