GSK has announced plans for a new manufacturing plant to "bring more medicines to the people of India" weeks after revealing that some drug wholesalers in the country have stopped buying its products.
West says it is one step closer to bringing the Daikyo Crystal Zenith (CZ) drug delivery system to commercialisation with the completion of a first-in-man study.
The US FDA is working with GEA to validate continuous manufacturing as the pharma industry enters “the start of the end” for batch manufacturing, according to GEA.
There are multiple ways to make amorphous dispersions in order to enhance bioavailability but spray dry dispersion (SDD) is often the most applicable, Bend Research says.
Understanding how a drug will interact with food is vital even if predicting it accurately during development can be a challenge according to speakers at AAPS yesterday.
India’s CDSCO has unveiled a list of clinical trial regulations that does little to explain how they will fix a system that has seen an increasing number of companies pulling their operations from the country.
Concerns recently introduced import laws would cause EU-wide API shortages now appear unfounded, but European industry groups say the buffering effects of stockpiling mean it is still too early to be sure supplies will not be affected.
Bend Research is expanding its commercial spray-dried dispersion (SDD) manufacturing with capital from new owners Capsugel in order to offer unique integrated capabilities, the firm says.
Roche could restart its antibiotic development activities if a superbug busting drug candidate being developed by new partner Polyphor fulfils its early clinical promise.
CatScI says pharma demand for catalysis services is increasing due to a greater focus on economic sustainability as it inks a deal with SAFC for its chemical processes.
Remediation at troubled Rocky Mount facility will continue into 2014 Hopira says as it awaits an inspection by the US Food and Drug Administration (FDA).
Plagued with tighter deadlines and calls for more efficiency, CROs (contract research organizations) seem to be increasingly turning to apps and cloud-based systems to develop CTMS (clinical trial management system) modules.
The US FDA and European Medicines Agency (EMA) is now offering additional joint guidance on the concept of quality-by-design (QBD) that focuses mostly on design space verification.
Third quarter growth in preclinical services was due to gain in market share and demand from Big Pharma, Charler River Laboratories (CRL) says as it reports solid Q3 earnings.
A third Amarin supplier has confirmed it will continue to supply the firm with pharma-grade omega-3 despite a US FDA panel recommending against a label extension for the heart pill Vascepa.
Persistence, endurance and a steadfast focus has led to AMRI receiving a close-out letter for its long suffering Burlington, Massachusetts facility, the company says.
Novartis has confirmed it is closing a UK facility as part of a global R&D review but remains silent on rumours specific business units will be divested.
The US FDA told us that China has “taken longer than FDA had hoped” in approving the visas of new FDA inspectors that would more than double the agency's presence in China.
DSM says it has not found the right partner for its pharmaceutical products business and is continuing to look for a collaborator with which it can grow in Asia.
In one of the largest healthcare fraud settlements in US history, Johnson & Johnson has pleaded guilty to introducing a misbranded drug and must pay approximately $2.2bn (€1.6bn) to resolve criminal and civil liability.
Payers should keep pharmaceutical firms’ quality records in mind when making purchasing decisions to help prevent drug shortages and stimulate manufacturing innovation according to the US FDA.
An IPEC-affiliated coalition is calling on USP (US Pharmacopoeia) to allow for the determination of physiologically relevant bioaccessible elemental impurity content for pharmaceutical products and components.
After almost two years of lagging early phase clinical research work, it seems some CROs are now seeing an uptick in specialized trials that require more scientific expertise.
Pharma service provider inVentiv Health has acquired Catalina Health and is merging it with its subsidiary Adheris to create the largest direct-to-patient adherence program in the US.
CRO Parexel’s stock fell to a four-month low and continued to hover around that level late last week following concerns about low bookings and increased competition in the first quarter of 2014.
Copley Scientific expects the new version of its flow rate control technology for dry powder inhaler (DPI) testing to be in demand among both generic drug firms and pharmaceutical innovators.
Merck & Co intends to close ten more manufacturing plants to further shrink its footprint as it continues to restructure after its 2009 megamerger with Schering-Plough.
Granules India has outlined plans to buy drug intermediate and API maker Auctus Pharma, set up an actives R&D site and announced its intention to wind up its ‘shell’ operation in Singapore.
Quintiles issued a mixed set of revised financial predictions for 2013, increasing its earnings per share forecast after a surge of new business wins and narrowing its service revenue.
The acquisition of Bend Research by Capsugel may be “a marriage made in heaven” for customers, the firms say, as the first drug delivery tech is transferred.
Lonza says its pharmaceutical business ‘performed as expected’ in the third quarter and that its restructuring efforts – which have seen it cut nearly 800 jobs– are on track to deliver productivity gains.
Covance produced solid Q3 results as expected by analysts though whether the CRO can fire both early and late stage development cylinders at once remains a question.
API, drug intermediates and formulations firm Granules India ended the second quarter of fiscal 2013 with higher revenue and profit thanks to gains made by all three of its units.
inVentiv Health has opened a new UK office in order to better target European customers, whilst Novum says its North Dakota facility will strengthen its offerings.
