Calliditas Therapeutics AB announced on Friday (October 5) that the European Medicines Agency (EMA) has issued a positive opinion on the company’s drug, setanaxib in Alport Syndrome (AS).
Novartis announced today (October 2) that it is excited about positive top-line results from its study into iptacopan, a drug to treat IgA nephropathy (IgAN).
Calliditas Therapeutics says it is optimistic about getting full marketing authorization for a drug to treat primary IgA nephropathy (IgAN) after submitting a request to the European Medicines Agency (EMA).
OSP spoke to Vesta Marciulioniene, director global regulatory clinical services at ICON Biotech, a contract research organisation who shares insights on the new EMA guideline for computerised systems and electronic data in clinical trials and what new...
Small molecule drug, Niraparib combined with abiraterone acetate (AA) and prednisone (P) significantly reduces the risk of disease progression, or death, in patients with a type of prostate cancer, a consultant in Spain has said.
The Dutch company Pharming Group N.V. has switched its rare disease drug leniolisib from an accelerated assessment to a regular review with the European Medicines Agency (EMA).
With updates to the Guideline for Good Clinical Practice Advancements on the horizon, an industry expert offers some perspective on what might be ahead.
A leader from the topical solutions centered CDMO discusses the differences between approaches by the FDA and EMA, and how to deal with them effectively.
Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.
A lease agreement has been signed for the EMA to move into tailor-made premises in Amsterdam, with staff set to begin working from the space in January.
The company’s Shanghai facility passes the European regulator’s inspection with no ‘critical’ or ‘major’ findings regarding the commercial products produced at the site.
Representatives from the EMA and China’s NMPA convene to share expertise on GMP for APIs, GCP standards, and on the environmental impact of manufacturing.
With nitrosamines back in the headlines due to the recent discovery of contaminants in ranitidine, the EMA releases the five potential causes of the impurities plaguing the industry.
The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
A joint study conducted by the EMA and FDA showed that marketing approval decisions were 90% shared for new medicines, as the agencies push for a closer working relationship.
The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.
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.
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 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’.
Panelist during the opening session of the DIA Annual Meeting last week stressed the need to work collaboratively, bringing patients into the fold as co-creators of clinical trials to ‘create a whole new landscape for research.’
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.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without 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 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.
MedPharm expands its US Center of Excellence in Durham, North Carolina, in response to increasing demand for its topical and transdermal formulation development, and performance testing services.
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.
WHO recently assessed Biopharma Services, which demonstrated compliance across multiple regulatory and organizational guidelines – opening the doors to conduct more work with the WHO foundations.
Takeda’s aim to acquire Shire for $62bn received a boost after regulators vote positively to approve the transaction following the divestment of Shire’s IBD drug.
Vertex was granted marketing authorization for its cystic fibrosis therapy in a combination regimen, marking the company’s third treatment for the condition to reach the market.
After Pharm-Olam conducted an orphan disease trial for therapy for a rare blood disorder, the European Commission granted it marketing authorization, and FDA is to give it priority review.
ScieGen Pharmaceuticals has recalled certain batches of hypertension drug irbesartan, after a probable carcinogen was detected in supplier Aurobindo’s API.
