The US FDA has cleared Lupin to restart production of drugs for the US market at its plant in Goa after the Indian firm fixed problems observed by agency inspectors.
A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.
A plan to attract advanced medicinal therapy manufacturing to the UK has emphasised the importance of the MHRA having a leading role in development of global regulatory standards.
While the temperature is dropping outside, keeping clinical trial therapeutics and biospecimens at the right temperature during transportation is a challenge year-round.
Efforts by Wockhardt to fix violations at drug plant in Wrexham, Wales are inadequate according to the US FDA which detailed its concerns in a warning letter this week.
Cel-Sci has responded to the partial clinical hold imposed on a Phase III trial of its candidate head and neck cancer cell therapy Multikine in September.
Sanofi Pasteur has confirmed the decision to stop making the bladder cancer drug TheraCys was prompted by long running problems at the Toronto manufacturing plant where it is made.
The new eConnect program enables integration of physician systems to clinical research and has the potential to improve data quality, decrease site visits, and expedite payment, says Medidata’s president.
Bracket has announced the strategic acquisition of CLINapps as it focuses on the “tremendous opportunities” to make the clinical supply chain more efficient.
Parexel has launched an Identification of Medicinal Products (IDMP)-focused solution to help biopharmaceutical companies meet impending regulatory requirements.
Industry efforts to comply with new US track and trace rules are accelerating, but concerns remain about the quality of symbols used to mark products according to GS1 US.
The flexibility of clinical development for products on designated accelerated pathways is leading to at-risk investments in commercial manufacturing, say Pfizer and the FDA.
The new packaging solution is the first innovation to emerge from World Courier's Climate Optimization Research & Engineering (CORE) Labs, which it launched in 2015.
Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
The US FDA has cleared Adaptimmune to start a trial of its fat cancer cell therapy, lifting the clinical hold imposed in August when the agency asked for more manufacturing data.
US public health programmes will use lower dose vaccines administered over longer periods from 2017 if President elect Donald Trump adheres to a plan he outlined last year.
CluePoints has launched a new solution to help support clinical data quality improvement as the industry looks to mitigate fraud – both unintentional and malicious.
Endo International has signed an agreement to sell its facility in Charlotte, North Carolina to an unnamed buyer that will take on 125 workers currently employed at the site.
Solithromycin’s benefits outweigh its risks but developer Cempra has not adequately characterized how likely the antibiotic is to cause liver damage according to a US FDA panel.
Exco InTouch has been granted a US patent for to its mobile health solutions, as the company works to establish its “leadership in the digital health field.”
Agilent Technologies has contracted the original creators of its RapidFire 365 High-throughput Mass Spectrometry System to further develop new applications.
The global clinical trials laboratory services organization, Q2 Solutions, is expanding its genomic companion diagnostics (CDx) capabilities through a new collaboration.
The US FDA has issued a complete response letter for Sanofi and Regeneron’s rheumatoid arthritis candidate sarilumab due to manufacturing deficiencies at a fill/finish plant in France.
The adoption of eTMF solutions is accelerating – with more than 50% of investigative sites expected to have access to a sponsor/CRO eTMF application within three years.
Daiichi Sankyo will commercialize an abuse-deterrent formulation of the opioid painkiller morphine sulphate in the US in an agreement with developer Inspirion Delivery Sciences.
Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.
Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO).
Cel-Sci has received written confirmation the US FDA has placed a late stage trial of its cancer cell therapy Multikine on partial clinical hold a month after agency first raised concerns.
The US Environmental Protection Agency (EPA) has fined Pfizer $190,000 for failing to disclose that it had ammonia and methylamine at its facility in Barceloneta, Puerto Rico.
The Chinese Food and Drug Administration (CDFA) has fired back on lack of context in media reporting “80% of China’s clinical trial data are fraudulent.”
Veeva has announced two new products and a series of new hires across its product management team after nearly doubling its customers over the past year.
EAG Laboratories has added 33,000-square-feet to its Easton, Maryland facility, with space for dedicated laboratories and equipment to support GLP-compliant ecotoxicology, environmental fate, metabolism, and other testing services.
The US FDA has told Aduro Biotech not to enrol subjects in trials of its listeria-based immunotherapies after one study subject tested positive for the bacteria.
Biotrial has accused French newspaper Le Figaro of leading a “smear campaign” through its coverage of the Phase I trial in which one man died and five others were hospitalised in January.
APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US Food and Drug Administration (FDA).
Validic and Sutter Health are collaborating on a federal pilot project that seeks to determine how patient-generated health data can be best delivered to researchers.
