Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

Moderna, reeling under a recent late-stage setback to its norovirus vaccine programme, finally has some good news to celebrate. After a winding regulatory battle, the FDA authorised the company's influenza vaccine mFlusiva (mRNA-1010) for use in all adults aged 50 years and older. The product is slated to hit the shelves in the coming weeks, ahead of the 2026–2027 respiratory virus season."Our fourth approved product in the US and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform," said CEO Stéphane Bancel. "Flu remains a significant public health challenge, and mFlusiva provides an important new option for America's seniors."mFlusiva now joins Moderna's diverse respiratory vaccine portfolio, which includes COVID-19 shots Spikevax and mNexspike, and RSV vaccine mResvia.The traditional approval of mFlusiva for adults aged 50 through 64 years was supported by a global Phase III trial of over 40,000 participants, wherein mFlusiva achieved a relative vaccine efficacy against influenza illness of 26.6% versus GSK's Fluarix, the standard-dose active comparator.Meanwhile, the mRNA flu vaccine secured accelerated approval in adults aged 65 and older based on a separate trial enrolling 2,992 US adults in this age bracket, pitting it against a high-dose inactivated influenza vaccine comparator. Confirmation of clinical benefit in this population will be evaluated through a 400,000-participant post-marketing study in this cohort.Story so far..mFlusiva's regulatory journey was anything but straightforward. In February this year, the FDA's Center for Biologics Evaluation and Research (CBER) issued a refusal-to-file letter, declining to review the marketing application for the vaccine despite Moderna's use of a priority review voucher. The letter, signed by then-CBER director Vinay Prasad, raised no safety or efficacy concerns but objected to the company's use of a licensed seasonal flu vaccine as its Phase III comparator. While Moderna dubbed the decision "inconsistent" with earlier feedback, the FDA's then-commissioner Marty Makary countered that the company had ignored "very clear" agency guidance.The stand-off, however, was short-lived. Another meeting shortly followed — reportedly under pressure from the White House — and the regulator agreed to accept the application, setting a target action date of August 5. Amid this, Prasad announced he would step down from CBER for a second time following a string of contentious decisions on vaccines and gene therapies.An FDA advisory committee (adcom) meeting was scheduled for June 18, and briefing documents released ahead found no major deficiencies with mFlusiva's application, sending Moderna's shares up more than 6% at the time. The agency staff, however, did flag evidence gaps in immunocompromised and frail older populations, and noted that pivotal trial data covered only a single flu season. At the adcom, panel members voted 9-0 in favour of mFlusiva, praising the vaccine's immunogenicity data and its potential to elicit stronger T-cell responses than existing flu shots, while urging the company to ensure its large post-marketing trial addresses remaining uncertainties in high-risk populations.Regulatory submissions for the Moderna vaccine also remain under review in the EU, Canada and Australia, with additional filings planned during the year.mRNA under fireThe Department of Health and Human Services has repeatedly raised unsubstantiated safety concerns regarding mRNA vaccines, and last August cancelled about $500 million in funding for 22 mRNA vaccine programmes.The increased scrutiny of mRNA vaccines prompted Moderna to withdraw its FDA application for influenza/COVID-19 combination vaccine mRNA-1083 last year after regulators sought additional Phase III flu efficacy data. The filing had been intended to follow the review of mFlusiva.Meanwhile, Pfizer too is developing a standalone mRNA influenza vaccine — which showed favourable Phase III efficacy data — in addition to an influenza/COVID-19 combination vaccine in collaboration with BioNTech.

GlaxoSmithKline (GSK) Pharmaceuticals has announced its financial results for the first quarter ended June 30, 2026. During the quarter, the company delivered strong growth across both its core and innovative portfolios. The performance reflects continued progress in the company's portfolio transformation strategy, supplemented by execution excellence, and a favorable base effect from the comparable period last year. Revenue for the quarter stood at INR 924 crore, up 15 percent Year-on-Year (YoY). Profit After Tax (PAT) increased by 24 percent to INR 253 crore, while EBITDA margins stood at 32 percent. The General Medicines portfolio grew strongly during the quarter, with the top 5 promoted brands outperforming the market (EI* >100; Source: IQVIA). Key promoted brands such as Augmentin, Ceftum and T-Bact reinforced their leadership positions in their respective categories, driven by a combination of deeper scientific and in-clinic engagement, omnichannel execution, and pricing measures. The Respiratory portfolio continued to further the management of chronic respiratory diseases with Nucala (mepolizumab) benefitting a large number of patients and Trelegy Ellipta gaining traction through new access pathways. The vaccines business grew through continued leadership in the self-pay private pediatric vaccines market, led by Infanrix Hexa and Fluarix Tetra. In the adult vaccination space, the company’s focus on elderly patient-cohorts with underlying Cardiovascular and Metabolic Diseases (CVMD) led to stronger endorsement from the healthcare professional community, translating to higher vaccinations with Shingrix (Recombinant Herpes Zoster Vaccine, Adjuvanted). The oncology business, led by specialised therapies Jemperli (dostarlimab) and Zejula (niraparib), has grown significantly since its launch in August last year. Jemperli is now the leading immunotherapy for first line primary advanced and recurrent endometrial cancer while Zejula is among the top PARP inhibitors in the maintenance treatment of recurrent ovarian cancer. Together, both therapies have touched the lives of a growing number of women suffering from gynecological malignancies, with GSK committed to expanding access and patient reach. Commenting on the results, Bhushan Akshikar, Managing Director (MD), GSK India, said, "GSK India's broad-based growth demonstrates the resilience of the core General Medicines and Vaccines portfolio and the growing contribution of the innovative business. This growth was enabled by a relentless focus on scientific excellence, sharper execution in the field and meaningful investments in technology and talent development. With a strong innovation pipeline and launch opportunities ahead, we are well-positioned to deliver sustainable growth and meaningful impact for millions of patients in India." The company has made progress in strengthening supply chain resilience through diversified sourcing, enhanced contingency planning and improved end-to-end visibility, substantially mitigating disruptions experienced in recent quarters. Looking ahead, GSK India is preparing for key pipeline launches. Blenrep (belantamab mafodotin), an anti-BCMA ADC therapy indicated for second-line treatment in relapsed or refractory multiple myeloma in adults, is set for launch. Arexvy, a vaccine to prevent Lower Respiratory Tract Disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults over 60 years of age and older adults (50 to 59 years) at high-risk, has received Marketing Authorisation (MA).