Bioclate (recombinant factor VIII) / Takeda - LARVOL DELTA

Takeda to discontinue Hemofil M, Recombinate for hemophilia A (Hemophilia News Today) - "Takeda Pharmaceuticals has decided to discontinue Hemofil M (human antihemophilic factor) and Recombinate (recombinant antihemophilic factor), both of which are approved as replacement therapies to prevent and control bleeding episodes in children and adults with hemophilia A....Hemofil M and Recombinate will be supplied until stocks run out or expire by mid-2026, depending on how many patients are still using them before switching to alternative treatments, according to the company."

Discontinued • Hemophilia A

Genetic and recombination heterogeneity of Canine Bufaviruses detected in diarrheal dogs in China. (PubMed, Vet J) - "Through comparative analysis with 51 reference BuV strains, six strains might recombinate from the CBuV strains (HUN/2012/22, CaBuV/9AS/2005/ITA and CaBuV/35/2016/ITA) in Hungary and Italy as the parents, and two genetic recombination events from various parents were predicted to occur on the BUV-422 strain...The BUV-422 and BUV-512 strains show sequential mutation sites identical to the divergent strains of CaBuV/9AS/2005/ITA and CaBuV/35/2016/ITA. This study would enrich the molecular data of CBuV in China and provide essential reference for the epidemiological research and vaccine development of CBuV in the future."

Heterogeneity • Journal

Influence of Milk Pasteurization on the Key Aroma Compounds in a 30 Weeks Ripened Pilot-Scale Gouda Cheese Elucidated by the Sensomics Approach. (PubMed, J Agric Food Chem) - "Finally, an aroma recombinate prepared based on the quantitative data well agreed with the aroma profile of the PM-G...The different rankings of these key aroma compounds clearly reflect the aroma differences of the two Gouda-type cheeses. A higher activity of lipase in the RM-G and higher amounts of free l-leucine in PM-G on the other side were responsible for the differences in the concentrations of some key aroma compounds."

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Insights into the Key Odorants in Large-Leaf Yellow Tea (Camellia sinensis) by Application of the Sensomics Approach. (PubMed, J Agric Food Chem) - "An aroma recombinate consisting of 17 odorants (all OAVs ≥ 1) in an odorless nonvolatile LYT matrix mimicked the overall aroma of the original infusion, verifying the successful characterization of key aroma components in a LYT beverage. The knowledge of key odorants obtained showed potential for simplifying industrial flavor optimization of the LYT product."

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"Comisia Europeană a semnat un acord de achiziţie cu producătorul farmaceutic spaniol #HIPRA privind furnizarea de vaccinuri anti-#COVID19 bazate pe proteine recombinate, care vor deveni disponibile în #UE dacă vor fi autorizate de Agenţia Europeană pentru Medicamente (@EMA_News)." (@RRInternational)

Infectious Disease • Novel Coronavirus Disease

Sensoproteomic Discovery of Taste-Modulating Peptides and Taste Re-engineering of Soy Sauce. (PubMed, J Agric Food Chem) - "Addition of the 14 newly identified peptides to the taste recombinate (aRec) increased the overall taste intensity and mouthfulness of the recombinate, and comparison with the authentic soy sauce confirmed the identification of all key tastants. Finally, these data as well as the quantitative profiling of several (non)-fermented foods highlight the importance of fermentation with respect to taste formation. On the basis of this knowledge, microorganisms with specific digestion patterns may be used to tailor the taste profile and especially the salt taste sensation of soy sauces."

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Unravelling the key aroma compounds in the characteristic fragrance of Dendrobium officinale flowers for potential industrial application. (PubMed, Phytochemistry) - "In addition, a progressive addition test showed that the aroma recombinate prepared with 18 reference key odorants was able to reconstruct the characteristic aroma of DFF. In comparison, the recombinate constituted by mixing all 34 reference odorants in the same concentrations as determined in the DDF sample could mimic the flower scent and closely match the sensory attributes of the original D. officinale fresh flower."

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Characterization of Key Odorants in Scallion Pancake and Investigation on Their Changes during Storage. (PubMed, Molecules) - "Ten compounds with OAVs ≥ 1 were determined as the key odorants; a recombinate model prepared from the key odorants, including (E,E)-2,4-decadienal, dimethyl trisulfide, methyl propyl disulfide, hexanal, dipropyl trisulfide, maltol, acetoin, 2-methylnaphthalene, 2-pentylfuran and 2(5H)-furanone, successfully simulated the overall aroma profile of SP. The changes in odorants during storage were investigated further. With increasing concentrations and OAVs during storage, hexanal became an off-flavor compound."

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"Bro, ese es el nuevo juguete de @Bayer es un Recombinate Pegilado, la competencia de Eloctate... Chequea:" (@albuccasis)

[VIRTUAL] Immunogenicity of recombinant growth hormone and relationship its growth-promoting effect in the children with short stature (ESPE 2021) - "Background/Aim: Although there are many well-known components that affect the growth response to recombinate growth hormone (rGH), its effect on total height gain is still not fully predictable... This study showed that GH-Ab formation is common in children with short stature, especially those with ISS, before and during rGH treatment, and also GH-Ab positivity is associated with lower first-year height velocity. It also indicates that GH-Abs both could play a role in the etiology of GH-related short stature and that immunogenicity against rGH could have an impact on first-year height velocity."

Clinical • Endocrine Disorders • Growth Hormone Deficiency • Idiopathic Short Stature

Characterization of the Key Aroma Compounds in a Commercial Fino and a Commercial Pedro Ximénez Sherry Wine by Application of the Sensomics Approach. (PubMed, J Agric Food Chem) - "But, although most odorants were identical in the three sherries, their amounts differed significantly. The results are discussed considering the different winemaking processes and the different aroma profiles."

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Characterization of the Key Aroma Compounds in a Freshly Prepared Oat (Avena sativa L.) Pastry by Application of the Sensomics Approach. (PubMed, J Agric Food Chem) - "Quantitation of the 36 most important compounds by means of stable isotope dilution assays followed by a calculation of odor activity values on the basis of odor thresholds in corn starch revealed 2-acetyl-1-pyrroline, vanillin, the tautomers 2-acetyl-3,4,5,6-tetra-hydropyridine and 2-acetyl-1,4,5,6-tetrahydropyridine, 3-(methylthio)propanal, 2-propionyl-1-pyrroline, and methanethiol as the key aroma-active compounds. An aroma recombinate prepared in odorless oat pastry material containing 30 odorants in the concentrations determined in the oat pastry was able to successfully mimic the overall aroma profile of the original oat pastry."

Journal

RESIST NAIVE: Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (clinicaltrials.gov) - P=N/A; N=0; Withdrawn; Sponsor: City of Hope Medical Center; N=148 ➔ 0; Active, not recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Hematological Disorders • Hemophilia • Rare Diseases

Quantitation of Key Aroma Compounds in Fresh, Raw Ginger (Zingiber officinale Roscoe) from China and Roasted Ginger by Stable Isotope Dilution Assays and Aroma Profiling by Recombination Experiments. (PubMed, J Agric Food Chem) - "In the roasted ginger, 1,8-cineol and myrcene remained the most odor-active compounds, however, the increase in some odorants, for example, in geraniol and (Z)-2-decenal, in combination with the newly formed caramel-like smelling 4-hydroxy-2,5-dimethyl-3(2H)-furanone (caramel-like) and 3-(methylthio)propanal (potato-like) most likely caused the differences in the aroma profile initiated by the thermal treatment. A biomimetic aroma recombinate based on 21 aroma compounds was able to successfully simulate the aroma profile of the roasted ginger."

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Characterization of the Key Aroma Compounds in a Commercial Milk Chocolate by Application of the Sensomics Approach. (PubMed, J Agric Food Chem) - "An aroma recombinate prepared with 39 reference odorants in the same concentrations as those determined for the compounds in the milk chocolate showed a good similarity with the overall aroma profile of the milk chocolate. A comparison of the results with the recent literature data on dark chocolates also evaluated by the Sensomics approach suggested that, in particular, methanethiol and a series of lactones may contribute to the milky, creamy odor note because these were reported with much lower odor activities in the dark chocolates."

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Elucidating the odor-active aroma compounds in alcohol-free beer and their contribution to the worty flavor. (PubMed, J Agric Food Chem) - "The important contribution of these flavor compounds to the worty and honey aroma of AFB was determined by sensory assessment of the recombinate in a beer-like matrix with omission tests. The role of 5-ethyl-3-hydroxy-4-methyl-2(5H)-furanone in AFB aroma was reported for the first time. The outcomes from this study are of relevance for the brewing industry to design strategies for the reduction of the wortiness of AFB."

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A butter aroma recombinate activates human class-I odorant receptors. (PubMed) - "Recently, we demonstrated chemosensory receptors, especially class-I OR, to be expressed on blood leukocytes, which may encounter foodborne aroma compounds postprandially. Here, we show that butter aroma recombinate induced chemotaxis of isolated human neutrophils in a defined gradient, and in a concentration-dependent and pertussis toxin-sensitive manner, suggesting at least a GPCR-mediated activation of blood leukocytes by key food odorants."

Journal • Biosimilar

Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study) (clinicaltrials.gov) - P2/3; N=159; Completed; Sponsor: Baxalta US Inc.; Active, not recruiting -> Completed

Trial completion • Biosimilar • Hematological Malignancies • Hemophilia

BAX 855 Pediatric Study (clinicaltrials.gov) - P3; N=60; Not yet recruiting; Sponsor: Baxter Healthcare Corporation

New P3 trial • Biosimilar • Hemophilia

Characterization of the Key Odorants in a High-grade Chinese Green Tea Beverage (Camellia sinensis; Jingshan cha) by Means of the Sensomics Approach and Elucidation of Odorant Changes in Tea Leaves Caused by the Tea Manufacturing Process. (PubMed, J Agric Food Chem) - "Finally, an aqueous recombinate containing all 27 aroma compounds in the concentrations measured in the beverage successfully mimicked the overall aroma profile of the tea infusion...Linalool, geraniol, and hexanal showed the highest concentrations in the fresh tea leaves, while significantly lower concentrations were measured in the final tea. The same was observed for all lipid degradation products, such as (E,E)-2,4-heptadienal."

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Changes in the Key Aroma Compounds of Raw Shiitake Mushrooms (Lentinula edodes) Induced by Pan-Frying as well as by Rehydration of Dry Mushrooms. (PubMed, J Agric Food Chem) - "The overall aroma profile of pan-fried shiitake could very good be mimicked by an aroma recombinate consisting of 15 reference aroma compounds in the concentrations determined in the pan-fried mushrooms. Further results showed that the sulfur compounds were even higher in rehydrated dry shiitake as compared to the pan-fried mushrooms."

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Status of Recombinant Factor VIII Concentrate Treatment for Hemophilia a in Italy: Characteristics and Clinical Benefits. (PubMed, Front Med (Lausanne)) - "The Italian health care system has authorized the use of a wide range of rFVIII concentrates of the first, second, and third generation, as well as new innovative rFVIII preparates with an extended half-life (EHL) (Kogenate FS®-Bayer, belonging to the second generation and replaced since 2017 by a product consisting of the same modified molecule; because it is only available until the end of the current year, it will not be considered in this review)...The first-generation full-length rFVIII (FL-rFVIII), octocog alfa (Recombinate® Baxter/BIOVIIIx), although the oldest rFVIII product, has several desirable features. Third-generation products include two modified octocog alfa molecules (Advate®, Shire; Kovaltry®, Bayer) as well as the B domain-deleted rFVIII (BDD-rFVIII) moroctocog alfa (ReFacto®-Pfizer). The B domain-truncated (BDT-rFVIII) turoctocog alfa (NovoEight®, Novo Nordisk), the BDD-rFVIII simoctocog alfa (Nuwiq®, Kedrion), the..."

Clinical • Journal • Review

Quantitative Validation of the In-Bean Approach in Coffee Roasting. (PubMed, J Agric Food Chem) - "For this purpose, the water-soluble fraction was replaced by a biomimetic recombinate in reconstituted beans prior to roasting...In addition, the final quantities of key odorants in both types of samples were quite comparable. Hence, the refined biomimetic approach was validated as a valuable tool in studying different aspects of flavor formation upon coffee roasting."

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Characterization of the Key Aroma Compounds in the Crust of Soft Pretzels by Application of the Sensomics Concept. (PubMed, J Agric Food Chem) - "Compared with other pastry crusts, in particular, the low odor activities of the Strecker aldehydes 2- and 3-methylbutanal, the lipid degradation product ( E)-2-nonenal, and the lack of pyrazines were elucidated as the main reasons for the different aroma profile of pretzel crust. An aroma recombinate, which is among the first established for the crusts of breads and pastries, clearly mimicked the overall odor of the pretzel crust, in particular when a solution in ethanol was sprayed in the ambient air."

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Characterization of the Key Aroma Compounds in Yeast Dumplings by Means of the Sensomics Concept. (PubMed, J Agric Food Chem) - "The twenty-one odorants were quantitated by stable isotope dilution assays (SIDA), and a subsequent calculation of odor activity values (OAV; ratio of concentration to odor threshold) revealed 3 methyl-1-butanol (malty), 2 phenylethanol (honey-like), trans-4,5-epoxy-(E)-2-decenal (metallic), 2,3 butanedione (buttery), 3-methylbutanoic acid (sweaty), (E)-2-nonenal (cucumber-like), 1-octen-3-one (mushroom-like) and 3-(methylthio)-propanal (potato-like) as the most important contributors to the overall aroma of the dumpling. To verify the analytical results, a recombinate was prepared to show that a blend of the twenty-one aroma compounds in a buffered starch suspension resulted in a good replication of the overall yeast dumpling aroma."

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