Stem Cell Theranostics has secured rights to the technology it uses to make cellular heart disease models for drug development through a deal with GE Healthcare.
A new four-year research project involving a consortium of government, non-profit and other large biopharma partners is aiming to create a set of measures that can be used in clinical trials to determine which ASD (autism spectrum disorder) treatments...
In an industry with high employee turnover rates, CROs (contract research organizations) are now turning to new, creative ways to try to recruit and retain top talent.
Thermo Fisher Scientific has developed new software via a partnership with the Special Bacteriology Reference Laboratory at the CDC (Centers for Disease Control and Prevention) that helps public health labs to more quickly identify microbial pathogens...
Mylan has recalled 14 lots of calcium chloride intravenous infusion after customers found the prefilled syringes were not compatible with needless adaptors.
AMRI has bought Spanish contractor Gadea Pharmaceutical Group for $174m (€160m) to add muscle to its steroid API business and sign up more customers outside the US.
NASA has used a remote control plane and a fleet of drones to deliver drugs in an approach that could help pharma firms get medicines to patients in hard to reach locations.
API firms that invest in waste management find it hard to compete with those that pollute according to DSM Sinochem, which wants environmental criteria included in GMP standards for environmental and business reasons.
Agilent and A*STAR have partnered to create quicker, more accurate ways of testing the sugar content of therapeutic proteins and monoclonal antibodies (mAbs) that are tailored for commercial producers.
Full-service CRO (contract research organization) Frontage Laboratories has acquired a 45% stake in BDM Consulting to expand its offerings in biostatistics, data management and SAS (statistical analysis system) programming.
Eisai has agreed to transfer ownership of its Research Triangle Park (RTP) manufacturing campus to Biogen, which will continue to manufacture oral solid-dose products and parenteral products at the sites for Eisai.
Celgene has shelled out $7.2bn (€6.6bn) to acquire Receptos which is developing an oral lymphocyte trafficking agent for multiple sclerosis and inflammatory bowel disorder.
Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine, which is hoping to commercialise its breast cancer candidate.
Drugmakers risk losing financial backing if they source APIs from Indian suppliers that pollute according to Nordea Asset Management's head of responsible investments, Sasja Beslik.
Proteon Therapeutics has extended a deal with Lonza for the development and manufacture of its lead product, the pancreatic elastase candidate vonapanitase.
France’s AB Science has received a warning letter from the US FDA for its failure to adhere to agency regulations and to protect trial subjects’ safety in a pancreatic cancer study and GIST (gastrointestinal stromal tumor) studies from 2009 to 2013.
The latest EMA (European Medicines Agency) report on GCP (good clinical practice) inspections reveals that deficiencies around SOPs (standard operating procedures), sponsor monitoring, data management, and essential documents linked to trials were most...
With no active production at the plant since 2013, the company said it would shutter its Mumbai, India-based facility in mid-September, according to a Bombay Stock Exchange filing.
The founder of a phony pharma company which made $12m importing fake chemo drugs to the US has been banned for life by the US FDA from working with any pharma businesses.
The almost-private China-based CDMO (contract development and manufacturing organization) WuXi is looking to reap larger rewards from investing in US and China pharma and biotech firms.
With an exclusive board of directors and now some funding, Nuvelution Pharma is looking to get its risk-sharing clinical trial venture for late-stage candidates off the ground and will engage with CROs (contract research organizations) in the near future.
India’s Emcure Pharmaceuticals has been banned from shipping any of the drugs manufactured at its Maharashtra-based facility to the US, according to an import alert from the US FDA.
DNA-based diagnostics company Cancer Genetics has partnered with the lab services group of CRO Icon to provide clients with new offerings, including oncology-focused genomic testing, central lab analysis, project and data management, and sample logistics.
CDMO (contract development and manufacturing organization) Aptuit is investing in additional scale and capabilities at its Italian site to augment its 1600L scale API capability and to add a commercial GMP license.
CiMaas BV, a company developing cellular immunotherapies to treat cancer, has selected CMO (contract manufacturing organization) PharmaCell, to help in the clinical development and manufacturing of CiMaas’ ATMPs (Advanced Therapy Medicinal Products).
Antibiotic API makers have an obligation to ensure their activities do not spread resistance says a group that welcomed DSM-Sinochem’s commitment to environmentally-friendly production.
China-based CDMO (contract development and manufacturing organization) WuXi PharmaTech has raised about $80m for subsidiary SynTheAll Pharmaceutical Co. (STA) via the private placement of 7.16m common shares of STA stock.
Following an FDA inspection in March, Catalent’s Center of Excellence for Analytical Services in Morrisville, NC was hit with a Form 483 with six observations.
With an overwhelming majority, the House on Friday morning passed a new bipartisan bill that would increase NIH funding by about $8.75bn and the FDA by $550m over the next five years.
The fanfare that accompanies Big Pharma strategic partnerships with CROs is rarely followed by progress reports according to an industry consultant, who warns the lack of feedback means mistakes are repeated.
Massachusetts-based CRO Parexel has expanded its services and capabilities in model-based drug development (MBDD) via its Quantitative Clinical Development (QCD) unit.
With the bipartisan 21st Century Cures Act coming up for a vote Friday in the US House, the White House and others are raising a number of concerns over how the bill would be paid for and what it will actually do to speed new cures to market.
An operational rejig at DPT Laboratories, an expansion at UDG, and a synthesis and toxicology testing contract win for Dalton – welcome to Outsourcing-Pharma’s CDMO round-up.
Proposed amendments to TTIP backed by MEPs will either encourage foreign investment or allow US drug firms to sue EU states whose laws restrict profits, depending who you ask.
US and China-based CRO FMD K&L has expanded into Armenia with a new office to support clients’ needs in the region and grow the company’s business further in Europe.
Epic and LabCorp’s Covance have agreed to extend their partnership to provide circulating tumor cell (CTC) technology and oncology clinical trial support in Asia.
A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption...
