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Home » Newsletters » BioWorld

BioWorld

Dec. 16, 2019

View Archived Issues
neurology-major-depressive-disorder

Gemini Ascendant: Axsome questions, get good phase III answers in MDD

Fueled by new positive data, Axsome Therapeutics Inc. plans to seek approval during the second half of 2020 for its dextromethorphan/bupropion modulated delivery tablet, AXS-05, an oral NMDA receptor antagonist to treat major depressive disorder. Read More

Mirum, FDA meetings more than double the company’s stock value

With two FDA meetings in its hip pocket to discuss maralixibat for treating pruritus associated with Alagille syndrome, Mirum Pharmaceuticals Inc. got a resounding boost from the market Monday as its stock (NASDAQ:MIRM) closed up 111%, at $17.28. Read More
AI-tech-head.png

AI, machine learning offer hope for speeding Alzheimer’s development

Machine learning and artificial intelligence (AI) are already being actively used in drug discovery to evaluate potential binding of small-molecule drugs to proteins, but there's potential for the technologies to be used on the development side as well, especially in hard-to-treat diseases such as Alzheimer's disease. Read More

FDA approves Amarin's Vascepa to reduce CV disease risk

Little more than a month after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously supported approval of Amarin Corp. plc's fish oil-based Vascepa (icosapent ethyl) for reducing the risk of cardiovascular (CV) events in adults with elevated triglyceride levels, the agency has greenlighted a label expansion for the already-approved medicine, allowing for its adjunctive use in that indication. Read More
Unicorn company

Aprogen listed as South Korea’s first biotech unicorn

HONG KONG - With a corporate valuation of $1.04 billion, the South Korean biosimilar company Aprogen Inc. has become the country’s first biotech “unicorn,” according to U.S. market research firm CB Insights. Korea now ranks fifth, tied with Germany, in terms of the number of unicorns, with total of 11 unicorns, a term used to describe private ventures with $1 billion-plus valuations. Read More

Chinese investors launch new AU$45M fund to develop South Australian biotech

PERTH, Australia – Private Chinese investors have launched a new AU$45 million (US$31.17 million) investment fund to accelerate the development and commercialization of new biotechnology from South Australia for the global market. The Adelaide China Biotech Investment Fund is backed by a group of private investors based in Nanjing, China, underwritten by the Bank of Nanjing. Read More
Approval-stamp-blue.png

Qilu scores first Avastin biosimilar approval in China, set to drive down prices

BEIJING – Jinan, China-based Qilu Pharmaceutical Co. Ltd. has won the first approval for a China-developed biosimilar to Avastin (bevacizumab, Roche Holding AG). Its biosimilar QL-1101, to be sold under the trade name Ankada, has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer. Read More

Financings for Dec. 16, 2019

Biopharmas raising money in public or private financings. Read More

In the clinic for Dec. 16, 2019

Clinical updates, including trial initiations, enrollment status and data readouts and publications. Read More

Other news to note for Dec. 16, 2019

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief. Read More

Regulatory actions for Dec. 16, 2019

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More

Regulatory front for Dec. 16, 2019

The latest global regulatory news, changes and updates affecting biopharma. Read More

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