Operating income at Kendle fell by 48 per cent in the first quarter, driven by a dip in net revenues, but the CRO is encouraged that improvements in April suggest the market is improving.
A track and trace packaging system designed to integrate into existing operations, bringing companies into compliance with new regulations, has been launched by Crest Solutions and Eisai Machinery.
French CRO Porsolt and UK counterpart KWS BioTest have teamed up to offer preclinical immunology and inflammation analysis services under a strategic alliance announced yesterday.
Cambrex has posted a 55 per cent drop in operating profit in the first quarter, underpinned by the timing of orders, disruption to a customer’s supply chain and lower pricing of certain generic APIs.
DSM Biologics says combining its XD platform with newly-acquired Rhobust chromatography platform will create high yield, low cost bio-manufacturing option.
Rheumatoid arthritis (RA) sufferers may soon have a new treatment delivery option thanks to US delivery specialist Antares Pharma’s partnership with Canadian injectables specialist Uman Pharma.
India-based HCL Technologies has entered into a five-year, $500m (€380m) agreement with Merck & Co to provide the big pharma with business and technology services.
Covance has cut its full-year guidance despite an increase in Q1 revenue, citing delayed late-stage trials, lower demand for chemistry services and costs associated with facility closures as the reason for the adjustment.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at PharmaNet, Synexus, KCAS, Catalent and CIS.
Cardiac monitoring and ePRO specialist ERT has added respiratory diagnostics and device manufacturing services to its offering with the acquisition of CareFusion Research Services (CRS) for $81m (€61m).
The Office of the United States Trade Representative (USTR) has expressed particular concern about the proliferation of counterfeit drugs in countries including Brazil, China, India, Indonesia and Russia.
EyeGate Pharma is collaborating with GlaxoSmithKline (GSK) to evaluate the delivery if several of the big pharma’s therapies using an ocular delivery system.
BioFocus is expanding its Huntingdon’s disease collaboration with CHDI by committing to take targets it developed in its earlier deal, through discovery as part of a five year, $41m (€31m) agreement.
Freeslate has entered into a strategic partnership with Johnson and Johnson (J&J) to provide the pharma with integrated workflows, software and research services until 2012.
The WHO has called for recall and destruction of all batches of Indian drugmaker Shantha Biotechnics’ Shan5 vaccine after the discovery of “white sediment” in some vials.
Norwich Pharmaceuticals is expanding beyond its traditional manufacturing focus by launching a CRO in India to provide clients, and its parent company Alvogen, with clinical research services.
Pfizer will lose patent protection for Viagra in Brazil on June 20 after the Supreme Court (STJ) accepted recommendations by national intellectual property watchdog, the INPI.
CMO Goodwin Biotechnology Inc (GBI) is collaborating with Hyprocell to help clients that need manufacturing services but have a sub-optimal cell line producing low concentrations.
The US FDA says Teva Pharmaceutical Industries’ plan to fix cGMP violations observed at its plant in Irving, California “lack sufficient corrective actions.”
The CRO and eClinical results period is underway, with Icon, Parexel, Phase Forward and OmniComm publishing generally positive financials in the past two days.
Manufacturing problems at Mitsubishi Tanabe Pharma (MTP) have forced CEO Michihiro Tsuchiya to relinquish his vice presidency of the Japanese Pharmaceutical Manufacturers Association (JPMA).
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Roche, AVI BioPharma, Amgen and Delcath Systems.
US firm SAFC plans to turn its dry powder culture media manufacturing plant in Lenexa, Kansas into a “centre of excellence” with $6.3m (€4.7m) capacity expansion.
US drug packaging firm Comar says acquisition of Universal Container Corp (Unicon) provides capacity for growth, particularly in key liquid medication delivery device market.
The USP and FDA must work to identify counterfeited or intentionally adulterated products before they enter the healthcare system by collaborating on the modification of monographs, according to Margaret Hamburg.
Integration expenses, lower revenues, higher R&D spending and rising corporate costs impact PPD in Q1, but cancellations back to normal levels and requests for proposals increase.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Quintiles, Harlan Laboratories and Emerald BioStructures.
Charles River Laboratories (CRL) has admitted that areas of overlap created by the WuXi acquisition will lead to a “refinement of certain operating units” but is yet to disclose details.
Charles River Laboratories (CRL) is to acquire WuXi PharmaTech for $1.6bn (€1.2bn), creating a global CRO capable of offering fully integrated services from molecule creation to first-in-human testing.
US CRO Medpace has move into medical device trials with acquisition of Symbios Clinical in a bid to tap into what CEO August Troendle said was a growth area for the contract research sector.
The incoming Xcellerex CEO plans to move the company from validation to penetration, boosting revenues and client base, and invest in the contract manufacturing side of the business.
ACRO is aiming to increase recognition and analysis of the value CROs bring to drug development, spanning their role as strategic partners throughout the process, by funding academic research.
Colorcon has acquired excipient business NP Pharm, adding sugar spheres to its portfolio and production capacity that will become “an integral part” of its manufacturing network.
Delegates lucky enough to have made the trip to Interphex 2010 in New York, US bore witness to the launch of a wide range of new drug manufacturing technologies with products by O'Hara, Corning and PTI being some of the highlights.
Syntagon is implementing a strategic pricing initiative to give “substantial cost savings” to pharma and biotech companies taking compounds into Phase I and II clinical trials.
Lonza has reported stronger demand in the first quarter, but volatility remains in the custom manufacturing sector and it is uncertain if improvements “represent true and full economic recovery”.
Datatrak has added Safety Export to its eClinical suite, reducing errors, shortening timelines and cutting costs by ending reliance on paper to exchange data between sites, sponsors and regulators.
KryoTrans International claims its developmental KT1500 reusable container for drug shipments will be first passive temperature-controlled unit capable of accepting pallets and a boon for CROs in the globalised trial sector.
Indian CRO Siro Clinpharm says partnering with Taiwanese counterpart Virginia Contract Research Organisation (VCRO) furthers its geographical reach and access to patients.
Pfizer failed to ensure proper monitoring of a clinical trial in which in number of patients received overdoses, according to the US Food and Drug Administration (FDA).
Capacity at Blu Pharmaceutical’s recently acquired solid dosage production plant in Puerto Rico is set to expand considerable over the next three years according to company president Bill Luster.