For the first time since 1998, the US FDA is offering draft guidance on what it expects from IRBs (institutional review boards), clinical investigators and sponsors regarding informed consent.
CRO inVentiv’s Clinical Trial Recruitment Solutions (iCTRS) and the non-profit Alliance for Clinical Research Excellence and Safety (ACRES) are partnering to accelerate the development of a global standards system to improve the conduct of clinical trials...
The complex nature of biopharmaceuticals dictates the choice of contract manufacturer when compared with selecting a partner for small molecule drugs, according to a life sciences consultant.
Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.
Hovione has teamed up with delivery tech developer Merrion Pharmaceuticals to provide developers of BCS class III and IV drugs with more solubility enhancement options.
Janssen Pharmaceuticals is prepared for Tramadol's reclassification by the US Drug Enforcement Administration (DEA) and says the supply of its versions of the opioid analgesic will not be interrupted.
CRO Theorem Clinical Research and Excel Life Sciences have formed a strategic relationship to bolster Theorem’s clinical development offerings in India just as regulations begin to shift on the subcontinent.
UK-based CRO Chiltern has agreed to acquire Ockham, a North Carolina-based full-service CRO, and the combined company will now compete with mid-sized CROs. Financial terms of the acquisition were not announced.
Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing...
While the overall bioscience industry has seen 7.4% jobs growth between 2001 and 2012, the sector encompassing CROs and other research, testing and medical labs has grown by more than 28%, according to a new report from industry group BIO and Battelle.
The Association of Clinical Research Organizations (ACRO) offered a number of recommendations to the US House Energy and Commerce Committee’s “21st Century Cures” initiative last week as part of an effort to keep the US research industry competitive globally.
Actavis says it is closing facilities in St. Louis, Missouri affecting 190 jobs a week after completing the $28bn (€21bn) acquisition of Forest Laboratories.
A quality assurance audit is as beneficial to the CMO as it is to the sponsor selecting a third-party manufacturer, according to an ex-Merck Serono and MHRA consultant.
G-CON says a multi-million dollar investment by Pfizer could hasten the “paradigm shift” in pharma manufacturing towards flexible cleanroom technology and portable facility design.
Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.
CDMO Aesica Pharmaceuticals is adding additional services to its Zwickau, Germany oral solids capabilities, including a new roller compaction unit for dry granulation production.
The Management Board of the EMA (European Medicines Agency) has postponed the formal adoption of its policy on publication of clinical trial data, though the agency stopped short of revealing exactly why.
The US FDA has given stakeholders more time to comment on the 40-year old monograph system used to regulate OTC drugs and reiterated its concerns that the approach does not allow it to keep up with new drug safety testing advances.
Several international CMOs will establish themselves in Russia over the next few years as pharma looks to satisfy the country's manufacturing policies, the CEO of R-Pharm predicts.
Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and inspection programme, a Standard & Poor report has said.
European drugmaker Nicox has agreed to acquire all of the outstanding equity of US-based Aciex Therapeutics, an ophthalmic development company, which will also be a boon for ophthalmic CRO Ora.
Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16.
The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College, London, who told in-Pharmatechnologist.com the key to encouraging antibiotics manufacture is lightening companies’ regulatory burden.
M+W says a lack of synergies with its engineering and construction business drove the decision to sell its automation divison to ATS for €255m ($348m).
Pharma services firm Peakdale Molecular has joined with two UK environmental testing providers to form Concept Life Sciences in a private-equity backed agreement.
The latest draft revisions of the Declaration of Helsinki (DoH) weaken protections for trial participants in low and middle income countries, Rafael Dal-Ré, director of clinical research at Universidad Autónoma de Madrid, and other researchers argue.
Sponsors and CROs must ensure that clinical studies are properly designed and that investigators work on a maximum of three trials simultaneously under new guidelines issued by Indian regulators.
An oral solid dose manufacturing plant in Bangalore, India operated by CMO Kemwell Biopharma has passed a customer-prompted audit by European regulators and had its cGMP status renewed for the next three years.
Hospira has paid Orchid Chemicals and Pharmaceuticals $218m (€160m) for an API plant in Aurangabad, India to increase its antibiotics production capacity and cut reliance on external suppliers.
In a sweeping report on the industry as a whole, the European Commission says that with an annual output of €220bn, and nearly 800,000 employees, the pharma industry is vital for the EU economy, though more needs to be done to meet its full potential.
Elelyso has been certified as kosher by a US Jewish group, which says the process used to make the lysosomal storage disease drug means it conforms to religious dietary laws.
Recipharm AB will manufacture commercial supplies of a topical formulation of the anaesthetic lidocaine called Shact that is soon to be launched by developer Pharmanest AB.
The Center for Responsible Science has asked the US FDA to adopt informed consent rules which ensure that trial participants know the experimental drugs they receive may be unsafe or ineffective.
Bulk pharmaceutical ingredients increasingly used by compounding pharmacies have seen astronomical price hikes over the past two years and now payers are catching on to the trend and stepping in.
