Roche’s Spark Therapeutics is taking a big new step in gene therapy development, a field where it’s known as an early pioneer.
Spark will invest $575 million to build a new ‘gene therapy innovation center’ on the Drexel University campus in Philadelphia, the company announced Friday morning. The plan includes a 99-year lease for 500,000 square feet of land, with construction expected to begin in the fourth quarter of 2022.
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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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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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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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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.’
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.
Pfizer CEO Albert Bourla (Evan Vucci, AP Images)
The Covid-19 pandemic has been an extremely profitable time for Pfizer, and the massive drugmaker is using that leverage to advance its portfolio writ large. Now, Pfizer’s emerging gene therapy biz will have some new elbow room as it continues to grow in the coming years.
Pfizer this week opened a $68.5 million gene therapy manufacturing facility in Durham, North Carolina, as part of a multi-year, $800 million plan to outfit its next-gen therapeutics business, the company said Wednesday.
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Jay Bradner, President, Novartis Institutes for BioMedical Research
John Carroll: Well, hello everybody. This is John Carroll. I’m the editor of Endpoints News, the editor and founder of Endpoints News. I’m here with Jay Bradner, the president of the Novartis Institutes for BioMedical Research. Jay, we’re going to be talking about ASH in just a second, but you’ve just recently celebrated your sixth anniversary as president of NIBR. And I’m curious, it’s such a significant amount of time for anybody to spend in one career phase. And looking back over the last six years, is everything fundamentally different about the research process and the translational arena that you’re in?
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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.
https://endpts.com/roches-spark-invests-575m-for-new-gene-therapy-center-in-central-philadelphia-as-part-of-drexel-partnership/
