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On July 8th, Ascentage Pharma announced on its official account that its original Category 1 new drug, Olverembatinib, has been officially approved for marketing by the Drug Regulatory Authority of the Macao Special Administrative Region (ISAF). The approved indications are as follows: - Treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) or accelerated phase (AP) who are resistant to any tyrosine kinase inhibitors (TKIs) and have the T315I mutation. - Treatment of adult patients with CML-CP who are resistant and/or intolerant to first- and second-generation TKIs. This marks another significant milestone for Olverembatinib following its approval for marketing in mainland China. Olverembatinib is an original Category 1 new drug by Ascentage Pharma, supported by the National Major New Drug Creation Special Project, and it is the first third-generation BCR-ABL inhibitor approved by the National Medical Products Administration (NMPA) of China. As a best-in-class new drug on a global scale, this medication has shown outstanding efficacy against BCR-ABL and multiple BCR-ABL mutants, including the T315I mutation. It has also been included in the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of CML. #APIs #Medical #Rawmaterials #Pharma #Medicine #Pharmaceutical

Gilead to buy CymaBay in $4.3B deal for liver disease drug The acquisition would hand Gilead a now-under-review medicine for primary biliary cholangitis, a chronic condition affecting some 130,000 people in the U.S. Gilead Sciences will acquire CymaBay Therapeutics and the biotechnology company’s liver disease drug in a $4.3 billion deal announced Monday. The proposed buyout would hand Gilead an experimental medicine for primary biliary cholangitis, or PBC, a chronic condition characterized by the toxic build-up of bile acid in the liver. CymaBay disclosed Monday that the Food and Drug Administration has accepted its application for the drug, called seladelpar, and will decide on approval by mid-August. #lifesciences #pharmaceuticals #biotechnology #medtech #pharmanews #mergerandacquisition

Heidelberg Pharma AG has announced that its lead candidate HDP-101, an antibody-drug conjugate, was granted Orphan Drug Designation for the treatment of multiple myeloma by the US Food and Drug Administration. Heidelberg Pharma is investigating HDP-101 in a clinical Phase I/IIa study for the treatment of relapsed/refractory multiple myeloma. HDP-101 consists of an anti-BCMA antibody, a specific linker and the Amanitin toxin. BCMA is a surface protein that is highly expressed in multiple myeloma cells and to which BCMA antibodies specifically bind. https://lnkd.in/dH5mE5en

🌐 rizochem.com | rizochem.ae Novartis gains first FDA approval for touted blood disorder drug. The U.S. Food and Drug Administration (FDA) has approved Novartis' drug Asciminib (Oncraset) for the treatment of chronic myeloid leukemia (CML) in adult patients who are resistant or intolerant to other tyrosine kinase inhibitors (TKIs). This marks the first FDA approval for Asciminib, which is considered a potential blockbuster drug for Novartis. Japan approves CSL and Arcturus' Covid-19 vaccine. Japan's Ministry of Health, Labor, and Welfare (MHLW) has approved CSL and Arcturus Therapeutics' COVID-19 vaccine, which is based on Arcturus' self-amplifying mRNA technology. This is the second Covid-19 vaccine to be approved in Japan, following Pfizer-BioNTech's vaccine. #pharma #healthcare #health #medicine #pharmacy #technology

Top 🔟 most anticipated pharma drug launches of 2024 The days of #blockbuster medications are far from over. Meanwhile, blockbuster drugs are moving beyond the traditional uses of #cancer and #obesity. This time a drug for #schizophrenia is on top of the list. A clear sign of the potential that still can be realized and which diseases can be combated to an even greater extent. Check out the top 10 most anticipated drug launches of the year below 👇 01 | Karuna Therapeutics Drug: KarXT Used for: Schizophrenia Est. 2028 sales: $2.8 billion 02 | Eli Lilly and Company Drug: Donanemab Used for: Alzheimer’s disease Est. 2028 sales: $2.2 billion 03 | Madrigal Pharmaceuticals Drug: Resmetirom Used for: Nonalcoholic steatohepatitis Est. 2028 sales: $2.1 billion 04 | Merck Drug: Sotatercept Used for: Pulmonary arterial hypertension Est. 2028 sales: $2 billion 05 | Daiichi Sankyo, Inc. / AstraZeneca Drug: Datopotamab deruxtecan Used for: Lung and breast cancers Est. 2028 sales: $1.8 billion 06 | BridgeBio Drug: Acoramidis Used for: ATTR cardiomyopathy Est. 2028 sales: $1 billion 07 | Moderna Drug: mRNA-1345 Used for: RSV vaccine Est. 2028 sales: $913 million 08 | ImmunityBio, Inc. Drug: Anktiva Used for: Nonmuscle invasive bladder cancer Est. 2028 sales: $878 million 09 | Verona Pharma Drug: Ensifentrine Used for: Maintenance of chronic COPD Est. 2028 sales: $784 million 10 | Geron Corporation Drug: Imetelstat Used for: Lower-risk myelodysplastic syndromes Est. 2028 sales: $737 million #pharma #blockbuster #innovation Source: fiercepharma

🌐 rizochem.com | rizochem.ae Novartis gains first FDA approval for touted blood disorder drug. The U.S. Food and Drug Administration (FDA) has approved Novartis' drug Asciminib (Oncraset) for the treatment of chronic myeloid leukemia (CML) in adult patients who are resistant or intolerant to other tyrosine kinase inhibitors (TKIs). This marks the first FDA approval for Asciminib, which is considered a potential blockbuster drug for Novartis. Japan approves CSL and Arcturus' Covid-19 vaccine. Japan's Ministry of Health, Labor, and Welfare (MHLW) has approved CSL and Arcturus Therapeutics' Covid-19 vaccine, which is based on Arcturus' self-amplifying mRNA technology. This is the second Covid-19 vaccine to be approved in Japan, following Pfizer-BioNTech's vaccine. #pharma #healthcare #health #medicine #pharmacy #technology

𝐊𝐲𝐦𝐞𝐫𝐚 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐄𝐱𝐩𝐚𝐧𝐬𝐢𝐨𝐧 𝐨𝐟 𝐊𝐓-𝟒𝟕𝟒 𝐏𝐡𝐚𝐬𝐞 𝟐 𝐓𝐫𝐢𝐚𝐥𝐬 𝐛𝐲 𝐒𝐚𝐧𝐨𝐟𝐢 Kymera Therapeutics, Inc. (NASDAQ: KYMR) Kymera Therapeutics, a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD), today announced that Sanofi Sanofi intends to expand the ongoing Hidradenitis Suppurativa (HS) and Atopic Dermatitis (AD) Phase 2 trials following a review of preliminary KT-474 safety and efficacy data by an Independent Data Review Committee. “We are pleased that Sanofi has taken steps to expand these studies, as we are firm believers in the potential for KT-474 to address significant unmet needs with large market potential,” said Nello Mainolfi, PhD Nello Mainolfi, Founder, President and CEO, Kymera Therapeutics. “This expansion, supported by the interim analysis, is intended to accelerate timelines and inform future registrational trials. We look forward to sharing further information as it becomes available.” About KT-474 IRAK4 Degrader KT-474 (SAR444656) is a first-in-class IRAK4 degrader in development for the treatment of immune-inflammatory diseases such as HS and AD. IRAK4 is a key protein that mediates signaling through IL-1 and toll-like receptors, crucial for initiating immune responses. By eliminating IRAK4 through degradation, KT-474 has the potential to achieve a broad, well-tolerated anti-inflammatory effect. KT-474 is the first heterobifunctional small molecule protein degrader to enter clinical development for immunological diseases. Sanofi, collaborating with Kymera, is conducting randomized, placebo-controlled Phase 2 clinical trials of KT-474 in HS and AD. #Biotech #ProteinDegradation #ClinicalTrials #HidradenitisSuppurativa #AtopicDermatitis #KymeraTherapeutics #Sanofi #HealthcareInnovation

Drug Delivery System enables Phase 3 approval of AZ/Ionis antisense oligo Wainura (eplontersen), with momentum to displace other ATTR drugs. It is interesting that Ionis also originally created Tegsedi, (inotersen), an antisense oligo with identical sequence as Wainura. The progenitor Tegsedi drug was licensed to Akcea for distribution, but due to lagging sales (less than $70M), Ionis acquired Akcea in a take-over, and transfered Tegsedi to Sobi Pharma, the Swedish rare disease pharma. Wainura is a second generation drug, and is simply Gal-Nac conjugated Tegsedi. Gal-Nac modified oligos enhance liver targeting. This drastically extends PK/PD and allows monthly dosing of Wainura, compared to weekly dosing of Tegsedi. Both still target the same defective RNA encoding TTR. https://lnkd.in/euMux_qd For a rare amyloidosis disease found mostly in Portugese descendents, it seems that iteration of better drugs will give this small patient population more choices of treatment in the future. The current cost for Tegsedi is ~$450K per year, cost of Wainura is not yet available.. For Astra Zeneca development partner, Wainura may be on the road to dominate certain forms of ATTR therapy. From Fierce - " Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. More specifically, the agency signed off on the ligand-conjugated antisense oligonucleotide (LICA) drug to treat polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (ATTRv-PN), a rare and often fatal disease that affects 40,000 people globally, the companies said in a press release. " - Disclaimer - Views expressed here are of the Author only. https://lnkd.in/eGm4GAQG

Assessment of Celiac Disease Pipeline 2023: Clinical Trials, FDA Approvals, Therapeutic Advances, and Companies by DelveInsight | AMYRA Biotech AG, Equillium Bio., Chugai Pharma, Calypso Biotech #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech

CDSCO Panel Approves Sanofi's Protocol Amendment Proposal For To Study Fitusiran The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has approved drug major Sanofi's protocol amendment proposal of Fitusiran, a subcutaneous investigational small interfering RNA therapeutic, targets antithrombin to rebalance haemostasis in people with haemophilia A or haemophilia B, irrespective of inhibitor status. However, this approval is subject to the condition that the firm has to submit the that interim analysis reports every 24 weeks of the proposed drug. This came after the firm presented protocol amendment 03 version 1 dated 20.10.2023 and protocol amendment 04 version 1 dated 24.11.2023 protocol No. EFC1546. Fitusiran is a monthly subcutaneous RNA interference therapy targeting antithrombin to increase thrombin generation and reduce bleeding in hemophilia with or without inhibitors. #cdsco #sanofi #Fitusiran #haemophilia #protocolamendment