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Home » Newsletters » BioWorld

BioWorld

Aug. 13, 2019

View Archived Issues

Amgen stock continues rise after court ruling against Sandoz

A choppy year for Amgen Inc. may be smoothing out after the U.S. District Court of New Jersey ruled that patents for Sandoz Inc.'s biosimilar, Erelzi (etanercept-szzs), a potential competitor to Amgen's highly lucrative arthritis treatment Enbrel (etanercept), should never have been granted. Read More

Health Canada lays foundation for national pharmacare

The Canadian government took its first big step in laying the groundwork for a national pharmacare program Friday when it finalized amendments to its 1987 Patented Medicines Regulations. Read More

Sweet-toothed E. coli thrives in health care settings

LONDON – The largest-ever genomics study of Clostridium difficile has found an emerging new species of the bacterium is selected to thrive on a Western sugar-rich diet and to produce high levels of resistant spores, adapting it to maximize transmission in hospitals and other health care facilities. Read More

South Korea's blockbuster ambitions need more private investment, effective policies

HONG KONG – South Korea is the third biggest pharmaceutical market in Asia following China and Japan. Even though it accounts for 1.8% of the global pharmaceutical market, the country aims to launch at least two blockbuster drugs by 2030. Backed by massive support from the government, Korea's biopharmaceutical industry is focusing on R&D, production and out-licensing to make high-value new drugs. Read More

Data seen as replacing policy as coverage tool for precision medicine

The era of big data might still be in its infancy, but payers are already dealing with a deluge of bits and bytes that threatens to overwhelm their ability to keep up with recent developments in medical science. Clynt Taylor, CEO of Intervention Insights Inc., of Burlington, Mass., told BioWorld that payers are starting to see the light when it comes to reacting to data that suggest a shift in coverage policy, but that over time, payers will replace those fixed policies with a data-driven approach that adapts to patients' needs in real time. Read More

Big changes are coming to BioWorld! Your opinion is requested

We're working to enhance BioWorld's news services by moving to a brand-new platform later this year. Upgrades will include: same-day news delivery, improved functionality, easier accessibility on all devices, more analysis and dynamic data visualization. We value your opinion on these changes. Please take 2 minutes to complete this short survey to help guide our work: https://www.surveymonkey.com/r/Q5TK8JL Read More

Other news to note

Biotime Inc., of Carlsbad, Calif., said it rebranded as Lineage Cell Therapeutics Inc. to better reflect its cell therapy platform. The company's NYSE American ticker changed to LCTX effective at Monday's market opening, with shares dropping 2 cents to close at 90 cents. Read More

Financings

Biovie Inc., of Los Angeles, revised the terms of its upcoming IPO. The firm plans to raise $15 million by offering 1.3 million shares at a price of $11.44. Biovie intends to trade under the ticker BIVI. Thinkequity is the sole bookrunner on the deal, expected to price this week. Read More

Earnings

Evolus Inc., of Newport Beach, Calif., reported that second-quarter net revenue was $2.3 million and recognized upon delivery of Jeuveau (prabotulinumtoxinA-xvfs) for injection to customers. The gross margin was 71.4% and may fluctuate in the future due to various marketing programs, the company said. Read More

Regulatory front

Stand Up to Cancer Canada, the Canadian Cancer Society and the Canadian Institutes of Health Research launched a "dream team" to investigate a new way to treat metastatic breast cancer by making it impossible for the cancer cells to manufacture the proteins they need to continue to spread. The team will receive up to CA$6 million (US$4.5 million), with the first phase of CA$2 million supporting an initial clinical trial. Read More

Clinical data for Aug. 12, 2019

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Regulatory actions for Aug. 12, 2019

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Regeneron cocktail and Ridgeback MAb top Zmapp and Gilead candidate in first Ebola RCT

Stopped early for favorable results, an African trial testing four Ebola drugs has found two of the therapies, Regeneron Pharmaceuticals Inc.'s REGN-EB3 and the NIH-developed MAb-114, gave Ebola-infected participants a greater chance of survival than either Gilead Sciences Inc.'s remdesivir or Zmapp (Mapp Biopharmaceutical Inc., Defryus Inc.), considered the standard of care based on the previous Prevail II trial. Read More

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