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Maternal RSV Vaccine: Further Analysis Is Urged on Preterm Births

The BMJ reported:

Experts have called for further analysis of trial data and post-approval monitoring of Pfizer’s maternal RSV vaccine candidate after GSK’s trials of a similar product were halted over a rise in preterm births and neonatal deaths.

An advisory committee from the U.S. Food and Drug Administration (FDA) is set to discuss the vaccine on May 18 as part of a fast-tracked priority review, with a decision expected by August.

Pfizer published the results of an interim analysis of its phase 3 trial in April 2023, saying that the vaccine was effective against medically attended severe RSV in children and that no safety concerns were identified.

But the results have raised concerns about a possible increase in preterm births, and experts are calling for further analyses of the data and for post-approval monitoring of the vaccine, should the FDA approve it.

Moderna’s Revolutionary Cancer Vaccine Sets Investors Abuzz

Forbes reported:

Shares of Moderna (MRNA) closed Tuesday up 19.6% after company executives announced a jointly developed vaccine showed great efficacy in fighting cancer in stage 3 and 4 melanoma patients. Moderna has been working since 2019 with Merck (MRK) to develop mRNA-4157/V940, a personalized mRNA therapy. And Merck announced in October that the company would pay $250 million to pick up its option to take a larger portion of the partnership. Clearly, Merck executives were expecting positive results from the ongoing early-stage patient trials.

Stephane Bancel, chief executive at Moderna called the results a homerun in an interview with CNBC, and he pledged to move the development of personalized mRNA vaccines to many more types of cancers.

The COVID-19 experience is partially responsible for the current $17 billion cash hoard on Moderna’s balance sheet. It’s money that Bancel says will fund new research and development, and the construction of manufacturing facilities capable of producing personalized vaccines at scale.

The company currently has 30 vaccines in development, including an inhalable product for cystic fibrosis, jointly developed with Vertex Pharmaceuticals Inc. (VRTX). Moderna will also work closely with Merck and its Keytruda portfolio for cancers that affect breast, skin, colon, uterus, cervix, stomach, kidney, gut, liver and bladder.

FDA Advisers Vote Unanimously in Support of Over-the-Counter Birth-Control Pill

CNN Health reported:

Advisers for the U.S. Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over the counter, saying the benefits outweigh the risks.

Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer. If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

Alzheimer’s Doctors See Promise, Limits in Lilly’s Latest Drug Data

BioPharma Dive reported:

To investors, last week’s news from Eli Lilly was clear-cut. One of the company’s most closely watched drugs, an experimental treatment for Alzheimer’s disease, had hit every major goal of a large clinical trial evaluating whether it could slow the neurodegenerative disease. Analysts now expect these results to get the drug, named donanemab, approved, handing Lilly what could be another blockbuster product.

The company subsequently saw its market value surpass $400 billion, putting it within reach of becoming the world’s most valuable drugmaker.

But among Alzheimer’s doctors and experts, any kind of consensus around these results has yet to be reached.

Drawing firm conclusions about donanemab is currently difficult for doctors because Lilly has only released high-level data from its trial, which enrolled nearly 1,750 participants who had Alzheimer’s symptoms but were still early in the course of the disease.

Bernie Sanders-Led Senate Committee Takes Pharma and PBMs to Task — Even After Insulin Price Cuts

Fierce Pharma reported:

The Senate Committee on Health, Education, Labor and Pensions (HELP) met Wednesday to press pharma and PBM leaders in a hearing dubbed “The Need to Make Insulin Affordable for All Americans.” In effect, bringing both sets of executives together allowed them to play the blame game on the Senate floor.

Eli Lilly’s CEO David Ricks, Novo Nordisk’s chief Lars Fruergaard Jørgensen and Sanofi’s head Paul Hudson all offered testimony, along with CVS Health’s executive vice president and president of pharmacy services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.

At the hearing, all three pharma chiefs committed to “keeping their drugs affordable,” including Lilly’s Mounjaro upon its potential approval for weight loss.

But asked whether the companies would no longer raise prices on their existing insulins, only Ricks gave a definitive answer. The Sanofi and Novo Nordisk chiefs did not.

Horizon Therapeutics Opposes Centralization of Tepezza Infusion Lawsuits in MDL

AboutLawsuits.com reported:

Despite facing a growing number of Tepezza infusion lawsuits, each involving similar allegations that the drug manufacturer failed to warn about the risk of permanent hearing loss, Horizon Therapeutics is opposing a request to centralize the litigation before one judge as part of an MDL, or multidistrict litigation.

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment introduced by Horizon Therapeutics in January 2020, as the first medication approved to treat thyroid eye disease or bulging eyes, which is caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye.

Hundreds of former users are now coming forward to report that they experienced various forms of hearing loss side effects from Tepezza infusions, including persistent ringing in the ears known as tinnitus, and complete hearing loss. In many cases, the problems persist long after the thyroid eye disease treatments, leaving users with irreversible hearing damage.

Increased Chikungunya Cases Adds Urgency to Vaccine Race

Bloomberg reported:

When you think of mosquito-borne illnesses, chikungunya is probably not the first one that comes to mind. But it’s a virus you may soon be hearing about more often.

Chikungunya is a virus that’s prevalent in the southern hemisphere and can cause severe, chronic joint pain. But last week, experts at a World Health Organization panel said chikungunya is now spreading to new areas like Paraguay that have previously seen fewer cases. This year, over 200,000 cases of chikungunya have already been reported in South America. As summer brings warmer weather, that number is all but sure to tick up.

That has made the development of a chikungunya vaccine particularly pressing, as there is currently no shot or treatment for the disease. But there are seven vaccines in development, and several are getting closer to approval. The U.S. Food and Drug Administration accepted France-based Valneva’s chikungunya vaccine license application for priority review in February. The vaccine was found to protect nearly all adult patients from the chikungunya virus in the six months following the shot in phase 3 clinical trial.

Another vaccine, soon to be owned by Bavarian Nordic, has completed a phase 3 trial for people aged 12- to 65 years old and has a second, active trial for older patients. Results for the completed trial have not yet been posted.

Novartis Targets New Treatment Fields — and CAR-T — for Next Phase of Immunology Growth: Exec

Fierce Pharma reported:

Novartis’ star drug Cosentyx recently hit a sales slump thanks to tough competition from newer biologics. But for the company’s next phase of growth in immunology, the Swiss pharma giant is targeting a slew of indications that remain underserved.

Cosentyx has been successful in psoriasis, a common battleground among drugmakers. But Novartis decided it’s “not going to play this game anymore” and is angling the blockbuster IL-17A inhibitor — and much of the rest of its immunology portfolio — at less cultivated indications, which Chief Commercial Officer Marie-France Tschudin said are still “lost out there.”

Common diseases such as psoriasis, atopic dermatitis, rheumatoid arthritis and inflammatory bowel diseases are almost absent in Novartis’ current immunology pipeline. Instead, it’s full of less familiar targets such as hidradenitis suppurativa (HS), Sjögren’s syndrome and chronic spontaneous urticaria.