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November 20, 2023

Big Pharma News Watch

Bayer Told to Pay $1.56 Billion After Losing Roundup Case + 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.

Bayer Told to Pay $1.56 Billion After Losing Roundup Case

The Wall Street Journal reported:

Bayer faces a payout of $1.56 billion after a Missouri jury found in favor of the plaintiffs who blamed its Roundup weedkiller for causing their cancers.

The decision is the fourth in a row to go against Bayer during a roller-coaster five-year legal battle over Roundup, the world’s most popular weedkiller, which included nine straight victories for the company, as well as earlier losses. The cases represent tens of thousands of claims from farmers and gardeners.

The mounting charges from cases tied to the herbicide come against the backdrop of Bayer’s restructuring efforts. The overhaul could lead to the separation of its health business and its agriculture unit, which includes the U.S.-based Monsanto operation that developed Roundup. Analysts said how any Roundup-related liabilities are divided would affect the potential valuation of the two businesses.

Bayer has acknowledged that the legal status of Roundup litigation remains a hangover. “The challenge has been around some confusion about the safety of glyphosate,” Chief Executive Bill Anderson said recently at a conference in Washington, DC. “We think the evidence is super clear, this is a very safe and very important agricultural chemical.”

Jurors in state court in Jefferson City, Mo., disagreed in a decision released Friday. They awarded the plaintiffs Dan Anderson, Jimmy and Brenda Draeger and Valorie Gunther a combined $61.1 million in damages and another $1.5 billion in punitive awards. The plaintiffs maintained that years of Roundup use in their gardens caused their non-Hodgkin’s lymphomas.

Researchers Return to Alzheimer’s Vaccines, Buoyed by Recent Drug Success

Reuters reported:

Breakthrough Alzheimer’s treatments that remove toxic proteins from the brain have revived interest in vaccines to treat the memory-robbing disease, potentially offering a cheaper, easy-to-administer option for millions of people, according to interviews with 10 scientists and company executives.

Clinical trials are underway or completed for at least seven Alzheimer’s vaccines designed to harness the immune system to rid the brain of the disease-related proteins beta-amyloid or tau, a review of the U.S. government’s ClinicalTrials.gov database found. More are on the way.

The renewed interest in Alzheimer’s vaccines follows a promising first attempt more than 20 years ago that was abandoned after 6% of study volunteers developed life-threatening brain inflammation known as meningoencephalitis.

Scientists, including those at Vaxxinity (VAXX.O), AC Immune and Prothena (PRTA.O), believe they now understand what went wrong with the first vaccine and are testing shots they hope will provoke an immune response without causing excess inflammation. The U.S. Food and Drug Administration has given the first two fast-track status, which should speed the review of those vaccines.

The COVID Vaccine Windfall Turns for Pfizer and Moderna

The Wall Street Journal reported:

Fast-forward to today. The pandemic is over. Demand for COVID vaccines and treatments has plunged. Pfizer’s total revenue has fallen more than 40% since last year. Earlier this month the company took a $5.5 billion write-off on its COVID products owing to “lower-than-expected demand.” Only 14% of American adults have received the latest updated booster shots.

But declining demand for COVID products is neither surprising nor bad news. If anything, it’s a salutary development as it will drive pharmaceutical investment and research to better uses.

Recall that the purpose of the Trump administration’s Operation Warp Speed was to reduce the risk and opportunity costs for developing vaccines to end a once-in-a-century pandemic. The vaccines flattened the curve for a time, to borrow the metaphor Anthony Fauci popularized. But two-thirds of COVID deaths have occurred since the vaccines rolled out in January 2021.

The jabs’ greatest benefit was in providing political leaders with the courage to lift destructive lockdowns and mask mandates. The vaccines were supposed to be a two-shot-and-done regimen, not blockbuster medicines that rung up tens of billions of dollars in sales every year with government support.

But Washington rewrote the memo. From vaccine mandates to annual booster recommendations and misleading marketing campaigns, its salesmanship is matched only by its efforts to dump electric vehicles on an unwilling public. Statins and diabetes medicines prevent heart attacks, but the government doesn’t run ads urging Americans to use Lipitor or Ozempic.

NYC Launches $4 Million COVID Vaccine Campaign Targeting Poorer Neighborhoods

New York Post reported:

Mayor Eric Adams’ health team is launching a $4 million “vaccine equity” campaign aimed at curbing infections and deaths from the latest coronavirus strains and the flu, predominantly in the city’s poorer communities.

The Health Department funding will provide grants to 18 not-for-profit groups to expand vaccine coverage in two dozen mostly minority neighborhoods with lower vaccination rates.

The city is looking to bridge the “vaccine inequity gap” in neighborhoods designated by the Mayor’s Taskforce for Racial Inclusion as those most impacted by COVID-19 and a large proportion of other health disparities. The task force started under former Mayor Bill de Blasio — who was at the helm during the initial COVID-19 outbreak in 2020 — and continues under Adams.

Only ~14% of U.S. Adults Have Gotten Latest COVID Vaccine Update

Forbes reported:

As you probably know from seeing all those noses out there, many people have completely dropped the use of face masks as if the masks were soiled underwear. Fewer and fewer businesses seem to be maintaining any type of COVID-19 precautions such as running air purifiers or even keeping hand sanitizer dispensers filled. And just 5.4% for children, 14.8% of all adults 18 years and older, and 31.7% of adults 65 years and older have gotten the latest set of COVID-19 vaccines, according to Centers for Disease Control and Prevention (CDC) numbers as of November 17.

Why have these updated vaccine numbers been so low? Well, the KFF survey revealed that over half of those adults who had gotten vaccinated against COVID-19 previously but did not get the latest “updated” COVID-19 vaccine pointed to, guess what, not being worried about COVID-19 as being the main reason for not getting the latest shot that became available over past couple months.

No matter how many may try to spin it, the roll-out of the updated vaccine this Fall has been far from a rousing success. The updated vaccine targets the XBB.1.5, Omicron subvariant of the SARS-CoV-2, which sounds like a mouthful and is the subvariant that was the dominant circulating one through early 2023.

Doctors Allege Pfizer Turned Blind Eye to Possible Vaccine-Enhanced COVID

Western Standard reported:

Pfizer failed to look into thousands of possible cases of vaccine-associated enhanced disease (VAED), allege some U.S. physicians.

Medical doctors Barbara Gehrett, Joseph Gehrett, Chris Flowers and co-author Loree Britt made their allegations in articles 90 and 92 of a continuing series on the DailyClout. The articles analyze court-mandated disclosures of documents Pfizer submitted to the U.S. Food and Drug Administration.

By February 2021, researchers from the Brighton Collaboration Network had already documented VAED in the journal Vaccine as a more severe clinical presentation of a disease in a person vaccinated against that disease than would normally be seen in an unvaccinated person.

As that month ended, Pfizer released a post-marketing report showing 2,585 “serious” COVID-related adverse events in those who received the vaccine.

The report showed that 136 of these patients died. Half of COVID-related adverse events began within five days of injection and 77% constituted COVID-19 infections. Two infants and one child were among those who reported adverse events, even though those under age 12 had not yet been approved for the vaccine.

Bayer Woes Pile Up as Blood Thinner Drug Trial Fails

Reuters reported:

Germany’s Bayer (BAYGn.DE) has aborted a large late-stage trial testing a new anti-clotting drug due to lack of efficacy, dealing a fresh blow to the embattled drugmaker and throwing its most promising development project in doubt.

Its shares slid 16.4% at 0903 GMT on Monday to their lowest in 12 years, with separate news overnight that the company had been ordered to pay $1.56 billion in the latest U.S. lawsuit over its commonly-used Roundup weedkiller also hitting sentiment.

Bayer said in a statement late on Sunday that experimental anticoagulant asundexian was shown to be inferior to Bristol-Myers Squibb (BMY.N) and Pfizer‘s (PFE.N) established Eliquis in preventing strokes in high-risk patients part-way into a Phase III trial.

It had hoped the drug would generate annual sales of more than 5 billion euros ($5.5 billion) and replace revenue from one of its pharmaceutical best-sellers, blood thinner Xarelto, which is set to lose protection from key European patents in 2026.

How Drug Makers Manipulate Patents to Keep Insulin Prices High

TIME reported:

The financial burden of high insulin costs that patients and insurers face is often blamed on the Food and Drug Administration’s (FDA) regulatory framework, but a new study suggests pharmaceutical companies have also been using patenting processes to unfairly maintain high costs.

In the FDA’s master list of approved medications, devices, and other therapeutics, a document known as the Orange Book, patent ownership of each item governs which companies are allowed to manufacture and sell which therapies. The FDA deals with drug approval, but patents are granted by another agency entirely, the U.S. Patent and Trademark Office (USPTO).

Though there are rules governing which developments by pharmaceutical companies merit inclusion in the FDA’s Orange Book, experts have long said that the book remains full of improper patents that unfairly hamper market competition. Because patents in the Orange Book lock in a period of market exclusivity for the holder that’s stayed at least 30 months even in the face of legal challenges from smaller companies, filing additional patents on product lines can allow manufacturers to operate without competition — and thus sell at higher prices — for longer periods of time. While a patent remains in the Orange Book, the FDA cannot approve an equivalent generic.

A Nov. 16 study highlights how the ease of manipulating the Orange Book has caused pricing issues for one group of therapeutics: insulin products. The gaming of the patent process is rife in the insulin marketplace, says William Feldman, an associate physician at Brigham and Women’s Hospital, an instructor at Harvard Medical School, and a lead author of the new study, published in PLOS Medicine.

Poor People in the Developing World Have a Right to Medicine

The Guardian reported:

As Chairman of the U.S. Senate Health, Education, Labor and Pensions Committee (Help) I’m going to do everything I can to develop a new approach to the development and manufacturing of prescription drugs that responds to medical need, rather than short-term shareholder profit. Given the power and greed of the pharmaceutical industry, this is not an easy task, but it’s one that must be pursued.

The tragic reality is that, today, millions of people around the world are suffering, and dying, from preventable diseases because they can’t afford the outrageous prices charged by pharmaceutical companies. According to the World Health Organization (WHO), one-third of humanity lacks access to essential medicines. For a staggering number of people around the world, this leads to what the WHO calls “a cascade of preventable misery and suffering.”

First, too often drug companies abuse patent monopolies to charge outrageous prices or otherwise keep lifesaving drugs out of reach for people around the world. For example, the Boston-based drug company Vertex is neither selling a transformative new treatment for cystic fibrosis in the developing world nor allowing other local companies to produce it. Put simply, the company is not only refusing to bring a life raft to people drowning with cystic fibrosis in poor countries, it is also blocking others from deploying their own life rafts to people who need them to stay alive.

Second, far too often, the medicines that are desperately needed by millions of people in poor countries are not being produced by the pharmaceutical industry because the drug companies cannot make sufficient profits by doing so. In the U.S. and other developed countries, people often pay exorbitant prices for life-saving medicines. Poor people in developing countries can’t. They don’t have the money. The result: they die. Because the business model of the pharmaceutical industry values dollars gained over lives saved, there are not enough companies looking for transformative treatments, especially for diseases that afflict poor people.

FDA Signs Off on New Uses for Astellas and Pfizer’s Xtandi, Merck’s Keytruda

Fierce Pharma reported:

The FDA has signed off on label expansions for two of the world’s most important cancer medicines — Merck’s Keytruda and Pfizer and Astellas’ Xtandi.

Keytruda’s expansion is in stomach cancer, allowing its use alongside chemotherapy to treat first-line patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer. It now becomes the only androgen receptor inhibitor approved by the FDA for patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). These patients can be treated with Xtandi with or without GnRH analog therapy.

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