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Fentanyl Vaccine Poised to Be ‘Game Changer’ in Fight Against Addiction

Fox News reported:

The end to the fentanyl crisis may be in sight, thanks to a team of researchers in Texas who claim they have successfully developed a vaccine that could be a “game changer” in addiction treatment. A team led by the University of Houston has developed what they say is a fentanyl vaccine that can block the synthetic opioid from entering the brain — essentially curing addiction by eliminating the euphoric high.

Their vaccine works in an entirely different way, said Dr. Colin Haile, a research associate professor of psychology at UH and the Texas Institute for Measurement, Evaluation, and Statistics (TIMES), from other treatments for opioid use disorder and overdose deaths.

It essentially produces antibodies much like other vaccines make those antibodies against a virus or bacteria. Dr. Haile’s vaccine does the same by blocking fentanyl from entering the user’s brain.

Testing on lab rats and mice showed very promising results, said Haile, and he believes they will see the same findings once human trials begin in the coming weeks. He believes the vaccine could be available to the public within two years, he said.

Feds Recall Eyedrops Over Vision Loss, Bacterial Infections

New York Daily News reported:

A popular brand of eyedrops sold in stores like Walmart and on Amazon is being recalled over vision loss and bacterial infection concerns, according to the U.S. Centers for Disease Control and Prevention.

The CDC recall of EzriCare Artificial Tears came Thursday after dozens of reports in 12 different states, as well as one death. Three people have been blinded by the drops, according to the agency.

At least 55 people have reported contracting Pseudomonas aeruginosa, an antibiotic-resistant bacteria, in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin.

The CDC is investigating with the Food and Drug Administration and state and local health agencies.

Drugmakers Brace to Be Grilled by Bernie Sanders-Led HELP Committee

Washington Examiner reported:

Pharmaceutical lobbyists are bracing in the crosshairs of the Health, Education, Labor and Pensions Committee now that it is chaired by “Medicare for All” proponent Sen. Bernie Sanders (I-VT), who has long taken an antagonistic view toward the industry.

The Vermont independent has already hinted he plans to take on the “greed of the pharmaceutical industry,” which could involve calling in drug company executives to testify, leaving some lobbyists apprehensive that it won’t be business as usual, making it harder to push their legislative priorities.

When asked about the possibility of calling executives to testify at hearings on drug pricing, Sanders told Axios that they are “working on a strategy right now that will be very aggressive.”

Gilead’s Breast Cancer Drug Secures U.S. FDA Approval for Third Indication

Reuters reported:

Gilead Sciences Inc (GILD.O) said on Friday the U.S. Food and Drug Administration had greenlighted expanded use of Trodelvy to treat the most common type of breast cancer, marking the third approval for the drug.

It was approved for an advanced form of breast cancer with a subtype known as HR-positive/HER2-negative in patients, who had stopped responding to a hormone-based therapy and at least two earlier systemic therapies.

The drug will likely face competition from AstraZeneca (AZN.L)-Daiichi Sankyo’s (4568.T) Enhertu, which is approved to treat breast cancer patients with HER2-low type, a subset of HER2-negative breast cancer.

Cowen analyst Tyler Van Buren expects peak sales of $600 million for the drug in the indication. Gilead reported fourth-quarter Trodelvy sales of $195 million late on Thursday.

In Mysterious FDA Approval, Pfizer Quietly Wins Ibrance Breast Cancer Expansion

Fierce Pharma reported:

It’s unusual to have the FDA chase down a pharma company and ask them to apply for a new drug indication. But Pfizer went through just that and has now quietly revealed a label expansion for blockbuster breast cancer med Ibrance.

The FDA has extended Ibrance’s approval in combination with an aromatase inhibitor to include newly diagnosed HR-positive, HER2-negative metastatic breast cancer patients regardless of menopausal status, Pfizer said Tuesday.

Previously, the combination of Ibrance and an aromatase inhibitor was limited to use in postmenopausal women. The FDA granted the new approval in mid-December, according to an approval letter, but Pfizer snuck the news into its fourth-quarter earnings announcement Tuesday.

There are other unconventional elements in this approval beyond Pfizer’s late, low-profile revelation. For one, a review of Ibrance’s updated prescription information shows no new efficacy data in the patient population.

BioNTech to Invest $43 Million in German Facility for mRNA Vaccine Building Block

Reuters reported:

BioNTech (22UAy.DE) will invest 40 million euros ($43 million) in a new facility in Germany that will allow it to produce an important building block in mRNA-based drugs, the German pharmaceutical firm said on Thursday.

German Chancellor Olaf Scholz, who visited the facility in Marburg, 90 kms (55.9 miles) north of Frankfurt, on Thursday, welcomed the investment.

After visiting the facility, Scholz stressed the need to speed up Germany’s approvals process for pharmaceutical companies when it comes to factories and drugs licensing in order to ensure Germany remains an attractive location for them.

BioNTech and partner Pfizer (PFE.N) — as well as rival Moderna (MRNA.O) — at the time scrambled to build a heavy-duty messenger RNA manufacturing network with dozens of external partners from scratch to produce COVID vaccines, in a technology that previously had no commercial application.

GSK Beats Expectations, Shingles Vaccine Bolsters Outlook

Reuters reported:

GSK (GSK.L) on Wednesday beat fourth-quarter profit and sales forecasts helped by sales of its blockbuster shingles vaccine Shingrix and unveiled an upbeat forecast for 2023.

That came after years of underperformance relative to its peers and largely missing out on the lucrative market for COVID-19 vaccines.

On Wednesday, the company reported adjusted fourth quarter profit of 25.8 pence per share on sales of about 7.4 billion pounds ($9.11 billion).

U.S. litigation over the heartburn drug Zantac has also spooked investors, hurting GSK’s shares in the second half of 2022. Some of those fears were abated with a favorable ruling in December, but other lawsuits remain.

The Last Drug That Can Fight Gonorrhea Is Starting to Falter

Wired reported:

To an unfamiliar eye, the press release from the Massachusetts Department of Public Health two weeks ago looked pretty routine. Its language was a little unnerving, maybe, but phrased carefully: Analysts had discovered a resident with a strain of gonorrhea that showed “reduced response to multiple antibiotics,” but that person — and a second with a similar infection — had been cured.

To a civilian, the announcement may have felt like bumping over a little wave in a boat: a moment of being off-balance, then back to normal. To people in public health and medicine, it felt more like being on the Titanic and spotting the iceberg.

Here is what the news actually said: A disease so old and basic that we barely think about it, even though it affects almost 700,000 Americans a year, is overcoming the last antibiotics now available to treat it.

If it gains the ability to evade those drugs, our only options will be desperate searches for others that aren’t approved yet — or a return to a time when untreated gonorrhea caused crippling arthritis, blinded infants as they were born, and made men infertile through testicle damage and women via pelvic inflammatory disease.

African Countries Lack ‘Immediate Access’ to Cholera Vaccine

Associated Press reported:

Africa’s public health agency says countries with deadly cholera outbreaks on the continent have no “immediate access” to vaccines amid a global supply shortage.

The acting director of the Africa Centers for Disease Control and Prevention, Ahmed Ogwell, told journalists on Thursday that the agency is working with the World Health Organization and the vaccine alliance GAVI on ways to obtain more doses.The Africa CDC is also working with two local manufacturers to explore if their facilities can be repurposed to manufacture cholera vaccines, Ogwell said. He didn’t say which ones.

WHO and its partners recommended in October that countries temporarily switch to using a single dose of the cholera vaccine instead of two because of the supply shortage as outbreaks of the water-borne disease surge globally. They said one dose of vaccine has proven effective in stopping outbreaks “even though evidence on the exact duration of protection is limited” and appears to be lower in children.

WHO noted that Haiti and Syria also are trying to contain large outbreaks. WHO and partner agencies manage a stockpile of cholera vaccines that are dispensed free to countries that need them.