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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

FDA 105
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Novartis drops presbyopia drug acquired with Encore Vision

pharmaphorum

The eyedrop formulation of UNR844 (lipoic acid/choline ester chloride) was acquired as part of the group’s buyout of privately-held ophthalmology biotech Encore Vision for $375 million upfront in 2017, and was designed to work by restoring the elasticity of the eye’s lens that declines with age.

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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?

Marketing 103
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Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Legacy MEDSearch

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical. Are you hiring?

Medical 52
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Why aren’t digital pills taking off?

Pharmaceutical Technology

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. But the pharmacology to quantify adherence also depends on race, gender, weight, and other factors.

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Beyond animal testing: the rise of organs-on-chips technology

Clarivate

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. They became integral to physiological and pharmacological research during the 19th century and started to be systematically used for drug development during the 20th century. Clinical Pharmacology and Therapeutics, 104(6), pp.