Johnson & Johnson (J&J) has agreed to acquire Abiomed, a NASDAQ-listed cardiovascular medical technology provider, in an all-cash deal valued at approximately $16.6 billion. The proposed acquisition is expected to further diversify and expand Johnson & Johnson MedTech (JJMT) portfolio into the heart failure and recovery segment through Abiomed’s Impella heart pump platform. Joaquin Duato […]
The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced the US Food and Drug Administration’s approval of its first bispecific T-cell engager antibody, TECVAYLI (teclistamab-cqyv). The medication is intended for the treatment of relapsed or refractory multiple myeloma patients. TECVAYLI is indicated for patients previously treated with a proteasome inhibitor, immunomodulatory drug, and […]
Granules India has secured approval for its abbreviated new drug application (ANDA) for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC) from the US Food & Drug Administration (FDA). The product is a bioequivalent to Imodium Multi-Symptom Relief Tablets, 2 mg/125 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. According to […]
Johnson & Johnson (JNJ) has announced plans to carve out its consumer health business into a new publicly traded company to focus on its biopharma and medical device businesses. According to the US healthcare conglomerate, the move will create two global majors that are better placed to deliver enhanced health outcomes for patients and consumers, […]
The European Commission has granted a conditional marketing authorization (CMA) for the single dose Janssen Covid‑19 vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The Janssen vaccine is the fourth Covid-19 vaccine authorized in the European Union (EU) after the vaccines developed by BioNTech and Pfizer, Moderna, and AstraZeneca. Ursula von der […]
Johnson & Johnson (J&J) said that the US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for Ad26.COV2.S, a single-dose COVID-19 vaccine developed by its subsidiary Janssen Pharmaceutical Companies for the prevention of COVID-19 in people aged 18 years or more. The FDA decision was driven by the totality of scientific evidence. […]
The US Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the Janssen COVID-19 Vaccine, Ad26.COV2.S, developed by Johnson & Johnson’s subsidiary, Janssen Biotech. This marks the third vaccine authorized by the FDA to combat COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Details of the Authorization: The […]
DARZALEX FASPRO FDA approval for AL amyloidosis : Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured approval from the US Food and Drug Administration (FDA) for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) for the treatment of light chain (AL) amyloidosis, which has been newly diagnosed in […]
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) seeking the expanded approval for DARZALEX (daratumumab) in subcutaneous (SC) formulation to include the treatment of patients having light chain (AL) amyloidosis. Considered as a rare and potentially fatal disease, AL amyloidosis is due […]
Johnson & Johnson (J&J) said that the European Commission (EC) has approved an advance purchase agreement for securing 200 million doses of the JNJ-78436735 Covid-19 vaccine candidate (Ad26.COV2.S) developed by its subsidiary Janssen Pharmaceutical Companies. Currently, the JNJ-78436735 vaccine candidate is being evaluated in the phase 3 ENSEMBLE Covid-19 vaccine trial across certain countries. The […]