MDRNA is selling its manufacturing business to US generics firm Par Pharmaceuticals in a bid to boost its coffers and complete its transformation into a purely RNAi focused organisation.
Pfizer will pay an out of court settlement to resolve a long-running case alleging that it carried out an illegal trial of its meningitis drug Trovan (trovafloxacin) in Nigeria that resulted in the death of 11 children.
United Drug’s contract packaging business is expected to report a significant dip in profits but strong performance in the sales division helped push up its share price.
Falling sales to hospitals are forcing Cardinal Health to cut 1,300 jobs from the clinical and medical products units that it plans to float under the CareFusion banner later this year.
Sanofi-Aventis had a €5bn ($6.6bn) bid for Solvay’s pharma business rejected, according to media reports, but several other companies are believed to be interested in the Belgian firm.
Bayer Technology Services GmbH, an affiliate of Germany's Bayer, has opened its first regional office in India, enlarging its presence in the fast-growing Asian markets.
Custom micronisation and milling firm SDTech has bolted on particle size analysis to its suite of drug industry offerings through a new collaboration with UK analysis specialist Malvern Instruments.
Since coming into effect late last year, US Code of Federal Regulations-21 parts 210 and 211 testing rules have been the subject of much confusion in the pharmaceutical industry, according to West Pharmaceutical Services.
Novartis is looking to buy an additional 39 per cent of its majority-owned subsidiary Novartis India for around 4.4bn rupees ($87m), or 351 rupees per share.
Senator Grassley has raised concerns that an email by acting Commissioner Torti to FDA employees could be viewed as an attempt to suppress whistleblowers following recent releases of internal agency documents.
Contract drug development group Systems Biology Worldwide (SBW) says the acquisition of Finnish data management specialist 4Pharma will facilitate its entry into the clinical trials sector.
US drug delivery specialist Hospira will reduce its workforce by around 10 per cent, or 1,400 employees, over the next 24 months as part of its $140m (€104m) a year “Project Fuel” cost cutting and efficiency drive.
The pharmaceutical rumour mill is still spinning with the latest speculation that UK drug major GSK is interested in Botox manufacturer Allergan causing the US firm’s share price to leap 13 per cent on the New York Stock Exchange.
The global economic downturn, impending blockbuster patent expiries and the wave of consolidation sweeping the pharmaceutical industry will drive demand for Patheon’s restructuring service according to CEO Wesley Wheeler.
Regulators in the UK and Australia have issued GMP certificates for Ranbaxy Laboratories' Paonta Sahib plant after a joint inspection deemed manufacturing practices were up to code.
Watson Pharmaceuticals has voluntarily withdrawn one lot of its arrhythmia drug propafenone HCl in the US after the tablets were found to contain slightly higher levels of the drug’s API.
US RNA interference (RNAi) specialist MDRNA has signed a non-exclusive licensing deal granting Swiss drug giant Novartis access to its liposomal siRNA delivery technology platform.
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.
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.”
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.
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.
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.
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.
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.
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.
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.
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”.
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.
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.
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.
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.
Sinovac’s recently opened vaccine filling and packaging facility in Beijing, China has received SFDA GMP certification, which the firm says will increase production capacity to around 40m doses a year.
Sales and marketing service specialist InVentiv Health slid to a loss in the fourth quarter of 2008, despite posting a 16 per cent hike in net revenues to $248m.
Genentech used its investor meeting to retaliate against criticisms made by Roche, saying it will debate its financial model “anywhere, anytime with anyone”.
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.
Faced with a tougher operating environment, Irish drugmaker Elan has decided to slash staff numbers by 230 – or around 14 per cent of its total workforce – shelve the construction of a new biologics manufacturing facility and shutter fill-and-finish capacity...
It is not compulsory to respond to form 483s detailing deficiencies at a facility but the FDAs latest guidance fully recommends companies do so to avoid being issued with a warning letter.
Pfizer’s primary care business unit has dropped two Phase III candidates, further reducing the drug giant’s product pipeline and raising more questions about its R&D decisions.
Pandemic influenza vaccine manufacturing technology will be made available to developing countries through a collaboration between the WHO and Schering-Plough.
The US subsidiary of world leading generics firm Teva Pharmaceutical Industries has called in procurement specialist ICG Commerce to help it cut its outsourcing spend as part of ongoing cost reduction operations.
