Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

 reported that FDA has approved Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinomawith disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. With this approval, Cyramza becomes the first FDA-approved treatment for patients in this setting.

FDA approval of Cyramza marks a regulatory milestone in Lilly's research and development program for the molecule, which it acquired when it purchased ImClone Systems in 2008. Cyramza has been granted Orphan Drug Designation by the FDA for this indication. Lilly expects to make Cyramza available in the coming weeks.

Articles

Lilly's Cyramza is the first FDA-approved treatment for advanced gastric cancer after prior chemotherapy.

Eli Lilly's Cyramza Receives FDA Approval for Treatment of Advanced Gastric Cancer

 reported that it has signed a deal to acquire the Antioxidants, Ibuprofen, and related businesses and assets from Albemarle Corporation. The transaction includes manufacturing sites in Orangeburg, South Carolina, andJinshan, China.

The acquisition will include Albemarle’s antioxidant product lines, as well as the Ibuprofen and Propofol businesses. In addition, applications and technical support capabilities in Shanghai and Baton Rouge, Louisiana will be included in the transaction. Subject to the required regulatory approvals, this acquisition is expected to be completed later this year.

SI Group agrees to purchase certain Albemarle assets and products.

SI Group to Acquire Assets from Albemarle

Pharmaceutical Research and Manufacturers of America

 (PhRMA) released a report that outlines two potential growth trajectories for the US biopharmaceutical sector. Developed by the Battelle Technology Partnership Practice, the report finds that coverage and payment policies, a science-based regulatory system, and strong intellectual property (IP) protections drive US leadership in biopharmaceutical innovation, and if negative trends in these key policy areas continue, jobs supported by the industry would decrease over the next decade. However, if reasonable pro-innovation policies are pursued, the biopharmaceutical sector stands to retain and addover 300,000 jobs by 2021. The report combines quantitative data with inputfrom industry leaders.
  
  As the ability to innovate is increasingly becoming the most important determinant of a nation’s future potential for economic growth and global competitiveness, the biopharmaceutical industry stands out among manufacturing industries as an example for future economic growth, the report says. Currently, the biopharmaceutical industry supports a total of 3.4 million jobs across the US economy, including over 810,000 direct jobs, contributes $789billion in economic output, and is responsible for about one in five dollars spent on R&D by US businesses. To put into greater context,  biopharmaceutical companies invested more than nine times the amount of R&D per employee than manufacturing industries overall from 2000 to 2010.
  
  Not only have PhRMA member companies invested an estimated $51.1 billion in R&D in 2013, representing the majority of all biopharmaceutical R&D spending in the US, but the medicines developed by the industry play an important role in helping control other health care costs. For example, theCongressional Budget Office recently adopted a scoring change that credits Medicare policies that increase use of medicines with savings on other Medicare costs. Similarly, Harvard researchers report savings on hospital and nursing facility costs of about $1200 per newly insured Part D beneficiary in 2007.This equals overall Medicare savings of $13.4 billion, more than one quarter of Part D’s total cost during the program’s first full year.
  
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A new report from PhRMA outlines potential growth trajectories affecting the biopharmaceutical industry.

PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth

Ian C. Read, chairman and CEO of Pfizer, was elected chairman of the 

 (PhRMA) at the trade association’s annual meeting. Also elected were Kenneth C. Frazier, chairman, president and CEO of Merck & Co, as chairman-elect of the PhRMA Board of Directors, and George A. Scangos, PhD, CEO of Biogen Idec, as board treasurer. Read succeeds Robert J. Hugin, chairman and CEO of Celgene Corporation, as PhRMA’s chairman.

Ian Read, chairman and CEO of Pfizer, is elected chairman of the PhRMA.

PhRMA Appoints New Board Members

 is moving the offices and laboratories of the Center for Biologics Evaluation and Research (CBER) from their current locations in Bethesda and Rockville, Maryland to the FDA White Oak campus in Silver Spring, Maryland. Most offices will commence moving on or about April 25, 2014, and will complete the move on or about May 18, 2014. Laboratories and remaining offices are scheduled to move in late June through August.  In order to facilitate continuity of operations, one division, the Division of Biological Standards and Quality Control, within the Office of Compliance and Biologics Quality, will remain in its present location in Kensington, Maryland and move after processes assuring the availability of 2014-2015 seasonal influenza virus vaccine are completed.

CBER will move to the FDA White Oak campus in Silver Spring, Maryland.

Center for Biologics Evaluation and Research Relocates

 consortium with Charnwood Technical Consulting, CatScI, and Biocatalysts, has won a Technology Strategy Board grant directed at funding sustainable, high-value chemical manufacturing achieved through industrial biotechnology. The winning project is focused on establishing an industrialbiotechnology process aimed at improving the sustainability of the manufacture of APIs.

The grant is designed to both assist commercial entities in trialing new processes and to create demonstration scale prototypes. The overall project, valued at £200,000 (approximately $335,000), is scheduled for completion in 2014.

The funding for the project meets the Technology Strategy Board’s objective of collaborations between chemical sectors and industrial biotechnology developers, combining biological and chemical practices. Biocatalysts will use design for manufacture principles to discover, develop, and manufacture new enzymes for the production of APIs. CatScI will perform the proof of concept studies to assess the feasibility of a value-adding new industrial biotechnology route to an API.  Charnwood Technical Consulting will provide expertise to help design and scale-up the process, as well as guidance on quality and regulatory issues. Aesica will manage the overall project and carry out scale-up studies to determine the probability of the technology at larger scale.

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Aesica's consortium project receives grant to investigate an industrial biotechnology process to improve the manufacturing of an API.