On July 24, 2024, Bio-Thera Solutions announced the FDA acceptance of its aBLA for BAT2206 (ustekinumab), a proposed biosimilar of Janssen and Johnson & Johnson’s Stelara® (ustekinumab), with a request for interchangeability....more
In April, the U.S. Food and Drug Administration (FDA) released the results of its 2023 sampling assignment, testing for asbestos in talc-containing products. The results confirmed the absence of asbestos in all 50 samples...more
Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more
On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more
Don’t doubt the central role that vaccines are playing in the battle against the coronavirus pandemic. Federal officials - even as the Delta-variant surge is easing - have dominated the news by approving yet more...more
As the summer’s deadly Delta variant surge slowly seems to be receding, questions are rising anew as to what further harms the coronavirus pandemic may inflict on a nation that already has suffered greatly. The infection...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
Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits - in settling claims over distributors...more
No matter what the carping critics may claim about the shortcomings of the civil justice system, when Big Tobacco, Big Pharma, and big organizations exploit and harm the vulnerable, lawsuits and what follows may provide a...more
We have seen biopharmaceutical companies around the world working to tackle COVID-19 in vaccine development, treatment development, and diagnostics, including the creation of world-class vaccines in record time, rapid tests...more
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others...more
In Washington: The Centers for Disease Control and Prevention (CDC) said it is looking to let cruise lines resume trips in the U.S. by mid-July and changing some of the rules to allow the ships to sail. A spokeswoman for...more
With the ever-increasing acceptance of marijuana as a legitimate treatment for a number of medical conditions, a newfound interest in the use of psychedelics as a form of medical treatment is gaining traction once again. ...more
Even as the latest coronavirus surge appeared to ease, including in hard-hit areas of the Midwest and Northeast, and as the federal government reported the nation has achieved key milestones in vaccinations, the battle to...more
In Washington: The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on Friday lifted the recommended pause on the use of Johnson & Johnson’s coronavirus vaccine, saying the benefits...more
In Washington: The Consumer Financial Protection Bureau (CFPB) on Monday proposed a rule ordering debt collectors to inform tenants about their rights under a federal eviction ban if they’ve been unable to pay rent during the...more
In Washington: On April 13, the Centers for Disease Control (CDC) and Prevention and Federal Drug Administration (FDA) paused the production of the Johnson & Johnson vaccine after six women participants in the U.S. developed...more
On April 13, 2020, the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) issued a Joint Statement on the Johnson and Johnson (J&J) COVID-19 Vaccine. The CDC and FDA are recommending...more
During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more
We have seen biopharmaceutical companies around the world partnering to tackle COVID-19 in diagnostics, treatment development, vaccine development, and other relief efforts, including monetary and in-kind donations of lab...more
In the past week, Johnson & Johnson and Merck agreed to cooperate on production of the Janssen vaccine, and the Biden Administration used the Defense Production Act (DPA) to facilitate the arrangement. In addition, the GAO...more
2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more
In Washington: The U.S. surpassed 500,000 deaths from COVID-19 on Monday, in a pandemic that has lasted almost a year. The nation’s total virus toll is higher than in any other country globally, and it means that more...more
In Washington: The White House is reportedly considering mailing masks directly to Americans. The plans have been discussed but no formal proposal has been delivered to Biden, a White House official told NBC News. Discussions...more
In Washington: On Friday, President Biden pushed Congress to act urgently on his proposed COVID-19 relief package as the White House scraps to garner bipartisan support. "[T]his is a time to act now,” Biden said during a...more