Last week, leaders from Amazon, Google, IBM, Microsoft, Oracle, and Salesforce reaffirmed a previously made commitment to interoperability among health information technology.
The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.
API recalls have sparked discussion on the development of impurities during manufacturing and the ways in which risks can be mitigated, according to an industry expert.
Biopharmaceutical companies are increasingly relying on CROs in Japan, says an executive with PRA, which recently established a new subsidiary in the country.
Roche agrees for Sanofi to be responsible for the OTC marketing and distribution of Tamiflu in the US market, as it works on approval for its Xofluza competitor product.
CordenPharma has a new CEO, Arbour Group advances plans to expand in RTP, Ashfield brings on a former Iqvia VP, and Recursion adds to its c-suite after raising $121m this month.
Years in the making, ACRES launches a global accreditation program, which will ‘dramatically’ benefit all research stakeholders, including sponsors, CROs, regulators, monitors, as well as patients, says CEO.
July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.
TransCelerate BioPharma – and its subsidiary BioCelerate – launch new initiatives aimed at enhancing the research and development ecosystem, progressing its mission of getting innovative therapies to patients faster, says EVP.
Astellas agrees a deal for the ex-US rights of Frequency’s lead drug candidate, FX-322, after the latter company posted positive results in a Phase I/II trial.
An Executive Order signed by President Trump aims to increase research, incentives, and treatment access for kidney disease patients and could 'fundamentally transform kidney therapeutics,' says president of the American Society of Nephrology....
Despite positive movement on the number of women serving on executive committees since 2018, the industry has seen a significant drop in positions governing profit and loss.
In a warning letter, the US FDA details how its inspectors discovered cGMP document awaiting shredding and records discarded in a 55-gallon drum at Strides’ facility.
Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.
Pharma and regulators are using machine learning to accelerate various pharmacovigilance activities – as the number of adverse event reports increases 10-12% each year, says Eli Lilly advisor.
Highlighting the threat of AMR, the UK government has worked with the pharma industry to develop a new antibiotics payment model based on ‘usefulness’ to the NHS.
Boehringer Ingelheim, Sanofi, Bristol-Myers Squibb, and Evotec are among the top companies with “AI-friendly” CEOs, according to a report, which suggests that these businesses will prosper driven by a more effective application of AI.
The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.
MediLedger Product Verification Solution, a DSCSA compliant platform, is announced that will assist drug supply chain stakeholders in product verification and authenticity.
Altaire instigates voluntary recall of sterile ophthalmic treatments, after concerns were raised about QA processes in place at its manufacturing facility.
Newly-minted Signant Health named a new CTO, Parexel bolstered its Japan presence, and BioAgilytix’s CEO was appointed to the board of FSD Pharma – a company developing products based on cannabinoids – among other people on the move in June.
Strides’ Puducherry, India, facility has received a warning letter from the US FDA, which the company announced will lead to deferrals for 10 pending ANDA approvals.
The strategic advisory company, Trinity, opens a new office in Germany, with leadership joining from Syneos Health to work “hand-in-hand” with biopharma clients.
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
