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Coronavirus Update: The Hunt For A Vaccine & Non-COVID-19 Trial Plans Go Awry

In addition to our daily in-depth coverage of key regulatory events relating to the coronavirus pandemic, we’re bringing you selected brief insights into the impact on biopharma commercial activities.

Coronavirus COVID-19 Companies

Biopharma, Payers Seek National Guidelines For Prescribing Potential COVID-19 Drugs

Guidelines for US health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.

Coronavirus COVID-19 Market Access

Amarin's Vascepa May Face Generic Competition In US Next Year After Patents Ruled Invalid

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

Legal Issues Intellectual Property

TV Drug Advertising Spend Rising, But Few Brands Provide Pricing Info

DTC spending had shown an uptick in 2020 compared with 2019. Many advertisers are not, however, providing clear drug pricing information in their TV spots, despite some voluntary commitments to do so.

Advertising, Marketing & Sales Ad Campaigns

Biosimilar Competition: Still More Focus On FDA Than FTC

A joint meeting of the US FDA and the FTC on biosimilar competition may have delivered a symbolic message about the need for a ‘level playing field’ in the biologics market – but it did not deliver much in the way of an actionable agenda for antitrust regulators.

Biosimilars Enforcement

Palforzia Peanut Allergy Immunotherapy: Aimmune CEO On REMS Restrictions, Manufacturing

Aimmune CEO Jayson Dallas tells the Pink Sheet how physicians and patients are being certified to use Palforzia and how the product's food-based manufacturing process is actually an advantage. 

Safety Manufacturing
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