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Usynova Pharmaceuticals Inks Licensing Deal with AstraZeneca for KRASG12D Inhibitor UA022
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Shanghai-based Usynova Pharmaceuticals Ltd has announced a licensing agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) concerning its pipeline candidate, UA022. UA022 is a small-molecule drug targeting the KRASG12D mutation, currently in the pre-clinical stages of development. Terms of the Agreement and FinancialsUnder the agreement, AstraZeneca (AZ) will secure…
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Ascentage Pharma Secures Additional Indication Approval for Olverembatinib from NMPA
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China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Category 1 drug, olverembatinib. This second market-approved indication is for the treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) who are resistant and/or intolerant…
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Apollomics’ Partner Avistone Wins Conditional Approval for c-Met Inhibitor in China
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US-based biotech Apollomics Inc., (NASDAQ: APLM) has announced that its Chinese partner, Avistone Biotechnology Co., Ltd, has received conditional market approval for the c-Met inhibitor vebreltinib from the National Medical Products Administration (NMPA). The approval is for the treatment of patients with MET exon 14 skipping non-small cell lung cancer…
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Fosun Pharmaceutical Secures Clinical Trial Approvals for VT-101 in China and the US
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced receiving clinical trial approvals for its VT-101 from both the National Medical Products Administration (NMPA) in China and the US Food and Drug Administration (FDA). VT-101 is a next-generation recombinant oncolytic adenovirus product that features a triple-targeted tumor regulation mechanism,…
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Baheal Pharmaceutical Group Enters Commercialization Partnership with Guangdong Ruidio Technology
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China-based health services and distribution giant Baheal Pharmaceutical Group has struck a commercialization partnership with Guangdong Ruidio Technology Co., Ltd. Under the terms of the agreement, Baheal acquires commercialization rights to Ruidio’s series of radioactive drugs, including 99mTc-3PRGD2, 99mTc-HP-Ark2, and 99mTc-POFAP, as well as imaging equipment products such as SPECT.…
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Pfizer and Astellas Pharma Secure FDA Approval for Xtandi in High-Risk Non-Metastatic Prostate Cancer
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Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval from the US Food and Drug Administration (FDA) for their androgen receptor signaling inhibitor Xtandi (enzalutamide). The drug is now approved as a treatment for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high…
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AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with fulvestrant. This treatment is indicated for HR-positive, HER2-negative locally advanced or metastatic recurrent or refractory breast…
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Alphamab Oncology’s JSKN003 ADC: Promising Preliminary Data in Advanced Solid Tumors
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Alphamab Oncology (HKG: 9966) has released preliminary data from a Phase I clinical study on its JSKN003-KN026 antibody drug conjugate (ADC) in Australia, focusing on advanced solid tumors. This open-label, multi-center, dosage escalation study is designed to evaluate the safety, tolerability, and preliminary efficacy of the molecule in treating these…
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BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase…
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Astellas Pharma Acquires Propella Therapeutics for $175 Million to Boost Prostate Cancer Treatment
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Japan’s Astellas Pharma (TYO: 4503) has announced the negotiation of a purchase agreement for US biopharmaceutical company Propella Therapeutics this week, with a transaction value of USD 175 million. The deal is anticipated to be finalized by March 2024, subject to the fulfillment of customary conditions. With this acquisition, Astellas…
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Eli Lilly Clears Final Regulatory Hurdle with NRC Approval for Point Biopharma Acquisition
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The Nuclear Regulatory Commission (NRC) of the US has given its approval for the transfer of a radioactive materials license from Point Biopharma (NASDAQ: PNT) to Eli Lilly (NYSE: LLY). This decision marks the final regulatory clearance necessary for Eli Lilly’s acquisition of Point Biopharma, which was announced last month.…
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Merck KGaA Outlines Expansion Plans for US Healthcare Market with Anticipated 2025 Drug Launches
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Germany’s Merck KGaA (ETR: MRK), a leading player in the global pharmaceutical industry, has this week unveiled its strategic plans for the US healthcare market. The company, which currently commercializes two cancer treatments in the US, is gearing up to launch two additional drugs by 2025. Furthermore, Merck anticipates continuing…
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EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
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Novartis Pharma AG Partners with Legend Biotech Corp. for CAR-T Therapies in $1.1 Billion Deal
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China-based Legend Biotech Corp., (NASDAQ: LEGN) has secured a second multinational partnership for its chimeric antigen receptor (CAR) T cell therapies with Novartis Pharma AG (NYSE: NVS) in a landmark USD 1.1 billion deal. The Swiss pharmaceutical giant has acquired exclusive global development, manufacturing, and commercialization rights to certain assets…
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BMS Secures ORM-6151 for Acute Myeloid Leukemia Treatment with Orum Therapeutics Deal
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Bristol Myers Squibb (BMS; NYSE: BMY) has made a significant move in the field of oncology by purchasing ORM-6151, a potential first-in-class antibody-drug conjugate (ADC) from US-based Orum Therapeutics. The acquisition includes approval from the local regulator for ORM-6151 to enter a Phase I study for acute myeloid leukemia (AML)…
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Bayer Withdraws Aliqopa FDA Filing Following Missed Phase III Endpoint
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Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for the kinase inhibitor Aliqopa (copanlisib) with the US Food and Drug Administration (FDA). Aliqopa, which received accelerated approval in 2017 for the treatment of relapsed follicular lymphoma (FL), failed to meet the primary endpoint of…
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AnchorDx Medical Partners with DiaCarta for Global Molecular Diagnostics Development
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AnchorDx Medical Co., Ltd, a specialist in methylation high-throughput sequencing based in China, has entered into a partnership with DiaCarta, Ltd, a US-based precision molecular diagnostics company. The collaboration aims to focus on the development and commercialization of cancer screening products, leveraging their proprietary technologies in DNA methylation and mutation…
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Beijing-Based Immupeutics Medicine Secures Tens of Millions in Pre-Series A+ Financing
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Immupeutics Medicine, a Beijing-based developer in the field of tumor immunotherapy, has reportedly secured tens of millions of renminbi in a pre-Series A+ financing round. The funding round was led by Beijing state-owned Capital Operation and Management Center, with additional investments from Junshi Bio, Alwin Capital, and the company’s founder.…
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Servier’s Tibsovo Receives FDA Approval for IDH1-Mutated R/R MDS, Expanding Indications
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France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has granted market approval for its drug Tibsovo (ivosidenib) for the treatment of recurrent or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutation. This marks the fifth indication for the drug in the IDH1 mutant cancer…
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AstraZeneca’s Imfinzi Gains NMPA Approval for First-Line Cholangiocarcinoma Treatment
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The National Medical Products Administration (NMPA) of China has indicated on its website that it has approved AstraZeneca’s (AZ, NASDAQ: AZN) programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab), for use in combination with chemotherapy for the treatment of first-line locally advanced or metastatic cholangiocarcinoma (BTC). This marks a significant expansion…
