Clinical trials in the UK are reportedly declining as the country grapples with Brexit – a change which could make access to preclinical and bioanalytical research materials, including NHPs, problematic, says QPS.
Non-profit organisation, Civica, sees membership reach over 800 hospitals as part of its plan to secure the supply of generic medicine in short supply.
The FDA is addressing increasingly complex eligibility criteria in an effort to expand patient participation in cancer clinical trials, a move which will help shorten study recruitment timelines, among several other benefits to both researchers and patients,...
US FDA announces that a new generic for valsartan will reach the market, after prioritising the review of the product to alleviate shortages resulting from recalled products.
CRF Bracket closes its first full quarter as a combined entity with more than a 20% increase in new clinical trial business – and will “aggressively look for partners” from its current and future customers, says CEO.
Datathon participants identify five repurposable drug candidates, applying AI to identify genes of interest and support target identification – a task that previously would have taken years, says industry expert.
Akorn announces fraud case launched by Fresenius has been denied by US courts, shortly after fourth quarter financials revealed problems within its manufacturing network.
Camber and Macleods voluntarily recall losartan tablets lots, after trace amounts of a possible carcinogen found in an API ingredient manufactured at the same third-party facility.
Parexel boosts its oncology team, Premier Research has a new COO joining from PPD, and SGS names a new biologics manager, among other new hires in February.
The goal of the learning health system is to improve based on the experiences of every participant, sharing research knowledge to drive a “person-centered future of health,” says LHC CEO.
Novartis exercises its option to license Ionis’ RNA-targeting cardiovascular drug, adding to its cardiovascular treatment portfolio, as Entresto reaches the three-year mark on its patent.
The pharmaceutical and biotech consultancy has opened a new office in Dublin, Ireland ahead of Brexit, the final outcomes of which remain unknown, says CEO.
A number of companies spent the early part of the year creating and then filling new positions, which has seen another big pharma company follow the trend of appointing a chief digital officer.
Clinical trial sites are challenged by fragmented financial processes, according to a new study by the Society of Clinical Research sites and Greenphire released this week at SCOPE 2019.
A low volume, high margin business model will facilitate the development of new antibiotics and see big pharma return to the space, suggests Entasis CEO.
Artificial intelligence advances threaten data privacy, according to a new study, which found it is possible to re-identify individuals using their physical activity data.
US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.
In full-year financials, AstraZeneca announced that its R&D arm, MedImmune, will be absorbed into the overall company as it restructures its R&D units into specific therapy areas.
The EMA needs to fix problems with the clinical trial registry to improve reporting across Europe, says TranspariMED founder, as seemingly small issues can “seriously hinder compliance.”
The industry has advanced to a point that should justify the financial investment in new technology, though uncertainty, and a lack of support, are hindering movement.
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
The FDA issued a warning letter to McKesson for violations concerning a possible distribution of illegitimate opioid products while calling for action in securing the supply chain from illegitimate medications, especially opioids.
US FDA is reaching out to the industry to agree upon ‘voluntary consensus standards’ to promote the development of drugs and reduce manufacturing cost.
US FDA Psychopharmacologic Drug Advisory Committee recommends Spravato, an intranasal form of esketamine, for approval based on its favorable benefit-risk profile.
Hugh Pullen, EMVO’s president, explains what the launching of the EMVS means for the industry, and details how a potential no-deal Brexit will impact the system.
Mylan’s recently FDA-approved Advair Diskus generic to be offered at 70% cost reduction to its reference drug, and 67% less than GSK’s generic version.
US FDA initiates a pilot project testing innovations in an aim to inform the development of the tracking and verification systems going into effect with the DCSA in 2023.
