The trade organization Society for Clinical Research Sites (SCRS) has broadened its relationship with PPD subsidiary Acurian to initiate a Site Advocacy Group (SAG) focused on global patient recruitment.
More drugs for tropical diseases have been donated since the London declaration of 2012, but getting them to the remote communities is still a challenge according to a consortium led by the Liverpool School of Tropical Medicine (LSTM).
Chinese cancer drug developer BeiGene will create production cell lines using a platform developed by Sigma Aldrich's custom manufacturing services business.
With operations across 19 European countries as well as the US, contract Research Organization KCR recently relocated its head office from Warsaw, Poland, to Berlin, Germany to be closer to clients.
China-based CDMO WuXi PharmaTech unveiled Thursday that it will soon begin construction on its third cell therapy manufacturing facility -- a 145,000-square-foot cGMP facility in Philadelphia.
The FDA has tested hundreds of creatively named bogus supplements and found they contain hidden APIs. Take in-Pharmatechnologist.com's quiz and tell us which name is your favourite.
Speciality Compounding has been ordered to cease production by the US Courts after tests confirmed injectable drugs made at its facility in Texas were contaminated by bacteria.
Following its three acquisitions over the last year, AMRI is now looking to extend its footprint into India further with the acquisition of a FDA-approved API site, William Marth, president and CEO of AMRI, told attendees at the Barclays Global Healthcare...
For the second time this year, the FDA has issued a warning letter to API (active pharmaceutical ingredient) and intermediate manufacturer Novacyl and this time it’s for the company’s manufacturing site in Thailand.
The European CRO (contract research organization) Federation is calling on the EMA (European Medicines Agency) to not allow for the “unrestricted publication of inspection reports” as only “findings that are of relevance to the public should be made publicly...
A type 1 diabetes vaccine will enter human trials this year according to the leader of the UK research team developing a preventative therapy for the autoimmune disorder.
Patients who mix Chantix with alcohol can become aggressive or suffer memory loss says the US FDA, which has ordered Pfizer to update the smoking cessation drug’s side-effects label.
Penn Pharma has added new tablet making technology at its facility in Tredegar, Wales citing drug industry demand for dry granulation manufacturing capacity.
Early phase clinical research service provider Altasciences is forming a strategic alliance with ITR Laboratories, a nonclinical services organization, to help more mutual clients customize their drug development programs from lead candidate selection...
With operations in more than 100 countries, the world’s largest CRO Quintiles is now looking to extend its global reach even farther, CEO Tom Pike told investors at the Barclays Global Healthcare Conference on Tuesday.
J&J unit McNeil-PPC has admitted breaking US law by selling contaminated liquid medications, including Infants’ Tylenol and Children’s Motrin, deemed adulterated under the federal Food, Drug and Cosmetic Act (FDCA).
Cancer Drug firms trying to block protein kinase Cs should rethink say researchers behind a study indicating that the enzymes suppress tumour development.
The Association of Clinical Research Organizations (ACRO) held the inaugural meeting of the previously announced CRO Forum, which was established in October to increase interactions between the CRO industry and industry group TransCelerate BioPharma.
The draft guidance comes in the form of a Q&A and offers clinical investigators, IRBs and others a look into how electronic informed consent (eIC) should be done properly.
CRO Icon has launched a new medical device and diagnostics research group following the combination of recently acquired Aptiv Solutions’ expertise with its own experts.
For the second time in just over a week, CDMO Patheon has made an acquisition, this time for Agere Pharmaceuticals, a privately held CDMO based in Bend, Oregon, that specializes in improving the bioavailability of drugs.
US desire for an alternative to the current multi-shot anthrax vaccine is a boon for delivery systems firm Glide Technologies, which had its contract extended by Pfenex this week.
Aggressive investment in new manufacturing capacity and new initiatives in genomics and cell therapy in 2015 is forcing CRO Wuxi to lower its expectations for 2015, and the lowered projections also seemed to have caused the company’s stock to fall by...
Quality troubles for Hospira continue as the company announced on Friday recalls of two injections, in addition to the recall of two infusion pumps, as well as a Form 483 for an Indian manufacturing site.
Chicago-based Rottendorf Pharmaceuticals, a top 20 contract development and manufacturing organization (CDMO), has signed three formulation development projects and two commercial transfer projects with multiple top pharma and biotech companies in the...
Higher capacity utilization is improving prices across the non-clinical research sector according to Huntingdon Life Sciences CEO Brian Cass, who told Outsourcing-pharma.com the preclinical CRO may add scale to US operations.
Irix Pharmaceuticals will cater for North American customers’ desire for local supply according to Patheon, which says it plans to retain the API firm’s 180 staff.
For the second straight year Charles River Laboratories has seen more of its revenue derived from biotech companies than Big Pharma, CEO James Foster told investors at two conferences on Tuesday and Wednesday.
Health Canada is telling drug and API manufacturers that it’s going to ramp up announced and unannounced inspections due to concerns raised around APIs and data integrity, and the findings will be published online beginning next month.
The SEC’s enforcement director is calling out pharma companies for failing to disclose and misinforming investors about correspondence with the US FDA.
The US Food and Drug Administration (FDA) has ordered makers of testosterone therapies to change their labelling and conduct clinical trials to investigate heart attack and stroke risk.
AstraZeneca will spend $40m spinning out its antibiotics R&D business into a separate subsidiary, saying the move will let it focus on its core disease areas.
CRO (Contract Research Organization) Rho collaborated with the NIH (National Institutes of Health) on its most recent study that found a major reduction of peanut allergies in children who began early, continuous consumption of peanuts.
Moscow-based Cromos Pharma, an international full-service CRO, has launched Cardiorus, a cardiology and cardiothoracic surgery site research organization (SRO), with its clinical base being at the Bakoulev Center of Cardiovascular Surgery in Moscow.
A US CMO industry group has backed plans to exempt privately paid user fees from Government spending cuts enforced if US politicians fail to agree a budget.
