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Today's Rundown

Featured Story

FDA grants priority review to ide-cel, keeping Bristol Myers on track to deliver Celgene payday

Bristol Myers Squibb has received a March 27 PDUFA date for its anti-BCMA CAR-T cell therapy. The priority review action date sets Bristol Myers up to win approval for the bluebird bio-partnered drug in time to satisfy the terms of its acquisition of Celgene.

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Top Stories

IPO, check: Now, ADC Therapeutics files for lonca approval

ADC Therapeutics nearly went through the entire alphabet before trying, twice, to get off an IPO. Now, it’s looking to become a commercial biotech.

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Anokion autoimmune pact rides out BMS-Celgene merger

Bristol Myers Squibb may have bounced Jounce from its roster of inherited partners, but it’s hanging onto Anokion, an autoimmune disease biotech Celgene teamed up with in 2016. The duo is expanding the deal to cover celiac disease as well as multiple sclerosis.

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Medicxi raises €200M to take 6 biotechs deeper into the clinic

Medicxi has secured €200 million ($235 million) to support six companies. The unidentified biotechs are drawn from the portfolio of a €150 million life science-focused fund that Index Ventures set up before spinning off Medicxi.

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Vaccinex's lead drug misses the mark in Huntington phase 2; focus shifts to Alzheimer's

There is no cure for Huntington disease—just treatments that focus on addressing muscle and movement problems and drugs like antidepressants and antipsychotics that help manage neurological symptoms. Vaccinex is working on an antibody that it hopes could be the first disease-modifying treatment for the progressive brain disorder, but that program has just hit a snag in phase 2.

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Emmecell exits stealth mode as FDA greenlights clinical trials of cornea cell therapy

Emmecell aims to make corneal transplant surgery, which can take up to a year to heal from and fails up to 20% of the time, a relic of the past by using a combination of magnetic nanoparticles and external magnets in a cell therapy to correct corneal swelling.

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NIH to fund 7 digital health projects aimed at COVID-19

The National Institutes of Health has picked seven companies and academic centers to help develop digital health solutions aimed at the COVID-19 pandemic—including smartphone apps, wearables and big data programs to mitigate the personal and public health impacts of the novel coronavirus.

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Resources

Whitepaper: Five Imperatives for Becoming More Patient-Centric

Achieving patient centricity depends on evolving how evidence is generated.

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Case Study: QED Therapeutics accelerates launch of rare cancer drug into niche market with analytics-driven insights

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Executive Summary: Keys to a Successful Rapid Commercial Launch

Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better.

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Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

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