US desire for an alternative to the current multi-shot anthrax vaccine is a boon for delivery systems firm Glide Technologies, which had its contract extended by Pfenex this week.
Pharmaceutical and chemical manufacturers may have to wait until 2017 to see the benefits of the Transatlantic Trade and Investment Partnership, VP of SOCMA (Society of Chemical Manufacturers and Affiliates) told attendees at InformEx in New Orleans.
Sanofi will invest in biologics and vaccine manufacturing capacity in 2015 to sustain product launches and ease constraints that impacted its Sanofi Pasteur division in the past few years.
Novo Nordisk wants “a political debate” and changes to financial disclosure laws after Danish authorities fined it $90,000 for not immediately telling investors the US FDA had rejected Tresiba and Ryzodeg in 2013.
The Association of Clinical Research Organizations (ACRO) offered a number of recommendations to the US House Energy and Commerce Committee’s “21st Century Cures” initiative last week as part of an effort to keep the US research industry competitive globally.
US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.
For the seventh time since 2006, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify and root out Internet-based makers and distributors of illegal drug products and medical devices.
Biopharma executives believe there will be strong growth in domestic R&D activities and biopharma manufacturing, but fewer workers will be needed as efficiencies in productivity are achieved across the industry, according to a new survey from industry...
Regulatory compliance will be the number one focus for Sun Pharma, the company says, following its $3.2bn (€2.3bn) takeover of Indian generics firm Ranbaxy.
Quality and IP issues are driving firms back to the US and Europe for their contract manufacturing according to experts, but Kemwell says there are still opportunities for Indian CMOs.
An expression system developed by Cevec Pharmaceuticals has achieved 'very high' titres and bypassed problems that beset other platforms, moving the possibility of a commercial respiratory syncytial virus (RSV) one step closer.
Publication of a US FDA enforcement report detailing a recall by Ranbaxy in January saw the beleaguered Indian drugmakers’ share price fall 3% last week.
US and foreign generic drug manufacturers will see a more than $40,000 increase in US FDA facility fees for 2014, while API manufacturers will see a more than $8,000 increase.
Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association.
The US House of Representatives has passed a bill by voice vote that would for the first time create a system to track and trace drugs through the supply chain.
Ideal Cures has been granted a US patent for an immediate release film coating tech that - it claims - could rid the Pharma production sector of solvents.
Freeman Technology says growing Pharma demand for analytical data prompted the formation of US subsidiary and it behind its plans for a new laboratory.
It’s been a busy year for API (active pharmaceutical ingredient) manufacturers with new facilities, cost pressures and regulatory developments all hitting the headlines.And it seems recent developments in HPAPIs (high potency APIs) have caused a stir...
Intelliject has received tentative US FDA approval for its e-cue ‘talking’ autoinjector, setting the device maker up for a potentially lucrative partnership with licensee French drug giant Sanofi.
US Government Officials have implored ten major pharmaceutical companies to give up information in the race to solve the 2007-2008 contaminated Chinese herparin incident.
Lab Research's main Canadian lender has obtained an order appointing receivers under section 243 of the bankruptcy and insolvency act after the firm's US private equity suitor lost interest in a takeover.
Contract Research Organisation (CRO) Quintiles has opened a Phase I facility in Hyderabad, India, citing increasing demand for efficiency in early-phase drug research in the country.
WikiLeaks has published a list of overseas biopharmaceutical facilities considered vital to US national security as part of its release of leaked diplomatic cables.
IMS Health predicts that global drug sales will increase 5 to 7 per cent next year, driven by development of innovative pharmaceuticals and growth of emerging markets.
From 2005 to 2009 61 per cent of US NIH registered trials included at least one study site outside North America. Outsourcing-Pharma presents this, the 2009 downturn in US trials and other data as an interactive visualisation.
The opening of a New York office will help communicate Clintec’s global reach to US Pharmaceutical according to new associate director of US business operations, Susan Pavone.
Unilife has initiated a 24/7 manufacturing cycle at its facility at Lewisberry, Pennsylvania, US after it received marketing clearance for its Unitract 1ml insulin syringes from the US FDA.
CMO Vetter Pharma has expanded its manufacturing capacity with a new in Illinois, US that it says brings it closer to customers and will allow it to collaborate with clients earlier in the drug development process.
The US arm of packaging giant Schott has added ready-to-fill (RTF) glass syringe manufacturing capacity at its facility in Lebanon, Pennsylvania in a $14m (€9.4m) expansion designed to meet growing demand.
Philips has entered into a joint research programme to evaluate ThermoDox with MR-HIFU, a combination therapy that could provide a precise, non-invasive way to treat difficult cancers.
Europe is pulling ahead of the US in research productivity, according to a controversial new study by Washington public policy think tank Health Affairs.
Emergent BioSolutions believes it can reduce its debt, cut operating expenses and gain more flexible production capacity by reorganising its manufacturing operations.
