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ViiV Healthcare Advances HIV Care with Breakthrough Long-Acting Injectable Data at AIDS 2026

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ViiV Healthcare Advances HIV Care with Breakthrough Long-Acting Injectable Data at AIDS 2026

ViiV Healthcare, the global specialist HIV company majority-owned by GSK plc, announced landmark clinical, real-world, and pipeline data presented at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil. Headlining the presentation, 96-week results from the Phase III LATA trial demonstrated that Cabenuva (cabotegravir + rilpivirine) dosed every two months is superior to daily oral therapy in virologically suppressed adolescents aged 12 to 19. The study showed confirmed viral rebound occurred in just 0.9% of adolescents receiving Cabenuva compared to 6.4% on daily oral treatment, with 94% reporting that long-acting injections were much easier to manage than daily pills. 

Reinforcing these findings in adult populations, real-world evidence from the US-based OPERA cohort of nearly 6,800 adults showed Cabenuva maintained virologic suppression comparable to daily oral BIC/FTC/TAF, with low confirmed virologic failure rates of 1% and 2%, respectively. Additionally, six-month follow-up data from the Phase I CLARITY study revealed a significantly more favorableinjection experience for long-acting cabotegravir (CAB LA) compared to lenacapavir (LEN) after a single dose. Seventy percent of participants rated the CAB LA experience as highly acceptable versus 37% for LEN, with CAB LA demonstrating far lower rates of persistent injection-site nodules (20% vs. 90%). Real-world insights from CAPTIVATE and PrEPFACTS further highlighted strong preference (97%) and high adherence (89%) for CAB LA (Apretude) for HIV prevention. 

Advancing its next-generation long-acting pipeline, ViiV Healthcare also shared baseline demographics from the Phase IIb EXTEND 4M trial evaluating a novel intramuscular cabotegravir formulation administered three times per year. Together, these milestone data underscore ViiV Healthcare’s commitment to expanding access, improving patient adherence, and defining the future of HIV treatment and prevention.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Wockhardt Launches “Wockhardt Antibiotic Academy” to Tackle Growing Threat of Multidrug Resistance in India

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Wockhardt Launches “Wockhardt Antibiotic Academy” to Tackle Growing Threat of Multidrug Resistance in India

Wockhardt Limited announced the launch of the Wockhardt Antibiotic Academy, a national initiative dedicated to fostering patient-centric scientific dialogue and advancing continuous medical education to combat antimicrobial resistance (AMR). 

With approximately 10 lakh patients in India dying annually due to multidrug-resistant infections over four times the annual loss of life experienced during the COVID-19 pandemic,the Academy addresses an urgent public health crisis. Designed as an open-access scientific learning platform for registered healthcare professionals across India, the initiative aims to facilitate knowledge exchange, real-world clinical evidence sharing, and evidence-based decision-making at the patient’s bedside. 

“There is an urgent need not only to have a new antibiotic like Zaynich, but also to have a science-based platform that fosters constructive dialogue on antimicrobial resistance and its appropriate management,” said Dr. Habil Khorakiwala, Founder Chairman of Wockhardt. “It is essential to use the right antibiotic for the right patient at the right time. We hope this Academy will create a deeper understanding of the current realities of drug resistance and promote evidence-based solutions that enable clinicians to save patients’ lives.” 

Dr. Subramaniam Swaminathan, President of the Clinical Infectious Diseases Society, India, highlighted the initiative’s clinical impact: “Resistance is not solved by guidelines alone. It is solved at the patient’s bedside, one clinical decision at a time. Antimicrobial stewardship continues to evolve… Any initiative that brings clinicians together to exchange knowledge and remain closely connected to science is a step in the right direction.” 

Through the Academy, Wockhardt will facilitate interactions with national and international infectious disease experts, uniting clinicians, scientific societies, and hospitals nationwide.

Written by: Pragna Biswas

Optimus Pharma Secures Regulatory Approval for Non-Steroidal Tapinarof Cream to Treat Plaque Psoriasis

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Optimus Pharma Secures Regulatory Approval for Non-Steroidal Tapinarof Cream to Treat Plaque Psoriasis

Optimus Pharma, a leading Indian pharmaceutical manufacturer and subsidiary of Sekhmet Pharmaventures, announced that it has received regulatory marketing approval for Tapinarof cream, an innovative non-steroidal topical treatment for adult plaque psoriasis.

The regulatory clearance covers both the finished formulation and the active pharmaceutical ingredient (API), both of which will be produced in-house at Optimus Pharma’s cGMP-compliant manufacturing facilities.

Approval was granted following successful clinical trial outcomes in India. In a local study involving 213 patients, Tapinarof cream demonstrated statistically significant superiority over placebo in achieving Physician Global Assessment (PGA) success after 12 weeks of treatment. Additionally, the trial demonstrated clear numerical improvements across secondary endpoints, including Body Surface Area (BSA) involvement, the Peak Pruritus Numeric Rating Scale (PP-NRS), and Psoriasis Symptom Diary (PSD) scores. As part of the regulatory mandate, Optimus Pharma will initiate a post-marketing safety study within three months.

Tapinarof acts as a novel aryl hydrocarbon receptor (AhR) agonist, providing patients with a targeted, non-steroidal option for long-term management of chronic skin conditions. Internationally, the molecule is marketed under the brand name Vtama.

“The approval for Tapinarof is a significant milestone for Sekhmet and reflects our commitment to bringing differentiated pharmaceutical products to patients while maintaining the highest standards of quality,” said Sumit Kumar, Chief Commercial Officer at Sekhmet Pharmaventures.

With this approval, Optimus Pharma reinforces its position in advanced dermatology, strengthening India’s domestic supply chain for high-quality, vertically integrated therapies.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Enhertu Shows Better Results Than Standard Treatment in Lung Cancer Trial

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Enhertu Shows Better Results Than Standard Treatment in Lung Cancer Trial

AstraZeneca and Daiichi Sankyo announced that their antibody-drug conjugate Enhertu (trastuzumabderuxtecan) has achieved a statistically significant and clinically meaningful improvement in progression-free survival in the Phase III DESTINY-Lung04 trial, marking the first time a HER2-targeted therapy has outperformed the global standard of care as a first-line treatment for this cancer subtype.

The trial evaluated Enhertu against the current frontline regimen—chemotherapy combined with pembrolizumab immunotherapy—in adults with unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer carrying HER2 mutations. This subgroup represents roughly 2–4% of NSCLC cases and tends to affect younger patients, often non-smokers, who face a higher risk of brain metastases and poorer outcomes.

Study leaders noted the results support moving Enhertu earlier into the treatment sequence, addressing a longstanding gap since many patients fail to respond adequately to existing frontline immunotherapy-chemotherapy combinations. Daiichi Sankyo’s R&D leadership emphasized that Enhertu was already established as a second-line option for this population, and these findings now point to its potential benefit even earlier in the disease course.

No new safety signals emerged during the trial, with the therapy’s tolerability profile remaining consistent with prior data. The trial, which enrolled 454 patients across sites in Asia, Europe and North America, will continue to track overall survival as a secondary measure. Full data are expected to be presented at an upcoming oncology conference and submitted to regulators worldwide.

Enhertu, jointly developed by the two companies since 2019, is already approved across multiple HER2-driven cancers, including breast, gastric and previously treated lung cancers, in more than 100 countries. This latest result adds to a growing body of evidence supporting the drug’s expansion into earlier lines of therapy.

Written By: Sayan Das 

Graphics by: Pramit Hazra

AstraZeneca Halts Phase III eVOLVE-Lung02 Trial of Volrustomig in Advanced Lung Cancer

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AstraZeneca Halts Phase III eVOLVE-Lung02 Trial of Volrustomig in Advanced Lung Cancer

AstraZeneca has announced it is stopping its Phase III eVOLVE-Lung02 study, which was testing volrustomig combined with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (mNSCLC) in patients with PD-L1 tumour expression below 50%. The trial compared this regimen against pembrolizumab plus chemotherapy.

The decision follows guidance from an Independent Data Monitoring Committee (IDMC), which reviewed trial data on a scheduled basis and determined that the volrustomig arm was unlikely to achieve statistically meaningful improvements in either progression-free survival or overall survival — the trial’s two primary goals — among patients with PD-L1-negative tumours (below 1% expression), when measured against the comparator treatment.

Importantly, no new safety concerns emerged. The combination’s tolerability profile matched what has already been documented for each drug individually.

Susan Galbraith, the company’s Executive Vice President for Oncology Haematology R&D, expressed disappointment but framed the outcome as part of ongoing scientific learning, reaffirming AstraZeneca’s commitment to advancing its lung cancer pipeline.

Enrolling 895 patients across 25 countries, eVOLVE-Lung02 tested volrustomig — a bispecific antibody engineered to simultaneously block PD-1 and CTLA-4 pathways on T cells — against the established checkpoint inhibitor pembrolizumab. AstraZeneca confirmed that patients currently enrolled will continue receiving appropriate care and monitoring in coordination with study investigators.

Despite this setback, the company’s broader volrustomig development programme remains active, with Phase III trials continuing in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma.

Lung cancer remains the world’s deadliest cancer type, responsible for roughly 23% of all cancer-related deaths globally, with NSCLC representing the majority of diagnosed cases.

Written By: Sayan Das 

Graphics by: Pramit Hazra

Argenx’s Efgartigimod Clears Phase 3, Bringing New Hope for Autoimmune Myositis

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Argenx’s Efgartigimod Clears Phase 3, Bringing New Hope for Autoimmune Myositis

argenx SE (Euronext & Nasdaq: ARGX) reported on August 17 that its Phase 3 ALKIVIA trial of subcutaneous efgartigimod (marketed as VYVGART Hytrulo) achieved its primary goal in adults with autoimmune myositis, a chronic inflammatory muscle disease with few treatment options.

Across the combined cohort of immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) patients, those receiving efgartigimod posted a 15.4-point edge over placebo on the Total Improvement Score at one year (47.95 versus 32.56; p=0.0011). Benefits appeared as early as week four and held through a full year of dosing, even as background steroids were tapered.

Notably, IMNM patients, a group with no approved targeted therapy, showed a statistically significant 14.8-point gain over placebo. DM patients improved by a comparable 14.5 points, though this subgroup narrowly missed statistical significance given its smaller size. Investigators noted gains spanned muscle strength, physical function, and, in DM, skin involvement, with a tolerability profile consistent with efgartigimod’s established record.

“These results confirm that pathogenic IgG antibodies drive this disease, and blocking FcRn can meaningfully change outcomes for patients who have long relied only on steroids,” said Dr. Luc Truyen, argenx’s Chief Medical Officer.

The company plans to present full data at a forthcoming scientific congress and will discuss the readout on an investor call later today. argenx is also studying efgartigimod in Sjogren’s disease and systemic sclerosis. Zai Lab, argenx’s partner for Greater China, contributed patients to the global trial through its regional license for VYVGART Hytrulo.

Written By: Sayan Das

Graphics by: Pramit Hazra

Pfizer-Valneva Lyme Vaccine Clears Key EU Regulatory Step

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Pfizer-Valneva Lyme Vaccine Clears Key EU Regulatory Step

Pfizer Inc. and Valneva SE announced that the European Medicines Agency has formally accepted for review the Marketing Authorization Application for their jointly developed Lyme disease vaccine candidate, PF-07307405 (formerly known as VLA15). The validation confirms the submitted dossier is complete and clears the way for EMA’s scientific assessment to begin.

The vaccine targets six variants of the outer surface protein A found on the Borrelia bacteria responsible for Lyme disease, the most widespread tick-borne illness across Europe and North America. Its mechanism works within the tick itself: antibodies generated by vaccination attack the bacteria inside a feeding tick’s gut, cutting off transmission before infection can take hold in the human bloodstream.

Backing the submission is data from the Phase 3 VALOR study, which enrolled participants aged five and older and recorded efficacy exceeding 70% against symptomatic Lyme disease. Researchers also reported a favorable tolerability profile, with no significant safety signals emerging during the trial.

Pfizer’s chief vaccines officer, Annaliesa Anderson, noted that Lyme disease affects over 100,000 people annually in Europe, with untreated cases sometimes progressing to lasting joint, nerve, skin, or cardiac complications. She framed the vaccine as a potential added safeguard for people who spend time outdoors.

If ultimately approved, PF-07307405 would represent the first vaccine against Lyme disease authorized for human use in more than twenty years. The companies had earlier submitted supporting data to the U.S. FDA, with Phase 3 results first disclosed in March 2026. EMA’s review timeline has not yet been specified.

Written By: Sayan Das

Graphics by: Pramit Hazra

Telangana Government Merges Food Safety and Drugs Control Departments to Form Unified Authority ‘TG SAFE’

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Telangana Government Merges Food Safety and Drugs Control Departments to Form Unified Authority ‘TG SAFE’

In a major regulatory and administrative reform, the Government of Telangana has merged the Food Safety Department and the Drugs Control Department into a single administrative commissionerate named TG SAFE(Telangana Standards Authority for Food and Essential Drugs). Issued by the Health, Medical & Family Welfare Department under government order G.O.Ms.No. 67, the initiative establishes a high-quality, technology-enabled regulatory framework aligned with national and international best practices to protect public health across the state.

The restructuring addresses the rapid growth of licensed food business operators and pharmaceutical establishments across Telangana. While both departments have functioned independently since 1981, the surge in commercial activity necessitated a unified surveillance, intelligence, and enforcement mechanism. By bringing both wings under a single-line administrative structure, the state aims to eliminate operational silos, expedite inspections, upgrade sampling and laboratory testing workflows, and curb the circulation of unsafe, spurious, and substandard food and drugs.

Under the new unified framework, the statutory powers of the respective authorities remain fully protected under the Food Safety and Standards Act, 2006 and the Drugs and Cosmetics Act, 1940.

1. Designated officers will continue to exercise their legal mandates independently, backed by integrated administrative, legal, and operational support. This consolidation is designed to enhance consumer safety, streamline regulatory compliance, and establish Telangana as a national benchmark for food and drug governance.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Caplin Point Laboratories Signs ₹925 Crore MoU to Establish Four New Manufacturing Units in Tamil Nadu

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Caplin Point Laboratories Signs ₹925 Crore MoU to Establish Four New Manufacturing Units in Tamil Nadu

Caplin Point Laboratories Ltd has signed a Memorandum of Understanding (MoU) committing an investment of ₹925 crore to establish four new state-of-the-art pharmaceutical manufacturing units in Tamil Nadu.

The agreement was formalized at the Tamil Nadu Investors’ Conclave in Chennai in the presence of the Hon’ble Chief Minister of Tamil Nadu, Mr. C. Joseph Vijay. On behalf of Caplin Point Laboratories Ltd, Dr. Sridhar Ganesan (Managing Director) and Mr. D. Muralidharan (Whole Time Director) officially signed and handed over the MoU documents.

Under this strategic expansion, Caplin Point will set up four specialized facilities across the state, with dedicated units focusing on high-value segments including Biologics & Biosimilars as well as Hormone Injectables. This capital outlay is aimed at scaling the company’s research, development, and sterile manufacturing capabilities to meet growing global demand for affordable and critical healthcare formulations.

In addition to improving the regional pharmaceutical ecosystem, this major investment initiative is projected to generate approximately 2,400 new employment opportunities across Tamil Nadu, fostering technical skill development and economic growth within the state.

The initiative reinforces Caplin Point Laboratories’ ongoing commitment to enhancing healthcare access, strengthening domestic supply chains, and driving scalable manufacturing excellence across complex therapeutic categories including sterile injectables, oncology, and advanced APIs.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

New Genomic Study Reveals Origin of DRC’s Ebola Outbreak

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New Genomic Study Reveals Origin of DRC’s Ebola Outbreak

A new genomic analysis published in Nature Medicine has identified the cause of the Ebola outbreak sweeping the Democratic Republic of the Congo (DRC): a fresh spillover of the virus from animals to humans, rather than the resurgence of a strain from earlier outbreaks.

Scientists from the DRC, Uganda, Belgium, and other institutions examined viral genetic sequences from 22 patients across the DRC and Uganda. Their findings confirmed the current strain is genetically distinct from Bundibugyo ebolavirus strains responsible for outbreaks in 2007 and 2012, pointing to a single, independent zoonotic transmission event that then spread through human contact. The specific animal source remains unidentified.

The outbreak, formally declared in mid-May but traced back to February through sequencing, has already claimed more than 2,000 lives among 4,449 confirmed cases, making it the fastest-spreading Ebola event on record. The World Health Organization has cautioned that, at current rates, it could surpass the toll of the 2014–2016 West African epidemic, which killed over 11,000 people.

Unlike the Zaire strain behind that earlier crisis, no licensed vaccine or targeted therapeutic currently exists for Bundibugyovirus, though experimental candidates are in development. Public health experts emphasize that while the outbreak originated from a single spillover event, its rapid spread is now driven almost entirely by human-to-human transmission—underscoring gaps in early detection and surveillance at the human-animal interface.

More than 100 healthcare workers have contracted the virus, with roughly 35 fatalities among responders. Several nations, including Rwanda, Uganda, and Bahrain, have imposed travel restrictions on visitors from affected regions as containment efforts continue.

Written By: Sayan Das

Graphics by: Pramit Hazra

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