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Pfizer’s Twice Daily Pill for Obesity Hopes to Rival Wegovy and Mounjaro
Does Pfizer have a future in obesity? We’ll find out any day now when the company discloses all-important mid-stage data on an oral medicine it hopes can compete with the heirs to Wegovy and Mounjaro.
The drug, danuglipron, is a twice-daily pill that targets GLP-1, the biological target that has upended the drug industry and shifted billions of dollars of value on the stock market. Pfizer is running a Phase 2 study testing whether danuglipron can meaningfully reduce body weight for patients diagnosed with obesity, and Leerink Partners analyst David Risinger expects the company to disclose results as early as Oct. 31.
The stakes are uncommonly high for a drugmaker of Pfizer’s size. The declining demand for COVID-19 vaccines and treatments led the company to slash its revenue outlook, and Pfizer’s stock has fallen 40% since the start of the year.
The company’s once-promising future in GLP-1 took a hit in June when Pfizer discontinued one of its potential weight-loss pills. That puts added pressure on danuglipron, which will need to stack up to a promising oral GLP-1 therapy from Eli Lilly if Pfizer hopes to have a future in the fast-growing field.
Pfizer, BioNTech Say Flu-COVID Shot Generates Strong Immune Response in Trial
Pfizer (PFE.N) and German partner BioNTech said on Thursday that their vaccine to prevent flu and COVID-19 generated a strong immune response against strains of the viruses in an early- to mid-stage trial. The companies said they plan to start a late-stage trial in the coming months.
“This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunization practices,” Annaliesa Anderson, Pfizer’s head of vaccine research and development, said in a statement.
In the trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ updated COVID-19 vaccine given at the same visit.
The data from the trial showed that the flu-COVID vaccine demonstrated robust immune responses to influenza A, influenza B and SARS-CoV-2 strains, the companies said.
White House Presses for Money to Prevent Opioid Deaths as Congressional Dysfunction Stymies Aid
The White House on Wednesday requested $1.55 billion from Congress to address illicit fentanyl driving overdose deaths across the country as part of a broader funding package.
The funds sought by the Biden administration would be included alongside money for grants to states, territories and tribes through a Department of Health and Human Services program that aims to help strengthen addiction treatment, overdose prevention measures and recovery support services.
Researchers last month found the U.S. was in a “fourth wave” of the opioid crisis, with the proportion of overdoses involving fentanyl and a stimulant found to have increased more than fiftyfold from 2010 to 2021.
Legislation to address opioid overdoses hasn’t come to a floor vote in either chamber this year. The SUPPORT Act, a bill passed in 2018 that provided $20 billion toward opioid use treatment, prevention and recovery, expired Sept. 30.
Merck Raises Revenue Guidance Thanks to a Surprising Bump From COVID Pill Lagevrio
It’s been grounded in Europe and reduced to irrelevancy in the U.S., but Merck’s COVID-19 pill Lagevrio somehow remains a force. The antiviral treatment racked up sales of $640 million in the third quarter, shocking analysts who figured it would generate $120 million.
During a Thursday earnings call, Merck did not address the sales surge of Lagevrio. In its release, the company simply credited an increase in demand in Japan.
The upswing comes eight months after Europe’s Committee for Medicinal Products for Human Use recommended against the authorization of Lagevrio, saying that its clinical benefit could not be demonstrated.
In the U.S., Pfizer’s Paxlovid — spurred by superior efficacy data before the appearance of the Omicron variant — has become the dominant treatment for at-risk patients who have been recently infected by the virus. In June 2022, the FDA ruled that pharmacists could prescribe Paxlovid but did not extend the same privilege to Lagevrio.
RSV Vaccine Could Help Protect Some Adults as Young as 50, Drugmaker Says
An RSV vaccine approved for use in older adults could help protect people as young as 50 who have certain underlying medical conditions and are at increased risk from the respiratory virus, according to preliminary data released by vaccine maker GSK.
The company said it would submit the information to the U.S. Food and Drug Administration for potential expansion of the vaccine’s availability. Earlier this year, the FDA approved Arexvy for adults aged 60 and older. Respiratory syncytial virus, known as RSV, is a highly contagious virus that causes flu-like illness in people of all ages.
GSK said Wednesday that a Phase 3 trial found Arexvy elicited an immune response in adults ages 50 to 59 who were at an increased risk for RSV due to underlying medical conditions.
Data from the trial has not yet been peer-reviewed or published. The results were to be presented Wednesday at the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting.
WHO Pandemic Treaty: Negotiations Falter as Pharma Companies Warn That Intellectual Property Rules Will Harm Profits
Pharmaceutical representatives and Germany’s health ministry have publicly opposed the latest draft of the World Health Organization’s pandemic treaty as a disagreement over waiving intellectual property (IP) rights becomes a sticking point in negotiations.
WHO’s pandemic prevention, preparedness, and response accord is intended to prevent future health threats from becoming as catastrophic as COVID-19 by legally obligating countries to cooperate, share knowledge, and reduce health inequities.
Since WHO’s 194 member states officially began negotiating on the treaty’s content in March this year disagreements have centered on the scope of the accord and how strongly countries should be obligated to fulfill its stipulations. The disagreements, which often follow the dividing lines of lower and higher-income countries, seem to be hardening as the thorny issue of IP comes into focus.
U.S. CDC Recommends Routine Use of Bavarian Nordic Mpox Vaccine for Adults at Risk
Danish pharmaceutical company Bavarian Nordic (BAVA.CO) said on Wednesday a U.S. Centers for Disease Control and Prevention panel has voted in favor of recommending the routine use of the Jynneos vaccine for adults at risk of mpox.
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend that individuals 18 years and older with certain risk factors should receive two doses of Jynneos.
The panel had previously recommended the vaccine for individuals at risk of mpox only during an outbreak, Bavarian said.
Bavarian Nordic is targeting a commercial launch of Jynneos in the U.S. in the first half of 2024, pending approval of the updated recommendations, it said. The company on Monday reported second-quarter revenue that beat expectations, helped by the sale of its mpox/smallpox vaccine, sending its stock up around 10%.
Medicare Will Negotiate Drug Prices With Big Pharma for the First Time. Here’s How Your Prescription Costs Might Change
The Inflation Reduction Act will let Medicare negotiate prescription drug prices with manufacturers to combat soaring medication costs, which it’s never been allowed to do. So, the obvious question: If you’re on Medicare, will your drug costs come down? The not-so-obvious answer: possibly, though not imminently.
Medicare drug price negotiation “is a big deal,” says Andrea Ducas, vice president of health policy at the Center for American Progress, a progressive, nonpartisan policy institute. “Drug price negotiation actually puts America closer to sort of on par with where other countries are,” says Ducas. “It means that, for the first time, there will be an ability to have a little bit of counterweight to the pharmaceutical industry. It’s pretty remarkable.”
The Congressional Budget Office estimates that the negotiations — assuming they aren’t blocked by current lawsuits from drug companies and the U.S. Chamber of Commerce — will save the federal government roughly $100 billion by 2031.
One reason most beneficiaries won’t see their drug costs drop anytime soon due to price negotiations is that only 10 medications are on the initial list. They are the ones Medicare spends the most on, have no generic or biosimilar equivalents, and have been on the market for at least seven years.
