JD Supra1d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
Ozempic is in the next round of Medicare drug price negotiations. See the full list of 15 medications
The list includes Novo Nordisk’s blockbuster diabetes injection Ozempic, weight loss shot Wegovy and diabetes pill Rybelsus, ...
Targeted Oncology2d
FDA Oks Sotorasib/Panitumumab in KRAS G12C-Mutant Colorectal Cancer
The FDA has approved the combination of sotorasib (Lumakras) and panitumumab (Vectibix) for the treatment of patients with ...
Targeted Oncology2d
Acalabrutinib Plus Bendamustine and Rituximab Receives FDA Approval in MCL
Acalabrutinib with bendamustine and rituximab is now an FDA-approved treatment for patients with previously untreated mantle ...
DC Circuit Skeptical of FDA Rejection of Vanda’s Jet Lag Drug
The FDA met resistance from a three-judge panel Wednesday over its decision to refuse approval of Vanda Pharmaceuticals ...
Hosted on MSN4d
JNJ, GSK, LLY Announce M&A Deals at JP Morgan Conference
The JP Morgan Healthcare Conference, which is being held in San Francisco this year, has been much more active than last year. Among some of the top news at the conference were M&A deal announcements ...
Hoodline4d
Johnson & Johnson Bolsters Neuroscience Offerings with $14.6 Billion Acquisition of Intra-Cellular Therapies
Johnson & Johnson is set to acquire Intra-Cellular Therapies for $14.6 billion to enhance its neuroscience drug portfolio.
Outsourcing-pharma4d
Johnson & Johnson acquires Intra-Cellular for $14.6bn
Johnson & Johnson's $14.6bn acquisition of Intra-Cellular Therapies adds Caplyta and a robust pipeline targeting major ...
Business Insider4d
Hutchmed announces NMPA approval for Orpathys supplemental new drug application
Hutchmed (HCM) announces that the supplemental new drug application for Orpathys has been granted approval by the China National Medical Products Administration, or NMPA, for the treatment of adult ...
JD Supra5d
The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’
The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some ...
GEN5d
J&J to Acquire Intra-Cellular for $14.6B
Johnson & Johnson has agreed to acquire Intra-Cellular Therapies for approximately $14.6 billion, in the largest biopharma merger-and-acquisition (M&A) deal announced in two years.