People on the move in January include new CEOs at Lonza, Taconic, MaSTherCell, Pii, and Wasdell, among several other c-suite shakeups and new hires as the industry kicks off the New Year.
The UK-based private equity firm CBPE has purchased a majority stake in Simbec-Orion and will expand the CRO's reach both geographically and across all business units.
France, Germany, and the UK recently formed INSTEX to be able to secure trade despite US sanctions on Iran, a move that has been welcomed by Novo Nordisk.
The voluntary recall, originally initiated due to a product compliant in October 2018 for mislabeling, continues for anti-seizure drug, Levetiracetam injection in single-dose bags.
As complex drugs see little competition, the FDA will distribute guidelines to increase approvals of generic medicines for ‘economic stability’ and to bring affordable drugs to patients.
The global software provider is discounting its reporting software for academics, as universities globally struggle with compliance and face increasing pressure to publish clinical trial results.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
Celgene, Triphase Accelerator, and Facit entered a collaboration for a first-in-class preclinical therapeutic, targeting the WDR5 protein for the treatment of leukemia and other blood cancers.
FDA provided an update on its valsartan contamination investigation and suggested it had discovered two possible causes of the carcinogenic impurities.
Novartis joined industry associations in expressing concerns over the impact that a ‘hard’ or ‘disorderly’ Brexit could have on the life sciences sector.
The Wasdell Group’s new EU headquarters in Dundalk, Ireland is set to commence operations later this year as part of the company’s “proactive contingency plan” ahead of Brexit.
Digital health companies raked in more than $9.5bn as part of 698 global venture capital deals last year – with data analytics and mHealth apps leading the pack among the top-funded categories.
The new year has led to a new look to executive boards across the pharma industry, but the movement has arrived with a degree of intrigue in some cases.
The EMA announces further details on its move from current London headquarters to Amsterdam, which will begin on March 1 and see staff working in its new offices on March 11.
The UK Parliament is putting pressure on universities failing to publish data from clinical trials – with plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.
With offices in Philadelphia and Boston, Vynamic’s London office – co-located with STEM Healthcare – is the company’s first outside the US as it looks to support existing and new clients globally.
European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
The FDA approved Teva's generic for Sabril, the first generic for the drug, as the agency continues to focus its efforts to approve generics that face little competition.
Though larger pharma companies are investing heavily in biologics, the industry is set to be predominantly focused on small molecules moving forwards, claims CAS MD.
Genetic discoveries have taken place in narrow population groups, say researchers, who for the first time, reveal that such studies are concentrated in a handful of countries – and conducted by a ‘tight-knit group of researchers.’
Akorn received a warning letter from the FDA on January 4, relating to the inspection of its manufacturing facility in Decatur, Illinois, in April and May 2018.
The EMA recently outlined five strategic goals with a focus on fostering clinical trial innovation, optimizing capabilities in modeling and simulation, as well as exploiting AI and investing in special populations, among other objectives.
Driven by a more than 20% increase in adverse event volumes, Iqvia has developed a SaaS safety platform designed to reduce the cost and complexity of pharmacovigilance activities – and help companies add value back into their business, says VP.
The company’s anticoagulant reversal treatment received a complete response letter from the FDA in 2016 but will be made available today after its approval.
Access to an increasing amount of information is catalyzing research, while also lending to higher levels of professional burnout on behalf of health care professionals, says company executive.
The UK Government last week provided an update on the regulation of clinical trials in the event of a “no deal” Brexit, with a commitment to ensure any new requirements are not “unduly burdensome.”
Awareness around the potential opportunities created by artificial intelligence has never been higher, but pharma’s biggest challenge in 2019 will be adopting and scaling the right technology to improve patient outcomes, says an industry executive.
Most CROs are struggling with employee retention, a challenge not new to the industry, which has seen turnover levels at or above 20% for seven of the last 10 years, according to a recent report.
The Indian government seeks to boost local drug production by stipulating that the ‘local content’ of domestic products is 75% and 10% for those that are non-domestic.
The biopharma industry is on the precipice of making personalized medicine a reality with access to massive amounts of data, computing power, and artificial intelligence to run in silico clinical trials, says GNS Healthcare CEO.
Heavily indebted Teva says consolidating its global headquarters in Israel will generate “significant savings from a business and operations point of view”.
