22-May-2013 - Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its...
22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.
22-May-2013 - GlaxoSmithKline (GSK) says some manufacturing from the shuttering of an Australian packaging site will be picked up by Aspen and local third-party contractors.
22-May-2013 - Boehringer-Ingelheim’s German API and pharmaceutical manufacturing facility was cited by the FDA for two API and two drug cGMP violations, as well as failing to respond with sufficient corrective actions...
21-May-2013 - ADC Biotechnology says demand for antibody drug conjugates (ADC) services has skyrocketed as it receives a second financial boost to development in four months.
21-May-2013 - Almac says the joint programme with UCL will complement its partnership with DSM and increase its biocatalysis offerings.
21-May-2013 - Biopharma companies are looking for more pre-fabrication of their facilities and to be able to expedite construction and meet tighter timelines, an expert told Outsourcing-Pharma.com.
20-May-2013 - Cobra Biologics is confident it can win the commercial contract for Vaccibody AS’ candidate DNA vaccine, citing its production platform and recent capacity expansion as key.
15-May-2013 - Extra filling capacity is to be made available in preparation for West’s Crystal Zenith (CZ) system, though approval and increased sales are still at least 18 months away.
15-May-2013 - Kemwell says expansion of its Indian analytical services will service a major client but is part of an active growth strategy.
15-May-2013 - Better than expected growth in Wuxi’s manufacturing services has driven the CRO to exceed its earlier guidance in the first quarter of 2013.
14-May-2013 - Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.
14-May-2013 - Large scale manufacturing contract revenue in the first quarter of 2013 increased 14% over the same quarter in 2012 as AMRI (Albany Medical Research Inc.) saw an 11% increase in overall revenue.
14-May-2013 - Varicose veins could prove to be a big revenue stream for UK CMO SCM Pharma which has been named as commercial supplier for BTG’s candidate treatment, Varisolve.
13-May-2013 - Melding metals to APIs could make drugs easier to deliver according to Sweden's Recipharm which partnered to add a new chemistry to its offering last week.
10-May-2013 - Continued manufacturing issues at both American Regent and Hospira have caused the US FDA to begin allowing foreign imports as early as next week to combat a shortage of critical...
07-May-2013 - API makers Chemport and BASF have been cleared by US regulators to supply Amarin with omega-3 for its heart drug Vascepa.
06-May-2013 - Manufacturing problems and costs associated with a new device-focused strategy hurt in Q1, but Hospira says efforts to fix troubled Rocky Mount facility are still on track.
02-May-2013 - Following the completion of remediation efforts to deal with an FDA warning letter, Chris Phillips, AMRI's senior director of its Burlington, Massachusetts site, discusses what he considers to be a "new...
02-May-2013 - Goodwin Biotechnology has teamed up with Coldstream Laboratories to offer clients ADC services as another example of biopharma demand driving contract manufacturing and development.
30-Apr-2013 - Manufacturing disruptions at Lonza's Hopkinton, Massachusetts site are causing shortages of Ipsen Biopharmaceuticals’ growth failure treatment for children in both the US and EU, just as the company announces that...
30-Apr-2013 - The ribbon has been cut on Catalent’s new single-use biomanufacturing Centre of Excellence which will quadruple its current offering.
29-Apr-2013 - The US Department of Justice’s Attorney’s Office in Boston has sent subpoenaed documents related to AstraZeneca's UK manufacturing practices, which the company said it is complying with.
24-Apr-2013 - The US FDA is beginning to push CMOs and other manufacturers away from using real-time release testing as a shortcut to ensuring drug quality and reducing end product testing, experts...
24-Apr-2013 - With backing from the Australian Government, DSM has opened a mammalian cell culture operation to fuel the growing demand in the Asia-Pacific biologics market.