Vericiguat became the first oral soluble guanylate cyclase (sGC) stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. The FDA label clears vericiguat specifically to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient I.V. diuretics in adults with symptomatic heart failure and ejection fraction less than 45%. The NDA was accepted by the agency in July and granted priority review.

COVID-19 vaccine may not protect against South Africa variant

LONDON – There’s mixed news about emerging variants of SARS-CoV-2, with Pfizer Inc. and Biontech SE reporting their vaccine Comirnaty maintains its protective effect against B 1.1.7, first detected in the U.K., while researchers in South Africa said virus variant 501Y.V2 is able to escape neutralization by both monoclonal antibodies and convalescent plasma from previously infected individuals.

IPO filings continue momentum from a record year

The frenetic and record pace of biopharmas filing for IPOs in the U.S. continues as five more companies filed SEC paperwork, looking for gross proceeds totaling $356 million. Leading the pack is Adagene Inc., of Suzhou, China, which is seeking to raise $125 million. The company is developing antibody-based cancer immunotherapies with a platform that combines artificial intelligence algorithms with big data. Its two lead candidates are a clinical stage monoclonal antibody targeting CD137 and a preclinical monoclonal antibody targeting CTLA4. Others seeking IPO payoffs include Terns Pharmaceuticals Inc., which is developing nonalcoholic steatohepatitis therapies and Neximmune Inc., which used its nanoparticle technology platform to enter the clinic with acute myeloid leukemia and multiple myeloma therapies. In 2020, 106 new offerings were completed and raised $22.5 billion.

Many unkept promises, but USTR sees progress in China’s trade principles

When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made some good promises, but delivering on those promises is what matters. Throughout its annual assessment of China’s commitment to World Trade Organization principles, the U.S. Trade Representative noted the many promises China has made over the years that have yet to be kept. However, the report, released last week, has a hopeful tone, reflecting what it described as “key progress with the signing of an historic trade agreement,” the Phase One Agreement, between China and the U.S. last year. Whether China will continue to take the U.S.’ concerns seriously and engage on finalizing and implementing a comprehensive Phase Two Agreement under President Joe Biden’s administration remains to be seen.

Public biotechnology company gainers and decliners in 2020

It was a turbulent year for publicly traded biotechnology companies, but after a lackluster first quarter that saw biopharmaceutical equities plunge dramatically, particularly at the beginning of March, there was a gradual recovery over the final three quarters of the year. In order to determine just how well the sector performed on the capital markets, BioWorld examined the fortunes of 516 U.S. biotech and biotech-related stocks that it covers. The analysis included a total of 405 companies from this universe whose shares were trading above $1 at the beginning of 2020. Among this group, there were 214 gainers and 189 decliners, and they collectively recorded an average share price gain in valuation of just 0.45% for the year.

PD-1 checkpoint blockade can backfire in TB, study shows

Researchers at the U.S. National Institute of Allergy and Infectious Diseases have shown that optimal control of tuberculosis (TB) infection necessitated immune regulation as well as immune activation – and that PD-1 checkpoint blockers exacerbated TB infections in macaque monkeys by disrupting the balance between the two.

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