Schering-Plough has agreed to pay $165m to settle a class action lawsuit that claims the company’s failure to disclose manufacturing deficiencies defrauded investors.
A US trade organisation has drawn up its own set of standards for Braille on pharmaceutical packaging in the absence of any legislative decision by the US.
UK company Paraytec has introduced a new instrument designed to allow formulation scientists to visualise – in real time – what is happening at a tablet surface when it dissolves.
The European Medicines Agency (EMEA) has called for “in-depth, prospective analysis of potential ethnic factors” when considering whether clinical trials conducted outside the EU will be acceptable in marketing authorisation applications.
Covance has expanded its clinical pharmacology capabilities via the purchase of Swiss Pharma Contract, a 50-bed clinical research company based in Basel.
The tough operating climate facing contract research organisations (CROs) seems to have hit Canada’s MDS particularly hard, with a 13 per cent drop in fiscal first quarter revenues to $257m.
Alastair Riddell, CEO of UK firm Stem Cell Sciences (SCS), says the US governments’ reversal of the ban on federally funded stem cell research “opens up a market that was inhibited, restrained and impeded under the Bush administration.”
CIT is launching a tissue cross-reactivity service, which will allow biotechs to screen monoclonal antibody-based therapies for tissue binding, in response to rising market demand.
The safety of drugs imported into the US remains high on the FDA’s agenda, with the agency publishing new draft guidance that raises standards for labs inspecting products made overseas.
The three main international pharmacopoeias in the US, Europe and Japan are experiencing a difference of opinion on the tricky topic of testing pharmaceutical ingredients for heavy metals.
Roche is closing its manufacturing facility in Nutley, New Jersey and relocating its centre of commercial operations in the US to California following its $46.8bn (€36.3bn) takeover of Genentech.
US CMO Formatech has brought a new Virtis Benchmark 3000 luophilizer into service at its manufacturing facility in Andover, Massachusetts, boosting capacity by 13,000 vials per production run.
US Biotechnology firm Cel-Sci has unveiled a new manufacturing process, cold 4°C Aseptic Filling, that it claims can improve the shelf-life and potency of biologic drugs produced using stem cells.
Pall CEO Eric Krasnoff says delayed drug industry capital expenditure and moves to conserve inventory in the current global gloom caused life science sales to fall 8 per cent for the second quarter.
The International Pharmaceutical Excipients Council (IPEC) – currently represented by divisions in Europe, the Americas, Japan and China – could see sister organisations open up in Latin America and India in the coming months.
The slashing of pharma’s in-house teams did not help contract sales provider PDII in 2008, with the company recording an operating loss of $36.4m (€28.5m), compared with a $14.3m deficit the previous year.
German coating technology specialist Driam hopes its new Driaconti-T continuous tablet coating platform will win over manufacturers wishing to improve process efficiency in times of economic gloom.
The backlash against the re-importation bill has begun, with PhRMA warning that the legislation could cripple the FDA’s ability to protect patients and open the door to counterfeits.
Drug giants Pfizer and GSK may be among the first affected by last week’s US Supreme Court ruling upholding a product liability lawsuit against Wyeth despite FDA approved labelling.
US contract research organisation ACM Global Central Laboratory has bought its longstanding business partner Pivotal Laboratories of the UK in a bid to boost its international reach.
Private equity firm JLL Patheon Holdings went ahead yesterday with its unsolicited $2-per-share bid for Patheon that would take the company into private ownership.
The US green light for federally funded embryonic stem cell research is being hailed as a victory by the US drug industry, which predicts it will open the flood gates for novel medications and help revitalise the sector.
BioFocus DPI, the service division of Belgian drug discovery firm Galapagos, made a profit of €3.4m on revenues a little over €56m in 2008, reversing a loss of about the same magnitude in 2007.
UK CRO Richmond Pharmacology has unveiled a new data management offering for the drug industry that it claims will help trial sponsors cut costs, save time and help guarantee data integrity.
Following the proposal of his bill re-importation bill Senator Byron Dorgan has accused some of big pharma of taking actions that would be illegal under the Act and outlined the punishments they could face.
Belgian biopharmaceutical company UCB has contracted Proteros Biostructures of Germany to provide support in the structure-based discovery of small-molecule drugs.
The FDA has found “significant objectionable conditions” at the Genzyme manufacturing facility that makes Lumizyme, creating another issue in the product’s approval process.
Macao Health Bureau director Lam Ping-yan says tabletting delays at Euopharm Laboratories' plant in Hong Kong, China may have led to contamination of the hyperuricemia drug Purinol (allopurinol) linked to several deaths.
Patheon chief Wes Wheeler says the drop in Q1 losses the firm recently reported is due to the “restructuring activities and rigorous cost containment efforts” it enacted towards the end of last year.
The year of the mega-merger continues with Merck & Co’s move to buy Schering-Plough for $41.1bn, with the intention of boosting its pipeline, entering new markets and creating a “powerful biologics presence”.
eClinical company etrials saw losses increase in the fourth quarter of 2008, but pointed to a healthy increase in orders as evidence of the underlying strength of the business.
MannKind is trying to buy a Pfizer insulin facility for $33m (€26m) as it continues to push Afresa towards commercialisation but, like many things in the saga, the deal might not be straightforward.
Merck & Co is to buy fellow US drug major Schering Plough for $41bn (€32.6bn) to boost its pipeline in the face of impending patent expiry for key products.
UK drugmaker SkyePharma may reduce the workforce at its production plant in Lyon, France by a third after “long-running” underutilisation of its manufacturing capacity.
Two approvals in a week for drugs made at Ranbaxy’s New Jersey OHM Laboratories subsidiary have eased the generics firm’s North American regulatory woes and strengthened its position in the expanding US market.
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.
An undercover investigation at a primate centre that conducts preclinical research has raised allegations of routine and unlawful mistreatment of the apes and wastage of taxpayers’ money.
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.
UK CMO SCM Pharma has completed a supply contract to make lisinopril tablets for a University of Cambridge trial investigating the drug in Rheumatoid arthritis.
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...
Yesterday’s US Supreme Court decision upholding a $7m damages award to a Vermont woman who sued Wyeth means that drugmakers are still vulnerable to State consumer liability lawsuits despite FDA approval for a drug and its labelling.
Evolution is collaborating with C&QP to offer a more comprehensive range of GMP services to clients, covering plant and equipment qualification, calibration and maintenance.
Acusphere has laid off two thirds off its staff, with manufacturing employees among the affected, and closed its headquarters, citing financing difficulties as the cause of the cutbacks.
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.
Money can be saved throughout early-stage and Phase II trials by using the Collect, Ready, Hold service in preemption of a central review of imaging data, according to WorldCare Clinical.
Genentech believes a far-sighted approach to patent expiration, unique and life saving drugs and an unrivalled scientific culture will protect it from recession and ensure greater growth than Roche envisions.
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.
Use of graphs and tables depicting pharmacokinetic attributes is among the recommendations made in the FDA’s latest guidance on clinical pharmacology labelling of prescription drugs.