Motif Bio plc has secured £10m ($14m) to support the potential commercialization of its lead candidate – iclaprim – which was granted FDA fast-track status in 2015.
An improved relationship between drugmakers and excipient suppliers could help drive development in the novel inactive ingredient sector, says industry expert.
The US FDA has issued a warning letter to CDMO Ei LLC stating that topical drugs and pesticides are being made in the same building and with shared equipment.
Regulatory agencies are doubling down on compliance – and withholding funds – as the clinical research industry enters an era of accountability and transparency, say NIH officials.
LMC Manna Research has expanded its site network providing Phase I-IV clinical trial services to customers, such as Sanofi, which has launched a new program to reduce site burden.
Marken has expanded its cryogenic services to support demand driven by an increasing amount of global cell and gene therapy clinical trials – a market projected to reach $363m by 2022.
PolarityTE has acquired a preclinical biomedical research facility which will serve as a CRO to accelerate research and development and “help drive the field of biotechnology,” says CEO.
Inadequate temperature control and a lack of ‘appropriately’ designed manufacturing equipment are among the GMP violations that landed Goran Pharma a warning letter.
Icon has announced a clinical research partnership with DuPage Medical Group, a Chicago, IL-based network with more than 700 physicians across more than 100 locations.
The US FDA has issued a policy that provides the proper definition of an outsourcing facility in an effort to ensure compounded drugs are made under appropriate quality standards.
Researchers at John Hopkins Bloomberg School of Public Health cite lack of staff as one of the main causes of many academic institutions being slow to adhere to new clinical trial reporting requirements.
The Chinese contract research and development company WuXi AppTec has raised more than $353m in its initial public offering of common stock on the Shanghai Stock Exchange.
In a deal worth up to $538m, AstraZeneca has entered into an agreement with Luye Pharma Group for the sale and license of the rights to Seroquel and Seroquel XR in several markets.
Suven Life Sciences has completed a US FDA renewal inspection at its Pashamylaram-based facility, which manufactures and supplies APIs, intermediates, and formulations.
The UK-based CRO RxCelerate continues to expand with its recent acquisition of The Cambridge Partnership for £1.45m ($1.96m) as it aims to carry out its vision of supporting virtual biotech companies.
Evotec has entered into a strategic collaboration to accelerate Carna Biosciences’s program CB-1763, which is being developed for the treatment of blood cancer.
Novartis’ recently launched FocalView app will be used in a new study to remotely collect electronic device reported outcome measurements (eDROs) from 150,000 users.
Sanofi has awarded Meditope Biosciences a BioLabs’ “Golden Ticket” to support the development of its bioconjugation platform and create new antibody-based therapeutic constructs.
To distance itself from its troubled past, Valeant Pharmaceuticals is set to change its name to Bausch Health Companies, marking an important point in the "turnaround process," says CEO.
ANI Pharmaceuticals has completed its acquisition of six generic products, related manufacturing and supply agreements, and equipment from Amneal Pharmaceuticals and Impax Laboratories.
monARC Bionetworks has announced an integration with Roivant’s drug development platform, as part of which the healthcare technology provider will receive a strategic investment.
The company, which has partnerships to support clinical trials recruitment, has received an unsolicited acquisition offer from Elliott Management – skyrocketing the EHR provider’s stock.
Scientists at the University of Leeds may have found a new way to reduce the number of animals used in research while also gaining improved insight into treating cancer and other diseases.
Takeda has acquired Shire for approximately $62.11bn (£46bn) to create a Japan-headquartered biopharmaceutical company with a robust pipeline and expanded geographical footprint.
AuroMedics Pharma LLC is voluntarily recalling two lots of injectable antibiotics following customer complaints of “red particulate matter” in the product.
A new partnership between Haselmeier and Common Sensing aims to develop smart connected monitoring and support solutions for users of injectable medicines.
WuXi STA has passed its first FDA inspection at its active pharmaceutical ingredient (API) development and manufacturing facility located in Changzhou, China.
Significant regulatory changes by the Chinese government will accelerate drug development timelines and positively affect sponsors’ bottom line, says CRO.
The UK government has provided the “strongest possible reassurance” that it will implement the incoming European Union Clinical Trial Regulation, whatever happens in the Brexit negotiations.
A new method for determining the crystal structures of organic salts – which make up 40% of all APIs – could “greatly speed up” the drug development process, say researchers.
The global contract research organization (CRO) market is forecasted to grow 12% year-on-year through 2021 – led by IQVIA with 12.4% of the market share.
Responding to the need of ensuring information integrity, Scientist.com has launched DataSmart – which applies blockchain technology to protect data throughout the drug development process.
Codexis is setting up Porton Pharma Solutions with its biocatalyst technology as part of a strategic collaboration aimed at liberating potential cost reductions of up to 20%, says CEO.
The US FDA has issued Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. a warning letter, in which it says the API maker admitted to deleting test data by accident.
PSI CRO has opened a new office in the California Bay Area to support continued growth organically – which, according to the company, is what drives its success.
Novartis has launched FocalView, a new app that aims to allow researchers to track ophthalmic disease progression by collecting real-time data from patients.
The US FDA has issued a warning letter to Mexican drugmaker Degasa SA. de C.V for violating good manufacturing practice (GMP) regulations for finished pharmaceuticals.
Sterling Pharma Solutions is boosting its small to mid-scale active pharmaceutical ingredient manufacturing capabilities, marking the CDMO’s second £6m investment in as many years.
UK-headquartered RxCelerate has acquired the specialist bioanalytical contract research organization Total Scientific – increasing its staff to 37 following its expansion stateside in November 2017.
