Top Stories
The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.
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The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.
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DCAT Week: Business Development—Networking—Education
DCAT Week is the premier global event for the business of pharmaceutical development and manufacturing (March 19-22 in New York City). Organized by the Drug, Chemical & Associated Technologies Association, its unique model brings together members for high-level strategic meetings with key decision makers, timely educational programs and important networking opportunities.  Learn more |
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Industry News
The company will use funding from the Bill & Melinda Gates Foundation to develop a new production method for artemisinin, a therapeutic used to treat malaria.
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The 2018 Short Course program at Pittcon, taking place Feb. 24–Mar. 1, will feature 23 new short courses geared towards laboratory professionals.
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Supplier News
Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.
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The company completed its oral solid dose production facility in Suzhou, China.
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Bio/Pharma News
The acquisition, valued at EUR 520 million (US$631 million), would expand Takeda’s late-stage pipeline in gastroenterology and would extend an already existing collaboration between the two companies.
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Athenex is moving forward with the construction of a new 320,000-square-foot pharmaceutical manufacturing facility in Dunkirk, NY, and has hired the German engineering firm, M+W, to design and construct the facility.
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Regulatory News
The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.
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The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
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Outsourcing
The industry will see an impact from financing, M&As, advanced therapies, generic drugs, and the retail market in 2018.
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Global Perspectives
Brexit-related challenges cast shadows on prospects for the European bio/pharma market in 2018, but optimism may let some sun shine through.
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Events
February 7–8, 2018
February 11–14, 2018
February 20–22, 2018
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eBOOKS
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible. |
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