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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).

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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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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. 5) monitoring access to biosimilars.

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Senju Pharmaceutical and Novaliq close agreement for dry eye disease therapy

Pharmaceutical Technology

The agreement covers rights for the development, manufacture and commercialisation of NOV03 in the country. NOV03 is the first and only water-free and preservative-free prescription treatment for dry eye disease, and targets the evaporation of tears by forming a monolayer at the tear film’s air-liquid interface.

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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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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”