-
AstraZeneca’s Fasenra Shows Non-Inferior Efficacy to Nucala in EGPA: Phase III Results
•
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III study, demonstrating the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) compared to GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab) in the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The study highlights that Fasenra…
-
AstraZeneca’s Tagrisso Combination Therapy Shows Improved Efficacy in EGFR-mutated NSCLC
•
UK-headquartered AstraZeneca (AZ; NASDAQ: AZN) has announced interim Phase III data demonstrating that the addition of pemetrexed plus cisplatin/carboplatin chemotherapy to tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) improves therapeutic effects in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of…
-
AstraZeneca’s Ultomiris Faces FDA Rejection for NMOSD Indication Extension
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has received a rejection from the US Food and Drug Administration (FDA) for an indication extension of its complement inhibitor Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. The FDA has requested modifications to the drug’s…
-
Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
•
Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab, to the US Food and Drug Administration (FDA) for the treatment of the rare disease paroxysmal nocturnal hemoglobinuria (PNH). The filing is bolstered by Phase III clinical data that demonstrates crovalimab’s non-inferiority and a similar…
-
AstraZeneca’s Calquence Approved by NMPA for Chronic Lymphocytic Leukemia Treatment
•
UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic…
-
AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an indication extension approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its orphan drug Soliris (eculizumab). The drug is now approved as a treatment for generalized myasthenia gravis (gMG) in pediatric patients who…
-
AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
•
The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) two breakthrough therapy designations (BTDs) for their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). This recognition is for its potential as a therapy for HER2-positive malignancies, including unresectable or metastatic solid tumors…
-
HHS Releases List of 10 Drugs for Medicare Price Negotiations Starting 2026
•
The Department of Health and Human Services (HHS) in the US has released a list of the first 10 medicines that will be subject to a novel mechanism for negotiating drug prices under the Medicare health insurance program starting from the 2026 period onwards. The institution plans to publish the…
-
AstraZeneca Challenges US Government’s Drug Price Negotiation Plan for Medicare
•
UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has filed a legal claim against the US government’s plan to negotiate the price of selected drugs for the 2026 period onwards through the elderly health insurance program, Medicare. This move makes AstraZeneca the fourth company to contest the initiative this year, following…
-
AstraZeneca and MSD’s Lynparza Gets Green Light for Prostate Cancer Treatment in Japan
•
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca (AZ; NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for the use of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a treatment for BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant…
-
AstraZeneca Restructures to Capture Opportunities in Guangdong-Hong Kong-Macao Greater Bay Area
•
UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) is taking strategic steps to capitalize on the opportunities in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) by adjusting its team structure and changing personnel. New Divisional Leadership for GBA ExpansionAstraZeneca will split its respiratory, digestive, and autoimmune business unit into two distinct…
-
Scott-Moncrieff & Associates Preparing 50 Cases Against AstraZeneca Over Vaccine Concerns
•
Scott-Moncrieff & Associates, a UK-based law firm, has disclosed that it is preparing nearly 50 cases against pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) in relation to its SARS-CoV-2 vaccine. The move follows the filing of a product liability claim by a plaintiff earlier this month, who alleged that his wife’s…
-
AstraZeneca’s Forxiga Demonstrates Clinical Benefits in Heart Failure and COPD Patients
•
UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced evidence that its SGLT2 inhibitor, Forxiga (dapagliflozin), provides significant clinical benefits in patients with heart failure (HF) with preserved ejection fraction (pEF) and chronic obstructive pulmonary disease (COPD). This announcement highlights the potential of Forxiga in treating these conditions and underscores…
-
AstraZeneca’s Forxiga Gains New Indication Approval in China for Chronic Heart Failure
•
UK-based pharmaceutical major AstraZeneca plc (AZ, NASDAQ: AZN) has announced that China’s National Medical Products Administration (NMPA) has granted a new indication approval for its SGLT-2 inhibitor, Forxiga (dapagliflozin). The drug is now approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits…
-
HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Gastric Cancer
•
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN) and approved in China on July 12, is to be awarded breakthrough therapy designation (BTD) in China. The BTD status is specifically for savolitinib’s use as a third-line treatment…
-
AstraZeneca to Invest Additional USD 250 Million in Qingdao for Aerosol Production Plant
•
UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) is set to invest an additional USD 250 million to establish an inhalation aerosol production and supply plant in Qingdao, China. This significant investment follows an earlier cooperation agreement signed in March 2023 between AstraZeneca and the Qingdao city government, which initially focused…
-
Burning Rock Partners with AstraZeneca to Develop Companion Diagnostics for Cancer Therapies
•
Guangzhou-based medical device giant Burning Rock (NASDAQ: BNR) has announced a strategic partnership with AstraZeneca (AZ, NASDAQ: AZN). The collaboration will utilize Burning Rock’s world-leading testing technology and high-quality, standardized testing capacities to develop and commercialize companion diagnostics (CDx) products for AstraZeneca’s breast cancer and prostate cancer therapies. Financial details…
-
CanSino Biotechnology Partners with AstraZeneca for mRNA Vaccine Development and Manufacturing
•
China-based vaccines specialist CanSino Biologics Inc., (HKG: 6185) has announced a product supply cooperation framework agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN). The agreement entails providing contract development and manufacturing services for AstraZeneca’s mRNA vaccine, with no financial details disclosed. Focus on mRNA Production Platform and Vaccine R&DThis…
-
MSD’s Q2 2023 Earnings: Keytruda and Gardasil Drive Growth Amid COVID-19 Sales Decline
•
US-based major Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has released its financial results for the second quarter of 2023, showing a 7% year-on-year (YOY) growth in worldwide sales, reaching USD 15 billion in constant exchange rates. The pharmaceuticals business reached USD 13.457 billion, up 8% YOY, while Animal…
-
AstraZeneca’s Alexion Secures Gene Therapy Portfolio in Deal with Pfizer
•
AstraZeneca’s rare disease unit, Alexion (AZ, NASDAQ: AZN), has signed a significant purchase and license agreement with Pfizer (NYSE: PFE), focusing on a portfolio of preclinical gene therapy programs and related enabling technologies. This strategic deal will provide Alexion with access to several novel adeno-associated virus (capsids), which are crucial…
