Category Archives: Biotech

Global Biosimilars Market to Reach $2.4 Billion in 2013

By Guest Blogger | Published: May 17, 2013

By Adeline Siew, Editor, Pharmaceutical Technology Europe. The global market for biosimilar drugs has been forecasted to be worth $2.445 billion this year, according to a new report by British market research specialist Visiongain. The growth represents a 20% increase from last year and accounts for approximately 2% of the overall biologics market. Moreover, the global [...]

Also posted in Global, Guest Blog, R&D | Tagged biosimilars, mAbs, monoclonal antibodies, R&D | Leave a comment

FDA: From Risk Aversion to Approval Activism

By Ben Comer | Published: May 7, 2013

During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news. On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]

Also posted in Agency Insight, FDA, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy, leadership | Tagged access, breakthrough therapies, CDER, Cole Werble, FDA, IMS, Rachel Sherman, Regulatory | 2 Comments

AstraZeneca's R&D Trimdown, Points to Shift in The Way Big Pharma Invents

By Clark Herman | Published: March 20, 2013

AstraZeneca’s decision to cut 5,050 jobs by 2016 and cease R&D operations at its Alderley Park, UK facility has many wondering where CEO Pascal Soriot plans to take the company. The opening of a new $500 million facility in Cambridge is at once a consolation prize for the UK government’s efforts to placate a skittish [...]

Also posted in Europe, R&D, Strategy | Tagged AstraZeneca, Pascal Soriot, UK | Leave a comment

Patients on the Picket Line

By Ben Comer | Published: February 5, 2013

Good science can’t be rushed, even when the lives of patients hang in the balance. But regulatory science, and its relationship to a drug’s commercial success or failure, can inadvertently block access to individual patients in their hour of need.

Also posted in FDA, Legal, Market Access, Regulatory, Safety, healthcare | Tagged Abigail Alliance, breakthrough therapies, Breast cancer, Cancer, compassionate use, Expanded Access Programs, FDA, FDA safety and innovation act, HHS, Market Access, patient advocates, PDUFA V, policy | Leave a comment

Amid Flu Epidemic a Focus on Vaccine Innovation

By Reid Paul | Published: January 29, 2013

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Also posted in Europe, FDA, Manufacturing, R&D, Video | Leave a comment