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Technology News- BioPharm News
- Shire Gains European Approval for its Gaucher Disease Treatment
- Mtech Bioprocess Scale-Up Facility to Double in Staff and Size
- ImClone Closes Plant in New Jersey, Consolidating Erbitux Manufacture
- EMA and FDA Seek Applicants for Joint GMP Inspections
- ATMI Expands Bloomington, Minnesota Manufacturing Facility
- Clinical Trials News
- CRF Health Achieves EXACT ePRO Vendor Certification for Windows Mobile Systems
- ACR Image Metrix Establishes Global Presence
- BioPharm Systems Named to the 2010 Inc. 500|5000 List of Fastest-Growing Companies in the U.S.
- CRF Health Doubles North American Headquarters
- Oracle Completes Acquisition of Phase Forward
Author Archives: William Looney
Europe’s Fiscal Crisis: Can Big Pharma Emerge Unscathed?
Europe’s current fiscal crisis, symbolized by the meltdown in Greece, is seen by big pharma as a temporary situation to be taken in stride—after all, the EU southern and eastern tier, with its chronically shaky finances and per capita incomes as low as a third of the EU norm, has historically been a marginal player [...]
Posted in Europe Tagged Andrew Witty, Drug Prices, Europe, Financial Crisis, Greece, GSK, Spain 2 Comments
WHO Threatens Industry Shut-out on Counterfeit Regulation
Big Pharma believes that a global generics franchise might give it a softer landing off the patent cliff, but governments that sponsor and regulate the industry are still acting a bit slow on the uptake. The reason? Anti-IP activists are again poisoning the well on global access to medicines, engaging the bigger emerging market governments [...]
Posted in Global Tagged Brazil, generics, IFPMA, india, WHO, World Health Assembly, World Health Organization Leave a comment
Post-Approval Regulatory Priorities: Progress or Pile-Up?
An enduring falsehood about the pharmaceutical industry is that the heavy lifting ends with a successful new drug registration. What comes after is the equivalent of a well-funded retirement, where providers embrace the therapy, payers meet the price, and patients push the boundaries of clinical practice toward lucrative new indications. The reality, however, is starkly [...]
Posted in Regulatory Tagged approval, Celebrex, FDA, Geodon, Harvard Medical School, post-approval strategies 1 Comment
BIO Convention: Potemkin Pavilions and the Power of NICE
Image by Getty Images via Daylife
Last week’s annual meeting of BIO in Chicago once again proved illustrative in showcasing the high profile that governments now plays as the biotech sector’s chief advocate. While private venture capitalists confined themselves to the margins of the meeting, the Convention hall was bursting at the seams with host [...]
Options for Oncologists Get Tougher