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The stock-for-stock acquisition adds a clinical-stage neuroplastogenic pain programme to Ensysce’s pipeline, with concurrent financing expected to fund CY200 through Phase II proof-of-concept data and towards registrational development. Ensysce Biosciences has completed the acquisition of Cy Biopharma in a stock-for-stock merger, adding CY200, a clinical-stage neuroplastogenic therapy with FDA Orphan Drug Designation for complex regional pain syndrome (CRPS) type 1, to its pain portfolio. The transaction is accompanied by $17.1 million of Cy Biopharma cash and up to approximately $60.1 million in new private financing, including a $38.6 million milestone-dependent second tranche, providing potential funding of up to approximately $77 million to advance CY200. Field Content Alert Type Deal Companies Ensysce Biosciences; Cy Biopharma Deal Type Acquisition through stock-for-stock merger, accompanied by private placement financing Asset or Company Cy Biopharma and its lead candidate CY200 Therapy Area(s) Neurology; Pain; Complex regional pain syndrome Technology or Modality Neuroplastogenic therapy Deal Value The acquisition consideration consists of 282,122 shares of Ensysce Series C preferred stock, representing 282.1 million shares on an as-converted basis. Separately, the transaction brings $17.1 million of Cy Biopharma cash from pre-acquisition financing and is accompanied by approximately $43 million of private placement financing across two tranches: approximately $21.5 million at initial closing and up to $38.6 million at the milestone closing, resulting in up to approximately $77 million of potential funding when Cy Biopharma’s cash is included. The second financing tranche is contingent on achievement of a clinical trial milestone. (Newswire) Development Stage Clinical stage; CY200 is being advanced towards a randomised Phase II trial in CRPS type 1. Geography United States What Happened On 6 August 2026, Ensysce Biosciences announced completion of its acquisition of privately held Cy Biopharma through a stock-for-stock merger. Cy Biopharma’s former equityholders received Series C preferred shares and are expected to own approximately 74.94% of the combined company on a fully diluted basis following stockholder approval of their conversion, excluding shares potentially issued in the milestone financing. Concurrently, Ensysce entered a private placement expected to provide approximately $21.5 million initially and up to another $38.6 million following achievement of a clinical trial milestone; Cy Biopharma also brought $17.1 million of cash from pre-acquisition financing. (Newswire) Why It Matters The acquisition expands Ensysce beyond its existing opioid safety programmes into neuroplastogenic treatments for complex pain and gives the company control of CY200, which has FDA Orphan Drug Designation for CRPS. Importantly, the associated financing is expected to support CY200 through Phase II proof-of-concept data and preparations for registrational development, reducing the immediate financing requirement around a key clinical milestone. (Newswire) Supporting Context CRPS is a severe chronic pain disorder with limited effective treatment options. Cy Biopharma is developing CY200 as an approach intended to address the underlying neurobiology of CRPS rather than solely managing symptoms, although its clinical benefit remains to be established through controlled trials. (Newswire) Strategic Rationale Ensysce gains a clinical-stage programme addressing complex pain while continuing development of its existing PF614-MPAR opioid overdose-protection programme. Cy Biopharma gains access to a public-market platform and financing intended to support CY200 through its next major clinical development milestones. (Newswire) Potential Impact If CY200 produces supportive Phase II results, the transaction could give Ensysce a second differentiated pain-development platform alongside its TAAP and MPAR programmes. Progress towards registrational development will depend on the clinical results, achievement of financing milestones and subsequent regulatory requirements. Key Takeaway The Cy Biopharma acquisition adds a clinical-stage neuroplastogenic pain programme to Ensysce while providing potential financing through CY200’s Phase II proof-of-concept milestone. What to Watch Topline results from the planned randomised Phase II CY200 trial, achievement of the clinical milestone required to unlock the second financing tranche, and Ensysce stockholder approval for conversion of the Series C preferred shares into common stock. (Newswire) Primary Source https://www.newswire.com/news/ensysce-biosciences-announces-acquisition-of-cy-biopharma-and-up-to-77-million Relevant Date 6 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The orexin receptor agonist provides adults with a treatment that targets the underlying loss of orexin signalling rather than managing individual symptoms separately. The US Food and Drug Administration (FDA) has approved Orzeyful (oveporexton) for the treatment of adults with narcolepsy type 1, making it the first medicine approved to address the condition as a complete disorder by restoring orexin signalling. The approval introduces a new therapeutic approach for patients experiencing excessive daytime sleepiness, cataplexy and other symptoms, although commercial launch must await scheduling by the US Drug Enforcement Administration (DEA). Field Content Alert Type Drug Approval Drug Name Orzeyful (oveporexton) Indication Treatment of narcolepsy type 1 in adults. Therapy Area(s) Neurology; Sleep Medicine Geography United States (FDA) What Happened On 5 August 2026, the FDA approved Orzeyful (oveporexton) for adults with narcolepsy type 1. The twice-daily oral treatment is the first approved therapy designed to address the disorder as a whole and the first to directly activate orexin receptors, targeting the loss of orexin signalling underlying the condition. The FDA has recommended scheduling under the Controlled Substances Act, and Orzeyful cannot be marketed until the DEA issues its final scheduling decision. Why It Matters Current narcolepsy treatments generally manage individual manifestations such as excessive daytime sleepiness or cataplexy. Orzeyful introduces a different approach by targeting the underlying orexin deficiency and demonstrated improvements across multiple symptoms, including wakefulness, daytime sleepiness, cataplexy, sleep paralysis, hallucinations and disrupted night-time sleep. Supporting Context Narcolepsy type 1 is caused by the loss of orexin-producing neurons, disrupting regulation of wakefulness, sleep and muscle tone. Approval was supported by two randomised, double-blind, placebo-controlled 12-week trials involving 273 adults, with common adverse reactions including insomnia, increased urinary frequency, urinary urgency and increased saliva production. Key Takeaway Orzeyful is the first FDA-approved treatment to target the underlying orexin deficiency while addressing the broad range of symptoms experienced by adults with narcolepsy type 1. What to Watch The DEA scheduling decision will determine when Orzeyful can enter the US market, after which commercial availability, reimbursement and clinical uptake will determine patient access. Primary Source https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-full-range-narcolepsy-type-1-symptoms Relevant Date 5 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The research collaboration combines Mediar’s fibrosis biology and antibody discovery capabilities with Ono’s drug development expertise to identify new treatments targeting fibro-inflammatory disease mechanisms. Ono Pharmaceutical has entered a drug discovery partnership with Mediar Therapeutics to identify and develop novel antibody therapeutics against an undisclosed target involved in fibro-inflammatory diseases, with Mediar receiving an upfront payment and research funding alongside potential future milestone payments and royalties. The collaboration expands Ono’s access to specialist fibrosis biology while providing Mediar with funding and a potential route to advance newly discovered antibodies into global clinical development and commercialisation. Field Content Alert Type Deal Companies Ono Pharmaceutical; Mediar Therapeutics Deal Type Drug discovery and research collaboration Asset or Company Novel antibody therapeutics against an undisclosed target associated with fibro-inflammatory diseases Therapy Area(s) Fibrosis; Inflammatory diseases Technology or Modality Antibody therapeutics Deal Value Financial terms were not fully disclosed. Mediar will receive an upfront payment and research funding and is eligible for research, development, regulatory and commercial milestone payments, plus tiered royalties on future global net sales. Development Stage Discovery Geography Global What Happened On 6 August 2026, Ono Pharmaceutical and Mediar Therapeutics announced a drug discovery partnership to create novel antibody therapeutics targeting an undisclosed molecule involved in fibro-inflammatory diseases. Mediar will use its expertise in fibrosis biology and antibody discovery to conduct research and identify therapeutic candidates. Ono will have the right to obtain an exclusive worldwide licence to develop and commercialise resulting antibodies, subject to the terms of the agreement. Why It Matters Fibro-inflammatory diseases involve persistent inflammation and pathological fibrosis that can progressively impair organ function, creating a need for therapies that intervene in the biological mechanisms driving fibrosis. The collaboration gives Ono access to Mediar’s specialised fibrosis research capabilities and potential new antibody candidates, while the early discovery stage means their therapeutic potential remains to be established. Supporting Context Mediar Therapeutics focuses on developing therapies that target myofibroblasts, cells involved in the development and progression of fibrosis. The company is building a pipeline of antibody-based programmes intended to intervene in fibrosis across multiple organ systems. Strategic Rationale Ono gains access to Mediar’s expertise in fibrosis biology and antibody discovery without acquiring the company or an existing clinical-stage asset. Mediar receives upfront and research funding while retaining the opportunity to earn milestones and royalties if Ono exercises its licensing rights and resulting programmes progress successfully. Potential Impact If the collaboration identifies viable therapeutic candidates, it could add new antibody programmes to Ono’s pipeline and extend Mediar’s fibrosis research into additional fibro-inflammatory diseases. Any clinical or commercial impact will depend on successful discovery, preclinical development, licensing and subsequent clinical trials. Key Takeaway The partnership gives Ono access to Mediar’s specialised fibrosis discovery capabilities while creating a route for new antibody programmes to progress towards global development. What to Watch Identification of lead antibody candidates, Ono’s exercise of its exclusive licensing rights and any subsequent preclinical or clinical development programmes arising from the collaboration. Primary Source https://www.businesswire.com/news/home/20260806851824/en/Ono-Pharma-Enters-into-a-Drug-Discovery-Partnership-with-Mediar-Therapeutics-to-Create-Novel-Antibody-Therapeutics-for-Fibro-inflammatory-Diseases Relevant Date 6 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The agreement gives an undisclosed global pharmaceutical company worldwide rights to use Alteogen’s ALT-B4 technology to develop and commercialise a subcutaneous formulation of an existing biologic. Alteogen has signed an exclusive global licensing agreement with an undisclosed pharmaceutical company for ALT-B4 (berahyaluronidase alfa), based on its Hybrozyme platform, in a transaction worth up to $365 million including contingent milestone payments. The agreement extends the commercial reach of Alteogen’s drug-delivery technology, which enables biologic medicines normally administered intravenously to be reformulated for subcutaneous administration. Field Content Alert Type Deal Companies Alteogen; undisclosed global pharmaceutical company Deal Type Exclusive licensing agreement Asset or Company ALT-B4 (berahyaluronidase alfa), based on Alteogen’s Hybrozyme platform, for development of a subcutaneous formulation of an undisclosed biologic Technology or Modality Recombinant human hyaluronidase drug-delivery technology Deal Value Up to $365 million, comprising an upfront payment and potential development, regulatory and commercial milestone payments. The maximum value is contingent and should not be treated as guaranteed consideration. Development Stage The partner’s underlying biologic is already marketed, while the ALT-B4-enabled subcutaneous formulation remains in development. Geography Worldwide What Happened On 6 August 2026, Alteogen announced an exclusive licensing agreement granting an undisclosed global pharmaceutical company worldwide rights to use ALT-B4 to develop and commercialise a subcutaneous formulation of an existing biologic product. The agreement has a potential value of up to $365 million, including contingent development, regulatory and commercial milestones. The partner and underlying biologic have not been disclosed because of competitive considerations. (Yahoo Finance) Why It Matters The agreement adds another pharmaceutical partner for Alteogen’s Hybrozyme platform and extends the potential application of ALT-B4 to an additional commercial biologic. Converting intravenous biologics to subcutaneous administration can reduce administration time and change treatment delivery, although the clinical and commercial significance of this programme cannot yet be assessed fully because the partner and product remain undisclosed. (Yahoo Finance) Supporting Context ALT-B4 temporarily breaks down hyaluronic acid beneath the skin, enabling larger-volume subcutaneous administration of biologics. Alteogen has previously licensed Hybrozyme technology to pharmaceutical companies including MSD, AstraZeneca, GSK, Daiichi Sankyo, Biogen, Sandoz, Intas and Sanofi. (알테오젠 ALTEOGEN) Strategic Rationale The partner gains access to technology that could enable an existing intravenous biologic to be developed as a subcutaneous formulation, while Alteogen expands the number of programmes using ALT-B4 and retains potential milestone-based economics from successful development and commercialisation. Potential Impact If successfully developed and approved, the programme could provide a more convenient administration option for the undisclosed biologic and further validate Hybrozyme as a platform for converting established intravenous therapies to subcutaneous formulations. The impact will depend on the identity of the product, clinical development and regulatory approval. Key Takeaway The $365 million agreement extends Alteogen’s Hybrozyme licensing network by adding another global programme aimed at converting an established biologic to subcutaneous administration. What to Watch Disclosure of the pharmaceutical partner and underlying biologic, initiation of development and subsequent clinical and regulatory milestones for the ALT-B4-enabled formulation. Primary Source Alteogen corporate disclosure, 6 August 2026 Relevant Date 6 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The rights reversion gives Actimed full control of the muscle-wasting candidate across all indications, with amyotrophic lateral sclerosis remaining its primary development focus. Actimed Therapeutics has reacquired from Faraday Pharmaceuticals the worldwide development, manufacturing and commercialisation rights to S-oxprenolol (ACM-002), ending a 2021 licensing agreement that included up to $126.2 million in potential milestone payments. The transaction consolidates the asset under Actimed's control and gives the company greater flexibility to develop the programme in amyotrophic lateral sclerosis (ALS) and evaluate other muscle-wasting indications. Field Content Alert Type Deal Companies Actimed Therapeutics; Faraday Pharmaceuticals Deal Type Rights reacquisition / termination of licensing agreement Asset or Company S-oxprenolol (ACM-002) Therapy Area(s) Neurology; Muscle-wasting disorders; Cachexia Technology or Modality Anabolic-catabolic transforming agent (ACTA) Deal Value Financial terms of the rights reversion were not disclosed. Under the original 2021 agreement, Actimed received $550,000 in upfront cash and equity, was eligible for a $2.7 million near-term milestone and up to $123.5 million in total potential milestone payments, plus royalties. These contingent payments should not be treated as consideration received under the new transaction. (Actimed Therapeutics) Development Stage Preclinical / pre-clinical development for S-oxprenolol; Actimed plans to initiate clinical development in ALS following completion of chemistry, manufacturing and controls (CMC) work. (Fierce Biotech) Geography Global What Happened On 6 August 2026, Actimed announced that it had negotiated the return of all rights to S-oxprenolol from Faraday Pharmaceuticals, giving Actimed worldwide development, manufacturing and commercialisation control. Under the original 2021 agreement, Faraday had obtained global rights to develop and commercialise S-oxprenolol for cancer cachexia and other indications outside ALS, while Actimed retained ALS rights. The reversion therefore reunifies the asset's global rights under Actimed. (Fierce Biotech) Why It Matters Reacquiring the rights allows Actimed to determine S-oxprenolol's development and partnering strategy across indications rather than retaining control only in ALS. The company continues to identify ALS-associated muscle wasting and cachexia as its primary focus for the asset, which has received FDA Orphan Drug Designation for ALS, while the wider rights could enable exploration of other muscle-wasting disorders. (Fierce Biotech) Supporting Context Actimed licensed most S-oxprenolol rights to Faraday in 2021 while retaining global ALS rights. S-oxprenolol is an ACTA that has generated preclinical evidence in models of muscle wasting, but its potential clinical benefit remains to be established in human trials. (Actimed Therapeutics) Strategic Rationale Full ownership gives Actimed control over future development, manufacturing, commercialisation and potential partnering of S-oxprenolol worldwide, removing the indication-based division of rights established under the Faraday agreement. (Fierce Biotech) Key Takeaway Reacquiring S-oxprenolol reunifies worldwide rights under Actimed and gives the company control over the asset's future development across ALS and other potential muscle-wasting indications. What to Watch Completion of CMC work and Actimed's planned initiation of an ALS clinical development programme, together with any decision to advance S-oxprenolol in additional muscle-wasting indications or seek new partners. (Fierce Biotech) Primary Source Actimed Therapeutics announcement, 6 August 2026 Relevant Date 6 August 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The 56-week observational findings add longer-term clinical evidence for the eculizumab biosimilar in both complement-inhibitor-naive patients and those previously treated with reference eculizumab. A prospective, multicentre observational study of 50 patients found that treatment with the eculizumab biosimilar Elizaria maintained haematological control over 56 weeks in atypical haemolytic uraemic syndrome, with normal platelet counts reported in 100% of treatment-naive patients and 96% of previously treated patients by study end. The findings provide additional real-world evidence relevant to clinicians and healthcare systems considering biosimilar initiation or switching, although the uncontrolled study design limits direct comparisons with reference eculizumab. Field Content Alert Type Industry Update Topic Clinical research; biosimilars Organisation(s) Multicentre study investigators; Karger Publishers Affected Stakeholders Nephrologists, haematologists, paediatric specialists, hospital formulary committees and healthcare systems involved in treating atypical haemolytic uraemic syndrome Therapy Area(s) Nephrology; Haematology; Rare Disease Geography Study geography not clearly stated in the accessible abstract; findings published internationally in Nephron What Happened A prospective observational study evaluated 56 weeks of routine-practice treatment with Elizaria, an eculizumab biosimilar, in 50 patients aged 1–55 years with atypical haemolytic uraemic syndrome. Of these, 31 patients were complement-inhibitor naive and 19 had previously received eculizumab. By study end, all treatment-naive patients and 96% of previously treated patients had normal platelet counts; 80% of the overall cohort remained free from thrombotic microangiopathy events at week 52. The study was published online on 12 June 2026. (Karger Publishers) Why It Matters Long-term evidence is particularly relevant for biosimilars used in rare, life-threatening diseases, where clinicians and formulary decision-makers may require reassurance regarding sustained disease control, safety and immunogenicity. The findings support the continued evaluation of Elizaria as an option for both treatment initiation and switching, but they do not establish equivalence with reference eculizumab because the study had no randomised comparator group. (Karger Publishers) Supporting Context Atypical haemolytic uraemic syndrome is driven by uncontrolled complement activation and can cause thrombotic microangiopathy, haemolysis and progressive kidney injury. Eculizumab inhibits terminal complement activity and is an established treatment, while biosimilar development may broaden procurement and treatment options where products are approved and available. (Center for Biosimilars) Who Is Most Affected Clinicians managing aHUS and organisations making formulary or procurement decisions are most directly affected, particularly where a biosimilar switch or first-line biosimilar use is being considered. Industry Impact The results add to the evidence base that may inform biosimilar adoption, formulary reviews and pharmacovigilance planning. Their practical effect will depend on local regulatory approval, pricing, reimbursement and the availability of further comparative and longer-term data. Key Takeaway Elizaria maintained broadly stable haematological outcomes over 56 weeks in a mixed aHUS population, providing supportive but non-comparative evidence for longer-term biosimilar use. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The guidance gives sponsors clearer recommendations for addressing trial design, safety monitoring, abuse potential and the operational challenges associated with hallucinogenic drug effects. The US Food and Drug Administration has issued final guidance for sponsors conducting clinical investigations of psychedelic drugs for medical conditions, replacing the draft guidance published in June 2023. The non-binding recommendations matter to developers because they clarify the evidence and study-design issues FDA expects sponsors to consider when evaluating products that can create distinctive safety, blinding and treatment-delivery challenges. Field Content Alert Type Industry Update Topic Regulation and clinical drug development Organisation(s) US Food and Drug Administration (FDA) Affected Stakeholders Pharmaceutical and biotechnology companies developing psychedelic drugs, clinical researchers, trial sites and investigators conducting studies of these therapies Therapy Area(s) Psychiatry and substance use disorders Geography United States What Happened The FDA issued the final Level 1 guidance, Psychedelic Drugs: Considerations for Clinical Investigations, on 14 July 2026. It provides general recommendations for sponsors developing psychedelic drugs for medical conditions and finalises the draft guidance issued in June 2023. The document represents the FDA’s current thinking rather than a legally binding requirement, and alternative approaches may be used where they satisfy applicable statutory and regulatory requirements. (U.S. Food and Drug Administration) Why It Matters Psychedelic drug trials can present challenges that are less prominent in conventional drug development, including functional unblinding caused by perceptible effects, the contribution of accompanying psychotherapy, prolonged patient observation, abuse-potential assessment and questions around repeat dosing. Clearer FDA recommendations can help sponsors anticipate these issues earlier when designing development programmes and engaging with the agency, although the guidance does not lower approval standards or indicate that any individual product will succeed. (U.S. Food and Drug Administration) Supporting Context The FDA first issued draft guidance on psychedelic drug trials in June 2023 in response to growing interest in their potential use for psychiatric, substance use and other medical conditions. Enveric Biosciences said the final version is relevant to the development of EB-003, its planned non-hallucinogenic neuroplastogenic candidate, but the company’s claimed advantages remain dependent on confirmation in clinical studies. (U.S. Food and Drug Administration) Who Is Most Affected Sponsors developing compounds that produce acute psychedelic effects face the most direct implications because their trials may require specialised blinding strategies, monitoring arrangements and evidence addressing safety and abuse potential. Developers of psychedelic-inspired but potentially non-hallucinogenic compounds may also use the guidance when considering how product pharmacology could affect trial design and treatment delivery. (Enveric Biosciences) Industry Impact The final guidance may support more consistent regulatory planning across the sector by giving developers a clearer framework for discussing clinical design, safety monitoring and supportive evidence with the FDA. Its practical effect will depend on how sponsors apply the recommendations and how individual development programmes perform. (U.S. Food and Drug Administration) Key Takeaway Psychedelic drug developers now have final FDA recommendations for addressing the distinctive clinical and operational issues associated with investigating these therapies. What to Watch The FDA will hold a public hearing on 14 September 2026 to gather views on the potential therapeutic use of psychedelic drugs in supervised and supportive settings, including patient monitoring, provider requirements and treatment-delivery infrastructure. Written comments are due by 5 October 2026. (U.S. Food and Drug Administration) Primary Source https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations Relevant Date 14 July 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The room-temperature-stable product provides an alternative for adults who require plasma when conventional plasma products are unavailable, including in emergency, remote and austere settings. The US Food and Drug Administration has licensed Ezplaz Freeze Dried Plasma for transfusion in adults who require plasma when other plasma products are not available, making it the first freeze-dried plasma product licensed in the United States. Its room-temperature storage, rapid reconstitution and transport-friendly packaging may support plasma access in settings where frozen products cannot be stored or prepared readily. Field Content Alert Type Drug Approval Drug Name Ezplaz Freeze Dried Plasma Indication Transfusion in adult patients when plasma is required and other plasma products are not available, including bleeding patients, patients requiring massive transfusion and certain patients receiving warfarin who are bleeding. Therapy Area(s) Transfusion Medicine; Emergency and Critical Care Geography US (FDA) What Happened On 29 July 2026, the FDA granted a biologics licence to Vascular Solutions, LLC, a Teleflex subsidiary, for Ezplaz Freeze Dried Plasma. The product is the first freeze-dried plasma licensed in the United States and is approved for transfusion in adults who require plasma when other plasma products are unavailable. Ezplaz is derived from a single unit of fresh frozen plasma and is available as Group AB and Group A with low-titre anti-B plasma. (U.S. Food and Drug Administration) Why It Matters Conventional plasma must be stored frozen and thawed before use, which can limit availability in combat zones, disaster response, rural areas and other settings without conventional blood-bank infrastructure. Ezplaz can be stored at room temperature, withstand temperature fluctuations and be reconstituted rapidly, providing clinicians with a licensed plasma option when standard products are unavailable. (U.S. Food and Drug Administration) Supporting Context Each kit contains one unit of freeze-dried plasma, sterile water for injection, a fluid-transfer set and a blood-transfusion set. The product is packaged in a plastic bag rather than a glass bottle, reducing breakage risk during handling and transport; its safety profile is consistent with other plasma products, although the established risks associated with plasma transfusion remain. (U.S. Food and Drug Administration) Key Takeaway Ezplaz extends access to licensed plasma transfusion for adults in settings where frozen plasma cannot be made available promptly. What to Watch Commercial availability, procurement by military and emergency-response organisations, and adoption by rural or remote healthcare services will determine how widely the product changes access to plasma outside conventional hospital settings. Primary Source https://www.fda.gov/news-events/press-announcements/fda-licenses-first-ever-freeze-dried-plasma-product-us Relevant Date 29 July 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The two regulatory decisions could expand first-line treatment options for patients with ESR1-mutant ER-positive disease and HER2-positive metastatic breast cancer, although Enhertu still requires European Commission approval. The European Commission has approved Etcamah (camizestrant) with a CDK4/6 inhibitor for adults with ESR1-mutant, ER-positive, HER2-negative locally advanced or metastatic breast cancer whose disease has not progressed during first-line endocrine therapy, while the EMA’s CHMP has recommended Enhertu (trastuzumab deruxtecan) with pertuzumab for first-line unresectable or metastatic HER2-positive breast cancer. Etcamah introduces a biomarker-triggered treatment switch before clinical progression, whereas the Enhertu combination could provide a new first-line option if the Commission endorses the CHMP opinion. Field Content Alert Type Drug Approval Drug Name Etcamah (camizestrant); Enhertu (trastuzumab deruxtecan) in combination with pertuzumab Indication Etcamah with palbociclib, ribociclib or abemaciclib: adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of an ESR1 mutation and without disease progression during first-line endocrine therapy with a CDK4/6 inhibitor. Enhertu with pertuzumab: proposed first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. (ema.europa.eu) Therapy Area(s) Oncology; Breast cancer Geography European Union — European Commission and EMA Committee for Medicinal Products for Human Use What Happened The European Commission granted marketing authorisation for Etcamah on 20 July 2026, following the CHMP’s positive opinion in May. The approval permits clinicians to replace the aromatase-inhibitor component of first-line therapy with camizestrant when an ESR1 mutation is detected, while continuing the existing CDK4/6 inhibitor. Separately, on 23 July 2026, the CHMP recommended extending Enhertu’s authorisation to include its use with pertuzumab as first-line therapy for unresectable or metastatic HER2-positive breast cancer; this is a recommendation rather than a final EU approval. (ema.europa.eu) Why It Matters Etcamah provides a treatment strategy based on detecting emerging endocrine resistance before radiological disease progression, offering eligible patients an alternative endocrine backbone while retaining their CDK4/6 inhibitor. The Enhertu opinion could move the antibody–drug conjugate into the first-line setting, where taxane, trastuzumab and pertuzumab has remained a standard approach for more than a decade, but clinical use in this setting depends on a final Commission decision. (ema.europa.eu) Supporting Context In SERENA-6, median progression-free survival was approximately 17 months with Etcamah plus a CDK4/6 inhibitor versus around nine months when patients continued letrozole or anastrozole with the inhibitor. In DESTINY-Breast09, Enhertu plus pertuzumab produced median progression-free survival of 40.7 months versus 26.9 months with taxane, trastuzumab and pertuzumab, with no new safety concerns identified by the companies. (ema.europa.eu) Key Takeaway The Etcamah approval and Enhertu recommendation advance two distinct biomarker-led first-line strategies for advanced breast cancer in Europe. What to Watch The European Commission’s final decision on the Enhertu–pertuzumab indication and the implementation of ESR1 mutation monitoring to identify patients eligible for an Etcamah treatment switch. Primary Source https://ec.europa.eu/health/documents/community-register/2026/20260720170116/dec_170116_en.pdf; https://www.ema.europa.eu/en/medicines/human/variation/enhertu Relevant Date 23 July 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The updated vaccine is authorised for individuals aged six months and older and aligns the EU COVID-19 vaccination programme with the currently circulating XFG variant. The European Commission has authorised the Pfizer-BioNTech XFG-adapted COVID-19 vaccine for active immunisation against COVID-19 in individuals aged six months and older across the European Union, Iceland, Liechtenstein and Norway, following a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The approval updates the vaccine composition for the 2026–2027 respiratory season, supporting continued protection against the currently circulating XFG variant while maintaining the established mRNA vaccine platform. Field Content Alert Type Drug Approval Drug Name Pfizer-BioNTech XFG-adapted COVID-19 vaccine (COMIRNATY®, COVID-19 Vaccine, mRNA) Indication Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six months and older. (Pfizer) Therapy Area(s) Infectious Diseases; Vaccines Geography European Union (European Commission) What Happened On 29 July 2026, the European Commission granted marketing authorisation for the Pfizer-BioNTech XFG-adapted COVID-19 vaccine for the 2026–2027 vaccination season. The updated formulation targets the XFG variant of the JN.1 lineage following the EMA Emergency Task Force recommendation and is authorised for active immunisation in individuals aged six months and older throughout all EU Member States, as well as Iceland, Liechtenstein and Norway. This updates the existing marketing authorisation with a revised seasonal vaccine formulation rather than representing a first approval. (Pfizer) Why It Matters The authorisation ensures healthcare providers have an updated COVID-19 vaccine aligned with the variants expected to circulate during the 2026–2027 respiratory season. Updating vaccine composition in response to viral evolution is intended to maintain vaccine relevance, although uptake and public health impact will depend on national vaccination programmes and recommendations. (Pfizer) Supporting Context The approval follows the CHMP's positive opinion issued on 23 July 2026 and the EMA Emergency Task Force recommendation to target the XFG variant after reviewing available epidemiological and immunogenicity data. Pfizer and BioNTech stated that manufacturing had already begun to support vaccine availability ahead of the respiratory virus season. (Pfizer) Key Takeaway The European Commission has authorised an updated Pfizer-BioNTech COVID-19 vaccine targeting the XFG variant, enabling deployment of the 2026–2027 seasonal formulation across the EU. (Pfizer) What to Watch National vaccination recommendations, country-level procurement and rollout schedules, and regulatory decisions in other jurisdictions will determine when the updated vaccine becomes available to eligible populations. (Pfizer) Primary Source https://www.pfizer.com/news/press-release/press-release-detail/european-commission-authorizes-pfizer-and-biontech-xfg Relevant Date 29 July 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The expanded indication moves radioligand therapy into an earlier stage of metastatic prostate cancer, providing an additional treatment option for eligible patients before progression to castration-resistant disease. The US Food and Drug Administration (FDA) has approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer. The approval expands Pluvicto's use into an earlier treatment setting, offering eligible patients a radioligand therapy alongside standard systemic treatment before progression to metastatic castration-resistant disease. Field Content Alert Type Drug Approval Drug Name Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) Indication In combination with an androgen receptor pathway inhibitor for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. Patients should be selected using Locametz® (gallium Ga 68 gozetotide) or another FDA-approved PSMA PET imaging agent. (U.S. Food and Drug Administration) Therapy Area(s) Oncology; Prostate Cancer Geography United States (FDA) What Happened On 31 July 2026, the FDA approved Pluvicto in combination with an ARPI for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. The decision expands Pluvicto's existing indication beyond metastatic castration-resistant prostate cancer into an earlier metastatic treatment setting and is based on results from the Phase III PSMAddition trial. (U.S. Food and Drug Administration) Why It Matters The approval enables eligible patients to receive targeted radioligand therapy earlier in the course of metastatic disease while continuing standard androgen receptor pathway inhibition. It broadens treatment options for PSMA-positive disease, although appropriate patient selection remains dependent on PSMA PET imaging and long-term overall survival data are still maturing. (U.S. Food and Drug Administration) Supporting Context In the PSMAddition trial, Pluvicto plus standard of care reduced the risk of radiographic progression or death compared with ARPI-based standard therapy alone. Overall survival data were immature at the time of approval, although an encouraging trend was reported. (U.S. Food and Drug Administration) Key Takeaway FDA approval extends Pluvicto into the metastatic hormone-sensitive setting, introducing radioligand therapy earlier in the treatment pathway for eligible patients with PSMA-positive disease. (U.S. Food and Drug Administration) What to Watch Longer-term overall survival results from PSMAddition and how rapidly PSMA PET-guided patient selection is incorporated into routine first-line metastatic prostate cancer care. (U.S. Food and Drug Administration) Primary Source https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy Relevant Date 31 July 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com