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January 8, 2024

Big Pharma News Watch

Moderna COVID Vaccine Sales Plunge by Two-Thirds in 2023, but Meet Company’s $6 Billion Forecast + 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.

Moderna COVID Vaccine Sales Plunge by Two-Thirds in 2023, but Meet Company’s $6 Billion Forecast

CNBC reported:

Moderna on Monday said its COVID vaccine sales plunged by about two-thirds in 2023 to $6.7 billion, as fewer people rolled up their sleeves for an updated version of the jab.

The revenue from the shots met Moderna’s forecast for the year, even as sales plummeted from the more than $18 billion the company booked in 2022.

Moderna’s announcement, which came ahead of its presentation at the annual JPMorgan Healthcare Conference, shows the steep drop in demand for COVID products last year as cases and public concern about the virus dwindled from their pandemic peaks. Weakening demand for the company’s shot, its only commercially available product, led shares of Moderna to fall nearly 45% last year.

Roughly $6.1 billion of Moderna’s revenue related to the shot came from sales of the vaccine. Another $600 million was deferred revenue related to the company’s work with Gavi, a nongovernmental global vaccine organization that coordinated a global shot distribution program, Moderna said in a release.

Johnson & Johnson Will Pay $700 Million to Resolve Baby Powder Marketing Probe, Report Says

Forbes reported:

Johnson & Johnson will pay an estimated $700 million to resolve an investigation by more than 40 states into the pharmaceutical firm’s marketing of its talcum powder, according to Bloomberg, following thousands of lawsuits alleging it failed to warn customers about cancer risks.

The tentative agreement will end an ongoing probe into Johnson & Johnson’s talcum-based baby powder and whether the company wrongfully marketed the product, according to Bloomberg, which cited people familiar with the deal.

Johnson & Johnson and representatives for state attorneys general involved in the investigation have agreed on the settlement amount but not other terms for the agreement, Bloomberg reported. The agreement is expected to protect Johnson & Johnson from future lawsuits involving its talc-based baby powder and alleged cancer risks.

50,000. That’s how many lawsuits Johnson & Johnson faces over its talcum-based baby powder, according to Reuters. Several cases allege the powder caused several forms of cancer, including ovarian and mesothelioma.

Drugmakers Kick Off Industry Conference With Two Cancer Deals

Reuters reported:

Johnson & Johnson and Merck on Monday announced plans to buy cancer therapy developers on the first day of a major U.S. healthcare conference, igniting what industry participants hope will be a strong year for deals after a solid end to 2023.

Deals announced on Monday had a combined equity value of more than $6 billion, including one by medical device maker Boston Scientific (BSX.N) for Axonics Inc (AXNX.O). That follows roughly $25 billion worth of U.S.-listed biotech deals last month, according to data provider LSEG Deals Intelligence.

Global pharma companies’ efforts to replace revenue from older drugs with promising new ones were largely stymied in 2023, but looming patent expirations and easing financing costs are setting up 2024 well, industry sources say.

On Monday, J&J (JNJ.N) said it would buy Ambrx Biopharma (AMAM.O) for $2 billion to gain promising targeted cancer therapies known as antibody drug conjugates (ADC). Interest in these drugs has spiked and several related companies have been acquired in recent months, including ImmunoGen (IMGN.O) by AbbVie (ABBV.N) and Seagen by Pfizer (PFE.N).

Separately, Merck (MRK.N) said it would buy cancer drug developer Harpoon Therapeutics (HARP.O) for about $680 million, gaining access to early-stage immunotherapies being tested for lung cancer and multiple myeloma.

Paxlovid May Not Be Associated With Lower Long COVID Risk, Survey Suggests — One in Five Treated With the Agent Reported Rebound COVID Symptoms, Researchers Found

MedPage Today reported:

Nirmatrelvir-ritonavir (Paxlovid) did not reduce the odds of developing long COVID in vaccinated, non-hospitalized adults, survey data showed.

About 16% of those treated with nirmatrelvir-ritonavir during acute infection with SARS-CoV-2 self-reported long COVID symptoms that persisted for 3 months or longer after infection, compared with 14% of those who were not treated with the medication (P=0.310), noted Matthew Durstenfeld, MD, of Zuckerberg San Francisco General Hospital, and colleagues in the Journal of Medical Virology.

Commonly reported symptoms of long COVID included fatigue, shortness of breath, confusion, headache, and altered taste and smell.

The survey data also showed a high rate of rebound among participants who took nirmatrelvir-ritonavir. About 21% of participants who had symptomatic improvement with the agent went on to report rebound symptoms. Also, nearly 26% of patients who completed treatment and tested negative for SARS-CoV-2 reported a subsequent positive antigen test, indicating rebound.

Bayer’s Menopause Drug Succeeds in Two Final-Stage Studies

Bloomberg reported:

An experimental Bayer AG drug successfully alleviated hot flashes and other disturbances associated with menopause in two studies, clearing a path for a medicine that Bayer says could become a blockbuster.

The drug, elinzanetant, lowered the frequency and severity of hot flashes and met all the research goals in studies that included about 800 post-menopausal women, the German company said Monday. Bayer was testing the therapy, which is administered orally once a day, against a placebo.

FDA’s Authorization of Florida Drug Importation Plan Draws Heat From U.S., Canadian Trade Groups

Fierce Pharma reported:

Florida has secured a major win in its yearslong quest to import cheaper drugs from Canada — though the backlash from pharma trade groups on both sides of the border has been swift and fierce.

The FDA on Friday authorized Florida’s drug importation program, which will be valid for two years after the first shipment of medicines.

But before Florida can actually draw drugs down from the Great White North, the state will need to submit medication-specific information for the FDA’s review and approval, the regulator said in a press release.

Florida must also ensure that the drugs it seeks to import have been tested for, among other things, authenticity and compliance with FDA standards. The imported drugs will also need to be relabeled consistent with FDA regulations.

India Orders New Drug-Making Standards After Overseas Deaths

Reuters reported:

Indian pharmaceutical companies must meet new manufacturing standards this year, according to a government notification released on Saturday, although small companies have asked for a delay, citing their debt load.

Jolted by a string of overseas deaths linked to Indian-made drugs since 2022, Prime Minister Narendra Modi’s government has stepped up scrutiny of pharmaceutical factories to clean up the image of the $50 billion industry.

The health ministry said in August that inspections of 162 drug factories since December 2022 found an “absence of testing of incoming raw materials”. It said fewer than a quarter of India’s 8,500 small drug factories met international drug manufacturing standards set by the World Health Organization (WHO).

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