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.
Following fresh criticism of the agency’s handling of the heparin case, in-PharmaTechnologist reports on a FDA official’s explanation of the what, the when and the why of the scandal, from first deaths to continued vigilance.
Althea Technologies has signed a contract manufacturing deal, under which it will produce Bio-Path’s lead novel therapeutic drug for upcoming clinical trials.
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.
Janssen-Cilag’s quality control unit has found a defect in certain batches of its Ionsys (fentanyl hydrochloride) management system that could lead to a potentially life-threatening overdose.
Questions about the safety in children of a number of azo dye food colourings which are routinely found in pharmaceutical products could be answered within the next 18 months, according to the European Food Safety Agency (EFSA).
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.
Metrics’ new potent and cytotoxic drug development facility was the subject of a press conference at this year’s AAPS, where the company explained how the plant “raised the industry bar”.
The US CRO market is predicted to have a healthy future, with the greatest potential for growth in the preclinical sector, according to a report by Frost & Sullivan.
Troubled contract research organisation Encorium Group finally published its delayed financial results yesterday, posting a net loss of $3.9m, three times the year-earlier loss.
An open-source software suit for electronic data capture (EDC) in clinical trials – OpenClinica - is starting to see a dramatic rise in usage, according to its developer Akaza Research.
Watson Pharmaceuticals has paid Israeli generics firm Teva $36m (€27.6m) for 17 products that the latter firm is selling under the terms of its $7.5bn acquisition of Barr Pharmaceuticals.
Contract development firm Azopharma has established a new laboratory facility in Welwyn Garden City, UK, which it hopes will facilitate its move into the European market.
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.
King Pharmaceuticals’ $1.6bn (€1.2bn) acquisition of Alpharma heads a busy week of deals that has seen J&J agree to pay $438m for Omrix and India’s Sun further its presence in the US narcotic APIs sector through the purchase of Chattem Chemicals.
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”.
Members of the Committee on Energy and Commerce have said that recent actions by the FDA have been politically motivated and insufficient, although they did acknowledge the moves were necessary.
Sepha has launched PakScan, its new leak testing machine that the company claims can quickly and non-destructively test for holes in sachets and sealed pouches.
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.
Pfizer’s Exubera failure need not be the final nail in the coffin for inhaled biopharmaceuticals as long as developers focus on proving “healthcare value” and addressing payer needs, according to Bruckner Group’s David Balekdjian.
Irish oral dosage specialist Merrion Pharmaceuticals is to develop and commercialise Novo Nordisk’s range of insulin analogues as the Danish firm seeks to tighten its grip on the $9bn (€7bn) a year diabetes market.
Aptuit presented a seminar at this year’s AAPS explaining how it had implemented its INDiGO programme, which takes an API to IND in 26 weeks, and how it can benefit clients.
The proportion of women in clinical trials has become more representative, although there are still areas for improvement, according to research by the FDA.
MicroCHIPS scooped the drug delivery technology award at this year’s AAPS, after which CEO John Santini spoke to in-PharmaTechnologist.com about the device and what the future holds for the company.
After collecting the drug delivery award at this year's AAPS, John Santini, CEO of MicroCHIPS, was on hand to explain what the gong meant to the company.
Isogen will start operations in January at a new contract facility in Delaware that will provide small-scale sterile filling services to the pharmaceutical industry.
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.
The US Food and Drug Administration (FDA) has issued draft guidance on process validation, updating its 1987 document to incorporate advances in manufacturing technology and thinking.
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.
The pharmaceutical industry’s vigilance in ensuring the safety of raw materials was criticised at this year’s AAPS, with significant, challenging alterations needed to improve the system.
Clinical research organisation Encorium has postponed the release of its third quarter results but said it still expects the figures to be in line with its most up-to-date guidance.
UK company ProImmune has launched a suite of services to help drugmakers determine at an early stage whether a biologic drug will elicit an immune response in humans.
Patheon has signed a slew of agreements to boost its portfolio of contract drug development and manufacturing services, forging new alliances with Omnicare, Depomed, Senopsys and Solvias.
India’s Jubilant Organosys has bolstered its mid-range contract research portfolio by buying Canadian electronic data capture (EDC) specialist TrialStat ClinicalAnalytics.
Canada’s Orbus Pharma has decided to exit the contract manufacturing business, saying that the division “posed a distraction to the core business and generated low or negative margins.”
CiVentiChem president Bhaskar Venepalli says that the CiVentiAnalytical unit, the firm’s new state of the art GLP/cGMP accredited laboratory in Cary, North Carolina, will help customers find novel method development solutions for API production.
German chemical giant BASF chose this year’s AAPS meeting in Atlanta, US to showcase its growing library of USP excipient verification certificates, making good on its commitment to apply the highest manufacturing standards to this area of its business.
Contract research group Recipharm has leased AstraZeneca Biotech Laboratory (ABL) in Sodertalje, Sweden, bolting on recombinant protein and monoclonal antibody development capabilities to its offering.
Philips’ new intelligent pill (iPill) technology, which combines a sophisticate sensor array with a precise delivery mechanism, was one of the most talked about innovation presented at this year’s AAPS meeting in Atlanta.
Manufacturers of ingredients used as excipients in pharmaceuticals have faced some regulatory problems with a series substances known as 'atypical actives'.
The US authorities are turning up the heat on Icelandic generic drugmaker Actavis over manufacturing problems at the New Jersey plant which makes its recalled Digitek brand of the cardiac drug digoxin.
eClinical specialist etrials Worldwide saw its losses quadruple in the third quarter on the back of a dip in revenues and financial charges, including a $4m asset impairment charge related to goodwill.
