Search Results for “FDA” – Page 157 – media

US cigarette smoking rate falls to historic low, but e-cigarette use keeps climbing

The percentage of adults who smoked cigarettes in the United States fell to a historic low last year, the US Centers for Disease Control and Prevention found. However, e-cigarettes are becoming even more popular. About 11% of adults told the CDC last year that they were current cigarette smokers, according to the latest preliminary data from the National Health Interview Survey, a biannual survey that provides general information about health-related topics. The survey includes responses from 27,000 people age 18 and older. In 2020 and 2021, about 12.5% of adults said they smoked cigarettes. This is a significant drop from when surveys like these started. Surveys of Americans in the 1940s found that about half of all adults said they smoked cigarettes. Rates began to decline in the 1960s, and more recently, in 2016, 15.5% of adults said they smoked cigarettes. Recent studies have shown some groups ...
- Source: drugdu
- 125
- April 29, 2023
Precision eye therapy for dogs ready for human clinical development

A successful gene therapy trialed at Michigan State University in dogs with an inherited eye disease is ready to be developed for clinical use in human patients with a rare condition called retinitis pigmentosa. Simon Petersen-Jones, professor and Donald R. Meyers and William E. Dunlap Endowed Chair in Canine Health at the Michigan State College of Veterinary Medicine, and his collaborators have published “Development of a translatable gene augmentation therapy for CNGB1-Retinitis Pigmentosa” in Molecular Therapy. Retinitis pigmentosa encompasses a group of rare genetic diseases that cause vision loss due to death of the light-sensing cells in the retina. Vision loss begins at a young age, and progresses throughout the lifespan. “There is currently an unmet need for treatment to save the vision of patients with CNGB1-retinitis pigmentosa,” Petersen-Jones said. “This promising therapy that works so well in dogs is now sufficiently developed that the next step is to take it forward for ...
- Source: drugdu
- 126
- April 28, 2023
Pfizer, BioNTech enlist Marvel’s Avengers in latest COVID-19 vaccine booster push

Just like how the Avengers have repeatedly kept the world safe from Ultron, people need to protect themselves by updating their COVID-19 vaccination with the latest booster. That’s the message Pfizer and BioNTech are trying to get across in a new custom comic book partnered with Marvel. The companies unveiled the project Tuesday. “We are proud to work with Marvel, which is so firmly entrenched in global culture and entertainment, to help remind people of the actions they can each take to help protect themselves, similarly to how the Avengers protect their community,” Pfizer said in a statement shared with Fierce Pharma Marketing. The new comic, titled “Everyday Heroes,” represents Pfizer flexing its marketing muscle. COVID vaccines are slated to switch to the private commercial market after the U.S. government failed to secure additional funding from Congress. As Pfizer CEO Albert Bourla, Ph.D., has said, Pfizer can be “even more competitive” and ...
- Source: drugdu
- 242
- April 28, 2023
survey

The FDA approval of AbbVie’s oral CGRP inhibitor Qulipta in chronic migraine could unleash a fresh phase of growth for the drug. That is the conclusion of survey data gathered by Spherix Global Insights, which found most physicians are very willing to prescribe the drug to patients with chronic migraine. Prior to the FDA approval, Spherix spoke to 74 neurologists and 101 primary care physicians about the migraine market, including their interest in prescribing Qulipta for the treatment of patients who have headaches at least 15 days per month. The survey suggests that AbbVie’s work to drum up interest in Qulipta since winning approval in episodic migraine in 2021 has primed the product for growth. Almost two-thirds of the surveyed neurologists said they would be very willing to prescribe Qulipta to chronic migraine patients, up from half earlier in the launch. Similarly, more than 50% of primary ...
- Source: drugdu
- 131
- April 27, 2023
OTC Narcan will cost ‘less than $50’, company says

The maker of the first opioid treatment drug to be sold OTC has announced a pricing plan weeks after an FDA approval for Narcan. Emergent Biosolutions, maker of the opioid overdose reversing nasal spray Narcan, intends to price the treatment at less than $50 for a kit of two 4mg doses for over-the-counter use (OTC) the company said in a statement. The company has said its goal is to have an out-of-pocket retail price that is in line with its publick interest pricing strategy. Public interest groups including government agencies, harm reduction groups, and emergency responders pay less than $50 out of pocket for one carton of the spray, according to Emergent. Additionally, its pricing for both public interest groups and retailers going forward would be less than the current Wholesale Acquisition Cost (WAC) price of $125. While justifying the price, the Emergent statement said the company needs to “foster a sustainable ...
- Source: drugdu
- 112
- April 25, 2023
Apellis’ immune system drug hits a setback in ALS

Jacob Bell Senior Reporter In the latest setback for ALS research, Apellis Pharmaceuticals, a Massachusetts-based drug company, has discontinued a portion of a key clinical trial testing one of its medicines as a treatment for the nerve-destroying disease. The “MERIDIAN” trial began in the fall of 2020, ultimately enrolling around 250 participants who were given either a placebo or Apellis’ medicine, known as pegcetacoplan, over a two-year period. Following that period, participants could join a so-called “open-label extension” study, in which everyone would have access to the drug. But Apellis has chosen to stop that latter study, based on feedback from an external group of advisers who reviewed the data available and concluded further treatment with the drug was unwarranted. Analysts at the investment bank Mizuho Securities were the first to report this development. According to the analyst Graig Suvannavejh, Apellis announced the study discontinuation through a “company communication” that clarified that the ...
- Source: drugdu
- 168
- April 25, 2023
US Supreme Court delays abortion pill access decision

By Nadine Yousif & Robin Levinson-King BBC News The US Supreme Court has extended until Friday a temporary block on limits to access of a popular abortion pill. A Texas judge suspended approval of abortion drug mifepristone on 7 April, questioning its safety. Parts of that decision were upheld on appeal, prompting the Biden administration to make an emergency request to the Supreme Court. It’s the most significant such case since the Supreme Court last year ended the nationwide right to abortion. The pill – used in more than half of abortions in the US – was first approved by the Food and Drug Administration (FDA) more than two decades ago. Here’s how we got here. What has happened so far? Earlier this month, a federal judge in Texas issued a preliminary injunction revoking the FDA’s approval for the drug while he hears a lawsuit brought by a group of ...
- Source: drugdu
- 140
- April 24, 2023
GSK to buy Bellus Health and its chronic cough drug for $2B

GSK on Tuesday said it will pay $2 billion to acquire Bellus Health, a Canada-based developer of an experimental drug for chronic cough that’s in late-stage clinical trials. Deal terms value each Bellus share at $14.75, roughly double their closing price on Monday. The companies expect the acquisition will close in the third quarter, and Bellus’ board has unanimously voted in its favor. Bellus’ drug, called camlipixant, is currently being tested in two Phase 3 studies of people with persistent cough that either doesn’t have a clear cause or can’t be relieved by treatment for an underlying condition. Results are expected in late 2024 and in 2025, respectively. With the Bellus deal, GSK will gain a drug that could compete with a similar treatment being developed by Merck & Co. Both medicines are designed to work by targeting a receptor known as P2X3, and could become the first ...
- Source: drugdu
- 352
- April 20, 2023
CDC signs off on additional Covid-19 booster doses for certain people

The US Centers for Disease Control and Prevention updated its recommendations on the Covid-19 vaccines on Wednesday to allow another dose of the bivalent booster for people who are 65 and older or who have weakened immune systems and who “want the option of added protection” against the coronavirus. The move aligns with Tuesday’s US Food and Drug Administration actions to allow these groups to get additional booster doses ahead of the fall vaccination campaign. On Wednesday, members of CDC’s Advisory Committee for Immunization Practices met to discuss the changes and expressed their support for them, although the committee did not vote. Monovalent mRNA vaccines, which protect only against the original strain of the coronavirus, will no longer be recommended in the United States, the CDC says. The updated bivalent shots from Moderna and Pfizer/BioNTech protect against the original strain as well as the BA.4 and BA.5 subvariants ...
- Source: drugdu
- 107
- April 20, 2023
Study Suggests Increased Number of PMA Supplements Increase Recall Risk

Investigators also highlighted long-standing concerns that modified devices may bear little resemblance to the device originally FDA-approved. Katie Hobbins | Apr 19, 2023 Recently, a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall. Makers of Class III PMA devices are offered five different types of supplements to allow for product improvements. Only one of the supplements — namely, panel track supplements — actually require clinical evidence for implementation and, as such, are the least-used type of the five, (approximately 1%). In contrast, the most used supplement type is a 30-day notice. A 30-day notice is used when a company makes changes to a manufacturing procedure or the way it makes a device. In the study, investigators analyzed devices approved through ...
- Source: drugdu
- 140
- April 20, 2023

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