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Alexion’s Ultomiris Secures FDA Approval for Anti-AQP4 Positive NMOSD Treatment
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AstraZeneca’s (AZ; NASDAQ: AZN) rare disease unit, Alexion, has registered its biologic Ultomiris (ravulizumab) with the US Food and Drug Administration (FDA) for the treatment of anti-AQP4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) in adults. This registration follows an initial rejection by the FDA last year and positions Ultomiris…
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AstraZeneca to Acquire Fusion Pharmaceuticals in a Deal Valued at USD 2.4 Billion
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AstraZeneca (AZ; NASDAQ: AZN), the UK-based pharmaceutical giant, has announced its intention to acquire Fusion Pharmaceuticals (NASDAQ: FUSN), a Canada-based developer of radioconjugate (RC) therapies, in a deal valued at up to USD 2.4 billion, including upfront and potential contingent value payments. The acquisition is expected to be finalized in…
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AstraZeneca’s Lynparza-Imfinzi Combo Shows Promising Results in Endometrial Cancer Study
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has presented interim results from a late-stage study combining the PARP inhibitor Lynparza (olaparib) with the anti-PD-L1 Imfinzi (durvalumab) for the treatment of newly diagnosed advanced or recurrent endometrial cancer. The study has shown promising outcomes, with the combination therapy extending the…
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AstraZeneca Caps Monthly Costs for US Patients with Asthma and COPD Inhalers
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced an expansion of its accessibility program for inhaled respiratory drugs in the US. The initiative will cap monthly expenses at USD 35 for eligible patients suffering from asthma and chronic obstructive pulmonary disease (COPD). The savings program includes coverage…
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AstraZeneca Acquires Amolyt Pharma for $800 Million to Bolster Rare Disease Pipeline
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AstraZeneca (AZ; NASDAQ: AZN) has finalized a definitive agreement to acquire France-based biopharmaceutical company Amolyt Pharma for an upfront payment of $800 million, with an additional potential milestone payment of $250 million. The transaction is anticipated to close by the third quarter of 2024, pending customary regulatory approvals. Amolyt Pharma…
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KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
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Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug HL-085, aimed at treating advanced melanoma with NRAS mutations in patients who have experienced failure with anti-PD-1/PD-L1 therapies. HL-085 is a groundbreaking ATP non-competitive MEK inhibitor that specifically targets NRAS…
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EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
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The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell…
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AstraZeneca’s AZD0486 Receives NMPA Greenlight for Clinical Study in B-Cell Leukemia
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its drug candidate AZD0486 (TNB-486) in patients with recurrent or refractory B-cell acute lymphoblastic leukemia. AZD0486 is a bispecific antibody (BsAb) that targets both…
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AstraZeneca’s Fasenra Matches Nucala in EGPA Trial and Shows Steroid Reduction Benefits
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has presented results from a Phase III trial that previously announced the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) against GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab), the current standard of care for relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The data revealed…
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AstraZeneca Expands Global Footprint with Shanghai Strategic Center
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AstraZeneca (AZ, NASDAQ: AZN) has declared that Shanghai is now its fifth global strategic center, joining the ranks of Cambridge in the UK, Boston and Gethersburg in the United States, and Gothenburg in Sweden. This move is complemented by AstraZeneca’s plan to collaborate with innovative pharmaceutical companies in Shanghai for…
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AstraZeneca Launches Phase I Trial for siRNA Therapy in Collaboration with Silence Therapeutics
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AstraZeneca (AZ; NASDAQ: AZN) has commenced a Phase I trial for a short interfering RNA (siRNA) therapy targeting an undisclosed disease, marking the first clinical candidate to emerge from its 2020 collaboration with UK-based Silence Therapeutics (NASDAQ: SLN). This partnership aims to develop up to ten siRNA therapeutics across cardiovascular,…
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AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily…
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AstraZeneca Secures Shareholder Approval for $1 Billion Acquisition of Gracell Biotechnologies
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The proposed acquisition of China-based Gracell Biotechnologies Inc. (Nasdaq: GRCL) by UK pharmaceuticals giant AstraZeneca (AZ, NASDAQ: AZN) has received approval from Gracell’s shareholders during an extraordinary general meeting held on February 19, 2024. An overwhelming 99.9% of shareholders voted in favor of AstraZeneca’s $1 billion acquisition, with potential total…
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AstraZeneca’s Tagrisso Wins Expanded FDA Approval for EGFR-mutated NSCLC
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has received a new indication approval from the US Food and Drug Administration (FDA) for its lung cancer therapy Tagrisso (osimertinib). The fresh indication allows for the use of Tagrisso in combination with chemotherapy for patients with advanced or metastatic epidermal growth factor…
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AstraZeneca Reports 6% Revenue Growth in 2023, Driven by Oncology and Diabetes Drug Sales
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AstraZeneca (AZ; NASDAQ: AZN), the UK-based multinational, reported its financial results for 2023 this week, revealing a 6% year-on-year increase in annual global revenues, reaching USD 45.8 billion at constant exchange rates. Oncology revenue surged by 21%, while cardiovascular, renal, and metabolism (CVRM) sales rose 18%. Respiratory and immunology (R&I)…
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AstraZeneca Announces $300 Million Investment in Next-Gen Cell Therapies Manufacturing in the U.S.
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has announced a significant investment of $300 million to establish a next-generation cell therapies manufacturing facility in the United States. This new site is set to enhance support for global clinical trials and facilitate local product launches. This strategic move follows AstraZeneca’s…
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AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for Enhertu (trastuzumab deruxtecan), submitted in partnership with Japan’s Daiichi Sankyo (TYO: 4568) to the US Food and Drug Administration (FDA), has been granted priority review. The treatment is now under consideration for unresectable or metastatic…
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AstraZeneca Wins FDA Nod for Airsupra in Asthma Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK pharmaceutical company, announced this week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its respiratory drug Airsupra (albuterol + budesonide). The drug is now approved for the treatment or prevention of asthma symptoms and for the…
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AstraZeneca’s Imfinzi Meets Primary Endpoint in Hepatocellular Carcinoma Trial
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced the successful completion of the primary endpoint in a Phase III trial for its anti-PD-L1 drug Imfinzi (durvalumab). The trial investigated the combination of Imfinzi with bevacizumab, originally developed by Roche (SWX: ROG) as Avastin, and transarterial chemoembolization (TACE) for embolization-eligible hepatocellular…
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Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
