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June 25, 2018

Today's Rundown

Featured Story

FDA should be split up—and stop covering food, says White House

The FDA could become much smaller if a proposal by President Trump to separate the regulation of food and medicines comes into effect.

Top Stories

Phase 2 flop kills Merrimack pancreatic cancer drug, sinks stock

Merrimack Pharmaceuticals has dropped MM-141 after the pancreatic cancer therapy failed to move the needle in a midphase trial.

AbbVie taps Calibr’s ‘switchable’ CAR-T for solid tumors

After scrapping plans to grab a quick FDA nod for Rova-T, AbbVie is licensing CAR-T technology from Calibr to create safer, “switchable” CAR-T treatments for solid tumors.

[Sponsored] The Growing Need for Data Management Solutions in Clinical Labs

The increasing demand for innovation in research and the related pressures to deliver on the most promising findings from discovery are also driving the need for simultaneous innovation in the technologies that enable that innovation and, likewise, the reliance on data management solutions that respond to an increasingly complex scientific environment.

Boehringer commits €230M to build German biologics center

Boehringer Ingelheim has unveiled a €230 million ($268 million) investment in its biologics capacity. The investment will support the construction of a biologics development center at Boehringer's R&D site in Biberach, Germany.

Sophiris stops additional doses in topsalysin prostate cancer trial following patient death

Sophiris Bio has halted the progress of an open-label study of topsalysin in prostate cancer, as it investigates the death of a patient who died on the same day he received a second dose of the drug.

Nodthera nets $40M to take on chronic inflammation

Cambridge, U.K.-based Nodthera raised £28 million in series A funding to develop NLRP3 inflammasome inhibitors for diseases characterized by chronic inflammation.

Endocrine specialist Crinetics tees up for $86M IPO

Just months after Crinetics picked up $63.5 million in its series B, the GPCR specialist is filing to raise up to $86 million in its IPO.

Akero picks up $65M to advance Amgen-licensed NASH drug

Akero Therapeutics raised $65 million in series A financing to advance its lead program, a long-acting fibroblast growth factor 21 analog, for the treatment of nonalcoholic steatohepatitis (NASH).

Enrollment Showcase

SBMI Now Offering an Online Graduate Program in Bioinformatics

UTHealth SBMI now offers a M.S. track in clinical and translational bioinformatics.

Resources

[Survey] 2018 eClinical Technology Solutions Survey

Take this anonymous 10-minute survey to share your thoughts on leading eClinical technology solutions and earn up to $55 honoraria. Take the survey now!

[Whitepaper] Is the pharma business model ready for precision medicine?

Blue Latitude Health explores the commercial barriers and new stakeholder connections for pharma companies developing precision medicines, and reveals how to grasp novel opportunities in the new era of healthcare.

[Whitepaper] Implementing a Proactive Approach to Risk Management

A solid RBM plan will not only help you comply with the ICH guidelines, but will help you mitigate risks which could ultimately delay your trials and increase costs. Download today!

[Whitepaper] Getting to First-in-Human Clinical Trials: A Make-or-Break Milestone for Small Biopharmas

“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure.

[Whitepaper] Compliance Certificate and Training for Life Sciences Professionals

4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics.

[Whitepaper] Digitizing the Global Life Sciences Supply Chain: The Critical Role of Digital Transaction Management

Life science companies are experiencing a significant transformation in how they bring new products to market.

Events

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