Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). The FDA's Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner.

H. Lundbeck A/S (Lundbeck) and Prexton Therapeutics BV (Prexton) today announced signing of a definitive agreement in which Lundbeck will acquire Prexton. Under terms of the agreement, Lundbeck will pay EUR 100 million (approximately DKK 750 million) upfront and is furthermore required to later pay up to EUR 805 million (approximately DKK 6 billion) in development and sales milestones to the group of current owners.

AstraZeneca has announced results from a new analysis of its landmark CVD-REAL study, the first large real-world evidence study of its kind evaluating the risk of all-cause death (ACD), hospitalisation for heart failure (hHF), heart attack (myocardial infarction or MI) and stroke in patients with type-2 diabetes (T2D) receiving treatment with SGLT-2 inhibitors (SGLT-2i), including Farxiga (dapagliflozin) versus other glucose-lowering medicines.

Novartis announced today changes to its senior leadership team to support the implementation of its strategic priorities. Bertrand Bodson, Chief Digital Officer, Steffen Lang, Global Head Novartis Technical Operations, and Shannon Klinger, Chief Ethics, Risk and Compliance Officer, have been appointed to the Executive Committee of Novartis (ECN).

Novartis has announced an additional strategic alliance with Science 37, a leader in decentralized clinical trial technology and design, to initiate up to 10 new clinical trials over the next three years. The studies will blend virtual and traditional models, with increasing degrees of decentralization towards a mostly "site-less" model.

Bristol-Myers Squibb Company (NYSE:BMY) announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo ® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications.

A new global guideline on chronic urticaria (CU) recommends Xolair® (omalizumab), indicated as add-on therapy for the treatment of chronic spontaneous urticaria (CSU), for patients who are not responding to antihistamines[1],[2]. Xolair is the only licensed treatment option for CSU, a type of CU, for patients unresponsive to antihistamines[1].