The share price of BMS sank by over 7% after it stated that it would need to divest Celgene’s Otezla, a blockbuster treatment for psoriasis and psoriatic arthritis.
Zosano completes site qualification batches for its subcutaneous investigational migraine treatment and readies itself for NDA submission by the end of year.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
In a bid to increase clinical trial diversity, the FDA published a draft guidance suggesting sponsors rethink exclusion criteria, include children in adult studies when appropriate, use adaptive trials, and make sure other logistical barriers to participation...
Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.
In which areas is artificial intelligence most mature? What are the challenges to widespread adoption? Tufts and DIA recently teamed up to explore these questions.
The US FDA is set to center its drug compounding regulatory program in an office focused on stopping poor quality, unsafe and ineffective drugs reaching patients.
New this year to the discussion at DIA is the conversation around data ownership, as the industry continues to face a deluge of information from more sources than ever.
Zenith-Cognizant Technologies emerges from an acquisition aimed to streamline solutions as more complex “smart factories” become a greater focus in the biopharmaceutical industry.
To investigate blockchain processes and make distribution information retrieval more efficient, the FDA tapped big name companies for a supply chain security pilot program.
A report from the EUIPO demonstrated that a shift in the focus of counterfeited goods to include pharmaceutical products has caused significant loss of sales and employment.
Two US Attorney Generals have opened an investigation into the data breach at AMCA that compromised a combined nearly 20 million patients at LabCorp and Quest Diagnostics – as the companies’ efforts to notify the public are called into question.
Iqvia leads the real world evidence market, which is at an inflection point, as pharma furthers its investment and vendors improve capabilities, according to a recent report.
Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
Dassault Systèmes is set to acquire Medidata in an all-cash transaction valued at $5.8bn – a deal which will combine the power of modeling and simulation with data science to “catalyze the next generation of patient-inclusive therapeutics,” says CEO.
As regulators work to advance the modern clinical trial, the risk-averse clinical research industry is falling behind in the race to bring new therapies to patients, says an industry expert, echoing the former FDA commissioner’s calls for innovation.
Insys announces that it will file for Chapter 11 bankruptcy following the settlement of a legal case regarding its sales tactics for its opioid-based pain killer.
Achaogen sells majority of assets for a grand total of $16m ahead of bankruptcy, in another indication of the difficulties of relying on antibiotics for revenue.
Competitive costs, improving infrastructure, and a high burden of disease are increasing the demand for clinical research in Africa, says CRO, which has partnered with a US-based firm to expand its service offerings.
LabCorp and Quest Diagnostics this week disclosed unauthorized activity on the web payment page of the companies’ billing collections service provider.
The global oncology market last year set several records, though the industry continues to struggle with long development timelines, which in 2018 averaged 10.5 years from patent filing to regulatory approval and launch, according to a recent Iqvia report.
Broader clinical trial eligibility criteria would double patient numbers in lung cancer studies, according to a new report from ASCO, which has been leading efforts to expand access to oncology clinical trials.
The US FDA approves Merck’s application to expand the label of Zerbaxa for the treatment of hospital-acquired infections to address ‘global challenge’ of AMR.
Lonza announces that its Specialty Ingredients business will operate independently by ‘mid-2020’ and will cut away approximately 130 roles at the same time.
This month’s roundup includes the first CFO for CytoReason, a new CEO at Certara and Factory-CRO, as well as an expanded leadership team at BioDuro, among other people on the move in May.
Risk-based monitoring should be described as a “best practice,” says ACRO, which recently released a survey that found the majority of new trial starts in 2018 employed some form of RBM.
EMA assembles pharmaceutical developers to strengthen antimicrobial pipelines while, in the meantime, a study found the world’s rivers dangerously contaminated.
Last year saw heightened market volatility, marked by international trade disputes, regulatory unrest, and a general feeling of uncertainty – but 2019 is off to a strong start with several multi-billion dollar deals.
Vetter’s German sites will be supplied with only CO2 neutral energy from renewable energy sources as the company continues to work towards greater sustainability.
US FDA grants approval for Novartis’ Piqray to be used as combination treatment for advanced or metastatic breast cancer, a potential blockbuster drug.
Mallinckrodt states that its specialty branded portfolio will be named Sonorant Therapeutics and, in a U-turn, this side of the business will take Amitiza with it.
Heritage announces a recall of lots of amikacin sulfate injection and prochlorperazine edisylate injection, due to evidence of selected products being non-sterile.
BBK Holdings, parent company of BBK Worldwide, has established BBK Patient Experience Limited to support patient data protection in clinical trials and add to its footprint in the EU.
World Courier expands its commercial third-party logistics storage and distribution depots in strategic markets, as it continues its multimillion-dollar technology investment.
