In A Record Year For US FDA Approvals, Pfizer Came Out On Top

FDA’s approval teams cleared a total of 65 new molecular entities and novel biologics in 2018, blowing past previous records. Scrip looks at how that breaks down for industry leaders. 

2019 2018 Perspectives

Leading the pack of sponsors in the US FDA’s banner year of novel drug and biologic approvals was Pfizer Inc. – and its four approvals are double what any other big pharma put forward in 2018.

Pfizer has spent years trying to build up its cancer business, and its 2018 novel approvals certainly reflect progress. All...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Merck & Co.’s Winrevair Positioned For Expansion On HYPERION Results

 

The Phase III trial met the primary endpoint of time to clinical worsening in patients newly diagnosed with pulmonary arterial hypertension.

Novo And Lilly Lay Out Patient Segmentation Plans For Obesity Treatment

 

As competition heats up and the obesity market matures, the two frontrunners are tailoring their studies to the wants and needs of different patient groups.

Vertex Heralds ‘Unprecedented’ Zimislecel Type 1 Diabetes Data

 
• By 

The off-the-shelf stem cell therapy shows sustained glycemic control and a high rate of insulin independence.