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December 12, 2023

Big Pharma News Watch

AstraZeneca Buys U.S. Vaccine Company in $1.1 Billion Deal + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

AstraZeneca Buys U.S. Vaccine Company in $1.1 Billion Deal

The Guardian reported:

AstraZeneca is buying its first vaccine company in a $1.1bn deal that will expand the vaccine and immune therapy business it set up during the COVID-19 pandemic. Britain’s biggest drugmaker has agreed to take over the Seattle-based company Icosavax, which is developing a potential vaccine for two common respiratory diseases.

The U.S. firm’s lead product targets two diseases — respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) — that cause severe illness and hospitalization in adults over 60 and people with chronic conditions such as cardiovascular, kidney and respiratory disease. RSV and hMPV can also be serious in young children.

It is a combination protein VLP (virus-like particles) vaccine that is given as a jab in the arm.

AstraZeneca says because VLP vaccines mimic how naturally occurring viruses appear to the body’s immune system, they may offer benefits over other vaccines, including a stronger immune response, greater breadth of protection, longer durability requiring fewer boosters and, compared with the current RSV vaccine from GSK, fewer side-effects. GSK and Pfizer launched RSV vaccines this year.

The Massachusetts-based Moderna is awaiting regulatory approval in the U.S. and EU for its RSV vaccine, which is based on the mRNA technology that it used for its COVID-19 jab. It is also testing a combination and hopes to have a triple vaccine against flu, COVID and RSV ready for 2026.

Millions in Opioid Settlement Funds Sit Untouched as Overdose Deaths Rise

CBS News reported:

Nearly a year after Montana began receiving millions of dollars to invest in efforts to combat the opioid crisis, much of that money remains untouched. Meanwhile, the state’s opioid overdose and death counts continue to rise.

The money is part of the approximately $50 billion that states and local governments will receive nationwide in opioid settlement funds over nearly two decades. The payments come from more than a dozen companies that made, distributed, or sold prescription opioid painkillers that were sued for their role in fueling the overdose epidemic.

Many places have begun deciding where that money will go and making payments to schools, public health departments, and local governments. South Carolina, for example, has awarded more than $7 million to 21 grantees. Wisconsin has posted two years’ worth of spending plans that total nearly $40 million.

Montana began receiving its first settlement payments in January, and, by fall, payments totaled roughly $13 million. As of early December, the Montana Opioid Abatement Trust — a private nonprofit created to oversee 70% of the state’s share — had met once to agree to its rules of operation, and its money remained locked behind an inactive grant portal. The remainder, divided among the state and local governments, either hadn’t been spent or wasn’t publicly recorded.

Debbie Knutson, Rimrock’s medical unit and nursing supervisor, said there is widespread confusion about how and when the state’s settlement dollars can be used. “It’s very concerning if we have money available that we could use to help people that is just kind of sitting, waiting for somebody to decide where it should go,” Knutson said.

Kansas City Health Providers See ‘Little to No Interest’ in Latest COVID Vaccine

The Kansas City Beacon reported:

Alexandria Thompson’s job is to convince the most vulnerable people in her community to get vaccinated for the flu and COVID-19. She can offer education, transportation and up to $50 in gift cards to entice people to get the shots. But, she says, often that is not enough.

“I just tend to lead with the flu shot, and then I’ll say COVID right after,” said Thompson, the lead canvasser for G.O.T.V. (Get Out the Vaccines), an initiative of the Kansas City advocacy organization Communities Creating Opportunity. “Many times, people say no to the COVID shot and, a lot of times, people say yes to the flu shot.”

Going on four years since the SARS-CoV-2 virus devastated lives and economies worldwide, healthcare providers and public health advocates say a growing number of people seem to have lost sight of just how dangerous the virus can be. Perhaps as a result, most people aren’t rolling up their sleeves for the latest vaccine.

“There is little to no interest in it,” said Carole Thomas, vice president of clinical operations for KC Care Health Center.

Nationally, just 16% of adults and 7% of children had received the latest version of the shot by the start of December, said the U.S. Centers for Disease Control and Prevention. The Kansas City Health Department administered 1,420 doses between September and early December, fewer than the number given in just one week during the height of the pandemic.

Pfizer Gets OK for $43-Billion Seagen Deal After Donating Cancer Drug Rights

Reuters reported:

Pfizer (PFE.N) said on Tuesday it has agreed to donate the rights of royalties from sales of cancer drug Bavencio to address concerns from U.S. antitrust regulators related to its $43-billion deal to buy Seagen (SGEN.O).

Pfizer said it had now received all regulatory approvals to close the deal on Thursday, about 9 months after announcing the acquisition.

Pfizer added it would create a separate cancer drugs operation and split the rest of its commercial business into two divisions, one focused on the United States and the other on the rest of the world.

Pfizer in March signed away the development and commercialization rights related to Bavencio to its partner for the drug, Merck KGaA (MRCG.DE), while retaining rights to a 15% royalty on net sales of the drug.

Patients Regain Weight After Stopping Eli Lilly’s Zepbound, Study Says

CNBC reported:

Patients who took Eli Lilly’s weight loss drug Zepbound regained around half the weight they shed after stopping the newly approved treatment for a year, according to data released Monday.

The data, which represents the full results from an 88-week study funded by Eli Lilly, suggests that people have to stay on the weekly injection if they want to maintain significant weight loss.

Shares of Eli Lilly closed more than 2% lower Monday after the data was published in the research journal JAMA. The pharmaceutical giant released initial results from the same study, which was conducted by some Eli Lilly employees and some outside researchers, in July.

Zepbound, Novo Nordisk’s weight loss injection Wegovy and their blockbuster diabetes counterparts have soared in popularity, and in turn, have run in short supply in the U.S. over the past year because they help patients lose substantial weight without surgery. Some Wall Street analysts believe Zepbound, which uses the same active ingredient as Eli Lilly’s diabetes drug Mounjaro, could become the best-selling drug of all time.

U.S. Consumer Group Seeks Stronger Warnings on Botox, Similar Treatments

Reuters reported:

Consumer advocacy group Public Citizen on Tuesday filed a petition with the U.S. Food and Drug Administration seeking to require makers of Botox and several similar injections to include stronger warnings about the risk of a potentially fatal muscle-paralyzing disease.

These injections, which use various versions of botulinum toxins to contract specific muscles by blocking certain nerve signals to erase wrinkles, already have a ‘black box’ warning in their labels about the risks of the intended effect spreading to other areas. The consumer group asked the FDA to make it clear that these adverse effects could happen even at recommended dosages.

The new petition seeks a stronger warning on the label of six toxin-based injections including market leader Botox from AbbVie, Revance Therapeutics’ (RVNC.O) Daxxify, Evolus’ (EOLS.O) Jeuveau, Supernus Pharmaceuticals’ (SUPN.O) Myobloc, Galderma’s Dysport and Xeomin from Merz Therapeutics.

The request comes after the advocacy group analyzed over 5,400 reports of deaths, life-threatening events and other serious side effects related to Botox and rival toxin-based wrinkle treatments between January 1989 and March 2021 that were recorded in the FDA’s adverse events database.

Experimental Drug That Alters Gut Microbiome Shows Promise for Long-COVID Relief

CIDRAP reported:

A randomized controlled trial in Hong Kong finds that the synbiotic drug SIM01 relieves multiple symptoms of long COVID, or post-acute COVID-19 syndrome (PACS).

SIM01 contains strains of anaerobic Bifidobacterium bacteria (which are probiotics) and soluble fibers (prebiotics) to alter the gut microbiome and possibly modify the immune response.

From June 2021 to August 2022, researchers from the Chinese University of Hong Kong randomly assigned 463 adult long-COVID patients at a single hospital in a 1:1 ratio to receive SIM01 or a vitamin C placebo by mouth twice daily for 6 months. The median interval between infection and random assignment was 4 months.

“Decreased abundance of short-chain fatty acid-producing bacteria in the gut of patients with COVID-19 might represent one of the crucial mechanisms contributing to the gut-lung interaction and thereby disease severity in COVID-19,” the researchers wrote.

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