The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.
Warburg Pincus-backed HIV drug ingredient firm Laurus Labs has set up a US presence and development facility in a bid to win more North American customers.
Charles River Laboratories is nearing the acquisition of an early-stage drug discovery company, CEO James Foster told attendees at the Leerink Swann Global Healthcare Conference last week.
The US FDA is looking to set up master protocols that can continuously run and help cut down on waste that’s prevalent in the clinical trial industry, Director of FDA's Center for Drug Evaluation and Research Janet Woodcock said in an interview.
CRO inVentiv Health announced late last week new plans to open a Phase I/IIA clinic in Miami, thereby expanding its early phase clinical services to the US.
As the world’s largest CRO continues to snap up market share, CEO Tom Pike is questioning how smaller CROs will compete given the expertise and geographical breadth of their larger peers.
The increase in dodgy erectile dysfunction drugs seized in Switzerland does not mean the country is a weak point for counterfeiters shipping to Europe according to Swissmedic.
AMRI has announced plans to close an API development and manufacturing plant in Wales, UK, after efforts to establish it as a conduit between the US and Europe were deemed unsuccessful.
Opioid addiction drug Suboxone lost market share in 2014 according to newly independent Indivior, whose management says it is not intimidated by increased competition.
CRO Charles River Laboratories is further exploring the idea of re-opening a preclinical site in Shrewsbury, MA, though it will be more than a year before the site is ready.
US FDA inspections that uncover significant departures from good clinical practice are seldom included in peer-reviewed literature, according to a new study published in JAMA’s Internal Medicine.
The US FDA has rescinded Breakthrough Therapy designation of a second HCV treatment, but Bristol-Myers Squibb says submission timelines for daclatasvir will not be affected.
The NFL (National Football League) may be getting more serious about its players’ health as it recently signed a five-year agreement with Quintiles to continue and expand upon its Injury Surveillance and Analytics (ISA) service to track player injuries...
In a wide-ranging interview that included his take on competition from Google and R&D spending, Pfizer CEO Ian Read offered a number of clues as to where his company is headed.
The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’
Banishing kettles, 'Gemba walks' and encouraging employees to report near misses have helped Penn Pharma to remain accident free at its high potency compound manufacturing facility in Wales.
Cell-based cancer immunotherapy company Juno Therapeutics has entered into a lease agreement for a manufacturing facility in Bothell, Washington to produce its developing cell therapies.
Though it’s difficult to quantify, industry experts told investors at the BIO CEO conference in New York on Monday that the US FDA-industry interactions are improving though there’s still some inconsistency between FDA leadership, division directors and...
Ongoing demand for large-scale APIs combined with high capacity utilization has driven Cambrex Corporation to allot up to $85m (€70m) for manufacturing expansion in 2015.
Researchers from the Oncology Department of Tianjin Medical University Cancer Hospital in China recently published a study in Advanced Functional Materials announcing the creation of a new nano-carrier for pancreatic cancer treatments.
Pharmaceutical and chemical manufacturers may have to wait until 2017 to see the benefits of the Transatlantic Trade and Investment Partnership, VP of SOCMA (Society of Chemical Manufacturers and Affiliates) told attendees at InformEx in New Orleans.
CRO consolidation continues with Rockville, MD-based Accelovance expanding its footprint into Europe with the acquisition of Cambridge, UK-based Altair Clinical.
Sanofi will invest in biologics and vaccine manufacturing capacity in 2015 to sustain product launches and ease constraints that impacted its Sanofi Pasteur division in the past few years.
Bankrupt cell therapy firm Dendreon has attracted more suitors according to stalking horse bidder Valeant, which upped its offer for the Provenge (sipuleucel-T) developer to $400m this week.
When it comes to forging solid relationships between CMOs (contract manufacturing organizations) and drug developers, one thing is clear: deviations will occur.
Being a drug developer not just a service provider differentiates Simbec-Orion from the Big CROs according to CEO Ronald Openshaw, whose firm signed two strategic partnerships last week.
Covance’s 5% revenue growth and a book-to-bill ratio of 1.3 for the fourth quarter 2014 was better than anticipated and an encouraging sign for LabCorp, an analyst says.
Pfizer, Lilly and Novo Nordisk will not be revisiting inhaled insulin opportunities despite the US launch and expected success of Sanofi and MannKind’s Afrezza.
Most pharmaceutical companies are already behind on preparations for the EU Falsified Medicines Directive’s serialisation requirements for 2018, says one services firm.
Specialty chemicals firm Vertellus will continue to supply antiretroviral drugmakers sodium borohydride following its takeover of a Dow plant in Washington State.
Bangalore, India-based Apotex and Verna, India-based Micro Labs both received warning letters last month from the US FDA detailing data integrity questions linked to their quality systems.
