A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.
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.
Contract research organisation Bio-Imaging Technologies has decided to sell off its CapMed subsidiary in order to focus its efforts on its core business, providing imaging series to clinical investigators.
The proportion of global clinical trials conducted In India is expected to more than double between 2007 and 2012, according to market research firm RNCOS.
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.
Dr. Michael Butler has joined Xceleron as chief executive bringing an end to a search to replace Prof Colin Garner, the firm’s founder, who is retiring from the post.
There is no formal requirement to inform clinical trial participants of the results of the study, a situation which can leave them “confused, frustrated and, in some cases, lacking information that may be important to their health,” according to a report...
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.
Icon's recent $43.2m acquisition of New York-based Prevalere Life Sciences is the latest part of the firm's expansion in the US CRO market. Outsourcing-Pharma spoke with Icon's VP of bioanalytical development, Brian O'Dwyer, and Prevalere...
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.
Canadian contract manufacturer PharmEng International has managed to trim down its costs once again, but is still feeling the pain associated with the opening of its new facility in Sydney, Nova Scotia, and posted a loss of over C$8m (€5m).
Icelandic generics firm Actavis plans to use Malta as a distribution hub for the supply of drugs to the emerging African pharmaceutical market, according to reports in the Maltese press.
Qatar and Egypt are to set up a new drug manufacturing plant at a facility in Qatar, according to BusinessIntelligence. The new facility will begin by producing soluble drugs for the emerging Qatari and Egyptian drug markets.
Quintiles Transnational has boosted its array of services for companies developing cancer drugs via the purchase of Illinois, US-based firm Targeted Molecular Diagnostics.
Postponement of this year’s CPhI and P-MEC India events for “security reasons” may be only the first impact of last week’s Mumbai terror attacks on the country’s outsourcing industry, according to PwC’s life sciences head Sujay Shetty.
European facilities owned by Israel’s Teva Pharmaceuticals and French drugmaker Servier are among the firms raided by the EC’s competition unit earlier this week, according to media reports.
The US Food and Drug Administration has opened offices in three Chinese cities – Beijing, Shanghai and Guangzhou – to help improve the safety of medicines and ingredients imported into the US.
Taiwanese API maker ScinoPharm has been granted a US patent for new crystalline forms of irinotecan which are designed to allow for easier filtration during production processing.
A member of the US Congress has called on the GAO to launch an investigation into the FDA’s handling of the heparin crisis, citing “unanswered questions concerning [the] deaths”.
Chinese CRO Tigermed Consulting has teamed up with Russian and South Korean counterparts OCT and LSK to establish a global clinical trials network and expand its geographic footprint.
AstraZeneca is to cut 1,400 jobs and close more manufacturing facilities by 2013, as it attempts to slim down in preparation for impending generic competition for some of its cornerstone drugs.
DPT Laboratories chose this year’s AAPS in Atlanta to showcase its research and development capability with a unique poster presentation examining the role of various excipients in nasal drug delivery applications.
Demand for glycerin as an ingredient in pharmaceuticals, personal care and other products is expected to show brisk growth out 2015, when demand around the world is expected to reach 3.39 billion pounds, according to market research firm Global Industry...
Barrack Obama’s election as US president has been roundly welcomed by India’s generics sector, despite his somewhat contradictory desire to reduce the level of outsourcing but not "shy away" from globalisation.
Taiwan’s efforts to position itself as a major biotechnology hub received a further boost today with the opening of Merck KGaA’s dedicated technology training centre in Xizhi City, Taipei County.
The NAFDAC has banned 22 firms that it says are involved in the manufacture of fake drugs from ever again selling pharmaceuticals in Nigeria, as part of a countrywide clampdown.
The pharmaceutical industry must adapt its processes and strategies to cope with a new, tougher operating environment, according to Stefan Borgas, CEO of Lonza.
Contract drug development company Azopharma Product Development has set up a new business unit to cater for companies wanting to run microdosing or so-called Phase 0 studies.
Pharmaceutical Profiles of the UK has completed a groundbreaking study that bundles together a number of tests used to decide whether a drug development candidate is worth pursuing into a single clinical trial.
Wyeth Medica, an Irish subsidiary of US drugmaker Wyeth, plans to cut 250 jobs at its manufacturing plant in Newbridge, County Kildare, according to media reports.
The International Pharmaceutical Excipients Council (IPEC) of Europe has outlined the actions it is taking as it continues to develop awareness of the need for safe excipients.
Canada’s Ethica Clinical Research has expanded into the emerging Latin American market via a joint venture with Argentinean contract research organisation Blanchard y Asociados.
US contract research organisation Encorium Group has postponed its planned acquisition of Prologue Research International and cut staff in the latest twist in a rollercoaster ride for the firm in recent weeks.
Clinical trials that support the effectiveness of drugs filed for approval in the US are more likely to be published than those that are less supportive, according to researchers at the University of California at San Francisco.
Pharmaceutical companies on both sides of the Atlantic are facing a particularly difficult time over the next 12 to 18 months, according to a report by financial research and analysis company Moody’s.
Indian pharmaceutical company Lupin Ltd has expanded into Africa by acquiring a 60 per cent stake Pharma Dynamics, a generics company and contract manufacturer based in Cape Town, South Africa.
Active pharmaceutical ingredient specialist Calyx Chemicals and Pharmaceuticals is planning an acquisition within the next two years, probably in the US or Europe, according to chief executive Smitesh Shah.
UK-based Pharmaceutical Profiles has used an imaging technique known as scintigraphy to quantify the effects of Amylin / Eli Lilly’s latest diabetes drug on the stomach.
Exclusive interview with IPEC China chairman Nevin Cheng
IPEC China must become a “harmonisation bridge between China and other countries,” according to Colorcon’s Nevin Cheng who was recently elected chairman of the new organisation.
Bilcare GCS, the clinical supplies arm of Indian packaging giant Bilcare, has considerably expanded its Phase III trial offering in an effort to provide drugmakers with a complete package.
