Life Sciences
Top stories summarized by our editors
12/10/2019

The popular expression "digital transformation" is vague and leads to confusion, writes Centerline Digital's Kristen Powers, who suggests marketers should focus on digital maturity or "a company's ability to understand, find, engage, respond to and serve its customers." Powers contends digital maturity or customer experience is a "primary differentiator in the digital economy" and can be assessed by considering experience touchpoints, marketing platforms, and data and measurement capabilities.

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SmartBrief/Marketing
12/10/2019

A South Korean court has sentenced three Samsung Electronics executives for up to two years in prison for their role in hiding and destroying data and documents at Samsung BioLogics that were related to an alleged accounting fraud case involving joint venture Samsung Bioepis. The value of Samsung Bioepis was allegedly inflated by $3.9 billion before an initial public offering in 2016, according to South Korean financial regulators.

12/10/2019

House GOP leaders unveiled a drug pricing bill Monday and touted it as a bipartisan alternative to Democrat-backed legislation introduced by Speaker Nancy Pelosi, D-Calif. The provisions include a cap on out-of-pocket costs for seniors covered by Medicare Part D, measures to rein in anti-competitive actions by drugmakers and a requirement that pharmaceutical firms justify large price increases.

12/10/2019

One in 4 Americans responding to a Gallup poll said they or a family member deferred treatment for a serious medical issue in the last 12 months due to costs, while an additional 8% said they or someone in their household delayed treatment for a less serious issue for cost reasons. Adults in households earning less than $40,000 annually and those with pre-existing conditions were especially likely to forgo treatment, the poll found.

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Gallup
12/10/2019

A federal judge has ruled that the FDA made an incorrect decision to regulate a barium sulfate product, a contrast agent ingested before imaging, as a drug and not a medical device. The court's decision is a win for Genus Medical Technologies, which argues its Vanilla SilQ should be regulated as a device because the agent does not chemically interact with the body.

12/10/2019

Lantheus Holdings' microbubbles will be incorporated with Carthera's Sonocloud system to develop a treatment for recurrent glioblastoma. Under the terms of the deal, Lantheus will provide microbubble vials and Carthera will take charge of regulatory submissions and commercialization.

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BioWorld MedTech
12/10/2019

Abeona Therapeutics announced it had been advised by the FDA that the clinical hold has been lifted on its trial to assess its investigational therapy EB-101 as a treatment for recessive dystrophic epidermolysis bullosa, also known as butterfly disease. The company said it will launch the late-stage study that will enroll 10 to 15 participants within the first quarter of next year.

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Endpoints News
12/10/2019

Aurinia Pharmaceuticals announced last week that its investigational drug voclosporin met the primary and secondary endpoints in a late-stage study assessing the drug as a treatment for patients with lupus nephritis. Due to the positive results from the trial, the company also revealed it plans to file a New Drug Application in the first half of 2020.

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Xconomy
12/10/2019

Roche has once more extended its offer to acquire shares of gene therapy developer Spark Therapeutics with all terms and conditions for the $4.3 billion transaction remaining the same. The new deadline is Dec. 16.

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Reuters
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Spark Therapeutics, Roche
12/10/2019

British biotech Autolus recently presented preliminary data from four clinical trials evaluating two of its chimeric antigen receptor T-cell therapies for patients with blood cancers AUTO1 and AUTO3 and results indicate that the next-generation CAR-T therapies did not trigger adverse side effects similar to those experienced by other patients who have received similar treatments. The findings were presented at the annual meeting of the American Society of Hematology.

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Labiotech (Germany)