Genzyme Stumbles Again: New Cerezyme Problems
Serious manufacturing problems are often difficult to resolve, but the Genzyme team appears determined to take the experience to new levels. The beleaguered biotech, which is now both a headache and an opportunity for Sanofi, just sent a letter to Gaucher disease patients to say that supplies of its Cerezyme medicine are being rationed on […]
Read More »Category : News
FDA Inspects Sabinsa’s Indian Facilities
After inspecting five of Sabinsa’s manufacturing facilities in India, FDA found no issues of concern in four of the facilities, but issued a 483 observation to the herbal intermediates manufacturing facility. The issue involved a polyliner becoming tangled in the conveyer belts leading to the extraction chamber, and Sabinsa reported it corrected the issue and […]
Read More »Category : News
FDA announces new staff training for medical device reviewers
The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH). Advertisement: New Webinar Oct. 25 – Audit Your Lab Like an FDA Auditor Featuring Carmen Medina […]
Read More »Category : News
FDA says industry must take responsibility for supply chain security
The US Food and Drug Administration has called on lawmakers to grant the agency more regulatory powers so that it can place the onus on industry to tighten pharmaceutical supply chain security. In testimony before the Senate Committee on Health, Education, Labor and Pensions (HELP), FDA Deputy Commissioner for Global Regulatory Operations and Policy Deborah […]
Read More »Category : News
Michele Bachmann And The HPV Vaccine Bounty
Now that the Minnesota congresswoman and Republican presidential candidate Michele Bachmann has contended that the Merck Gardasil vaccine for combating HPV may have been responsible for mental retardation, she is encountering some pushback. This is not surprising, given that such comments feed into the ongoing controversy over vaccine safety, in general. To date, there is […]
Read More »Category : News
FDA, Compounded Animal Drugs & Overreaching
Should the FDA have the authority to stop pharmacies from using bulk ingredients to compound prescription meds for non-food producing animals, such as dogs and horses? In an interesting case, a federal court judge has ruled the agency does not have this authority but, moreover, attempted to overstep its bounds in a potentially draconian way […]
Read More »Category : News
Pfizer Cuts Jobs In Germany: Is It Payback?
There is certainly nothing surprising that Pfizer or any other large drugmaker is planning to cut jobs. A few hundred here. A few thousand there. The drumbeat is been sounding for a few years now. And so a story that Pfizer is eliminating about 500 positions in Germany, at first blush, may not generate much […]
Read More »Category : News
Novartis Plans More Cuts And Consolidation
During an investor presentation the other day, Novartis execs spent considerable time not only discussing recent financial performance and pipeline progress, but also the many steps taken to save money. These include a raft of cuts across various divisions around the globe and, in the US, consolidating some operations, such as shifting some research from […]
Read More »Category : News
Deadly Drug Contamination Inevitable, FDA Tells U.S. Senate
Fatal drug contamination like a 2008 incident involving Baxter International Inc. (BAX)’s blood thinner Heparin that sickened and killed hundreds is inevitable unless the agency gets enhanced inspection and recall powers for non-U.S. factories, a top regulator said. Another crisis is “not a matter of if, it’s a matter of when,†Deborah Autor, the Food […]
Read More »Category : News
Most Protocols Are Amended During Clinical Trials
Nearly 60 percent of all protocols used in clinical trials for new drugs are amended during the trial, but one-third of those changes could have been avoided and saved countless dollars, according to an analysis by the Tufts Center for the Study of Drug Development. Specifically, the review found that completed protocols across all clinical […]
Read More »Category : News
