The US FDA has updated its list of activities during the Government shutdown and says it is unable to accept new fee-based regulatory submissions until the shutdown is over.
Vetter says plans for a $100m (€74m) expansion are driven by continued growth in the biopharma industry and keep the firm one step “ahead of the curve.”
In a move that could be a sign of a changing tide in India, the Ministry of Health and Family Welfare said the government will invest almost $3bn (€2.2bn) to add hundreds of new inspectors for drug manufacturers and other oversight initiatives that could...
Lanxess backed enzyme and fine chemicals producer evocatal has moved to a new HQ, beefed up production capacity and is on the look out for new scientific staff.
An intravaginal ring filled with an anti-retroviral drug being developed by Northwestern University could be used to deliver drugs for a number of indications, says the Professor behind the research.
Enteris has secured its first partnership to develop metabolic peptides for Nordic Bioscience using an oral delivery platform it says offers unparalleled bioavailability.
Kiadis Pharma has called on the German Red Cross to make its candidate cancer treatment ahead of contractors with less experience of manufacturing blood-derived products.
Bliss GVS says allegations of supplying fake medicines and a blanket ban imposed on its products by the Food and Drugs Authority Ghana (FDA) are both “harsh” and “baffling.”
AAIPharma says the merger with Cambridge Major Laboratories (CML) will bring clients the benefits of integrated Chemistry and Manufacturing Controls (CMC) services from two high-growth CMOs.
CRO Quintiles says it is in favor of the voluntary sharing of de-identified and masked clinical and preclinical data that protects the interests of research participants and proprietary data, though it stopped short of calling for the public release of...
Cromsource has opened offices in Paris in response to the growth of pharma R&D which is flourishing under French Government incentives, the company says.
Merck, Novartis, GlaxoSmithKline, Celgene and industry groups are taking issue with recent FDA draft guidance on how manufacturers can reject or limit agency inspectors.
CRO Covance has launched an external laboratory management service offering for biopharmaceutical sponsors looking to external lab testing for its clinical trials.
Investing in antibody-drug conjugates (ADCs) made sense despite CMO competition and the fact few of these hybrid drugs have been approved to date says Carbogen Amcis CEO, Mark Griffiths.
Beleaguered sterile injectables manufacturer Ben Venue Laboratories has announced it will close permanently by the end of 2013 and lay off 1,100 employees in Ohio.
A new range of culture media dishes cut contamination risk during analysis of facility microbiological QC samples says developer Sartorius Stedim Biotech (SSB).
United Drug has rebranded its contract pharmaceutical packaging business and unveiled plans to build in Asia in a move it says provides “global opportunities” for employees.
Marken on Wednesday announced its pharma depot network is expanding to Russia to meet the growing needs of clients looking to store materials for clinical trials there and in Eastern Europe.
Germany-based CMO CPM Contract Pharma was hit with the first US FDA warning letter for failing to self-identify its manufacturing facility and pay the facility fee required by the Generic Drug User Fee Amendments of 2012.
India’s Supreme Court has called for all of the data supporting the approval of 162 clinical trials between July and August of this year by the Drug Controller General of India.
SCM Pharma says its ‘blank canvas’ manufacturing space fulfills evolving client development demands as the industry moves towards low-volume high-potency drugs.
Sartorius Stedim Biotech (SSB) has launched a new range of culture media dishes designed cut the risk of contamination during lab analysis of facility microbiological QC samples.
Full-service CRO JSS Medical Research is extending its presence in Latin America permanently with the acquisition of LatAm Clinical Trials, a multinational CRO based in South and Central America.
Interest in the US biosimilars market is still growing despite Big Pharma delaying tactics and continuing regulatory uncertainty according testing services CRO, BioOutsource.
Continued manufacturing problems at CMO Ben Venue Laboratories will cause an interruption of supplies of the cancer treatment Doxil in mid-to-late October, Janssen said.
The US House on Saturday passed legislation that calls for the tracking and tracing of pharmaceuticals through the nation's supply chain after agreeing on the bill with the Senate last week.
In the wake of recent bribery scandals, Boehringer Ingelheim (B-I) has called for stricter regulations in China, as it plans to triple production at its Shanghai manufacturing site.
A collaboration to develop portable, flexible and continuous processing systems has the potential to transform oral solid dose (OSD) manufacturing, according to Pfizer, GEA and G-CON.
After nearly 50 years in use, UK’s MHRA is now looking into whether it should update and replace its system for reporting drug side effects to increase incident reporting and decrease confusion.
