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FDA Approves AstraZeneca’s Calquence for Mantle Cell Lymphoma
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UK-based pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) last week revealed that the US Food and Drug Administration (FDA) has approved its BTK inhibitor Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic…
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MHRA Approves Gilead’s Livdelzi for Primary Biliary Cholangitis
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The Medicines and Healthcare products Regulatory Agency (MHRA) last week signed off on US-based Gilead Sciences Inc.’s (NASDAQ: GILD) Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), including pruritus. This approval marks a significant step forward in the treatment options available for patients suffering from this chronic liver…
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FDA Clears Amgen’s Lumakras and Vectibix Combo for KRAS G12C-mutated mCRC
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US-based Amgen (NASDAQ: AMGN) has announced receiving clearance from the US Food and Drug Administration (FDA) for its Lumakras (sotorasib) combined with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). This approval is for patients whose cancer has been identified through an FDA-approved…
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Luye Pharma Launches Erzofri in US Market
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China-based Luye Pharma Group (HKG: 2186) has announced the initiation of commercialization of its in-house developed Erzofri (paliperidone palmitate extended-release injectable suspension) in the United States, with the first batch of products already shipped. This marks a significant milestone in the company’s global expansion strategy. Erzofri: Long-Acting Injection for SchizophreniaErzofri…
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Novo Nordisk’s Semaglutide 7.2 mg Shows Superior Weight Loss in Phase III Study
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Denmark-based Novo Nordisk A/S (NYSE: NVO) has announced positive headline results from the Phase III STEP UP study, assessing the efficacy and safety of subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo. The study met its primary endpoint, demonstrating superior weight loss outcomes with the higher dose.…
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Zai Lab’s KarXT NDA Accepted by NMPA for Schizophrenia Treatment
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that a New Drug Application (NDA) filing for its KarXT (xanomeline and trospium chloride) in adult schizophrenia has been accepted for review by the National Medical Products Administration (NMPA). This milestone underscores Zai Lab’s commitment to advancing innovative treatments…
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Frontier Biotechnologies Gains NMPA Approval for Albuvirtide Phase II Study
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Nanjing-based Frontier Biotechnologies Inc. has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its version of albuvirtide, China’s first domestically developed innovative HIV therapy. The study will assess the drug’s efficacy in addressing immune reconstitution insufficiency in HIV-1 infected patients…
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Wanbangde’s Huperzine A Receives FDA Clearance for HIE Study
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China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) has announced receiving clearance from the US Food and Drug Administration (FDA) to study its huperzine A in neonatal hypoxic-ischemic encephalopathy (HIE). This indication has earned the drug a rare pediatric disease (RPD) designation and orphan drug designation (ODD) from the…
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FDA Approves Datroway for HR+/HER2- Breast Cancer Treatment
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Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate co-developed by Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (AZ, NASDAQ: AZN), last week received approval from the US FDA for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor…
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Allist Pharmaceuticals Gains NMPA Approval for Furmonertinib Clinical Study
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its furmonertinib as an adjuvant therapy for stage IB-IIIB non-small cell lung cancer (NSCLC) carrying non-classical epidermal growth factor receptor (EGFR) mutations. The study will evaluate the…
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Junshi Biosciences’ Toripalimab Gains TGA Approval for Nasopharyngeal Carcinoma
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Aged Care for its toripalimab. The anti-PD-1 monoclonal antibody can now be used in combination with cisplatin and gemcitabine for the…
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Aosaikang’s Limertinib Approved for EGFR T790M-Mutated NSCLC
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Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharm, SHE: 002755) has recently received approval from the National Medical Products Administration (NMPA) for the registration and market launch of its drug Limertinib (Brand name: Aoyixing). The drug is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell…
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Johnson & Johnson Submits NDA for TAR-200 in High-Risk Bladder Cancer
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US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced the initiation of the submission of a New Drug Application (NDA) filing with the US Food and Drug Administration (FDA) for TAR-200. The drug is intended for use in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma…
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Eli Lilly’s Omvoh Approved by FDA for Crohn’s Disease Treatment
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US major Eli Lilly and Company (NYSE: LLY) has announced receiving marketing approval from the US FDA for its Omvoh (mirikizumab-mrkz), an interleukin-23p19 (IL-23p19) antagonist, to treat moderately to severely active Crohn’s disease in adults. This approval follows the FDA’s nod for its use as a first-in-class treatment for moderately…
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Boehringer Ingelheim’s Iclepertin Fails to Meet Phase III Study Endpoints
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German giant Boehringer Ingelheim has disclosed negative top-line results from the Phase III CONNEX study for its iclepertin, a treatment for cognitive impairment in adults with schizophrenia. The study failed to meet either primary or key secondary endpoints, indicating no statistically significant effects on cognition or functioning in patients treated…
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Telix Pharmaceuticals’ TLX591-CDx Approved in Europe via Decentralized Procedure
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that the marketing filing in Europe via the Decentralized Procedure (DCP) for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer, has been approved by the regulatory body in the region. This approval marks…
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Daiichi Sankyo Acquires Gatipotuzumab IP Rights for $132.5M
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Japan-based Daiichi Sankyo Company, Ltd (TYO: 4568) has announced an investment of USD 132.5 million to acquire the intellectual property (IP) rights of gatipotuzumab, an antitumor-associated mucin-1 (TA-MUC1) antibody, from Germany-headquartered Glycotope GmbH. This strategic acquisition strengthens Daiichi Sankyo’s portfolio in cancer therapy. Acquisition Details and BackgroundDaiichi Sankyo obtained global…
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Impact Therapeutics’ Senaparib Cleared by NMPA for Ovarian Cancer Therapy
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China-based Impact Therapeutics has announced receiving marketing clearance from the National Medical Products Administration (NMPA) for its senaparib to be used as maintenance therapy in adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The clearance is for patients who have achieved complete or partial…
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SciClone and Menarini Submit NDA for Vaborem in China
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China-based SciClone Pharmaceuticals Inc and its Italy-based strategic partner Menarini have announced the submission of a New Drug Application (NDA) for Vaborem (meropenem vaborbactam) to the National Medical Products Administration (NMPA). The sought-after indication is complex urinary tract infections, including pyelonephritis. This submission marks a significant step in making this…
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Asieris’ USP1 Inhibitor APL-2302 Cleared for Clinical Trials
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its APL-2302 (ASN-3186) in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced cancer. APL-2302: Mechanism of ActionAPL-2302…
