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Advanced Solutions for Sustained Delivery of Ocular Therapies

PharmTech

Pharmaceutical companies have responded with growing investment in the research and development of novel eye treatments and drug delivery systems designed to address key challenges in ocular therapy. PLoS ONE 2011 6, e24513. In addition, many patients are hesitant to receive eye injections. Johnson & Johnson Vision.

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Who is Dr. George Tidmarsh, the new director of CDER?

PharmaVoice

Despite past criticism of public health policies, Tidmarsh recently praised the FDA and said he’ll focus on boosting review efficiencies. But his history as a physician, academic, biotech entrepreneur and importantly, his blossoming ties to the FDA’s new band of leadership, were enough to land him a top post at the agency.

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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

The application of Bayesian methodology has been recognised by the US Food and Drug Administration (FDA) as useful in early phase clinical trials involving paediatric populations. Dr Maier has over 25 years of experience in drug development and commercialisation at pharmaceutical companies in Europe, Canada, the United States and Asia.

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Over-the-Counter Birth Control Pills: FDA Considering HRA Pharma’s Opill

Birth Control Pharmacist

In June 2022, the AMA urged the FDA to approve an OTC contraceptive method with no age restriction. In order for a drug to be approved for OTC use by the FDA, certain criteria must first be met. The next step is having a pharmaceutical company manufacture a product that can be FDA-approved for OTC use.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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Low-Priced Oncology Disruptors: The Cuckoo in the PD-1/PD-L1 Nest or the Runt of the Clutch?

pharmaphorum

Although the sticker shock that was at first associated with Yervoy (ipilimumab) in 2011 – in the early days of immuno-oncology monoclonal antibodies – has fallen by the wayside, especially in light of CAR-Ts and other “one and done” cell and gene therapies, the field of non-orphan oncology remains a target for cost savings by payers.

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The future of targeted alpha therapy development and manufacture

European Pharmaceutical Review

Lastly, there is growing prominence and interest in radioligand therapeutics within major pharmaceutical companies, who are increasingly investing in this field, evident through recent acquisitions of Point Biopharma and RayzeBio. What makes targeted alpha therapies a promising new approach against cancer?