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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
An updated guide from the Therapeutic Goods Administration proposes that sponsors of marketing applications for drugs that require companion diagnostics should provide reassurance that Australian patients will have access to at least one IVD that is adequate for companion testing.
User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.
Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
The European Commission says the new agency will be the “cornerstone of addressing Africa’s health needs” by ensuring equitable access to safe and effective health products.
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Guidance on production reporting and on facility switching are part of the agency's new searchable quality guidance listing.
New drug pricing program under the Inflation Reduction Act could reduce the value of the 340B drug discount for safety net providers by as much as $1 billion in the first year, an analysis by the 340B Health association suggests.
Agency asks manufacturing facilities to volunteer for prototype quality management maturity assessment protocol, while industry questions overall direction of QMM program and points to emergence of better ways to predict quality and reliability.
As Medicaid enrollment climbed to historic levels amid the COVID-19 pandemic, the number of prescriptions per enrollee dropped to 9.4, while net spending per prescription rose to $58, our infographic details. 90-day scripts and higher launch prices could be driving the trends.
SAHPRA and MCAZ have signed an MoU to cooperate with each other on medicines regulation, quality control and pharmacovigilance.
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Legislation is brewing that could establish agency posts in Abraham Accords countries to help unleash their potential to supply pharmaceuticals to the US and reduce its dependence on China. But the FDA has not warmed to the idea.
Submission order, identifiers and electronic signatures in pdfs are among the issues that the Health Sciences Authority is addressing as it prepares to implement the electronic common technical document format for dossier submissions this year.
FDA is most often thought of as a regulator of off-label communication, but a new citizen petition on a contentious topic highlights the murkiness of the agency’s own obligations to discuss unapproved uses of drugs – particularly when effectiveness comes into play – and the challenges when medicine use becomes politically polarized.
The Centers for Medicare and Medicaid Services requests stakeholder feedback on how extensively copay maximizers are being used by insurers, which could help pave the way for restrictions on large employer and self-insured plans.
House Energy and Commerce health subcommittee easily clears a bill that would prevent another class-based national coverage determination from Medicare, but with an amendment clarifying it is for prospective decisions only, making it too late for new Alzheimer’s drugs.