During a House Oversight Committee hearing at the end of September, Democratic representatives harshly criticized pharmaceutical executives at Celgene, a Bristol Myers Squibb subsidiary, and Teva over drug prices and charitable contributions. 

Rep. Katie Porter (D-CA) noted the disturbing similarities between bonuses that former Celgene CEO Mark Alles received in recent years and the price increases for Revlimid, a cancer therapeutic that cost 215 dollars in 2005 and 763 dollars today. Alles could not confirm that the higher price correlated with drug improvements, to which Porter responded, “To recap here: The drug didn’t get any better. The cancer patients didn’t get any better. You just got better at making money. You just refined your skills at price gouging.” 

Rep. Rashida Tlaib (D-MI) considered internal documents from Teva that calculated the return on investment from charitable contributions and called out the drugmaker, saying, “Your pharmaceutical company makes these so-called charitable donations so you look like you give a shit about sick people.” Teva’s CEO Kare Schultz was so underprepared for the virtual hearing that one lawmaker told him he “might as well get off the screen,” while Rep. John Sarbanes (D-MD) said, “It would have been nice to come, maybe, equipped a little bit better.” 

Smith & Nephew will acquire Integra LifeSciences’ orthopedics business in a 240 million dollar cash deal set to close at the end of 2020. The focus will be on growing the upper and lower extremity markets, adding products covering shoulder replacements and reconstructions of the hand, wrist, elbow, ankle, and foot. Through the acquisition, Smith & Nephew will also gain access to Integra’s next-generation shoulder replacement system, which is scheduled for a commercial launch in 2022. Additionally, it will bring a strong sales force and distributors to the United States, Canada, and Europe.

About 300 employees are expected to move from Integra, which is based out of Lyon, France, and Austin, Texas. Although sales decreased due to COVID-19 and the postponement of elective surgeries (down 48.6 percent in the second quarter of 2020 versus the same time in 2019), Smith & Nephew anticipates the business to deliver double-digit revenue growth in 2021 and 2022. 

For Integra, the acquisition will allow the company to focus its efforts on developments in neurosurgery, surgical instrumentation, and regenerative medicine. 

The United States Food and Drug Administration (FDA) is taking a deeper dive into the investigation of AstraZeneca Plc’s COVID-19 vaccine study and will now look at data from previous trials of similar vaccines developed by the same researchers at Oxford University. Despite taking a closer look, they don’t believe there are any safety issues associated with these vaccines. “It just shows that the FDA is being thorough,” explains a source. 

AstraZeneca’s trial in the U.S. has been on hold since September 6th, when a participant in Britain fell ill with transverse myelitis, a rare spinal inflammatory disorder. Regulators in the United Kingdom, Brazil, India, and South Africa have already resumed studying the efficacy of the vaccine. 

Given the increased FDA investigation, further delays are likely for what was one of the most advanced COVID-19 vaccine studies in the U.S. The additional data requested by the FDA was expected to be delivered in early October and will require time to review.

An effective vaccine is essential for efforts to end the global COVID-19 pandemic that has already killed over one million people. President Donald Trump (who announced that he tested positive for COVID-19 on October 2nd) and his administration have pledged 1.2 billion dollars to support the development of AstraZeneca’s vaccine and to secure 300 million doses for American citizens. Pfizer Inc, Moderna Inc, and Johnson & Johnson are also in the U.S. vaccine race. 

The FDA declined to comment, and Oxford University did not respond to requests. In a statement, AstraZeneca said: “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the U.S. trial.”

“Bill Gates used to think of the U.S. Food and Drug Administration as the world’s premier public-health authority. Not anymore.”

“And he doesn’t trust the Centers for Disease Control and Protection either. Both, in his view, are casualties of a presidency that has downplayed or dismissed science and medicine in the pursuit of political gain. One recent example came when FDA Commissioner Stephen Hahn, speaking at one of President Donald Trump’s news conferences, exaggerated the benefit of blood plasma as a treatment for Covid-19, then backtracked the following day.

“We saw with the completely bungled plasma statements that when you start pressuring people to say optimistic things, they go completely off the rails. The FDA lost a lot of credibility there,” Gates, the billionaire philanthropist, said in an interview on Bloomberg Television.

“Historically, just like the CDC was viewed as the best in the world, the FDA had that same reputation as a top-notch regulator,” Gates said. “But there’s been some cracks with some of the things they’ve said at the commissioner level.”

At stake is nothing less than public confidence in the vaccine that could end the coronavirus pandemic, and which the FDA would have to approve. Polls conducted in the past two months show a majority of Americans worry the development of the vaccine is being rushed and a third wouldn’t get inoculated.”

AstraZeneca vaccine trials continue in the United Kingdom, but U.S. regulators are continuing to investigate.

“The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

Top pharmaceutical executives planned to meet with the president on Tuesday.