Patheon is “better positioned” to serve clients following the Thermo Fisher Scientific Inc. acquisition, says CDMO president, whose initial focus will be integration.
Recipharm will make clinical trial capsules to support oncology candidate KAND567, a former AstraZeneca Fractalkine receptor inhibitor being developed by Kancera.
3-D microparticles which degrade at differing rates in the body could allow multiple doses of drugs or vaccines to be administered in a single injection, say MIT researchers.
Bristol-Myers Squibb will also make up to $160m in milestone payments for each candidate developed using Halozyme Therapeutics’ large-volume biologics delivery platform.
CordenPharma has completed development of an early development suite for highly potent, oral solid dosage products at its Plankstadt, Germany location.
The clinical research environment in Japan has evolved dramatically since Parexel first began operations in the country, says the CRO, who recently established an alliance with a local cancer institute.
Invicro has acquired Imanova in a move that bolsters the company’s biomedical imaging capabilities and gives it a foothold to expand its services into Europe.
The biometrics contract research organization (CRO) and clinical trial software provider is continuing with its expansions plans as it opens a new office in King of Prussia, Pennsylvania.
Aging pharmaceutical manufacturing facilities have become a major concern as the industry tries to keep pace with advancements in technology while balancing costs.
Alexion will close its Rhode Island manufacturing facility as part of a cost cutting plan that will also see it reduce its workforce by 20% over the next year.
Biocon says its insulin plant in Malaysia has been awarded a European GMP certificate after an inspection by Ireland’s Health Products Regulatory Authority (HPRA).
A new formulation of Euthyrox linked to a surge in adverse event reports in France is safe, effective and more consistent than the older version of the drug say ANSM and Merck.
Researchers conducting smoking cessation clinical trials should use biochemical measures to determine if participants have quit – as many falsely self-report, according to a recent study.
US WorldMeds has teamed up with Catalent Pharma Solutions to manufacture lofexidine, an investigational drug designed to treat symptoms associated with opioid withdrawal.
CTTI has released new evidence-based recommendations to enable sponsors and investigators to better plan for and make decisions about pregnancy testing in clinical trials.
Clinical trial exclusion criteria has increased nearly 60% over the last 30 years – and may decrease the likelihood of successful trial completion and generalizability of results, say researchers.
The Parental Drug Association (PDA) is offering guidance to drug makers with ageing, sometimes non-compliant facilities, which it hopes will help combat drug shortages.
Clintec International has opened a centre of excellence for clinical research and quality assurance capabilities as part of its headquarters expansion in Glasgow, Scotland.
Cadila Healthcare says its formulation plant in Moraiya, Gujarat has passed a US Food and Drug Administration (FDA) inspection with no Form483 observations.
There are many opportunities in Asia Pacific for mid-sized CROs says PSI, after opening a new office in Seoul, South Korea in response to client requests.
Pfizer, Merck & Co (known as MSD outside of North America) and GlaxoSmithKline (GSK) have come together to support the development of continuous manufacturing and bio-catalysis technologies in Singapore.
Oramed is eying up commercial partnerships for its oral insulin candidate following a positive meeting with the US FDA to discuss an appropriate approval pathway.
AMRI has been acquired by a private equity firm and has already begun its search for “the next couple of acquisitions,” says its CEO – and the shopping list is long.
The mid-size contract research organization (CRO) sector continues to evolve and surprise experts with rich valuations – and what seems to be a never ending list of transactions.
Janssen and Mundipharma have expanded their alliance through which Munipharma will sell, market, and promote medicines for the Belgium-headquartered pharma company.
Centurion Labs has recalled two lots of cold and allergy meds after the US FDA warned they may have been made at a Pharmatech LLC plant linked to a Burkholderia cepacia outbreak.
After receiving approval Kymriah, Novartis must prove it can handle the supply chain complexities of manufacturing high-value and time-sensitive CAR-T cell therapies, says logistics firm TrakCel.
Siegfried Holding AG saw higher earnings in the first half of 2017 with cost synergies offsetting the negative impact facility maintenance work had on its API business.