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 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.
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.
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.
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...
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
An open house at GSK’s plant in Pennsylvania, US gave the world its first glimpse of the facility that the firm hopes will become the global hub of its vaccine packaging and filling business.
Since its inauguration last year, IPEC China has been working to improve the quality of excipient manufacturing in the country. in-PharmaTechnologist spoke with organisation president Nevin Cheng about the steps the body has taken so far and what it will...
Drug raw materials maker Akron Biotechnology has selected Austin Chemical Company to help expand its client-base in the global biotech, pharmaceutical, and diagnostic industries.
The FDA has established its first permanent presence in Latin America by opening an office in Costa Rica as part of “Beyond Our Borders Initiative”, which has also seen the agency set up three sites in China.
As 2008 drew to a close and people the world over welcomed the New Year, few would have noticed the passing of Europe’s paracetamol industry as Rhodia closed the doors of the region’s last manufacturing facility in Roussillon, southern France.
Australian drug development firm Cancer Therapeutics (CTx) has selected IDBS’ E-workbook and ActivityBase platforms to manage its global drug development programmes.
AstraZeneca has signed a five year deal with Infosys Technologies for “end-to-end” application maintenance services in areas such as manufacturing, supply chain, finance, human resources and other corporate functions.
The MHRA has renewed its approval of Almac’s facility in North Carolina, bringing an end to a busy and successful four months of inspections at the clinical services group’s facilities.
The European Union’s long-awaited reform of pharmaceutical regulations known as the ‘pharmaceutical package’ was unveiled yesterday after months of consultation and debate.
India’s Bilcare has expanded its clinical trial materials business in its own market with the opening of new packaging and storage capacity at its facilities in Pune, India.
Contract research organisation PRA International has signed an agreement with fellow US firm Frontage Laboratories to expand the range of laboratory services it can offer to its clients.
