Searching for "fda" found 52

India US FDA India Office Director Sarah McMullen discusses the importance of maintaining India’s role as a global supplier of low-cost generics while also navigating the complexities of innovating and producing more complex pharmaceutical products. She notes that increased product complexity will inevitably lead to more regulatory challenges, emphasizing the need…

Italy A roundup of some of the biggest stories from Italian pharma and healthcare, including Italfarmaco’s FDA approval for its DMD treatment; Alfasigma’s acquisition of Galapagos’s Jyseleca, the antibiotics deal between Venatorx Pharmaceuticals and Menarini, and the country’s drop in healthcare spending.   Stevanato Group Announces Public Offering of Ordinary Shares…

USA The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) approved no less than 55 new drugs in 2023, a number surpassing that of 2022 by almost 50 percent. While 28 rare disease treatments and five novel gene therapies got the green light, the agency also…

United Kingdom The recent FDA decision to investigate the serious risk of patients developing new cancers after treatment with CAR-T therapies may have created some bad press around cell and gene therapies, but AstraZeneca has continued to consolidate its ambitions in the area with the acquisition of China-based cell therapy biotech, Gracell…

USA The US Food and Drug Administration has increasingly recognized the importance of diversity and representation in clinical trials over the past few decades. This evolution reflects growing awareness across medicine that differences in age, gender, race, and ethnicity can impact disease risk, treatment response, and health outcomes. Darshan Kulkarni of…

USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity.   Development of cell and gene therapy (CGT)…

Global After a 12-year stint at Sanofi, Bill Sibold is leaving Big Pharma to join the Pennsylvania-based biotech Madrigal Pharmaceuticals as CEO. Sibold, no stranger to ground-breaking launches, having brought the blockbuster Dupixent to market, will be coming onboard just ahead of what looks to be a pivotal moment for Madrigal.…

Saudi Arabia The Saudi Food and Drug Authority (SFDA) has joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S), aimed at harmonising inspection procedures worldwide. Through PIC/S membership the SFDA looks to continue bolstering its capabilities and further its international collaboration efforts.   SFDA’s accession to PIC/S is one of the strategic projects of…

USA During a panel discussion at the BIO International Convention, Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research (CBER) discussed the positive regulatory outcomes of the COVID-19 pandemic as well as the backlogs it created and the challenges of carrying the lessons learned forward.   At…

India The latest news from the Indian pharma industry, including Dr. Reddy’s purchase of Mayne Pharma’s US portfolio; Sun Pharma’s acquisition of Concert Pharma; Bristol Myers Squibb’s expanded Indian footprint and the Cipla manufacturing site under FDA scrutiny.   Dr. Reddy’s to buy Mayne Pharma’s US business for USD 105 million…

CEE Some of the most important stories emanating from the Central and Eastern European (CEE) region’s pharma industry, including Polpharma’s bid for Zentiva, Richter’s acquisition of OC Distributors and MDD approval in the US, Hungary’s windfall tax on pharma, Presage’s collaboration with Pure Biologics and Lithuania’s biotech ambitions.   Polpharma working…

USA An up-to-date list of the US FDA’s Center for Biologics Evaluation & Research (CBER)’s biological license application approvals for 2022. There were nine such approvals in 2022, down from 13 in 2021. For the list of non-biological approvals from the FDA’s Center for Drug Evaluation & Research (CDER), click here.…