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GlobalData tracks 40 yrs of innovation in USFDA review designations

Express Pharma

For example, the orphan drug designation (ODD) is granted to drugs intended to treat a rare condition providing tax credits for qualified clinical trials, exemptions from user fees, and a potential of seven years market exclusivity following approval. Each designation offers specific benefits to the drugmakers.

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Race to the finish: pharma edges closer to approval with RSV vaccines

Pharmaceutical Technology

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

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Drug Repurposing: Unlocking access to rare solutions

Express Pharma

In the marathon of drug development, where billions of dollars and over a decade of research are the norm, drug repurposing is quietly reshaping the landscape. Challenges in drug repurposing Despite these technological and regulatory advancements, the journey of drug repurposing is not without its challenges.

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Streamlining bioprocessing for gene therapy

European Pharmaceutical Review

Production cost is currently a fundamental concern for many gene therapy developers, particularly given that some treatments cost millions of dollars per single dose (eg, $3.5 Single-use bioprocessing technologies enabling more rapid vaccines production [Internet]. million for Hemgenix [AAV5-hFIX-Padua]). Trends in Biotechnology.

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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

The safety and efficacy of mRNA vaccines should be a game changer and is the likely solution to antibiotic-resistant microorganisms and emerging viral pathogens.” The previous record for vaccine development and approval was four years for the measles vaccine.

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Monica Mann, VP, of Medical Affairs for Global MS and Pipeline at Biogen Shares Insights on New Data on MS Therapies and Digital Health Research

PharmaShots

In addition, our ongoing digital health research highlights progress in developing advanced measurement methods that aim to enhance drug development and personalized care for better patient outcomes. Smriti: Shed some light on the details (MOA, ROA, formulation, etc.) of TECFIDERA (dimethyl fumarate).

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Medicare Price “Negotiations” Will Jeopardize Patient Access to New Medicines, Result in Worse Health Outcomes

Safe Biologics

Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection. 3] “ Democrat plan on drug costs will stifle innovation”, San Antonio Express-News, May 12, 2021 [1] [link]