With almost 40% of attendees coming from outside the US, the political climate has had no effect on the latest CPhI franchise which starts today in Philadelphia.
WIRB-Copernicus Group (WCG) has acquired MedAvante and ProPhase, bolstering the company’s presence in the central nervous system (CNS) and behavioral health assessment markets.
AB Science SA has halted French trials of its Ph III drug candidate masitinib after regulators uncovered good clinical practice (GCP) and pharmacovigilance deviations in an earlier study.
Sanofi and Artificial Intelligence (AI)-driven Exscientia have announced a €250m ($271.9m) drug target research collaboration and licence option agreement.
Avantor has agreed to purchase independent laboratory product, supply chain and service provider VWR for approximately $6.4bn (€5.9bn), reflecting a share price of $33.25.
President Donald Trump should foster biotech investment if he wants more US-made pharmaceuticals say experts who argue that cutting regulations to attract small molecule drug manufacturers will only have a limited effect.
Sanofi says it will demolish a pilot plant in Montpellier that has been left idle since its completion in 2011, citing its evolving biologics-focused portfolio.
The full-service contract research organization (CRO) is moving to a new office in Boston, MA, which will serve at its fourth "hub," joining Berlin, Warsaw, and Kiev locations.
Aptar Pharma has acquired 20% of the US-based company, Kali Care, less than two months after inaugurating its first facility outside of France as it aims to expand globally.
Italian regulators say Kores Limited’s facility in Roha, India should be banned from supplying the API ambroxol hydrochloride to the EU and advised users to find an alternative source.
Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.
The US FDA has accused Vikshara Trading & Investments Ltd. of giving false statements about a strike to delay the inspection of an Ahmedabad API plant later found to be non-compliant.
PRA Health Sciences has launched a new Center for Pediatric Clinical Development and a correlating site network to facilitate patient recruitment and improved engagement and retention.
Ibuprofen patch developer Medherant Ltd. has hired France-based contractor Laboratoires Plasto Santé (LPS) to make the product for clinical trials due to start this year.
Pharmaceutical Product Development, LLC (PPD) has combined its medical affairs research operations (MARO) team and Evidera to create a dedicated real-world research and market access unit.
The NIH-FDA Joint Leadership Council and TransCelerate BioPharma have issued updated common protocol templates (CPT) to accelerate clinical development.
Shire has begun adding capability within its own network to manufacture the Hereditary Angioedema (HAE) product Cinryze, currently being made by Dutch CMO Sanquin.
The partnership helps accelerate site selection by enabling ACRP members to create a profile accessible to users of the DrugDev Spark Platform, the company’s unified clinical operations suite.
There are several opportunities for contract research organizations (CROs) to advance patient centricity and many are looking to do so over the next three years, according to a report.
Brineura's $702,000 (€640,000) a-year price tag reflects production costs and investment in tech used to administer the enzyme replacement therapy to the brain says BioMarin Pharmaceuticals.
update - WHO outlines biosimilarity requirements and inspection plan
The WHO has announced plans to extend its prequalification scheme to include cancer biosimilars and says it will pressure industry for fairer prices for all biologics.
endpoint has combined features of its IRT platform with its global inventory management tool, DRIVE, to extend IRT accessibility across the clinical development portfolio.
WIRB-Copernicus Group (WIRB) and Huron have announced an alliance to support research programs in the face of heightened expectations from industry sponsors.
The European Commission has urged UK Pharma firms to check how Brexit will impact their drugs, pointing out that EU law requires that authorisation holders have a base in a member state or EEA country.
EyeCRO and MPI Research are co-developing large mammalian preclinical models for ophthalmic diseases as clients look to perform pharmacology studies in larger species.
Schulman IRB has launched a new service to ensure sponsors, CROs, and others are compliant when conducting genetic engineering research – “given the diverse risks,” says committee lead.
AMRI has received a 5-year federal contract award from the National Institutes of Health (NIH) under which it will provide drug substance development and manufacturing services.
AMRI says it is well placed to win more NCATS contracts
AMRI has been hired by the NIH to provide synthesis and manufacturing services for APIs being developed by the National Center for Advancing Translational Sciences (NCATS) division of preclinical innovation.
The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).
