Sunday, March 7, 2021

FDA calls out Brainstorm’s ALS stem cell therapy, says data don’t show benefit

FDA sign, headquarters
  The FDA almost never reveals its thinking about a drug prior to issuing a regulatory decision, and when that decision is a rejection the letter to the company is always confidential. Brainstorm Cell Therapeutics hasn’t even submitted its amyotrophic lateral sclerosis therapy for review, but the regulator has taken the unusual step of...

In-home care startup DispatchHealth passes $1.7B valuation

At-home care startup Dispatch Health raised $200 million in funding. The startup plans to use the funds to expand from the 31 markets where it currently works to 100. “We felt like there was a readiness for expansion and receptivity by the market that prompted us to raise this capital,” CEO Dr. Mark Prather...

Promoting public health through the law: A Q&A with NY state counsel Deborah Beth Medows

Deborah Beth Medows has spent over a decade as a public health law influencer for the state of New York, first drafting health laws for the State Legislature, then advising on their implementation and now upholding them as a litigator. She was involved in the state’s implementation of the Affordable Care Act, and drafted...

Could AI reduce healthcare waste? Approach of online retailers could provide clues

When Amazon envisioned Alexa, an AI-powered, voice-activated customer recommendation system, it was a feat that required machine learning and massive amounts of data to provide answers to conversational queries quickly, even in a noisy environment. Now, the same data analysis capabilities that enable Amazon to become hyper-familiar with consumer purchasing patterns could hold...

Takeda to pay Ovid $196M for full rights to Phase 3-ready epilepsy drug

brain
When Takeda Pharmaceutical and Ovid Therapeutics began working together four years ago, the partners aimed to share in the development of a drug with the potential to treat rare forms of epilepsy. The partners are ending the alliance, but Takeda leaves with full rights to a Phase 3 ready compound while Ovid gains...

How digital health impacts the development and adoption of cancer immunotherapies

Essential to the future of cancer immunotherapies is a digital health infrastructure that can support reliable, secure and compliant data collection from disparate systems and devices. As more and more immuno-oncology (IO) treatments come to market, biopharma will require data to enable more efficient research and development; providers will require data to drive...

4 signs your compliance program is out of date

Life sciences companies tend to consider themselves leaders when it comes to compliance policies. In one sense they’re right. The close sales relations between their distribution agents and state-linked doctors and hospitals have long made them vulnerable to corrupt practices and put a target on their back for enforcement under the Foreign Corrupt Practices...

Apervita, Diameter Health join forces to improve data quality for value-based care contracting

                  A new health IT partnership aims to improve clinical data quality and thereby increase the volume of data available for care quality measurement. The partnership will combine Chicago-based Apervita and Farmington, Connecticut-based Diameter Health’s expertise to provide payers, providers and other healthcare stakeholders with access to clean clinical data for value-based care delivery,...

Going through their own pregnancies, founders launch hybrid maternity clinic

Adrianne Nickerson and Elaine Purcell launched maternity care startup Oula in 2019. The company began taking virtual visits in December and opened its first clinic on Tuesday. Photo credit: Oula Going through their own pregnancies, Adrianne Nickerson and Elaine Purcell launched a maternity care startup to help other parents through the experience. Called Oula,...

Biden invokes federal law to broker Merck, J&J Covid vaccine manufacturing alliance

President Biden
  Merck will shoulder some of the manufacturing work for Johnson & Johnson’s Covid-19 vaccine, an alliance President Biden brokered under a federal law that gives him the authority to secure production of critical products during national emergencies. With the additional manufacturing capacity from Merck, President Biden said that J&J’s plan to deliver 100...
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