Lonza has added to its hepatocytes portfolio to provide researchers with the foundation to create “more physiologically relevant” in vitro models for liver disease research.
Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher.
The US FDA has approved US WorldMeds LLC’s non-opioid treatment Lucemyra, adding another “tool to the toolbox” for withdrawal management, says American Society of Addiction Medicine.
Dr Reddy’s expects to have addressed all GMP violations at its Duvvada drug formulation plant and Srikakulam API facility within the next six weeks, says CEO.
WCG has opened a new office in Tokyo, Japan that will serve as a center of excellence for its patient engagement group and house the company’s clinical services division in Asia.
PPD and Evidera have joined MIT’s NEWDIGS initiative through which the CRO aims to scale sustainable, commercially viable tools to “drive more value faster.”
President Trump says he will sign the “big legislation” after the US House of Representatives passed the Right to Try Act – opponents of which warn lacks key patient protections.
GDP growth and low-priced generics in pharmerging countries have contributed to the growth of Asia Pacific's pharmaceutical market, which has surpassed Western Europe as the second largest globally, says report.
Astellas will contract out an internal testing laboratory to Eurofins Scientific, marking the CRO’s entry into biopharmaceutical product testing in Japan.
AstraZeneca is embedding Emulate’s Organ-on-Chips technology – and scientists – within its laboratories to further develop the technology as part of a strategic agreement, “with the overall goal to accelerate drug discovery,” says exec.
The global health research network today has announced the availability of TriNetX Research, a suite of analytics solutions designed to leverage real-world data during observational and outcomes research.
The newly-formed investment firm DORA Ventures has recapitalized Tedor Pharma, which recently completed a multi-million-dollar expansion of its manufacturing capabilities.
XenoGesis and BioAscent have teamed up to fill "a gap in the market" for integrated drug discovery services aimed at biotech, mid-sized pharma, and academic drug developers, says CEO.
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.
