NSCLC
Oct 22, 2024
Gilead and Merck Announce Encouraging Phase II Results of Islatravir and Lenacapavir Combo; REGENXBIO Highlights Positive Data from Phase II ABBV-RGX-314 Wet AMD Study at AAO 2024; FDA Greenlights Astellas’ VYLOY for Advanced Gastric and GEJ Cancer Therapy; Merck’s CAPVAXIVE Vaccine Yields Strong Immune Response in Adults Vulnerable to Pneumococcal Disease; FDA Postpones LUMAKRAS Colorectal Cancer Verdict to Early 2025
Gilead and Merck Reports Phase II Data Showing that Switching to a Once-Weekly Oral Combination of Islatravir and Lenacapavir Maintained Viral Suppression in Adults Through 48 Weeks Gilead Sciences, Inc. and Merck have shared new findings from a Phase II clinical trial assessing the experimental combination of i...
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Oct 15, 2024
Astellas & AviadoBio’s Exclusive Deal for AVB-101; GSK’s Depemokimab Shows Positive Results for Nasal Polyps; Lilly’s Mirikizumab Outperforms Ustekinumab in Crohn’s Study; TREMFYA Delivers Strong Results in Crohn’s & Colitis; ENHERTU Approved in China for HER2-Mutant NSCLC.
Astellas & AviadoBio Sign Exclusive Deal for Gene Therapy AVB-101 in Frontotemporal Dementia AviadoBio Ltd. and Astellas Pharma Inc. have announced a strategic partnership under an exclusive option and license agreement for AVB-101, an investigational AAV-based gene therapy currently in Phase I/II developmen...
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Oct 08, 2024
OPDIVO Approved for Resectable NSCLC; Palvella Gets $2.6M FDA Grant; First Patient Dosed in UGN-103 Bladder Cancer Trial; Recordati Acquires ENJAYMO for $825 Million; AIRSUPRA Reduces Severe Asthma Exacerbations
FDA Approves Perioperative OPDIVO Plus Chemotherapy for Resectable NSCLC The FDA has granted approval to Bristol Myers Squibb’s OPDIVO (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC), specifically targeting tumors that are 4 cm or larger or node-positive and hav...
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Sep 23, 2024
Roche’s TECENTRIQ HYBREZA: Setting New Standards as the First Subcutaneous Anti-PD-(L)1 Drug
Better late than never for FDA approval of the first subcutaneous PD-L1 inhibitor—Roche’s TECENTRIQ HYBREZA—after manufacturing delays disrupted the company’s initial launch plans last year. The FDA was originally set to decide on TECENTRIQ’s under-the-skin formulation in September, but Roche’s delivery technolo...
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Sep 20, 2024
Post WCLC 2024 Insights: Recent Advancements in Thoracic Malignancies
NSCLC is the most common type of lung cancer accounting for approximately 85% of all lung cancers (roughly 509,000 incident cases in 2019 [7MM: the US, EU4 and the UK, and Japan]). The real-world treatment trend depicts a significant shift towards targeted and immunotherapies (from only systemic therapies in the pa...
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Sep 03, 2024
Bayer Phase III NSCLC Trial; D&D Pharmatech Gets FDA Nod for GLP-1R Agonist in Multiple Scletosis; Merck Halts Two KEYTRUDA Trials; Novartis Expands LEQVIO After Phase III Success; Alnylam Reports Strong Phase III Data for Vutrisiran
Bayer Starts Phase III Trial In Non-Small Cell Lung Cancer (NSCLC) Bayer has officially enrolled the first patient in the global Phase III SOHO-02 trial, which will evaluate the efficacy and safety of BAY 2927088 as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with activating HER2 mutat...
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Jul 30, 2024
IMFINZI’s AEGEAN Phase III Trial Data for Treating Resectable NSCLC; Ipsen and Day One’s Exclusive Agreement to License and Market Tovorafenib Outside the US; Alzheimer’s Drug LEQUEMBI Rejected by EU; EU Apporves Pfizer’s Gene Therapy DURVEQTIX; CHMP Approves SPEVIGO’s New Indications
The FDA Advisory Committee Considers the AEGEAN Phase III Trial Data in their Review of IMFINZI for Treating Resectable NSCLC The FDA's Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s IMFINZI (durvalumab) achieved the primary endpoint of event-free survival (EFS) in resectable non-small...
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May 28, 2024
AstraZeneca’s Tropion-Lung01 Phase III Trial Positive Outcomes; Biogen’s LEQEMBI South Korea Approval; AltruBio’s $225M Series B Funding; GSK’s Depemokimab Positive Phase III Severe Asthma Results; Roche’s Inavolisib FDA Breakthrough Therapy Designation
The Tropion-Lung01 Phase III Trial Reveals that Datopotamab Deruxtecan Significantly Enhanced Overall Survival in Advanced Nonsquamous NSCLC Patients Compared to Chemotherapy The high-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which had previously met the dual primary endpoint o...
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May 14, 2024
Takeda and AC Immune’s Alzheimer’s Deal; Eli Lilly’s Donanemab FDA Review; Bristol Myers Squibb’s Phase III CheckMate -73L Trial Result; Regeneron Pharmaceuticals’ Dupixent sBLA; Excision BioTherapeutics’ EBT-101 Phase I/II Trial Results
Takeda and AC Immune Ink Exclusive Deal for Active Immunotherapy in Alzheimer’s, Focusing on Amyloid Beta Takeda and AC Immune SA have unveiled an exclusive global option and licensing pact concerning AC Immune’s active immunotherapies directed at harmful variants of amyloid beta (Abeta), notably ACI-24.060, int...
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Apr 30, 2024
X4 Pharmaceuticals’ XOLREMDI FDA Approval; ONO to Acquire Deciphera Pharmaceuticals; Johnson & Johnson’s SIRTURO CHMP Approval; BeiGene’s Tislelizumab EC Approval; Sanofi’s Rilzabrutinib LUNA 3 Phase III Trial
FDA Greenlights XOLREMDI Capsules from X4 Pharmaceuticals for WHIM Syndrome Treatment X4 Pharmaceuticals has declared that the FDA has granted approval for XOLREMDI™ (mavorixafor) capsules to be utilized in individuals aged 12 and above who have WHIM syndrome (characterized by warts, hypogammaglobulinemia, infec...
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