PharmTech News

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

Drug Pricing Dominates Senate Hearing on HHS Nominee Azar

The company announced 15 new collaborations focused on addressing unmet medical needs, including using artificial intelligence in the early detection of Alzheimer’s disease, saliva testing for throat cancers, and using the microbiome to treat sleep disorders.

J&J Announces 15 New Collaborations

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

FDA Commissioner Gottlieb Gives Update on Saline and Amino Acid Shortages

New tax legislation may result in savings for biopharma companies.

Tax Overhaul a Plus for Pharma

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

Federal Circuit Decides in Favor of Novartis in Biosimilars Patent Dispute with Amgen

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

EMA to Relocate to New HQ in Amsterdam in Wake of Brexit

The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.

FDA Approves Digital Pill

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

FDA to Recognize Inspections from EU Drug Authorities

The new BioLive event, which will be a global hub for biopharmaceutical manufacturing, will launch alongside CPhI Worldwide 2018 in Madrid.


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