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Should we be worried about pharma’s supply chain?

World of DTC Marketing

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.

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Alvotech receives CRL from FDA for AVT02 BLA

Pharmaceutical Technology

Alvotech has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for AVT02, a biosimilar to Humira (adalimumab). The FDA performed an inspection of the Reykjavik site in March 2022 and found deficiencies there.

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FDA tackles opioid crisis with OTC Narcan approval

Pharmaceutical Technology

On March 29, the US Food and Drug Administration (FDA) granted approval for the first nonprescription, “over-the-counter” (OTC) naloxone nasal spray, Narcan. Between 1999 and 2021, overdose deaths from synthetic opioids excluding methadone increased 97-fold, and prescription opioid overdose deaths increased 4.9-fold,

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FDA accepts Outlook Therapeutics’ BLA for wet AMD treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

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Finding Balance: A Decentralized Trial Strategy to Help Sponsors Address the New FDA Draft Guidance

PM360

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. The guidance document is short at 19 pages, and by design not prescriptive.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. Citizen Petitions before the FDA.

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Cresilon Receives First FDA Clearance For Human Use of Hemostatic Gel Technology

Legacy MEDSearch

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. .” Are you hiring?

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