Pharmaceutical Technology

MARCH 17, 2023

But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging. In contrast, non-prescription digital therapeutics do not need clinical data to enter the market, says Wasden, adding that evidence from observational studies suffices.

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Pharmaceutical Technology

MAY 4, 2023

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. These recommendations and the FDA approval were based on positive AReSVi-006 Phase III trial data.

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Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Indeed, Amgen’s biosimilar was approved in September 2016, but the company was not able to launch it until January 2023 in the US. While small molecule drugs can be remade into identical generics, biologics are more complex.

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Pharmaceutical Technology

MAY 15, 2023

If approved, the therapy could become the first FDA-approved gene transfer therapy for the condition. The FDA will assess the drug’s approval before its Prescription Drug User Fee Act (PDUFA) date on 29 May 2023. She said, “I wish the data were more persuasive”.

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Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

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Pharmaceutical Technology

MAY 9, 2023

New York-based Eyenovia has announced an FDA approval for Mydcombi (tropicamide and phenylephrine hydrochloride), the first ophthalmic spray for mydriasis or pupil dilation. The spray can be used for diagnostic procedures and conditions where short-term pupil dilation is necessary, such as cataract surgery or corrective prescriptions.

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Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. In a press release, the company said a generic launch would damage sales in FY 2023 by $300,000.

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