A lawsuit alleging that the US FDA unlawfully detained a batch of acetaminophen API destined for CMO Gemini Pharmaceuticals could have significant impact on the drug industry's definition of an ‘end user.'
Medical imaging software firm Median Technologies has signed a three-year contract with US Phase I clinical trial CRO South Texas Accelerated Research Therapeutics (START).
Soon to be merged CMO DSM Pharmaceutical Products (DPP) has been contracted to provide process development for a protein allergy drug being developed by Tunitas Therapeutics.
Packaging Coordinators Inc (PCI) has begun construction on a US clinical storage and global distribution facility with demand from international clients being a key driver.
The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals.
Soon to merge CMO Patheon has increased solid dosage form production capacity at its site in the UK and posted an improved set of preliminary results for the financial year.
Asking qualified persons (QP) to certify that drug batches comply with manufacturing quality rules in destination EEA markets is unrealistic say groups commenting on proposed revisions to Annex 16 of the EU GMP guidelines.
The US FDA has defined compounding pharmacies as ‘outsourcing facilities’ in new guidance issued days after the Drug Quality and Security Act (DQSA) became law.
Trust, transparency and end-to-end participation are just some of the reasons Merck Serono says its exclusive strategic partnership with Quintiles is the “first of its kind.”
Apotek Produktion & Laboratorier AB (APL) says manufacturing knowledge and drug delivery tech knowhow gained by its compounding business is a boon for its CMO unit.
As part of its global streamlining strategy a second Irish Merck & Co plant has been earmarked to close but the firm says it remains committed to Ireland.
Strategic partnerships are “the next phase” of sponsor-CRO relations, according to Parexel, and on top of saving pharma on oversight costs will reshape the industry.
Almac says it is in a unique position to offer Carbon-14 ADME radiolabeling for the growing antibody-drug conjugate (ADC) market and has already performed the service on a Pfizer candidate.
CRO Harlan Laboratories is partnering with BioXpert, a company specializing in laboratory animal science and services, to expand Harlan’s contract breeding services into Benelux, Germany. This was the second expansion in Europe over the last three months...
The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law last night.
Actavis says it is restructuring a Californian manufacturing facility at a cost of 56 jobs weeks after the announced closure of a plant in North Carolina.
Catalent says it is creating dedicated space and possibly jobs at its Missouri facility in order to service a commercial contract for Pharmacyclics’ oncology drug Imbruvica.
Unilife has signed a $40m long-term supply agreement with Hikma and says it is committed to becoming the world’s largest and most successful injectable drug delivery systems supplier.
Smartphones are changing the role of the patient in clinical trials and can be used for industry success, Pfizer and technology provider firm Exco InTouch said at PCT 2013.
Pfizer says it intends to shutter a manufacturing facility in Puerto Rico just days after Merck & Co. announced it was reducing its footprint on the island.
Particle Sciences has been tasked with creating a nasal formulation of the steroid hormone progesterone that can be used to treat patients who have suffered traumatic brain injury.
The high cost of energy in the UK is having a negative impact on drug and chemical firms' ability to compete according to manufacturers quizzed by the Chemical Industries Association (CIA).
Economic uncertainty and a bleak fiscal outlook will lead to over-regulation and increased fines in the clinical trial industry, according to an economic expert at PCT.
Strategic partnerships were put on trial yesterday at PCT and with a number of alliances coming up for renewal, Pfizer, Novartis, Amgen and Baxter spoke about the issues affecting a sponsor-CRO relationship.
CRA Assessments says its standardised simulation approach to clinical trial monitors is a novel way for CROs and pharma firms to save costs and ensure quality.
Eli Lilly is investing over $700m (€518m) at a number of its insulin producing sites globally saying it is a response to the “growing diabetes epidemic.”
US authorities will soon have a new system capable of tracking drugs from the factory floor to the pharmacy shelf after the Senate passed the “Drug Quality and Security Bill” last night.
Royal DSM wants to merge its pharmaceutical products business with Patheon and has signed a deal with the latter's owner, investment group JLL Partners.
US Senators will debate pharmaceutical track and trace legislation later today in a session that could have a dramatic impact on how drug supply chains in the country are monitored.
AstraZeneca says it would never outsource the manufacture of Zoladex after announcing plans to invest £120m ($190m) in a fifth production facility for the blockbuster cancer drug.
