Amneal Pharmaceuticals expects to bring production of some Impax Laboratories’ drugs in-house through a 100,000 sq. ft. expansion at its site in New York state.
Alligator Bioscience says an existing agreement with Theradex informed its decision to re-sign the CRO, this time to test metastatic cancer candidate ATOR-1015.
Apple has updated its Health app to give users access to their medical records – a new feature that could fundamentally change the way research is conducted, says Medidata.
Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.
XtalPi is advancing artificial intelligence models and prediction-driven research capabilities to improve drug design and small molecule development services.
Avista Pharma Solutions, Inc. has acquired Solid Form Solutions, Ltd. to provide customers with a broader suite of services as a single company, says CEO.
Sanofi and IONTAS have signed an agreement through which the company will use IONTAS’ proprietary technology – which aims to bridge the gap between a “great lead” and “poor developability,” says CBO.
Smart Containers Group is accepting cryptocurrency payments to ship pharmaceutical products, which the firm says will free up manpower and reduce transport costs.
Concept Life Sciences has teamed up with the UK-based bioanalytical contract research organization (CRO) Alderley Analytical to provide customers with bioanalytical and DMPK study services.
Rephine says its online Quality Assurance database transforms the lengthy active pharmaceutical ingredient (API) pre-selection process to just a couple of clicks.
The US FDA has asked Braeburn Pharmaceuticals for more information regarding its sustained-release subcutaneous buprenorphine injection in a complete response letter (CRL).
Paragon Bioservices plans to open a new 150,000 square-foot facility to help fulfill a growing demand for the company’s gene therapy manufacturing services, says CEO.
SQN Clinical has launched SQN Health, a mobile electronic Patient Reported Outcomes (ePRO) and Clinical Outcome Assessment (eCOA) application, which provides real-time and ongoing patient and data oversight.
The US Government shutdown only lasted one working day but the US FDA could take weeks to make up the lost time according to the Alliance for a Stronger FDA.
Apotex has recalled a batch its diabetes drug APO-Metformin XR in Australia after a pill was plastic from a cable or zip tie was found embedded in a pill.
Scientists say a modified plant extract traditionally used as an arrow poison in eastern Africa could inhibit sperm cells’ ability to swim, and lead to the development of a male contraceptive pill.
The Access to Medicines Foundation has launched a ‘benchmark’ that maps drug industry efforts to stem the spread of drug resistance at the World Economic Forum in Davos, Switzerland.
The US Food and Drug Administration (FDA) is launching a new pilot program this month aimed at increasing clinical trial transparency – though many opportunities remain to improve the scope, clarity, and usability of data, says TrialScope CSO.
Japan’s proximity to China, pharmaceutical infrastructure, and workforce capabilities helped inform Biorasi’s decision to launch regional headquarters in Tokyo, says executive.
Revisions to the Federal Policy for the Protection of Human Subjects has been delayed six months, possibly more, as regulators cite the rule’s complexity, lack of guidance, and other challenges.
Pfizer says ongoing remediation to the quality validation process at its supplier has resulted in a shortage of EpiPen auto-injectors in the 0.3 mg format.
Almac Group has invested £30m ($41.65) to expand its clinical and commercial drug supplies capabilities at its European Campus in Ireland as it prepares for the UK’s exit from the EU.
The Tjoa Group has launched Meditraq to help firms across the pharmaceutical supply chain meet data requirements, one year out from the EU serialization deadline.
Ipca Laboratories, a fully-integrated Indian pharmaceutical company, has purchased an NC-based CMO in a $9.65m deal that will enable it to manufacture small volume APIs for the US market.
Celerion has integrated its proprietary electronic data acquisition system, ClinQuick, with OmniComm’s electronic data capture (EDC) solution, TrialMaster, to create a fully automated clinical trial data management platform.
PPD and Quotient Sciences have announced a new collaboration to accelerate pediatric drug development – as developing age-appropriate medicinal formulations will continue to be a focus of regulators, clinicians, and parents, says PPD senior VP.
Radiopharmaceuticals firm Telix Pharmaceuticals Limited has established a subsidiary in Japan to support clinical development and manufacturing activities.
