Private Equity's Inversion Excursion: Pepper Hamilton Talks Tax With the Deal
What is a meningioma and what types of injuries qualify? Depo-Provera has many known side effects. However, the current Depo-Provera litigation mainly involves a “signature injury” that was not properly warned against by...more
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
On Monday, the Food and Drug Administration gave permanent approval to Pfizer’s COVID-19 vaccine. Similar approval of the Moderna vaccine may be forthcoming, with eventual approval of the Johnson & Johnson one-shot...more
The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more
On August 23, 2021, the U.S. Food and Drug Administration (FDA) fully approved the Pfizer vaccine for those 16 and older - the first full approval of the three COVID-19 vaccines available in the U.S. The Moderna and Johnson &...more
On August 23, 2021, the U.S. Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine. Moderna’s expedited application for full approval is still pending, and Johnson & Johnson plans to submit its...more
Seyfarth Synopsis: Today the FDA approved Comirnaty (COVID-19 Vaccine, mRNA), previously known as Pfizer-BioNTech COVID-19 Vaccine, to prevent COVID-19 disease in individuals 16 and older. This could be big news for those on...more
In Washington: Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky urged parents to vaccinate adolescents and teenagers against the coronavirus Friday, adding that COVID-19 can be severe for this age...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA revokes...more
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention and 1 no vote that based upon the available scientific evidence, the benefits of the Pfizer and BioNTech’s COVID-19 vaccine...more
Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more
On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved Pfizer’s NYVEPRIA (pegfilgrastim-apgf), a biosimilar of Amgen’s NEULASTA. NYVEPRIA is indicated to “decrease the incidence of infection, as manifested by...more
Today, Pfizer announced that it has launched or is launching the following three biosimilars in the United States at the following prices...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, Sarah...more
Yesterday, the U.S. FDA approved Pfizer’s Trazimera™ (trastuzumab-qyyp), a biosimilar of Genentech’s Herceptin®, for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or...more
In a tweet today, FDA Commissioner Scott Gottlieb stated: “FDA continues to be concerned about branded companies creating confusion about the safety and effectiveness of biosimilars and we’ll take action if we determine a...more
Following the FDA’s approval of Retacrit® (epotein alfa-epbx) as the first U.S. biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® this past May, today Pfizer announced that it has launched Retacrit® in the United...more
On July 20, 2018, Pfizer issued a press release reporting that the U.S. FDA has approved Nivestym™ (filgrastim-aafi), Pfizer’s proposed biosimilar of Neupogen®, for all eligible indications of the reference product. Pfizer...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more
The FDA announced that it has approved Pfizer’s Ixifi® (infliximab-qbtx) as a biosimilar to Remicade®. Ixifi® is indicated for the treatment of most of the same conditions as its reference product: Crohn’s disease, pediatric...more
Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a...more