PERSON – Page 5

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

1 month ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

HHS ousts MAHA implementation lead amid rushed cancellations of $500M in mRNA vaccine contracts

1 month ago talkbio0Tagged BARDA, CHARGE Syndrome, Contract agreement, Gray Delany, MAHA, Moderna, mRNA contracts, Pfizer, Policy, Robert F. Kennedy, Seqirus, Shakeup, SMPX gene, Staff, terminations, Vaccines

HHS; MAHA; Gray Delany; mRNA contracts; BARDA; Robert F. Kennedy Jr.; vaccine policy; contract terminations; Moderna; Pfizer; CSL Seqirus; staff shakeup

AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

1 month ago talkbio0Tagged AbbVie, Antibodies, Bispecific, Approved, Epcoritamab, EPKINLY, expansion, Genmab, Labels (device), lenalidomide, Lymphoma, Follicular, Phase 3 Clinical Trials, rituximab, T-Cell engager, United States Food and Drug Administration

Epkinly; epcoritamab; AbbVie; Genmab; follicular lymphoma; T cell engager; bispecific antibody; Phase III trial; FDA approval; label expansion; Rituximab; Lenalidomide

Strand Therapeutics Raises $153M Series B to Advance mRNA Tumor Drugs

1 month ago talkbio0Tagged Big Pharma investors, biotech financing, Clinical Trials, Genomic Orientation, interleukin-12, mRNA cancer, Series B funding, Solid Neoplasm, STX-001

Strand Therapeutics; Series B funding; mRNA cancer therapy; STX-001; IL-12; solid tumors; Big Pharma investors; clinical trial results; biotech financing

FDA Grants Accelerated Approval to Jazz’s Dordaviprone (Modeyso), the First Treatment for Ultra-Rare Brain Tumor

1 month ago talkbio0Tagged Accelerated, Approved, Brain Neoplasms, Chimerix acquisition, Confirmatory Trial, Dordaviprone, midline glioma, Modeyso, pediatric brain cancer, United States Food and Drug Administration

Dordaviprone; Modeyso; FDA approval; H3 K27M-mutant diffuse midline glioma; ultra-rare brain tumor; Jazz Pharmaceuticals; accelerated approval; pediatric brain cancer; Chimerix acquisition; confirmatory trial

XtalPi and DoveTree Announce Landmark $6 Billion AI-Powered Drug Discovery Collaboration

1 month ago talkbio0Tagged Aortic Valve Insufficiency, Artificial Intelligence, Collaboration, Dosage Forms, DoveTree Medicines, Drug Discovery, Gregory Verdine, Immunology, Metabolic Diseases, milestone payments, Neoplasms, Neurology speciality, Robotics, royalties, upfront payment, XtalPi

XtalPi; DoveTree Medicines; AI drug discovery; robotics; pharmaceutical R&D; Gregory Verdine; oncology; immunology; neurology; metabolic diseases; collaboration; upfront payment; milestone payments; royalties

HHS Ends BARDA Funding for Future mRNA Vaccine Development, Citing Efficacy Concerns

1 month ago talkbio0Tagged BARDA, CHARGE Syndrome, COVID19 (disease), Effectiveness, Influenza, mRNA Vaccines, project cancellation, public health policy, Robert F. Kennedy, Vaccines

mRNA vaccines; BARDA; Robert F. Kennedy Jr.; vaccine efficacy; HHS; COVID-19; flu; project cancellation; public health policy

HHS Cancels $500 Million in BARDA-Funded mRNA Vaccine Contracts Amid Strategic Shift

1 month ago talkbio0Tagged BARDA, CHARGE Syndrome, contract cancellation, COVID19 (disease), development aspects, federal funding, Moderna, mRNA Vaccine, Pfizer, Robert F. Kennedy Jr., Seqirus, Vaccines

HHS; BARDA; mRNA vaccine; vaccine development; contract cancellation; Robert F. Kennedy Jr.; COVID-19; federal funding; Moderna; Pfizer; Seqirus

Pfizer’s Embattled Obesity Program Loses Another GLP-1 Drug Due to Data and Competition Issues

1 month ago talkbio0Tagged Agonist, Clinical Trials, competition, Danuglipron, Drug Development, Glucagon-Like Peptide 1, Injury of liver, lotiglipron, Obesity, PF-06954522, Pfizer

Pfizer; obesity; GLP-1 agonist; clinical trial; liver injury; danuglipron; lotiglipron; PF-06954522; obesity drug development; competition

Pfizer CEO Holds ‘Extremely Productive’ Talks With Trump Administration Amid MFN Pricing and Tariff Threats

1 month ago talkbio0Tagged Albert Bourla, Direct-to-Consumer, Drug Industry, drug price, Jr., Mehmet, Nation, negotiation, ounce, Pfizer, PhRMA, Policy, Pricing, Robert F. Kennedy, tariffs, Trump administration

Pfizer; Albert Bourla; Trump administration; Most Favored Nation (MFN) pricing; drug pricing; tariffs; pharmaceutical industry; direct-to-consumer (DTC) sales; policy negotiation; Robert F. Kennedy Jr.; Mehmet Oz; PhRMA