Regulations and enforcement were big topics yet again in 2010. in-PharmaTechnologist presents five of our most read on the topics, covering starting material quality and overseas inspections.
PRA has relocated its Poland-based early development services and product registration teams into a larger shared office after achieving “solid increases in the placement of clinical studies”.
US CDMO DPT Laboratories has received FDA approval to make commercial supplies of a wound ointment at its sterile and specialty products plant in Lakewood, New Jersey.
Outsourcing-Pharma presents an interactive visualisation of clinical trial data submitted to the EMA in MAA from 2005-09, showing the number of trials, sites and patients from each country.
Recognition of glass vial quality issues is supporting interest in West’s analytical capabilities and Crystal Zenith (CZ) products, new sizes of which are being developed, said a company VP.
The European Medicines Agency (EMA) says 12-month API plant joint inspection programme has fostered greater collaboration between international drug industry regulators and cut the number of duplicate visits.
The FDA significantly increased the number of concluded post-marketing requirements and commitments (PMR/PMC) in the 2009 fiscal year, according to a report.
API maker AMRI cited arbitration costs, efforts to address a US FDA warning letter and acquisitions as key factors in Q3 loss, but predicted that large-scale contract manufacturing business will drive final quarter gains.
China leads the field in 'potential future' API suppliers, positioning it to become a dominant force as these companies develop, Thomson Reuters said at CPhI 2010.
Gilead Sciences has received a warning letter from the US Food and Drug Administration (FDA) concerning manufacturing problems at the San Dimas, California, plant, where HIV medicines are made.
Biomarkers are critical to discovery and can help pharmaceutical firms make development a more efficient and cost effective process accord to bioanalysis services provider KCAS.
The FDA has approved Alexion Pharmaceuticals’ Rhode Island, US plant for commercial supply of Soliris (eculizumab), giving the biopharm a second source.
Mandatory recalls of drugs posing an imminent threat to human health could be initiated by the US FDA if a bill introduced last week is passed into law.
Mylan are to acquire Bioniche Pharma’s global injectable pharmaceuticals business for $550m (€430m) in a deal that gives Mylan a significant foothold in meeting product and therapeutic gaps in the US injectables market.
Indian-based drug makers continue to come under intense scrutiny by the US Food and Drug Administration (FDA) as the regulatory body issues warnings to healthcare professionals not to use certain brands of antibiotics due to potential contamination.
Siegfried is to supply at least 60 per cent of Jazz Pharmaceutical’s global requirement for sodium oxybate, the active pharmaceutical ingredient (API) in Xyrem.
The US FDA should change its disclosure policy relating to manufacturing site inspections according to new draft recommendations by the Department of Health and Human Services (HHS) Transparency taskforce.
The US FDA says Teva Pharmaceutical Industries’ plan to fix cGMP violations observed at its plant in Irving, California “lack sufficient corrective actions.”
Pfizer failed to ensure proper monitoring of a clinical trial in which in number of patients received overdoses, according to the US Food and Drug Administration (FDA).
Demand in “Pharmerging” markets will offset declining revenues from off-patent blockbusters and drive prescription drug sales to $1.1tr (€819bn) by 2014, according to IMS Health.
A joint enforcement operation in the US has led to the arrests of two people accused of being involved in supplying counterfeit weight loss medication, including GSK’s Alli (orlistat).
GSK has confirmed that material from the PCV1 virus has been detected in Rotarix and, although there is no evidence of a safety risk, the FDA has recommended use is temporarily suspended.
US Food and Drug Administration (FDA) request for more Afrezza data is not safety related and will not require new clinical trials, says developer MannKind.
US FDA clearance for Italian antibiotics production facility is important for global growth says German contract development and manufacturing organisation (CDMO) Haupt Pharma.
US CDMO Avrio Biopharmaceuticals’ new aseptic fill-and-finish facility in Irvine, California has been approved for the manufacture of biologics by state drug regulators.
Indian drugmaker Lupin can start seeking US approval for new drugs made at its API plant in Mandideep, Bhopal after resolving the cGMP deficiencies that earned the facility a US FDA warning last year.
inVentiv Health claims the acquisition of ParagonRx positions it as the leading supplier of REMS services in the pharmaceutical contract services sector.
Watson Pharmaceuticals gained US rights to market a generic version of Lipitor (atorvastatin) in 2011 with the acquisition of non-branded drugmaker Arrow Group late last week.
Lonza is manufacturing GlaxoSmithKline’s (GSK) and Genmab’s antibody Arzerra (ofatumumab), which was recently approved by the FDA, under a long-term supply deal.
Abraxis Health has dedicated its manufacturing facility in Phoenix, Arizona, US which is the result of a $70m (€47m) investment to give the company the nanotech and biologics capacity needed for Abraxane production.
Profits doubled at MWV’s healthcare division in the third quarter, despite slightly lower sales, as the packaging company’s efforts to focus on high return opportunities and maximise production efficiency paid dividends.
Caraco Pharmaceutical Laboratories has entered into a consent decree with the FDA which details a series of measures that must be fulfilled to allow the company to resume manufacturing.
US approval for Sanofi-Aventis’ H1N1 vaccine last week is an “example of extremely rapid action by [the] FDA” that should be used more widely, according to Parexel Consulting’s VP of global strategy services Alberto Grignolo.
News of Bayer’s selection of ex-Thermo Fisher Scientific boss Marijn Dekkers as its CEO was somewhat overshadowed by a new FDA warning letter about quality testing at its manufacturing facility in Bergkamen, Germany.
