FDA Accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as…
Johnson & Johnson and Kenvue Announce Pricing of Upsized Kenvue Inc. Initial Public Offering
Johnson & Johnson (NYSE: JNJ) and Kenvue Inc. (“Kenvue”), a wholly owned subsidiary of Johnson & Johnson, today announced the pricing of Kenvue’s upsized initial public offering (“IPO”) of 172,812,560 shares of Kenvue’s common stock at a price to the…
Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies
Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture and commercialize next-generation chimeric antigen…
Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the first results from the open-label Phase 2 SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy (a novel investigational intravesical drug delivery system) and cetrelimab monotherapy (an investigational…
Johnson & Johnson Announces Launch of Kenvue Inc. IPO Roadshow
Johnson & Johnson (NYSE: JNJ) today announced that Kenvue Inc. (“Kenvue”), a wholly owned subsidiary of Johnson & Johnson comprising its Consumer Health Business, has launched a roadshow for the initial public offering (“IPO”) of 151,204,000 shares of its common…
Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone orprednisolone, for the…
Janssen to Highlight Innovation in Retinal Pipeline at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that five company-sponsored presentations will be featured during the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting in New Orleans from April 23-27, 2023. Janssen presentations will include updates…
Johnson & Johnson Reports Q1 2023 Results
Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2023. “Our first quarter results demonstrate strong performance across all three segments of our business and reflect the dedication of Johnson & Johnson colleagues around the world,” said Joaquin Duato,…
Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications
The Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics, an AbbVie Company, announced today the intent to voluntarily withdraw the U.S. indications for IMBRUVICA® (ibrutinib) for the treatment of patients with mantle cell lymphoma (MCL)…
Johnson & Johnson Subsidiary LTL Management LLC (“LTL”) Re-Files for Voluntary Chapter 11 to Equitably Resolve All Current and Future Talc Claims
Johnson & Johnson (NYSE:JNJ) (the Company) today announced that its subsidiary LTL Management LLC (LTL) has re-filed for voluntary Chapter 11 bankruptcy protection to obtain approval of a reorganization plan that will equitably and efficiently resolve all claims arising from…
ERLEADA® (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor with Once-Daily, Single-Tablet Option, Now Available in the U.S.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the availability of an additional tablet strength of ERLEADA® (apalutamide) in the United States. The introduction of the 240mg tablet provides the first-and-only option for a once-daily, single-tablet Androgen Receptor Inhibitor…
Haemonetics Sets Date for Publishing Fourth Quarter and Fiscal Year 2023 Results: May 11, 2023
Haemonetics Corporation (NYSE: HAE) announced that the Company intends to publish fourth quarter and fiscal year 2023 financial results at 6:00 am ET on Thursday, May 11, 2023. The Company will hold a conference call with investors and analysts to discuss results and…