Catalent has licensed an expression technology from Excelimmune it says could offer biologics makers a cost-effective and simple way to make antibody combination therapies.
Pfizer’s Exubera may have muddied the waters but MannKind is confident a marketing push can help its inhaled insulin product Afrezza succeed after disappointing early sales.
Biocorp has raised €8.9m ($9.8m) through an IPO during what it called a period of “deep macroeconomic uncertainty” and has underlined plans to grow its drug delivery tech business internationally.
While pharma and biotech companies are increasingly turning to CMO (contract manufacturing organization) partners earlier in the drug development process, they may want to reconsider engaging with a CMO prior to filing a patent after a recent ruling from...
As biopharmaceutical companies look to cut costs and understand their core competencies further, the use of outsourcing and off-shoring have become even more mainstream than in years past, according to the 12th annual biomanufacturing report from BioPlan...
ReNeuron will automate processing of its stem cell-based stroke therapy ahead of planned Phase III trials using a system acquired from Sartorius Stedim Biotech (SSB) subsidiary, TAP Biosystems.
Novo Nordisk has ended a development partnership using Zosana Pharma’s microneedle patch system with its GLP-1 analogue semaglutide, currently being investigated in an oral formulation.
Specialty trials services and tech provider BioClinica has acquired the patient recruitment and retention firm, MediciGroup. Financial terms of the deal were not disclosed.
With a House floor vote looming this week, legislators will decide on a revised bill that has decreased the amount of funding that will go to the NIH from the original bill, and removed a section that would have required NIH grant recipients to share...
The European Commission last week officially added Israel and Brazil to a list of countries outside the EU that have standards of manufacture and supervision of APIs equivalent to those of the EU.
Even if claims about Kumdang-2 are real, access to the drug and other pharmaceuticals in North Korea is limited to those who can pay black market prices according to a UK-based defector.
Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.
The world’s second-largest central lab services company is now operational, with Quintiles and Quest Diagnostics calling their new creation Q2 Solutions.
GSK’s HIV unit ViiV Healthcare and China-based Desano Pharmaceuticals have forged an agreement whereby Desano will manufacture the API of GSK’s HIV drug Tivicay (dolutegravir) in China.
A group calling for GMP assessments to consider the environmental impact of API production says pollution generated by suppliers in China is furthering the spread of resistant superbugs.
Manufacturing operations at an Actavis legacy site in Iceland will cease and products will be transferred out the country from 2016, Allergan has announced.
More evidence linking fake pharmaceuticals and organised crime emerged today with Dutch police seizing suspicious Viagra pills along with cocaine, MDMA and burglary tools.
Capsugel has pledged to continue investing internally in drug delivery R&D after completing construction of a spray-dried dispersion (SDD) commercial manufacturing site in Oregon.
Hospira has begun commercial production at a sterile injectable plant in India hit with several 483 forms after the US FDA deemed the site ‘acceptable.’
CRO Pharmaceutical Product Development (PPD) has formalized relationships with eight investigator sites to create a pediatric investigator network (PIN) as part of efforts to speed trial startups, more predictably enroll patients and offer higher quality...
In another setback for Alzheimer’s drug developers, European CRO/biotech Evotec and partner Roche have announced that their candidate did not meet its primary endpoint after 52 weeks treatment in a Phase IIb study.
GSK is investing £38m ($60m) in enzymatic manufacturing at an antibiotic facility in Singapore which the firm says is greener and more efficient than traditional approaches.
Europeans who want to fund organised crime can now do so more easily by buying medicines from web pharmacies that lack a new logo launched by the EC to stop the sale of fakes online.
Transgene will close a biomanufacturing facility with the loss of 120 jobs to cut costs after Novartis pulled out of an immunotherapy collaboration last year.
BioClinica has opened offices in London and Munich to provide its European clients with expanded clinical trial services including medical imaging, site training and support, and eClinical product lines.
As the outbreak of Middle East Respiratory System (MERS) slows in South Korea, logistics supplier Marken has been granted government permission to deliver the first direct to patient (DTP) shipments of clinical drugs and supplies in the country.
US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer.
Juniper Pharma Services has won a contract to manufacture ‘sono-sensitive particles’ used to aid delivery of cancer drugs into solid tumours for OxSonics.
In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices)...
Generic juggernaut Teva Pharmaceuticals has partnered with Microchips Biotech to use its implantable drug delivery device to improve outcomes for patients on chronic drug therapies.
Aeterna Zentaris has selected UK-based Ergomed again for a clinical trial, this time for a confirmatory Phase III study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone...
The proposed Perrigo merger with Mylan would be of no benefit to either firm in the “highly competitive” OTC sector, according to financial analysts BMO.
Allergan is set to acquire Kythera Biopharmaceuticals for $2.1bn (€1.9bn) and add the recently approved injectable ‘double-chin’ drug Kybella to its facial aesthetics portfolio.
Canada has asked importers to quarantine APIs made by India’s Polydrug Laboratories over concerns about its manufacturing plant in Ambarnath in Maharashtra.
Bracket Global has acquired Boston-based Clintara, which will allow Bracket to integrate the Clintara platform of trial surveillance tools into its electronic platform for Clinical Outcome Assessments (eCOA).
Swiss CMO Lonza and Canada’s Octane Biotech have entered an exclusive technology evaluation of the Octane Cocoon cell production platform for personalized cell therapy manufacturing with the goal of a global deployment.
