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Monday, June 1, 2020

Bristol Myers launches MS med Zeposia in U.S.

Bristol Myers Squibb (NYSE:BMY) announces the commercial launch of Zeposia (ozanimod) 0.92 mg for the once-daily oral treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
The FDA approved the product on March 25.
https://seekingalpha.com/news/3578930-bristol-myers-launches-ms-med-zeposia-in-u-s

Emergent Bio joins Warp Speed COVID-19 vaccine effort

Emergent BioSolutions (NYSE:EBS) has been issued a task order, valued at ~$628M, under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), to deploy its contract development and manufacturing (CDMO) capacities, capabilities, and expertise to support the U.S. government’s efforts to accelerate delivery of COVID-19 vaccines.
Emergent will deploy its molecule-to-market CDMO offering, committing manufacturing capacity, valued at ~$542.7M, for production of COVID-19 vaccine candidates through 2021.
Task order also includes an investment of ~$85.5M for rapid expansion of Emergent’s viral and non-viral CDMO drug product fill/finish capacity.
This task order also expands the partnership to include investments in Emergent’s Baltimore Camden and Rockville facilities to advance COVID-19 programs.
https://seekingalpha.com/news/3578929-emergent-bio-joins-warp-speed-covidminus-19-vaccine-effort

Regeneron to expand development deal with Intellia Therapeutics

Shares of Regeneron Pharmaceuticals Inc. REGN, +5.98% were down 0.5% in premarket trading on Monday after the company said it had expanded a collaboration with Intellia Therapeutics Inc. NTLA, -0.05% to include CRISPR/Cas9-based therapeutic targets and a new focus on developing treatments for hemophilia A and B. Intellia’s stock was up 23.6% before the market opened. Regeneron will pay $70 million upfront and make a $30 million equity investment in Intellia at $32.42 per share. Regeneron recently wrapped up a longtime development arrangement with Sanofi SNY, +0.88%. Year-to-date, Regeneron’s stock is up 63.2%, shares of Intellia have gained 19.3%, and the S&P 500 SPX, +0.48% is down 5.7%.
https://www.marketwatch.com/story/regeneron-to-expand-development-deal-with-intellia-therapeutics-2020-06-01

Amarin plans to increase Vascepa awareness

Amarin (NASDAQ:AMRN) intends to increase the promotion and education initiatives regarding VASCEPA (icosapent ethyl) as the only FDA-approved drug for lowering the persistent cardiovascular risk beyond statin therapy for high-risk patients.
Planned promotion and educational efforts include the sponsorship of continuing medical education, social media-based communications, and advertisements on television and other forms of media.
The company also plans increased sponsorship of investigator-initiated research, such as clinical investigation of VASCEPA in the treatment of COVID-19.
Amarin is also planning for international expansion.
https://seekingalpha.com/news/3578917-amarin-plans-to-increase-vascepa-awareness

FDA OKs emergency use Abiomed heart pump for COVID-19-related heart failure

The FDA has signed off on the emergency use of Abiomed’s (NASDAQ:ABMD) Impella RP heart pump for the treatment of hospitalized patients with COVID-19-related right heart failure or decomposition, including pulmonary embolism.
https://seekingalpha.com/news/3578916-fda-oks-emergency-use-abiomed-heart-pump-for-covidminus-19-related-heart-failure

Lilly Begins Human Trial of Antibody Against Covid-19

Eli Lilly and Co. said Monday that it has begun human trials of an antibody treatment for Covid-19.
The Indianapolis-based pharmaceutical company developed the treatment, called LY-CoV5555, with AbCellera. It is based on antibodies found in the blood of a recovered Covid-19 patient.
Phase 1 trials are taking place at medical centers including in New York City and Los Angeles. If the trials show that the treatment is safe, Eli Lilly plans additional trials both in non-hospitalized patients and in people who are not sick, to test the medicine’s value as a preventative.
If the trials are successful, the company said it hopes to have several hundred thousand doses available by the end of the year.

https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-and-Begins-Human-Trial-of-Antibody-Against-Covid-19-30703692/

FDA OKs expanded use of AstraZeneca’s Brilinta

The FDA approves AstraZeneca’s (NYSE:AZN) blood thinner Brilinta (ticagrelor), combined with aspirin, for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.
The med was first approved in the U.S. in July 2011 for acute coronary syndrome.
https://seekingalpha.com/news/3578904-fda-oks-expanded-use-of-astrazenecas-brilinta