Catalent Pharma Solutions will open a development lab for oral formulation in Japan, citing the popularity of fast dissolve formulations in the country as a key driver.
The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.
Until final regulations are finished, the US FDA has released draft guidance describing the agency’s expectations for outsourcing facilities and the cGMP requirements for them.
CRO Parexel has shifted its attention overseas with the acquisition of Atlas Medical Services, a provider of clinical research services in Turkey, the Middle East, and North Africa.
A regulatory expert has warned of the “unintended consequences” of that would require the US Food and Drug Administration (FDA) to begin reviewing drug candidates within 90 days of their approval in the EU.
The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry powder delivery technology used to get it deep into the lungs is effective.
UK API-maker and contract research organisation (CRO) Onyx Scientific is installing equipment for continuous flow manufacturing to offer customers an alternative to batch manufacturing.
Contract research organisations (CROs) have been slow to adopt next-generation means of recording study documents, with only 13% using the most up-to-date technologies, according to cloud-based services company Veeva.
US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.
With almost a week before Indian exporters would be required to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) in India has pushed back the deadline indefinitely.
Three years after Pfizer began strategic partnerships with CROs Icon and Parexel, and the companies are still ironing out differences and tweaking their relationships, Mark Sanders, senior director of global sourcing, told attendees at DIA’s annual conference.
Dutch API and excipients distributor IMCD has increased the number of shares it will make available in its initial public offering (IPO), citing demand.
Oasmia Pharmaceutical AB has teamed up with a “global pharmaceutical company” interested in its vitamin A-based nanoparticle formulation tech in a move that expands its business model to drug development partnering.
Pharmaceutical companies are rushing to respond to shortened deadlines from China’s Food and Drug Administration (CFDA) for serialising drug packaging.
An online quiz about drug R&D has been criticised by economists who say its developer - Eli Lilly - is misinforming the public about the cost and time it takes to develop new medicines.
The biotech boom of over 165 IPOs in 2013 has resulted in earlier and more lucrative work for CMOs (contract manufacturing organizations), experts say.
Small biotechs thinking of outsourcing should carefully weigh up the pros and cons say industry experts, who warn that for firms that do contract out clinical development choosing the right CRO is vital.
The United States Food and Drug Administration (FDA) has announced it will consider products outside the nanoscale, up to 1,000 nanometres (nm), to involve nanotechnology and so be potentially liable for “particular examination.”
Lonza has launched a new stem cell reprogramming and maintenance system that has already been used to support US NIH and pharmaceutical company preclinical drug development projects.
Parexel has predicted ten per cent year-on-year revenue growth for FY2015 but has been more modest about its operating margins ahead of its Investor Day tomorrow.
A new cell therapy development centre has opened at Guy’s Hospital in London today in the latest stage of a Government-backed effort to establish the UK as a global hub.
GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing endotoxin contamination problems at a Canadian plant hit with US FDA warning letter.
Copley Scientific has launched new technologies to help developers of generic inhalable drugs stick to specific testing guidelines issued by the US FDA and USP.
The ability to pinpoint radiotherapy in animal testing could give failed cancer drug candidates a new lease of life, says preclinical CRO (contract research organisation) Crown Biosciences.
The use of ethanol as a diluent in injectables is under the spotlight following a new US FDA warning that its presence in the cancer medicine docetaxel poses an intoxication risk.
Texas-based Kalon Biotherapeutics is in the process of building two new biomanufacturing facilities, including a $91m facility to produce flu vaccines for GlaxoSmithKline.
The US National Institutes of Health (NIH) has launched a 3D Print Exchange which will turn data submitted by the public into files for printing 3D models.
Hidden costs and quality issues have encouraged pharma to abandon China and India, but Western CMOs are now under threat from a return to in-house manufacture, says a procurement consultant
Representatives for GSK have targeted struggling graduates and unpaid interns as volunteers for clinical trials, saying the payments – up to £8,000 ($13,600) per year – “could be your solution” to money problems.
The WHO, the United States Pharmacopeial Convention (USP) and the US Agency for International Development (USAID) will work with regulators to help countries manufacture a key tuberculosis drug.
Big pharma industry group TransCelerate discussed but ultimately decided against allowing CROs to join the collaborative, though research contractors will be engaged routinely, members of the group said.
As CROs and sponsors look to use risk-based monitoring more for clinical trials, the role of clinical research associates (CRAs) will shift dramatically, experts said Wednesday.
Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which has called for a transformation in the vendor relationship.
A year after CRO Parexel saw what its CEO called “hyper growth,” the Massachusetts-based company is seeing revenue gains return to relatively normal levels.
Big pharma is moving towards strategic partnerships with CMOs, according to speakers at the Global Pharmaceutical Contract Manufacturing (GPCM) Conference, with the ideal number of partners being ten.
Novartis has called in a third party organization to review how it conducts clinical trials in light of the adverse event reporting scandal that broke in Japan last week.
Recipharm AB has not ruled out battling with Catalent and Patheon in the softgels market and confirmed that acquisitions were the key driver for its decision to go public.
CRO BioClinica will acquire Blueprint Clinical, which offers a cloud-based site scoring tool to help pharma address risk-based monitoring strategies for trials.
A US presidential report on plans to improve chemical facility safety and security has incorporated a number of recommendations from the Society of Chemical Manufacturers and Affiliates (SOCMA).
