Welcome to our dedicated page for GSK PLC news (Ticker: GSK), a resource for investors and traders seeking the latest updates and insights on GSK PLC stock.
News and regulatory disclosures for GSK plc (GSK) highlight the company’s ongoing activity across medicines, vaccines and strategic collaborations. As a global biopharma company, GSK regularly reports clinical trial milestones, product approvals, public health initiatives and agreements with partners and governments.
Recent news includes multiple regulatory approvals and data readouts in respiratory medicine. GSK has announced approvals for Exdensur (depemokimab) in markets such as Japan for severe asthma and chronic rhinosinusitis with nasal polyps, based on the SWIFT and ANCHOR phase III trials. The company has also reported that Nucala (mepolizumab) was approved in China as an add-on maintenance treatment for adults with COPD characterized by raised blood eosinophils, supported by the MATINEE and METREX studies.
In vaccines, GSK issues updates on Shingrix, including US FDA and European Commission approvals of a prefilled syringe presentation designed to simplify administration, and on its seasonal influenza vaccines FLULAVAL and FLUARIX, which are shipped ahead of each US flu season following FDA lot-release. News about Vaccine Track, GSK’s public data tool for US adult immunization trends, provides additional context on the company’s role in vaccination and public health analytics.
Oncology and specialty medicine updates feature prominently in GSK news. The company has reported US FDA approval of Blenrep in combination regimens for relapsed or refractory multiple myeloma, as well as positive phase III results for bepirovirsen in chronic hepatitis B with plans for global regulatory submissions. Additional releases describe collaborations with partners such as Hengrui Pharma and Summit Therapeutics to develop new respiratory, immunology & inflammation and oncology programs.
Investors and observers following GSK news can expect coverage of clinical trial outcomes, regulatory decisions, pricing and access agreements, and community initiatives such as the Linked by Lupus: Optimal Care Initiative. Bookmarking this page provides a centralized view of GSK’s latest announcements and SEC-reported developments.
ViiV Healthcare has received FDA approval for Cabenuva (cabotegravir, rilpivirine), the first long-acting HIV treatment specifically for virologically suppressed adolescents. The regimen allows for treatment as infrequent as six times a year, offering a crucial alternative to daily oral therapy. This approval highlights ViiV's commitment to addressing unmet needs in adolescent HIV care. The regimen's efficacy is supported by adult data and an interim analysis of the MOCHA study. However, adverse reactions were reported in 61% of adolescent participants, with injection site pain being the most common.
ViiV Healthcare announces US FDA approval for an updated label for Cabenuva, allowing treatment initiation directly with injections, bypassing the optional oral lead-in phase. This change enhances the user experience for HIV patients, streamlining the process of starting the first and only complete long-acting HIV treatment regimen. The label update is based on clinical trial results showing comparable safety and efficacy for both initiation methods. Cabenuva is indicated for virologically suppressed adults, reinforcing ViiV's commitment to innovative HIV therapies.
ViiV Healthcare announced the US FDA approval to update the label for Cabenuva, facilitating a streamlined initiation process for its long-acting HIV treatment. This update allows patients to start directly with injections, omitting the previously required oral lead-in regimen, after demonstrating comparable safety and efficacy between both initiation methods. Cabenuva, the only complete long-acting treatment for HIV-1, is approved for use in virologically suppressed adults. This approval is based on FLAIR trial results affirming effective treatment outcomes without the oral lead-in.
Alacer Corp. has launched Natean, a new eco-conscious oral healthcare brand featuring four toothpastes available exclusively at Walmart. Developed by a team of scientists and herbalists, Natean blends nature and science to meet consumer demand for effective, enjoyable, and sustainable oral care products. Each toothpaste is crafted with vegan-friendly ingredients, free from harmful additives, and packaged in sustainable materials. The new line includes formulations for cavity protection and sensitivity relief, catering to diverse consumer needs.
On February 11, 2022, GSK announced the launch of TUMSworthy Big Game Trivia ahead of the upcoming BIG GAME. TUMS® is hosting a trivia contest with a total of $88,000 in prizes, featuring a head-to-head challenge between football icons Terrell Davis and Hines Ward. Participants can enter via Twitter, answering trivia questions during the game for a chance to win a grand prize of $56,000 and additional prizes worth $32,000. This initiative aims to enhance fan engagement during the BIG GAME while promoting TUMS® as a go-to heartburn relief brand.
ViiV Healthcare, majority-owned by GlaxoSmithKline (GSK), presented groundbreaking research at CROI 2022, emphasizing long-acting HIV treatments. Key findings highlighted include:
- Cabenuva administered every two months shows sustained efficacy in virologically suppressed adults.
- Dovato demonstrates long-term efficacy over 144 weeks compared to TAF-based treatments.
- Insights from the MOCHA study reveal adolescent perspectives on long-acting injectables.
These results reinforce ViiV's commitment to innovative HIV treatment and prevention.
Cabenuva has received FDA approval for administration as few as six times a year for virologically suppressed adults with HIV-1, addressing treatment adherence challenges. This long-acting regimen combines cabotegravir and rilpivirine, initially approved in January 2021 for once-monthly dosing. The recent approval for every-two-month dosing was supported by the ATLAS-2M trial, showing comparable efficacy to monthly dosing. This innovation may significantly enhance patient experience and adherence, representing a noteworthy step forward in HIV treatment.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced the closure of its exclusive license agreement with GlaxoSmithKline (LSE/NYSE: GSK), initially revealed on November 22, 2021. The transaction's closing was contingent upon meeting customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. This milestone marks a significant step in Arrowhead's collaboration with GSK, potentially impacting its product development and market position.
The pandemic has significantly affected vaccination rates in the U.S., as reported by GSK. From January 2020 to July 2021, teens and adults missed an estimated 37.1 million doses of CDC-recommended vaccines, with monthly claims down 32% for adults and 36% for adolescents compared to 2019. This decline raises concerns over potential public health crises due to lower vaccination rates. GSK emphasizes the importance of increasing vaccine uptake to prevent future health risks.
908 Devices (NASDAQ: MASS) announced that GlaxoSmithKline (NYSE: GSK) has acquired an additional REBEL™ cell culture media analyzer, bringing GSK's total to five units. This device aids in optimizing cell cultures rapidly and is compatible with bioreactor setups. 908 Devices reported that there are now 15 customers with multiple REBEL devices, a significant increase year-over-year. All top 20 pharmaceutical companies are utilizing 908 Devices' products, enhancing their development processes.