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The high cost of novel drugs in 2019; License to Pill

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research approved 48 first-of-their-kind therapies in 2019, the second-highest number of new molecular entities cleared for the world's largest pharmaceutical market in the past two decades.

The agency set the record in 2018, with 59 new molecular entities approved by the FDA's Center for Drug Evaluation and Research, or CDER.

Many of the novel drugs cleared in 2019 are expected to change the trajectory of the diseases they were approved to treat, though a number of them come at a high cost.

Most of the 2019 approvals occurred under the oversight of acting FDA commissioners — first Ned Sharpless and later Brett Giroir — after Scott Gottlieb left the agency less than two years into the job.

Gottlieb's replacement, Stephen Hahn, was sworn in as commissioner Dec. 17, 2019, just in time to oversee the last few approvals of the year.

Among the notable 2019 approvals by FDA's CDER was Vertex Pharmaceuticals Inc.'s cystic fibrosis therapy Trikafta, Global Blood Therapeutics Inc.'s sickle cell disease medicine Oxbryta, and Novartis AG's Adakveo, a targeted therapy to reduce the frequency of vaso-occlusive crisis, a common and painful complication of sickle cell disease.

SNL Image

Story: 2019's novel drugs aim to change disease trajectories, often at a high price

Chart of the week

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Story: License to Pill: Biotech and pharma deals from Dec. 16-27

Must read

SNL ImageA U.K. health cost watchdog said Roche Holding's Tecentriq
was not a cost-effective initial treatment for extensive-stage
small-cell lung cancer.
Source: Roche

In draft guidance, UK's price watchdog says Roche's Tecentriq not cost-effective

The U.K.'s National Institute for Health and Care Excellence said Roche Holding AG's Tecentriq was not a cost-effective initial treatment for extensive-stage small-cell lung cancer, a hard-to-treat disease.

Illumina, Pacific Biosciences terminate $1.2B deal after antitrust concerns

Life sciences specialist Illumina Inc. and gene sequencing company Pacific Biosciences of California Inc. terminated their planned $1.2 billion merger agreement.

Hospital M&A did not improve patients' quality of care, study shows

Recent hospital M&A deals did not improve patients' quality of care, according to a new study published in The New England Journal of Medicine. The study counters claims from the hospital industry that M&A increases the quality of care for patients.

China approves 1st domestic HPV vaccine

The Chinese regulator approved Xiamen Innovax Biotech's human papillomavirus vaccine Cecolin, the first home-developed HPV vaccine in the country.

In other news

SNL ImageAmgen Inc. acquired a 20.5% stake in China's BeiGene Ltd. as part of the two companies' $2.8 billion cancer partnership
Source: AP Photo

Amgen, China's BeiGene close $2.8B cancer partnership deal

Amgen Inc. and China's BeiGene Ltd. completed their $2.8 billion collaboration deal after meeting the closing conditions of the agreement.

J&J acquires XBiotech's experimental drug bermekimab for $750M

Johnson & Johnson's Janssen Biotech Inc. acquired all rights to XBiotech Inc.'s experimental anti-inflammatory antibody bermekimab in a $750 million cash deal.

BeiGene's blood cancer drug wins Chinese approval

China's drug regulator approved BeiGene's medicine tislelizumab to treat patients with Hodgkin lymphoma who have received at least two prior therapies.

Sol-Gel stock zooms as drug helps attain clearer skin in acne patients

Sol-Gel Technologies Ltd. stocks soared after the company announced its medicine Twyneo benefited acne patients in two late-stage studies.

Essential Healthcare is a weekly collection of critical developments across the pharmaceutical, biotechnology, healthcare provider, healthcare technology and medical equipment industries that draws on exclusive analysis and value-added content from the Healthcare News team at S&P Global Market Intelligence. Subscribe now to get Essential Healthcare delivered to your inbox every week.