Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time in critical pre-IND/BLA meetings.
Profectus BioSciences has signed up San Diego-based CMO Althea Technologies to manufacture DNA vaccines after its deal with Boehringer Ingelheim ended due to currency issues.
Good ideas in drug delivery will continue to attract investment though the increasing cost of clinical trials does pose a difficulty according to MIT Professor Robert Langer.
Hospira has announced it is voluntarily recalling multiple lots of five different injections because of customer reports of faulty packaging and contamination.
CRO Covance is teaming up with M2Gen’s cancer-focused database to increase its ability to match more patients in oncology trials based on their tumour profiles.
Ireland-based CRO Icon unveiled higher than expected revenue and backlog increases in 2012 when compared to 2011, and the company expects even stronger results in 2013.
US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification.
Pantarhei Bioscience has sold in Estetra, its oral contraceptive development JV, to partner Uteron Pharma and will use the proceeds to fund further development.
Biopharmaceutical CMOs have seen their business slowly shrink as companies seek less volume and smaller batches, but outsourcing is expected to increase over the next three years.
West Pharmaceuticals says it is still intent on shifting to proprietary products following results from its packaging and contract manufacturing businesses.
The US FDA says draft guidelines on risk-based immunogenicity testing of protein drugs will encourage the pharma industry to continue development efforts.
European API distributors may see costs increase if guidelines requiring quality systems and ‘management representatives’ at distribution points are adopted.
Excipient firms that skip lot testing or use alternative analysis methods should justify their decisions according to a new COA guide issued by IPEC Americas.
CMO ProBioGen says its GlymaxX ADCC antibody enhancement technology can be adapted to any biomanufacturing cell line and will attract both Big and Small Pharma.
CMOs (contract manufacturing organizations) developing pharmaceutical intermediates have shifted their focus to complex nucleosides, peptides and carbohydrates over the last five years, an expert says.
Biocatalysis is emerging as a hot topic for CMOs in 2013 with AMRI, Almac and DSM all citing drug industry demand as the driver for recent collaborations.
‘Long awaited’ draft guidelines on excipient risk assessments proposed by the European Commission (EC) have been welcomed by industry group IPEC Europe.
In its second announcement of a closing research unit in little more than a week, Pfizer will axe its peptide therapeutic R&D unit CovX Research in San Diego, CA and lay off 100 employees there.
Takeda says it will help Nihon Pharmaceuticals bring manufacturing operations up to code after Japanese regulators order the CMO to halt production and recall one lot of its vitamin B1 shot.
Dow has contracted Cambrex to make its solubility enhancing polymer HPMCAS, adding manufacturing clout to its bioavailability-focused collaboration with Bend Research.
Aesica and EmulTech claim a new sterile formulation technology could help drugmakers resurrect abandoned projects and extend the lifespan of marketed medicines.
Quintiles painted a rosy picture of the CRO sector in its much anticipated IPO, predicting that biopharma R&D spending will increase and demand for outsourced research will grow.
