Tag Archives: Adrian Kemp

Wainzua Receives EU Recommendation for Treating Hereditary Amyloidosis, Offering New Monthly Self-Administered Option

(IN BRIEF) AstraZeneca and Ionis’ drug Wainzua (eplontersen) has been recommended for approval in the European Union for treating hereditary transthyretin-mediated amyloidosis (ATTRv-PN) in adults with stage 1 or 2 polyneuropathy. Based on the positive results from the NEURO-TTRansform Phase … Read the full press release

FluMist Becomes First At-Home Self-Administered Flu Vaccine Approved by FDA

(IN BRIEF) FluMist, a needle-free nasal spray influenza vaccine, has been approved by the FDA for self-administration in the US, making it the first flu vaccine of its kind to be used at home. Adults up to 49 years old … Read the full press release

FDA Approves AstraZeneca’s Fasenra for Eosinophilic Granulomatosis with Polyangiitis, Offering New Hope for Patients

(IN BRIEF) AstraZeneca’s Fasenra (benralizumab) has been approved by the US FDA for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis that can be fatal without treatment. The approval is based on results from the MANDARA … Read the full press release

AstraZeneca Completes Equity Investment in Cellectis for Cell and Gene Therapy Development

(IN BRIEF) AstraZeneca has finalized its equity investment with Cellectis, a clinical-stage biotechnology firm, following a successful research collaboration agreement announced in November 2023. This partnership aims to harness Cellectis’ gene editing technologies to design up to 10 novel cell … Read the full press release

AstraZeneca’s Truqap Receives EU Recommendation for ER-Positive Breast Cancer Treatment

(IN BRIEF) AstraZeneca’s Truqap, in combination with Faslodex, has received a positive recommendation from the European Medicines Agency (EMA) for treating estrogen receptor-positive, HER2‑negative locally advanced or metastatic breast cancer with specific genetic alterations. The recommendation follows promising results from … Read the full press release

AstraZeneca’s Imfinzi Shows Promising Results in Phase III Trial for Small Cell Lung Cancer

(IN BRIEF) AstraZeneca announces positive outcomes from the ADRIATIC Phase III trial, revealing that its immunotherapy drug Imfinzi (durvalumab) demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS) among patients with limited-stage small cell lung cancer (LS-SCLC) … Read the full press release

AstraZeneca and Daiichi Sankyo’s BLA for Datopotamab Deruxtecan Accepted by FDA for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been acknowledged by the US FDA for treating adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior systemic … Read the full press release

Ultomiris Receives FDA Approval as First Long-Acting Treatment for AQP4 Ab+ NMOSD, Redefining Patient Care

(IN BRIEF) Ultomiris (ravulizumab-cwvz) has gained approval from the FDA as the inaugural long-acting C5 complement inhibitor for treating adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The approval, based on the CHAMPION-NMOSD Phase III trial’s … Read the full press release

EMA Validates Marketing Authorisation Applications for AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan in Lung and Breast Cancer Treatment

(IN BRIEF) The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for datopotamab deruxtecan (Dato-DXd), developed by AstraZeneca and Daiichi Sankyo, for the treatment of nonsquamous non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast … Read the full press release

Voydeya Recommended for EU Marketing Authorization as PNH Treatment Add-On

(IN BRIEF) Voydeya (danicopan), a first-in-class oral Factor D inhibitor, has been recommended for marketing authorization in the European Union (EU) as an add-on to ravulizumab or eculizumab for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience residual haemolytic … Read the full press release

AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan Moves Closer to Approval for Advanced NSCLC Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the FDA for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in patients who have undergone prior … Read the full press release

FDA Approves AstraZeneca’s Tagrisso Plus Chemotherapy for EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca’s Tagrisso receives FDA approval for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) following a Priority Review. The decision is based on FLAURA2 Phase III trial results demonstrating that Tagrisso plus … Read the full press release

AstraZeneca Advances in Cell Therapy with Acquisition of Gracell Biotechnologies

(IN BRIEF) AstraZeneca has announced its definitive agreement to acquire Gracell Biotechnologies Inc. (NASDAQ: GRCL), a global biopharmaceutical company specializing in cell therapies for cancer and autoimmune diseases. This strategic move aims to bolster AstraZeneca’s presence in the field of … Read the full press release

AstraZeneca’s Imfinzi Combination Therapy Shows Promise in Phase III Trial for Liver Cancer Treatment

(IN BRIEF) AstraZeneca has reported positive high-level results from the EMERALD-1 Phase III trial, demonstrating that its drug Imfinzi (durvalumab), in combination with transarterial chemoembolisation (TACE) and bevacizumab, significantly improves progression-free survival (PFS) in patients with hepatocellular carcinoma (HCC) eligible … Read the full press release

AstraZeneca Secures Exclusive License for ECC5004, Promising Oral GLP-1RA for Cardiometabolic Conditions

(IN BRIEF) AstraZeneca and Eccogene have signed an exclusive license agreement for ECC5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) designed for the treatment of obesity, type-2 diabetes, and other cardiometabolic conditions. Initial results from the Phase … Read the full press release

AstraZeneca Teams Up with Cellectis to Accelerate Gene Therapy Development

(IN BRIEF) AstraZeneca has entered into a collaboration and investment agreement with biotech firm Cellectis to fast-track the development of cutting-edge therapeutics in areas such as oncology, immunology, and rare diseases. This partnership will leverage Cellectis’ gene editing technologies and … Read the full press release

Alexion and AstraZeneca Acquire Rare Disease Gene Therapy Portfolio from Pfizer for $1 Billion

(IN BRIEF) Alexion, in collaboration with AstraZeneca Rare Disease, has finalized an agreement to acquire a collection of preclinical rare disease gene therapy programs and related technologies from Pfizer Inc. This strategic move combines the expertise of Alexion and AstraZeneca … Read the full press release

AstraZeneca completes the transfer of Eklira/Tudorza and Duaklir global rights to Covis Pharma Group for $270 million

(PRESS RELEASE) CAMBRIDGE, 5-Jan-2021 — /EuropaWire/ — AstraZeneca (LON: AZN), a British-Swedish multinational pharmaceutical and biotechnology company, has announced the completion of the transfer of its global rights to Eklira (aclidinium bromide), popular as Tudorza in the US, and Duaklir … Read the full press release