The industry today celebrates Clinical Trials Day 2019, with events that will help promote awareness and a better understanding of study participation barriers, says ACRP, which aims to pilot a new initiative to advance the workforce early next year.
Novartis initiates a recall of Promacta after its contract manufacturer introduced peanut flour into the same facility as the treatment, potentially causing cross-contamination.
As generic competition looms, Gilead donates 2.4 million bottles of Truvada to the CDC to aid in the center’s fight against the HIV epidemic in the US.
Par Pharmaceutical initiates a recall of mycophenolate mofetil injection, after a vial containing a glass fragment was discovered during reconstitution.
Increasingly concerned with the potential for cyber attacks at third-party vendors, pharma looks to gain visibility into supplier performance, says industry expert after the recent breach at Charles River.
The industrialized process the industry has developed over the years is not ready for the non-blockbuster environment its entering but AI can help, says Numerate executive.
Lundbeck announces the acquisition of Abide, which provides the former with access to an R&D platform, a Phase II drug candidate, and drug discovery site in California.
The Indian company announced that the US FDA issued observations for both its Indrad and Dahej facilities, as well as being required to expand its losartan recall.
Synteract adds to its therapeutic centers of development, Sterling Pharma continues growth in the US, and WCG’s site division sees the addition of several executives, among other people on the move this month.
Hu-manity.co acquires Betterpath in a deal that will see both patients and pharma gain access to some 80% of health care’s “dark data” – information that comes with explicit consent under fair trade practices, which is not only a good ethical posture,...
The USTR stated that 20% of medicines on the Indian market were counterfeit, a claim that the country’s health secretary labelled as an ‘opposition to low-cost generics.’
The US FDA has issued draft guidance on the process of voluntary recalls, after a series of recalls involving sartan contamination with carcinogenic impurities.
Clinical trials are less safe today as researchers are inundated with increasing amounts of data and new processes developed in part by CROs, which have created “tier upon tier of bureaucracy,” argues industry expert, who warns that things are getting...
An international coalition of health integrity groups today demands that European universities must make clinical trial results public – with 83% all of due trials still unreported, according to a new report.
The Australian Government commits $100m to support rural, regional, and remote clinical trials – recognizing the importance of a “vibrant clinical trial ecosystem in underpinning a world-class health care system,” says industry expert.
Teva begins recall in the US of 35 lots of losartan tablets and Torrent expands its recall to include an additional 104 lots, after trace amounts of NMBA were discovered in both companies' products.
A US trade report identified that counterfeit drugs are becoming a greater issue through illegitimate online sales, particularly in countries such as China and India.
Centralized databases, reduced competition for patients, and higher starting doses are among some of the benefits to conducting research in Poland, which ranks seventh in Europe for clinical trial participation, says Moleculin CEO.
Senator Flake will discuss regulatory guidance impacting innovation and his perspective on the state of the industry during his keynote address at CPhI North America.
Acorn AI is designed to answer questions across all phases of drug development, making data “liquid” to help pharma make quick “go/no-go” decisions, accelerate clinical trials, and demonstrate value.
Patients in Southern and Eastern Europe wait on average five times as long for the same treatments as patients in Northern and Western Europe, an EFPIA report finds.
China-based pharmaceutical companies betting big and small biopharma able to quickly innovate will drive the use of AI for drug discovery – a market some analysts predict will reach a valuation of $20bn by 2024.
The $74bn deal appeared to be fraying around edges, as certain shareholders voiced dissent, but a vote saw the deal pass with support from more than 75% of investors.
An observation by the US FDA notes that Aurobindo had no established control procedures to monitor its manufacturing process, resulting in batches contaminated with unidentified material.
The European Commission approves Pfizer’s Vizimpro monotherapy for the first-line treatment of non-small cell lung cancer, as the market is projected to grow to $26.8bn by 2025.
The discussion surrounding clinical trial awareness has evolved “from mere conversations to action, creativity, and inclusivity from multiple stakeholders,” and will continue to evolve as we work together to create a paradigm shift in awareness, says...
Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a new Q&A that reinforces the importance of performing risk assessments for all studies.
US FTC rules that Endo used its dominant position in the market to delay competition from Impax with an illegal pay-for-delay deal for its Opana ER product.
The industry in March saw new c-suite appointments at CRF Bracket, PCI Pharma Services, George Clinical, and Paragon Bioservices – as well as moves to boost medical device and DMPK services at Premier Research and Sygnature Discovery, respectively.
