DelSiTech and Visus Therapeutics enter into Patent Licensing Arrangement

Slow-Release Jab for Child Growth Hormone Deficiency Gets FDA Nod

US FDA accepts Teva-MedinCell’s new drug application for drug to treat schizophrenia

US FDA accepts Teva-MedinCell’s new drug application for drug to treat schizophrenia

FDA Accepts NDA for Subcutaneous Risperidone Injectable

Ascendis Pharma A/S Submits Investigational New Drug

Lyra Therapeutics Announces Publication of Preclinical Pharmacokinetics and Drug Release characterization for XTreo™ Technology Platform

Hanmi Pharmaceutical has confirmed the efficacy of LAPSGLP-2 Analog, a short bowel syndrome treatment candidate

LeaderMed Group and OPKO Health Form Joint Venture to develop an oxyntomodulin analog

FDA grants Orphan Drug Designation in the US for CAM2029 for the treatment of polycystic liver disease

Vutrisiran Under Review for Approval in Europe for FAP Treatment

MedAlliance announces completion of enrollment in Japanese SELUTION SLR™ Study

A 'game-changing' treatment in the opioid-dependence fight

HIV treatment evolution: drug development to meet the modern needs of patients

Rice University lands grant to improve time-release drugs

Daewoong wins Australian approval to conduct clinical trial of hair-loss treatment

Small but mighty - Article by Noor Al-Rifai CEng MIChemE and Rene Holm

FDA Grants Priority Review for Cabotegravir to Prevent HIV

PROVENT Trial's AZD7442 demonstrated statistical significance in protecting against symptomatic COVID-19 infection

AstraZeneca seeks FDA approval for COVID-19 antibody treatment

PanTher Therapeutics Doses First Two Patients in Phase 1 Trial of PTM-101 for Treatment of Pancreatic Cancer

NanoZolid®-formulated Docetaxel is Safe and Tolerable Showing Signs of Clinical Efficacy

AstraZeneca gets positive results from COVID-19 drug trial

18-Month Below-the-Knee Data with MedAlliance's SELUTION SLR™ Presented as Late Breaking Trial at VIVA

Trials for clinical injectable ARVs start in Uganda

VectivBio Announces Successful Opening of US IND for Apraglutide for Acute Graft-Versus-Host Disease

AstraZeneca files for Health Canada approval of new COVID-19 therapy

'Great step forward’ for HIV treatment as long-acting jabs to replace daily pills

Long-Acting Antibody Combo Reduced Risk of Symptomatic COVID-19 in Phase 3 Trials

NIH Grant Boosts Delpor’s Plans for Tizanidine Implant

Europe gives green light to first long-acting injectable treatment for schizophrenia in adults

WHO Approves First Long-Acting Device to Shield Women From HIV

NIH Statement on World AIDS Day 2021

The Medicines Patent Pool and the University of Washington sign a licence agreement for an investigational long-acting injectable HIV drug combination candidate

AstraZeneca’s long-acting antibody drug lands FDA authorisation for COVID-19

National Institute of Health and Care Excellence has signed off on offering pre-exposure prophylaxis treatment to people at a high risk of contracting HIV

Implementing Injectables

New Injectable HIV Prevention Drug Approved By FDA

Long-acting injectable for HIV prevention 'overpriced'

GlaxoSmithKline's HIV drug Cabenuva scores FDA nod for 2-month dosing

Injectables for schizophrenia reduce hospitalisations better than oral medications, study shows

MHRA approval for Byannli

HIV Prevention, Treatment: Playing the Long Game

ViiV Healthcare Long-acting HIV treatment secures FDA approval

Lenacapavir shows continued promise for first-line treatment and highly resistant HIV

Europe Accelerates Long-acting RSV Antibody Assessment in Infants

Pfizer gets EU approval for long-acting human growth hormone, softening blow of FDA rejection

Long-acting HIV-1 Capsid Inhibitor Sustained Efficacy in Phase 2/3 Study

Long-acting monoclonal antibody shows potential to offer RSV protection for all infants

Cali Biosciences Announces Successful Results in Phase IIb Study of Long-Acting Ropivacaine (CPL-01) for Non-Opioid Treatment of Post-Operative Pain

Cidara Therapeutics Announces the Completion of Dosing the First Cohort of Healthy Volunteers in the Phase 1 Trial of CD388 in Development for Universal Prevent

U.S. FDA Approves CABENUVA (cabotegravir and rilpivirine) for Adolescents, Expanding the Indication of the First and Only Complete Long-Acting Injectable HIV Re

Long-acting cabotegravir significantly decreases incidence of HIV compared to daily oral tenofovir

DelSiTech and Anticancer Bioscience Announce a Collaboration Agreement for the Development of Long-acting Therapies in Oncology

FDA Lifts Clinical Hold on Long-Acting Lenacapavir

Second-Generation Long-Acting Injectables Significantly Improve Long-Term Severe Schizophrenia Outcomes

MedAlliance's SELUTION SLR drug-eluting balloon (DEB) receives FDA investigational device exemption (IDE) approval

ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure

Investigational Lenacapavir Receives Positive CHMP Opinion for investigational lenacapavir for the treatment of HIV-1 infection

Gilead Sciences Resubmits NDA to FDA for Lenacapavir

Combination anti-HIV antibody infusions suppress virus for prolonged period

ViiV Healthcare looks to make long-acting HIV prevention shot accessible in low- and middle-income countries

Injectable PrEP can only cost a little more than oral PrEP if it is to be cost-effective, South African study finds

ViiV agrees to expand access to long-acting HIV PrEP

Injectable HIV Prevention Better Than Pills in Two Trials

WHO recommends long-acting cabotegravir for HIV prevention

Brii Biosciences Announces Positive Data Demonstrating its Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, Retains Neu

Leading figures urge drugs firm to lower price of ‘game-changing’ HIV prevention drug

GlaxoSmithKline's long-acting HIV drug nabs FDA priority review as a preventative option

Injectable PrEP Works Equally Well for Transgender Women

Johnson & Johnson scores an FDA first with nod for twice-yearly schizophrenia drug Invega Hafyera

Cidara Therapeutics Announces Initiation of Phase 2a Human Viral Challenge Trial to Evaluate CD388 for Universal Prevention of Influenza

Medicines Patent Pool and MedinCell sign license deal to fight malaria

FDA approves new HIV treatment for patients who have limited treatment options

Long-Acting Naltrexone Effective in Alcohol Use Disorder

Zimbabwe becomes first African nation to approve HIV prevention drug

EMA validates ViiV marketing authorisation application for Cabotegravir long-acting injectable for HIV prevention

South Africa expected to begin piloting HIV prevention shot in early 2023

MedinCell’s partner AIC registers trial for drug for total knee replacement pain

Nanexa AB has received approval initiate a clinical trial of its drug candidate NEX-2

Broadly Neutralizing Antibody Shows Promise for Long-Acting HIV Treatment

Astria Therapeutics Announces Positive Preliminary Results From The Phase 1a Clinical Trial Of STAR-0215 In Healthy Subjects

Astria Therapeutics Announces Positive Preliminary Results From The Phase 1a Clinical Trial Of STAR-0215 In Healthy Subjects

Using machine learning models to guide the design of long-acting injectable drug formulations

Study: Long-acting PrEP could reduce HIV incidence, AIDS deaths in sub-Saharan Africa

Twice-Yearly Sunlenca Works Well for Initial HIV Treatment

Sciwind Biosciences Announces Initiation of Patient Dosing in Phase 3 Clinical Trials of Ecnoglutide (XW003), a Long-acting GLP-1 analog, for the Treatment of T

New formulation can provide up to six months of full protection against HIV

Assembly Biosciences Nominates First Herpesvirus Development Candidate ABI-5366, a Long-Acting HSV-2 Helicase Inhibitor Targeting High-Recurrence Genital Herpes

Reassuring Data on Durability of Long-Acting ART Every 8 Weeks

ViiV Healthcare to Present First Head-to-head Data for New HIV Treatment Regimen Cabenuva Against Biktarvy

Akari Therapeutics Announces Pre-Clinical Development Progress Toward Potential IND on Long-Acting PAS-Nomacopan for Geographic Atrophy (GA)

GSK's ViiV says study shows its long-acting HIV shot as effective as Gilead's daily pill

PrEP implant could enable long-term HIV protection

Sanofi gets FDA nod for long-acting haemophilia A drug

Long-Acting Glatiramer Acetate Appears Safe and Effective in Large Trial

Long-Acting ART Suppresses HIV in Individuals Without Virological Suppression

Lenacapavir plus broadly neutralising antibodies may offer twice-yearly treatment option

Long-acting GIPRA inhibits feeding and lowers body weight in mice with diet-induced obesity

Top 5 stories on injectable HIV treatment and PrEP from CROI 2023

Doctor Gives Cutting-Edge HIV Treatment to SF’s Most Vulnerable

Doctor Gives Cutting-Edge HIV Treatment to SF’s Most Vulnerable

Skin patches may be more convenient MS antibody medicine

Cali Biosciences Initiates Phase III Studies of CPL-01 (Long-Acting Ropivacaine) to Decrease Post-Operative Pain and Reduce or Eliminate Opioid Use

Valitor Presents Preclinical Data on its Long-acting Anti-VEGF Biologic in Development for Durable Treatment of Wet AMD at the Association for Research in Visio

FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII® (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI)

Ultomiris approved in the EU for adults with neuromyelitis optica spectrum disorder (NMOSD)

Anti-HIV injection to be made in South Africa

Phase 1 data of mdc-TJK investigational long-acting injectable of olanzapine for schizophrenia patients, exhibited favourable characteristics

Phase 3 Study Finds Dupilumab Reduces COPD Exacerbations in Patients With Type 2 Inflammation

FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder

Global Long-acting Therapeutics News from January 2024

There's been a lot of news and announcements about long-acting medications from around the world this month. Here are some key pieces from other researchers that we think will interest you.

Long-acting HIV Antiretrovirals adopted in Botswana

Last week, Health Minister Edwin Dikoloti announced Botswana has adopted the use of long-acting antiretroviral injectables for HIV treatment.

Medicenna Announce First Patient with Advanced Solid Tumours Dosed in ABILITY-1 Study of MDNA11 Combination with KEYTRUDA® (pembrolizumab)

Medicenna Therapeutics Corp., a clinical-stage immunotherapy company announced the first patient dosed in the combination arm of the Phase 1/2 ABILITY study evaluating MDNA11, a long-acting, “beta-enhanced not-alpha” interleukin-2 (IL-2) super-agonist, with KEYTRUDA® (pembrolizumab). The combination portion of the study is designed to evaluate the potential for a synergistic effect of MDNA11 with KEYTRUDA® in patients with advanced solid tumors.

Long-acting antiretroviral therapy (ART) maintains HIV virologic suppression regardless of obesity status

Data captured from phase 3/3b trials showed that long-acting injectable cabotegravir plus rilpivirine effectively maintains HIV virologic suppression in most adults regardless of obesity status.

Innovative Long-acting Drug Delivery Platform Implanted in Eyes

SpyGlass Pharma Unveils Compelling 1-Year Data of Its Innovative Drug Delivery Platform Implanted During Routine Cataract Surgery in Eyes with Glaucoma

Long-acting injectable for schizophrenia approved in the EU

A long-acting injectable (LAI), Abilify Maintena® 960 mg (aripiprazole), by Otsuka Pharmaceutical Europe Ltd, has been approved by the European Commission (EC) as a once-every-two-months formulation for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.

Positive phase 2 study of zilebesiran for patients with hypertension

Long-acting oral combo for HIV maintains viral suppression at Week 24

Medincell enters into strategic co-development and licensing agreement with AbbVie to develop next-generation long-acting injectable therapies

Real-world use of long-acting cabotegravir and rilpivirine: 12-month results of the inJectable Antiretroviral therapy feasiBility Study (JABS).

Unlocking innovative hydrogel treatments

New cabotegravir formulations approved to help prevent HIV-1 infection in adults and adolescents

SUPERNOVA Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19 in immunocompromised patient population

Injectable HIV medication is superior to oral medication for patients who frequently miss doses

U.S. clinical trials begin for twice-yearly HIV prevention injection

New data provide schizophrenia treatment insights into switching to UZEDY® extended-release injectable suspension from invega sustenna®

Tirzepatide Shows Efficacy Resolving Metabolic Dysfunction-Associated Steatohepatitis without Worsening of Fibrosis

Namibian first ladies call for new HIV medicine

South Africa's roll-out of HIV prevention jabs stymied by price

Landmark Trial in South Africa and Uganda Finds Twice Yearly HIV Prevention Injection Safe and Highly Effective

AVAC Calls for Accelerated Regulatory Review and Ambitious Introduction Plans.

ADAP Advocacy Publishes Final Report for Patient Perspectives on Long-Acting Injectables

Comprehensive Report Offers Patient Access Considerations for Injectable HIV Therapies & Injectable HIV Pre-Exposure Prophylaxis

Behavioural Providers Turn to Long-acting Injectables to Boost Adherence, Decrease Burden

Medication adherence is a critical issue for behavioural health providers. This is especially true for patients with serious mental illness.

New mRNA technology turns cells into long-lasting drug factories

A team of researchers has established a ribonucleic acid (RNA)-based method that drives cells in the body to produce therapeutic proteins and secrete them into the bloodstream. The approach could potentially extend the lifespan of drugs in the body, reducing the burden on patients who require frequent drug administrations.

Camurus announces positive Phase 3 results from the ACROINNOVA 2 study of octreotide SC depot (CAM2029) in acromegaly patients

Camurus have announced positive, final, topline results from the 52-week Phase 3 open-label ACROINNOVA 2 study, which evaluated safety and efficacy of the company’s once-monthly octreotide subcutaneous (SC) depot.

ViiV Healthcare announces positive new data for Apretude use during pregnancy at AIDS 2024

ViiV Healthcare, the global specialist HIV company, shared new maternal safety and pregnancy outcomes and pharmacokinetic (PK) findings from the HIV Prevention Trials Network (HPTN) evaluating cis-gender women in sub-Saharan Africa who became pregnant while using Apretude (cabotegravir LA for PrEP) for HIV pre-exposure prophylaxis (PrEP).

HIV drug could be made for just $40 a year for every patient

Generic version of a drug already on the market, which can suppress and prevent HIV, would still yield 30% profit if the current price was slashed, researchers say.

Concentric Analgesics Announces Data Highlighting Two Weeks of Durable Pain Relief and Earlier Cessation of Opioids in Two Surgical Procedures

Clinical Data from Phase 2 Studies in Total Knee Arthroplasty (TKA) and Bunionectomy to be Presented at the 2024 International Association for the Study of Pain (IASP) World Congress

Persist AI and Nivagen to Collaborate on AI-Driven Manufacturing Process for Long-Acting Injectable

The two companies intend to leverage their complementary expertise and technology to bring a novel long acting injectable and drug product manufacturing platform to market.

Peptron to boost long-acting drug production 10-fold with new factory, investing ₩65 billion.

Peptron, a Korean biotech company, said last Friday that it will invest 65 billion won (£37 million) to build a new manufacturing plant for peptide-based long-acting pharmaceuticals.

Nanoform and Celanese expand collaboration into long-acting biologics delivery through small implants

Nanoform Finland Plc, an innovative nanoparticle medicine enabling company, and Celanese Corporation, a global specialty materials and chemical company, announced an expansion of their collaboration to cover biologic drug delivery on 5 September.

GSK present data at ERS for depemokimab an asthma medication that last 6 months.

On 9 September, GSK presented the full results from the SWIFT-1 and SWIFT-2 phase III clinical trials which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterised by raised blood eosinophil count.1

First Patients Dosed in Debiopharm's Phase III Trial of a 12-Month Triptorelin Formulation for Children with Central Precocious Puberty

Debiopharm, a privately-owned, Swiss-based biopharmaceutical company aiming to develop innovative therapies and to improve patient quality of life. On 9 September, they announced the dosing of the first sentinel patients in its open-label, single-arm, multi-center Phase III study, NCT06129539 ‘A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty (LIBELULA)’.

Innovative semaglutide hydrogel could reduce diabetes shots to once a month

Once-a-month long-acting injectable hydrogel could greatly improve management of both type 2 diabetes and weight loss, drug adherence, and long-term health outcomes.

Patent Applications for HIV Prevention Drug Opposed in India: Vulnerable Group Seeks to Protect Generic Competition to Lower Prices of HIV Prevention Drug Lena

The Indian Patent Office is set to hear the objections of Sankalp Rehabilitation Trust against the grant of patent claims filed by US-based pharmaceutical company Gilead Sciences on the HIV drug lenacapavir (LEN). Sankalp, a civil society organisation working with populations vulnerable to HIV, opposed the patent applications in 2021 because the drug consists of a previously known compound, and should not be considered an invention according to India’s Patent Act.

Astria Therapeutics Receives FDA Orphan Drug Designation for Navenibart (STAR-0215) for the Treatment of Hereditary Angioedema

Astria Therapeutics, Inc., a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, announced on 30 September that navenibart (STAR-0215) has been granted Orphan Drug Designation for the treatment of hereditary angioedema (HAE) by the U.S. Food and Drug Administration (FDA).

UNAIDS response to Gilead’s announcement on signing voluntary licensing agreements on lenacapavir with six generic manufacturers

Astria Therapeutics, Inc., a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, announced on 30 September that navenibart (STAR-0215) has been granted Orphan Drug Designation for the treatment of hereditary angioedema (HAE) by the U.S. Food and Drug Administration (FDA).

EyePoint Pharmaceuticals Announces First Patient Dosed in Global Phase 3 LUGANO Clinical Trial of DURAVYUTM for the Treatment of Wet Age-Related Macular Degener

EyePoint Pharmaceuticals, Inc., a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, announced on 24 October that the first patient has been dosed in the Phase 3 LUGANO clinical trial of DURAVYU™, formerly EYP-1901, for the treatment of wet age-related macular degeneration (wet AMD).

Long-Acting Degradable Implants for Endometriosis Treatment

Women’s Health Research at Yale Initiates New Pilot Projects

First-ever long-acting injectable for malaria prevention administered to study volunteer

First-in-human study explores a single injection that provides 3 months of protection.

Simulations Plus and the University of Connecticut Receive New FDA Grant to Expand Mechanistic Modeling Approaches for Long-Acting Injectables

Funded collaboration will leverage current FDA partnership to include additional LAI technologies.

Rapid initiation with Sublocade improves retention for opioid use disorder treatment

New data show that rapid initiation with once-monthly Sublocade significantly improved treatment retention vs. standard initiation among patients with opioid use disorder, according to a press release.

MSF to roll out injectable HIV prevention drug in southern Africa

Increasing access to this long-acting preventive medicine could be a game changer in curbing the spread of HIV/AIDS.

Long-Acting Drugs Market Revolutionizing Therapeutics with Sustained-Release Innovations and Emerging Opportunities

The global healthcare landscape is witnessing a profound transformation, driven by the growing adoption of long-acting drugs (LADs). These therapeutic agents, designed to release their active ingredients over extended periods, offer significant advantages in patient compliance, convenience, and therapeutic efficacy. As chronic diseases rise and healthcare systems aim to optimize treatment outcomes, the long-acting drugs market is poised for robust growth. This article explores the dynamics of the market, the innovative sustained-release technologies shaping its trajectory, and the emerging opportunities for stakeholders.

Gilead Announces New England Journal of Medicine Publication of PURPOSE 2 Results

On Wednesday 27 November, Gilead Sciencesannounced The New England Journal of Medicine (NEJM) published the full results from the company’s pivotal Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people.

Sirius Therapeutics to Present Data from Its Phase 1 Clinical Trial of Factor XI siRNA, a Long-Acting Next-Generation Anticoagulant for Thromboembolic Disorders

On Wednesday 3 December, Sirius Therapeutics announced that preliminary data from its Phase 1 clinical trial of SRSD107, a next generation siRNA therapeutic under clinical development for the prevention and treatment of thromboembolic disorders, will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will take place December 7-10, 2024, at the San Diego Convention Center and online.

Unitaid invests US$22m to accelerate access to lenacapavir, a groundbreaking new HIV prevention drug

Ahead of World AIDS Day, Unitaid is announcing a US$22 million investment to accelerate the introduction and access to lenacapavir, a revolutionary long-acting HIV prevention option.

Neuraxpharm and Pharmathen enter into strategic co-development agreement to develop long-acting injectable therapies

Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, and Pharmathen, one of the largest pharmaceutical companies in Greece and leaders in the development and supply of long-acting injectable (LAI) therapies, announce a strategic alliance to co-develop new long-acting injectable therapies within the psychiatry field under Pharmathen's long-acting therapeutic technologies (LATT) program.

Global leaders in the HIV response call for access to long-acting medicines

On 10 December 2024, at the 55th Programme Coordinating Board for the Joint United Nations Programme on HIV/AIDS (UNAIDS), HIV leaders from across the world called for access to long-acting medicines for everyone who would benefit from them, to build toward a new era in the AIDS response.

ViiV Healthcare announces CHMP positive opinion for Vocabria + Rekambys, the first and only complete long-acting HIV treatment, for adolescents in Europe

GSK announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, on 16 December announced that the Committee for Medicinal Products for Human Use (CHMP) of the Europe Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson Innovative Medicine’s Rekambys (rilpivirine long-acting injections) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed.

Johnson & Johnson denied extension of patent on TB drug, to benefit patients

In a move that will benefit tuberculosis patients, Indian Patent Office (IPO) has denied the US giant Johnson & Johnson's request to extend its patent on the life-saving tuberculosis drug Bedaquiline.

Oruka Therapeutics Announces First Participants Dosed in Phase 1 Trial of ORKA-001, its Novel Half-life Extended Anti-IL-23p19 Antibody

Oruka Therapeutics, Inc., a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, on 19 December announced that it has initiated dosing of healthy volunteers in its first clinical trial of ORKA-001, the Company’s novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19.

WHO announces the development of new guidelines for lenacapavir and updated HIV testing guidelines

World Health Organisation (WHO) is convening a Guideline Development Group (GDG) for the development of new guidelines on the use of injectable lenacapavir as pre-exposure prophylaxis (PrEP) for HIV, and the optimization of HIV testing services for long-acting prevention products.

Novo Holdings invests in $200M Series A for Windward Bio launch to advance long-acting treatments for asthma and COPD

Novo Holdings, a leading life science investor, announced on 10 January 2025 that it has invested in a $200M Series A launch financing for Windward Bio. Headquartered in Switzerland, Windward Bio is a clinical-stage drug development company committed to improving outcomes for people living with advanced immunological diseases with an initial focus on severe respiratory conditions.

Long-acting Injectables: Microsphere Design, Development and Scale-up Using Lactide/Glycolide-Based Polymers, Upcoming Webinar Hosted by Xtalks

XTalks have announced a free webinar on long-acting injectables. Learn about the selection and optimization of long-acting microsphere formulations with releases ranging from weeks to one year. Attendees will learn about the critical quality attributes that can help achieve tunable release profiles in long-acting drug formulations.

Glaukos Announces Positive Clinical Updates for its iDose® Sustained-Release Procedural Pharmaceutical Platform

Glaukos Corporation, an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced on 14 January 2025 several positive clinical updates for its iDose® sustained-release procedural pharmaceutical platform.

Lyndra Therapeutics Announces Strategic Clinical Research and Commercial Manufacturing Services Collaboration with Thermo Fisher Scientific for Long-Acting Oral

Leveraging its Accelerator™ Drug Development, 360° CDMO and CMO solutions, Thermo Fisher will provide clinical research services for Lyndra’s phase 3 pivotal safety study for oral weekly risperidone (LYN-005), set to begin in 1H 2025, and commercial manufacturing of long-acting oral therapies utilizing Lyndra’s LYNX® drug delivery platform.

Health Canada approves (Pr)ABILIFY ASIMTUFII® (aripiprazole), the first, once-every-two-months, long-acting injectable treatment for schizophrenia

Otsuka Pharmaceutical Canada Inc. (Otsuka) and Lundbeck Canada Inc. (Lundbeck) announce that Health Canada has issued a Notice of Compliance for ABILIFY ASIMTUFII® (aripiprazole prolonged release injectable suspension) for intramuscular use, a once-every-two-months treatment for schizophrenia and maintenance monotherapy of bipolar I disorder in adults.

UNAIDS calls on leaders at Davos to commit to rapid global access to revolutionary new long-acting HIV medicines

UNAIDS urges speed and compassion urging pharmaceutical companies to enable access to new, life-saving medicines.

European Commission authorises ViiV Healthcare’s long-acting injectable Vocabria + Rekambys for HIV treatment in adolescents

On 31 January 2025, ViiV Healthcare, the global specialist HIV company majority owned by GSK with Pfizer and Shionogi as shareholders, announced that the European Commission has authorised Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson’s Rekambys (rilpivirine long-acting injections) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed.

Narrating medicine: Experiences of HIV treatment and prevention

Invivyd announces positive phase 1/2 clinical data for VYD2311, a monoclonal antibody to be a alternative to COVID-19 vaccination for the broad population

On 3 February 2025, Invivyd, Inc. announced positive data from its ongoing Phase 1/2 clinical trial of VYD2311, Invivyd's novel monoclonal antibody (mAb) candidate designed to be a superior alternative to COVID-19 vaccination for the broad population as frontline protection in a convenient form, as well as to provide a novel, potent, long-acting option for the treatment of COVID-19.

This new drug delivery method could offer long-lasting relief for eye diseases

University of Toronto Engineering researchers are working to enable a future where a single, non-invasive injection under the eyelid could replace months of daily eye drops in treating glaucoma, a leading cause of blindness.

EyePoint announces positive six-month results for phase 2 VERONA clinical trial of DURAVYU™ for diabetic macular edema meeting primary and secondary endpoints

On 5 February 2025, EyePoint Pharmaceuticals, Inc., a company committed to developing and commercialising innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), an investigational sustained delivery therapy delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor (TKI) formulated in proprietary bioerodible Durasert E™.

Foresee Pharmaceuticals Receives the Third Positive Recommendation from the DSMB to Continue the Casppian Study

Foresee Pharmaceuticals ("Foresee"), on 17 February 2025 announced the third positive safety review by the independent Data and Safety Monitoring Board for its Casppian Phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial as planned without any modification.

U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review

On 18 February 2025, Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).

ANEA and TAG Stand in Solidarity with Demonstrators Fighting to Save PEPFAR

The ACT NOW: END AIDS Coalition (ANEA) and Treatment Action Group (TAG) were proud to stand in solidarity with activists demonstrating on 26 February 2025, at the U.S. Capitol demanding that the U.S. government restore full funding to the President’s Emergency Plan for AIDS Relief (PEPFAR).

Assembly Biosciences Reports Positive Interim Phase 1a Results from Clinical Trial Evaluating Long-Acting Helicase-Primase Inhibitor ABI-1179 in Development for

On 20 February 2025 Assembly Biosciences, a biotechnology company developing innovative therapeutics targeting serious viral diseases, announced positive interim Phase 1a results in healthy participants from its ongoing Phase 1a/b study of ABI-1179, an investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate for recurrent genital herpes.

Daré Bioscience and Theramex Announce Co-Development and Licensing Agreement for a Potential Biodegradable Long-Acting Contraceptive Implant

Daré Bioscience, Inc., a leader in innovation for the health and wellbeing of women, and Theramex, a leading, global specialty pharmaceutical company dedicated to women and their health, announced that they entered into a co-development and licensing agreement for a potential first-in-category biodegradable contraceptive implant called Casea S recently acquired by Theramex.

FDA Acceptance of Supplemental New Drug Application for UZEDY(R) Extended-Release Injectable Suspension as a Treatment of Bipolar I Disorder

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL) announced that the supplemental New Drug Application (sNDA) for UZEDY extended-release injectable suspension for the maintenance treatment of BP-I in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA).

Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP)

GSK plc announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications.

ViiV announced three different long-acting HIV treatment and PREP news pieces this week

As the Conference for Retroviral and Opportunistic Infections (CROI) came to a close, so did the press embargoes and ViiV had a lot of news to share. See them below.

Gilead present two sets of new data for HIV prevention and treatment at CROI 2025

The Conference of Retrovirals and Opportunistic Infections (CROI) came to a close this week, and the press embargoes finished with it. Gilead brought some incredible new data from their work that they presented. Here are two pieces around HIV prevention and treatment.

Long-acting treatment benefits postpartum women with HIV and their babies

Switching to long-acting ART from oral treatments was cost effective for postpartum women with HIV and improved infant outcomes, researchers said at the Conference on Retroviruses and Opportunistic Infections.

TaiMed Biologics to Present Late-Breaking Phase IIa Data at CROI 2025 on Long-Acting TMB-365/TMB-380 Regimen for HIV Maintenance Therapy.

TaiMed Biologics announced the presentation of 24-week Phase 2a clinical study data at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco. The study results highlight the superior safety and efficacy profile of TMB-365/TMB-380—a first-of-its-kind long-acting dual bNAb regimen—for HIV maintenance therapy in participants switched from daily oral cART.

Engineers develop a better way to deliver long-lasting drugs

With tinier needles and fewer injections, the approach may enable new options for long-term delivery of contraceptives or treatments for diseases such as HIV.

New data strengthens Teva’s schizophrenia portfolio, including phase 3 SOLARIS trial survey demonstrating patient and healthcare professional satisfaction

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.c, announced the presentation of a patient and healthcare professional (HCP) attitudes and experiences survey study, complementing the successful Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) evaluating TEV-'749.

Luye Pharma announces U.S. launch of ERZOFRI® extended-release injectable suspension for the treatment of schizophrenia and schizoaffective disorder

Luye Pharma Group has announced that ERZOFRI® (paliperidone palmitate) extended-release injectable suspension is now available for commercial sale in the U.S. for the treatment of adults with schizophrenia and as a monotherapy or adjunct therapy for the treatment of adults with schizoaffective disorder.

Insights into the hepatitis C drug market growth projections from 2024 to 2035

The Hepatitis C drug market is entering a transformative phase as global health organizations, pharmaceutical companies, and governments ramp up their efforts to combat this chronic and often silent disease.

CHAI's 2025 HIV Market Impact Memo highlights significant risks to HIV service delivery following reductions in US foreign aid.

CHAI has released a comprehensive gap analysis to inform the response to disruptions in global HIV funding.

Pacira BioSciences announces two-year efficacy data following a single local administration of PCRX-201 in patients with osteoarthritis of the knee

Pacira BioSciences, Inc., the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced new data demonstrating its locally administered gene therapy candidate, PCRX-201 (enekinragene inzadenovec), provided sustained improvements in knee pain, stiffness, and function for up to two years following a single local administration in patients with mild, moderate, as well as severe osteoarthritis of the knee. The data was presented during a poster session at the 2025 Osteoarthritis Research Society International (OARSI) World Congress in Incheon, South Korea, on Friday, April 25, and Saturday, April 26.

New single-shot vaccine could offer controlled release of multiple doses over six months

Pioneering new research is set to investigate a promising vaccine technology designed to remove the need for cold-chain storage and condense multi-dose regimens into a single, controlled-release vaccination.

New data from phase 3 SOLARIS results demonstrating patient and healthcare professional with a once-monthly subcutaneous long-acting injectable

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the presentation of a patient and healthcare professional (HCP) attitudes and experiences survey study, complementing the successful Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) evaluating TEV-'749.

New study highlights monthly SUBLOCADE® as a potential treatment option for opioid use disorder during and after pregnancy

SUBLOCADE use during pregnancy showed no increased risk of birth defects, miscarriage, or maternal complications compared to general population rates.

Persons living with HIV can be treated safely, effectively with long-acting antiretroviral therapy at home

Medical University of South Carolina study shows that long-acting antiretroviral therapy for persons living with HIV can be administered safely and effectively at home.

Astria Therapeutics Announces Publication of Navenibart Phase 1a Healthy Subject Results in the Annals of Allergy, Asthma & Immunology

Astria Therapeutics, Inc., a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that results from a Phase 1a trial in healthy subjects supporting navenibart’s potential to provide long-acting, safe, and effective attack prevention for hereditary angioedema (HAE) with dosing every 3 and 6 months have been published in the Annals of Allergy, Asthma & Immunology.

Global leaders convene to accelerate access to long-acting HIV prevention technologies amidst funding cuts

The global response to HIV has reached a crucial juncture. Groundbreaking scientific advances, including the development of long-acting HIV prevention technologies like lenacapavir and cabotegravir, offer a transformative opportunity to curb the epidemic.

Teva presents latest schizophrenia portfolio data including real-world outcomes with UZEDY® (risperidone) showing lower rates of and longer time to relapse

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. have announced the presentation of real-world clinical outcomes, treatment patterns and healthcare resource utilization (HCRU) data evaluating UZEDY® (risperidone), an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, versus second-generation daily oral options. In the studies, patients receiving UZEDY had lower rates of and longer time to relapse as well as better treatment adherence and persistence rates, fewer inpatient, outpatient and emergency department (ED) visits, shorter hospital length of stay and lower all-cause HCRU.

Once-a-week pill for schizophrenia shows promise in clinical trials

The ingestible capsule forms a drug depot in the stomach, gradually releasing its payload and eliminating the need for patients to take medicine every day.

The end of the HIV epidemic is within reach

Médecins sans frontières / Doctors Without Borders (MSF) teams in Eswatini report success with long-acting pre-exposure prophylaxis (PrEP), which could be a turning point in ending the HIV epidemic—if people can access it.

CAN Community Health Launches Same-Day Injectable PrEP Model to Improve HIV Prevention Outcomes

Patients can now receive long acting injectables to advance closing the gap in HIV prevention.

Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection

Gilead Sciences, Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP.

UNAIDS urges Gilead to drop price of new HIV prevention shot

The United States Food and Drug Administration (FDA) has approved long-acting injectable lenacapavir for HIV prevention. The new medicine is administered by injection once every 6 months and is a significant step in improving prevention options for people at risk of HIV infection around the world. In an interview with the New York Times, Gilead Sciences has announced a US list price of $28,218 USD per person per year.

Indivior Presents New Data at CPDD Demonstrating that High Buprenorphine Exposure May Improve Treatment Outcomes in High Fentanyl Users

Indivior PLC presented new findings this week at the College on Problems of Drug Dependence (CPDD) Annual Scientific Meeting.

Innocan Pharma Announces Presentation of Narrative Review on Long-Acting Synthetic Cannabidiol for Chronic Pain at PAINWEEK Conference

Innocan Pharma Corporation, a pioneer in the pharmaceutical and biotechnology industries, proudly announces that the recently published narrative review titled "Considering Long-Acting Synthetic Cannabidiol for Chronic Pain: A Narrative Review" has been officially accepted for presentation at PAINWEEK 2025, the national conference on pain management, taking place this September in Las Vegas, Nevada.

Cidara Therapeutics Announces Positive Topline Results from its Phase 2b NAVIGATE Trial Evaluating CD388, a Non-Vaccine Preventative of Seasonal Influenza

Cidara Therapeutics, Inc., a biotechnology company applying its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b NAVIGATE trial evaluating CD388 for the prevention of seasonal influenza in healthy unvaccinated adults aged 18 to 64.

Perfuse Therapeutics Announces Positive Results from Phase 2 Clinical Trials in Glaucoma and Diabetic Retinopathy Patients

Perfuse Therapeutics, Inc., a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases, has announced positive results from two Phase 2 clinical trials of PER-001, a novel therapeutic designed to address two leading causes of global blindness: glaucoma and diabetic retinopathy.