PPD says it is unlikely to receive a $25m (€20m) milestone for US approval of Takeda’s diabetes drug alogliptin this year after the FDA said that cardio vascular (CV) safety data filed as part of the NDA are insufficient.
Tigermed is continuing with its plan of partnering to become the top Chinese CRO through an alliance with MacroStat to improve its range of statistical services, further broadening its business.
With M&A activity dominating Big Pharma's agenda at the moment, the contract research market is having to evolve and adapt to the turbulent environmnet. Outsourcing-pharma asked Frost & Sullivan analyst Barath Shankar to offer his opinion...
Cardiology and eClinical specialist eResearch Technology missed analysts estimates of sales and earnings in the fourth quarter of 2008, but still posted a near-14 per cent increase in operating profit.
Indian generics firm Piramal Healthcare says it "has no intention to dilute current ownership levels," but has not commented on rumours that it is in talks with French firm Sanofi Aventis.
Three plants owned by contract packaging maker Alcan have been cleared to produce containers for pharmaceutical products under the International Organization for Standardization’s ISO 15378:2006 guidelines.
Daiichi Sankyo, the Japanese drug firm that bought a controlling stake in India’s Ranbaxy last year, says it had no knowledge of FDA concerns that led to a block on ANDA reviews for drugs made at the latter’s Paonta Sahib facility.
Ranbaxy’s problems with the US FDA were ratcheted up a notch yesterday when the agency halted its review of products made at the firm’s plant in Paonta Sahib, India after uncovering “untrue statements” in ANDA’s and NDA filings.
Synexus' new trial site in Bulgaria, which is part of the firm’s clinical research centre strategy, will help sponsors cut development times and significantly reduce costs, according to CEO Michael Fort.
Kendle International posted a 22 per cent drop in net income to $5m, after a computer error led to problems with a clinical trial carried out for one of its customers.
Pandemic influenza vaccine manufacturing technology will be made available to developing countries through a collaboration between the WHO and Schering-Plough.
An active pharmaceutical ingredient (API) pilot project, implemented by the Pharmacopoeial Discussion Group (PDG) last summer and aimed at harmonising API monographs, should generate its first results before the end of the year.
The proposed FDA funding for 2009 has given a boost to the agency, with $300m more being offered than the agency requested to ensure the safety of products.
The Indian pharmaceutical and biotech sectors may see more M&A activity this year with rumours that GSK, Sanofi Aventis and Merck KGaA are on the look out for potential deals.
Barack Obama’s support for R&D tax credits to boost innovation is designed to assuage Big Pharma’s fears about a ban on “authorised generics,” and new “comparative effectiveness" tests, according to Datamonitor’s Sandra Reynolds.
Indian process technology firm ACE Technologies has won the contract to sell and service GEA Pharma Systems’ range of Courtoy tablet presses to local drug manufacturers as part of the latter company’s Asian expansion plan.
Study site operators want greater use of EDC technologies and more pharma industry investment to boost patient recruitment and reduce delays in clinical trials, according to an industry report due to be published next week.
Despite going through a difficult period PharmaNet is continuing to expand through the opening of another office in Latin America, which reinforces its commitment to the region.
Valois Pharma is installing precision plastic molding capabilities at its manufacturing facility in Congers, New York, US as part of ongoing efforts to modernise its global manufacturing operations.
Contract research organisation Bio-Imaging Technologies posted a 48 per cent hike on revenues in the fourth quarter of 2008, but still made a small net loss on the back of its CapMed division, which was sold last month.
Albany Molecular Research Inc (AMRI) faced a “challenging headwind” as 2008 drew to a close but still managed to boost its revenues by 19 per cent to $56.4m in the fourth quarter of 2008.
French drug major Sanofi Aventis is in talks about taking over market leading Brazilian generics firm Medley, according to reports the country’s Valor Economico newspaper.
US software specialist etrials Worldwide has added Belgian rival Unithink to an ongoing lawsuit that accuses two former executives, Robert Sammis and Brendon Ball, of breaching confidentiality agreements.
Charles River Laboratories will reduce its workforce by 3 per cent, close its preclinical facility in Arkansas, US and sell off its Phase I trial site in Edinburgh, Scotland as part of a cost reduction programme.
Crucell and DSM Biologics have added fellow Dutch firm Bioceros to the PER.C6 vendor network to provide manufacturing and support capacity in line with increased demand for the cell line.
Compass Pharma Services is targeting contract drug developers and clinical research firms with a new microfilling offering that, it claims, helps reduce waste and may even make excipients unnecessary in some drugs.
PPD has reached an agreement to buy AbCRO, which it hopes will strengthen its position in the thriving Central and Eastern European (CEE) clinical trials scene.
Pliva is laying off 790 employees over the next 12 months following its acquisition by Teva but still intends to significantly increase API and finished product output over this period.
Russia approved 615 clinical trials last year, a 9 per cent increase over 2007, lending weight to the notion that the country is becoming a global hub for clinical testing.
US company PRA International has entered into a strategic collaboration with two contract research organizations (CROs) in Southeast Asia in order to tap the fast-growing clinical research market in the region.
Regulators in India’s Maharashtra state have compiled a hit list of 110 drugmakers that they intend to prosecute for sub-standard manufacturing practices, according to media reports.
Contract research organisation PharmaNet Development Group has found a buyer just a few weeks after saying it was considering placing itself on the block.
Dr Rajashekar Reddy, chief minister of Andhra Pradesh, India presided over the inauguration ceremony for Biological E’s new INR3bn ($61m) vaccine and biopharmaceuticals manufacturing campus.
A US federal appeal court has reinstated lawsuits by Nigerian families against Pfizer in a move that could have wide ranging implications for companies conducting clinical trials abroad.
Almac Sciences, part of global contracting group Almac, chose this year’s Informex in San Francisco, US to showcase its solid state chemistry (SSC) services to drugmakers in North America.
US contract development firm Azopharma has begun offering microdosing at its AvivoClin facility in Daytona Beach, Florida, joining market leaders like Xeleron and Covance in the Phase 0 trial sector.
Indian IT company Satyam continues to be rocked by the fraud scandal, with media reports claiming that GSK and Novartis are on the verge of taking their business elsewhere.
Canadian contract manufacturing organisation PharmEng International, which has been hit by dwindling cash reserves in recent months, got a boost last week when its subsidiary Keata Pharma was awarded a C$3m research grant.
UK-headquartered Premier Research Group has signed a deal to buy the assets of fellow contract research organisation (CRO) Pivotal Research Centers, a specialist in Phase I to IIa trials, for $4.75m.
A new report suggests the large numbers of fake drugs produced in China could drive CMO customers away and see Central and Eastern Europe (CEE) emerge as a contract manufacturing hotbed.
The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations.
Pharmaceutical Product Development of the US is expecting to post a 12 per cent hike in revenues in 2009, helped by the recent opening of offices in Ireland and Singapore and new deals with Merck & Co.
Senator Richard Moore has criticised transparency laws in Massachusetts, US, which he claims allow pharmaceutical companies to hide payments made to physicians conducting clinical trials.
In the latest part of its “beyond our borders” scheme, the US FDA is asking drugmakers to volunteer supply chain information for drugs and APIs sourced outside the USA.
The market for packaging machinery is set to grow 5 per cent a year and be worth $40bn (€30.3bn) by 2012, driven partly by a hike in demand for drug products in “pharmerging” economies, according to a new industry report.
Despite criticism in certain quarters, joint GMP inspections represent the best use of resources in an increasingly globalised market, according to the EMEA.
