Drug manufacturers, retail pharmacies and regulators have a role to play in curbing antimicrobial resistance say campaigners urging industry to ensure their API suppliers are not part of the problem.
Cefic has agreed to make sure its members only sell the intermediate gamma butyrolactone (GBL) to legitimate users to stop it being abused or used in “date rape” drug GHB.
Cambrex Corporation is installing a fourth reactor suite at its High Point, NC-based facility as it continues to grow with its customers in the market, says company VP at CPhI North America.
LabCorp has completed its acquisition of Pathology Associates Medical Laboratories (PAML), which will be integrated into its national network of regional and specialty laboratories.
Nova DFL’s dental adrenaline product has been denied marketing authorisation after French regulators raised seven critical deficiencies at its facility in Brazil.
Thermo Fisher says Patheon will become the most competitive biologics CDMO in the market through direct access to its bioprocessing technologies and capabalities.
The US Food and Drug Administration (FDA) has given the go ahead to Frontida BioPharm’s Pennsylvania, US-based site, eight months after distributing a Warning Letter for the facility.
Flamma has opened a new cGMP workshop and R&D Center in Dalian, China and is looking to add capacity at several other sites as part of its “Flamma 2020 plan.”
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.
