News Notes (October)

October 16, 2020

A compilation of recent notable news developments that pertain to the clinical trials industry.

Trial resumptions slow as COVID cases rise again

Clinical trials disrupted by COVID-19 are expected to resume at a much slower rate than originally anticipated, as more nations are reinforcing lockdowns due to a globally rising number of COVID-19 cases, says GlobalData.

“The general trend shows a gradual increase in the overall percentage of trials for each trial status, the biggest of which has been seen in trials that are ongoing and recruiting and those that are ongoing but not recruiting,” commented Priya Nair, trials intelligence analyst at GlobalData. “Between Aug. 17 and Sept. 21, ongoing and recruiting trials decreased from 84.7% to 82.2%, while completed trials increased from 4.5% to 6.4%.”

The number of resumed trials increased from over 600 on Aug. 17 to 741 as of Sept. 21. Out of these trials, 82.2% are currently recruiting participants, 7.9% have completed recruitment but are still ongoing, and 0.5% of trials have yet to start recruiting subjects.

GlobalData reports that there is an overall steady increase of trials resuming activity. The U.S. has the highest number of resumed trials at 70.6%, followed by France at 7.6%, the UK and Spain at 7.3% each, and Japan at 7.2%.

“As large numbers of companies shift to alternative ways to conduct trials, it is possible that the use of virtual trials may still be prominent even after the COVID-19 pandemic ends,” said Nair.

BMS to acquire MyoKardia

Bristol Myers Squibb and MyoKardia, Inc. have entered into a definitive merger agreement under which BMS will acquire MyoKardia for $13.1 billion, or $225 per share in cash. The transaction was unanimously approved by both the BMS and MyoKardia Boards of Directors and is anticipated to close during the fourth quarter of 2020.

MyoKardia is a clinical-stage biopharmaceutical company that discovers and develops targeted therapies for the treatment of serious cardiovascular (CV) diseases. Through the transaction, BMS gains mavacamten, a potential first-in-class CV medicine for the treatment of obstructive hypertrophic cardiomyopathy (HCM), a chronic heart disease with high morbidity and patient impact. A new drug application for mavacamten for symptomatic obstructive HCM is expected to be submitted to FDA in the first quarter of 2021. BMS expects to explore the full potential of mavacamten in additional indications, including non-obstructive HCM, as well as develop MyoKardia’s pipeline of novel compounds, including two clinical-stage therapies

Genomic insights pact

Genuity Science, a genomics and data insights organization, and Ionis Pharmaceuticals, a company focused on antisense therapeutics, have struck a broad, multi-year collaboration aimed at accelerating the discovery and development of novel therapies across a range of conditions.

Genuity Science’s approach combines high-quality, whole-genome sequence and deep phenotype data resulting in better definition of the underlying disease mechanisms. This approach, when coupled with Ionis’ proprietary antisense technology, has the potential to significantly expedite the drug development process through a more direct translation of targets into drugs. Under terms of the deal, Genuity Science will receive a combination of upfront payments and development milestones, plus product royalties.

Behind its RNA-targeted antisense technology, Ionis has a pipeline of more than 40 drug candidates designed to potentially treat a broad range of disease, including neurological, cardiovascular, infectious, and pulmonary diseases.

PharmaLex adds specialized consultancy

PharmaLex Group, a provider of specialized services for pharma, biotech, and medical device industries worldwide, has completed its mergerwith Biopharma Excellence (BPE) GmbH. BPE is a consultancy based in Munich, Germany, which offers specialized biopharma consulting services, including biologicals, antibody-containing products, cell- and gene therapies/ATMPs, biosimilars, and vaccines.

Founded in 2013 by Diane Seimetz, PhD, and Gabriele Dallmann, PhD, BPE supports national and global life science companies from top 10 pharma organizations to emerging startups. The company offers integrated product development services in the EU, the US, and further territories, covering early- and late-stage scientific, regulatory, and strategic support up to submission of dossiers and lifecycle strategies.

Staff and wire reports

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