in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including mass director resignations at Gentium and executive lay-offs at Ambrilia.
Researchers have developed a drug delivery vehicle using liposomes and aptamers that targets specific cancer cells and can be switched off to stop adverse reactions.
Outsourcing-Pharma presents its latest round of movements in the pharmaceutical outsourcing sector, including appointments at inVentiv and GVK Biosciences.
Emergent BioSolutions believes it can reduce its debt, cut operating expenses and gain more flexible production capacity by reorganising its manufacturing operations.
The US Food and Drug Administration (FDA) has enhanced its debarment and disqualification procedures to ensure clinical trial investigators meet legal requirements.
France will lead growth in the European API market, according to a new report that believes the government’s cost-containment measures will put increased focus on the nation’s generic sector.
Nigeria is collaborating with Interpol and setting up offices in India to curb the flow of counterfeits, in particular allegedly China produced fakes labelled “Made in India”, according to media reports.
AMRI’s adjusted income from operations plummeted by 97 per cent in Q2 as a result of lower demand for contract services, in particular development and small scale manufacture.
The threat posed by animal rights activists has been highlighted by an alleged arson attack on the Novartis’ CEO’s lodge, with one group saying their only regret is that he was not home when it burned.
Cambrex has posted a positive set of Q2 results, recording an operating income of $9m (€6.3m), but warned that the second half of the year is likely to be down on the corresponding six months of last year.
West Pharmaceutical Services’ operating income fell by 33 per cent in Q2 but the company reported that demand for some of its drug delivery technology is strong.
OmniComm has acquired Logos Technologies’ electronic data capture (EDC) assets, the second deal of this type it has made in the past 6 weeks, further strengthening its presence in the market.
The FDA and EMEA are launching an 18 month pilot programme focused on good clinical practice (GCP), which is intended to increase collaboration and reduce the burden on the agencies.
Shin Nippon Biomedical Laboratories (SNBL) has posted a positive first report on the Phase II trial of its intranasal antiemetic, which it claims is a more convenient treatment for cancer patients.
Eli Lilly is among the organisations partnering to provide training for the Rozdravnadzor, Russia’s equivalent of the FDA, which is seeking to improve its knowledge of manufacturing standards.
Life Sciences Research’s (LSR) operating income fell by 60 per cent to $4m (€2.8m) in Q2 but believes that the contract research market will improve later this year or in 2010.
AmerisourceBergen’s contract packaging business believes the outlook for the sector is improving after it posted an 11 per cent rise in operating income in Q3.
in-PharmaTechnologist presents its latest round-up of movements in the pharmaceutical sector, including a new CEO at Caraco, appointments at Mylan and the return of the “Viking boss”.
eResearch Technologies (ERT) posted a Q2 operating income of $4.8m (€3.4m), down from $10.8m last year, and attributed the decline to companies delaying thorough QT trials.
US pharmaceutical giant Pfizer has teamed up with China’s Fudan University to set up a Master’s degree programme in clinical data management and statistical programming.
Ecron Acunova’s global partnering team had a busy end to July with the Indian CRO entering into collaboration deals on both sides of the Atlantic to further expand its global reach.
Despite some gains, demand for pre-clinical development services at Covance fell for the second quarter running, offsetting progress made by its late-stage trial and laboratory analysis businesses.
Good adherence pack sales and profits growth helped US packaging group MeadWestvaco to a positive set of Q2 financials, despite a 16 per cent drop in sales for the period.
In response to rising demand from the pharma industry NeuroScience Associates (NSA) is opening a new laboratory that will quadruple capacity for its brain and spinal cord histology services.
Shareholders have filed an $8bn (€5.7bn) lawsuit against Genzyme alleging that the company’s CEO “issued a series of materially false and misleading statements” about its manufacturing problems.
Medingo’s insulin dispensing patch has been approved by the US Food and Drug Administration (FDA), sending shares in its parent company soaring to a 12 month high.
In the latest twist in an increasing bitter takeover battle, the Ontario Superior Court of Justice has rejected JLL’s bid to oust directors elected to the board of Canadian CMO Patheon in April.
Meridian Life Science (MLS) has completed the expansion of its cGMP biotech facility, which will enable the contract production of vaccines and viral based products for Phase I trials.
Mylan and the FDA appear to be in disagreement about whether investigations into quality controls at a US facility are ongoing, with both releasing seemingly contradictory statements.
The financial impact of Caraco’s cGMP compliance issues have been revealed in its Q1 results, which saw a $14m (€9.9m) operating income in 2008 turn into a $14m loss this year.
US firm Isogen says the combination of aseptic filling, engineering and containment know-how on offer at its new Science Center is unique among facilities serving the clinical market.
Glenmark Pharmaceuticals and Omnicare have closed a clinical trial site in India operated by the contract research organisation (CRO) amid accusations that an investigator acted fraudulently.
Beauty packaging specialist Rexam is considering issuing new equity to service its burdensome debt pile, after market conditions failed to improve in the last quarter.
KV Pharmaceutical has hired a firm specialising in restructuring and bankruptcy and said “there are significant uncertainties regarding its ability to continue as a going concern during the upcoming fiscal year”.
US private equity group Water Street Healthcare Partners (WSHP) says its purchase of AAIPharma’s pharmaceutical development business was a “unique opportunity” to invest in an expanding market.
The EMEA is fast tracking the review of data on H1N1 pandemic vaccines to ensure it has checked submissions before the northern hemisphere flu season, which starts in September.
Sanofi-Aventis is continuing to expand in emerging markets by agreeing to acquire Indian vaccine manufacturer Shantha Biotechnics in a deal that values the company at €550m ($784m).
US firm Compass Pharma Services is now offering ISO class 8 certified packaging services in a bid to capture a share of the expanding high-potency drug sector.
Sterile injectables, specialty pharmaceuticals and discovery services will be key drivers for Jubilant Organosys over the 2010 fiscal year, according to executive finance director R Sankaraiah.
India’s Terrene Pharma has opened what it claims is the only gelatine capsule manufacturing plant in the country to be “designed from inception as per US FDA, EU EDQM and WHO GMP requirements.”