WuXi AppTec has adopted Elsevier’s technology as the company begins to focus less on point solutions, and more on provider partnerships, says VP of procurement.
After much speculation, Pfizer has confirmed it will renew its service agreements with its largest contract research organization customers – as analysts suspected.
CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.
Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.
The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.
With the emergence of the empowered patient, the reimbursement landscape is shifting and stakeholders must navigate who really holds the power – and how this changes the definition of value.
Risk algorithms and international agreements will help ensure imported API quality, says FDA Commissioner Robert Califf but industry must also take responsibility for its own supply chain.
Parties negotiating TTIP have discussed measures that would end EMA API and drug manufacturing plant inspections in the US and FDA inspections in Europe.
The US FDA says Ko Da Pharmaceutical facility in Taoyuan City, Taiwan will not be able to supply the US unless the firm corrects all GMP deviations identified during an inspection last May.
The new 50,000 square foot facility in Lexington, MA will be dedicated to late phase development and commercial manufacturing for advanced cell and gene therapies.
Cobra Biologics has teamed up with Touchlight to test an AAV vector production platform they claim will make manufacturing gene therapies for trials cheaper and faster.
The biopharmaceutical industry broke several records in 2015 – but to continue the trend will require a sustained investment from multiple stakeholders.
Researchers used pre-existing platforms to identify and recruit patients for a cancer research study – connecting advocacy groups, social media, and a dedicated website to register patients.
A new $60m facility at a MSD site in Ireland will offer Fujifilm Diosynth customers 20,000L of microbial biologics capacity in a collaboration between the two firms.
A revised concept paper on first-in-human trials will be ready next month according to the EMA which is reviewing the French Phase I trial in which one volunteer died in January.
Organisations that identify API manufacturers whose manufacturing activities spread antimicrobial resistance will be considered alongisde other NGOs for a new European Commission award.
CMC Biologics as upped its production capacity at its Copenhagen facility with plans to have equivalent capacity on both sides of the Atlantic in 2017.
Sensors, computer vision, machine learning, and cloud computing are enabling preclinical researchers to conduct higher quality studies in a shorter period of time.
Partners Group, a private markets investment manager, has agreed to acquire global pharmaceutical services provider PCI Pharma Services citing “trends towards outsourcing.”
The US FDA has approved Probuphine, a subdermal buprenorphine treatment for opioid dependence using Titan Pharmaceuticals’ ProNeura drug delivery platform.
A real-world trial of GSK's Relvar has prompted the development of a ‘game-changing’ database linking and tracking tech according to North West e-Health.
Industry backing for a G7 plan to preserve antibiotics is at odds with current marketing practices says an NGO calling for a clamp down on campaigns that promote overuse.
The US FDA has told Megafine Pharma it must determine the extent of data falsification at the plant in Nashik, Maharashtra that was banned from shipping APIs to the US last year.
Rising drug prices and the subsequent increasing number of drugs ineligible for reimbursement will challenge drug developers to provide clinical superiority evidence.
ClinTec International has opened two new offices in Spain as it prepares for an expanding local clinical trial portfolio and larger outsourcing engagements in the country.
Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.
