Novartis’ Mayzent OK’d in Europe for multiple sclerosis

As expected, the European Commission approves Novartis’ (NYSE:NVS) Mayzent (siponimod) for the treatment of adults with secondary progressive multiple sclerosis with active disease.

Two months ago, the advisory group CHMP adopted a positive opinion backing approval.

https://seekingalpha.com/news/3532960-novartis-mayzent-okd-in-europe-for-multiple-sclerosis

Bausch Health to drop Cipher’s Trulance

Cipher Pharmaceuticals (OTC:CPHRF) reports that Bausch Health Companies (NYSE:BHC) has notified it that it intends to terminate its license agreement for constipation med Trulance (plecanatide) due to an undisclosed breach of certain provisions of the contract.

It previously disclosed that it is reviewing certain distribution partnerships in Canada and is in active discussions to sub-license Trulance to multiple parties. It intends to “vigorously challenge” BHC over its planned exit.

Cipher acquired exclusive rights in Canada from Synergy Pharmaceuticals in February 2018.

https://seekingalpha.com/news/3532967-bausch-health-to-drop-ciphers-trulance

Ra Medical receives FDA IDE approval for atherectomy study

The FDA has approved Ra Medical Systems (NYSE:RMED) to initiate an investigational device exemption (IDE) to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses.

The trial will enroll up to 100 patients with symptoms of peripheral vascular disease (PAD) (Rutherford Class 2-4).

The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA, before any adjunctive treatment.

https://seekingalpha.com/news/3532969-ra-medical-receives-fda-ide-approval-for-atherectomy-study

Arcutis Biotherapeutics sets IPO terms

Arcutis Biotherapeutics (ARQT) has filed a preliminary prospectus for its IPO of ~7.8M common shares at $15 – 17 per share.

Underwriters’ over-allotment will be an additional ~1.2M shares.

https://seekingalpha.com/news/3533070-arcutis-biotherapeutics-sets-ipo-terms

Glaxo balantamab mafodotin nabs accelerated review in US for myeloma

The FDA grants Priority Review status to GlaxoSmithKline’s (NYSE:GSK) marketing application for belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma (MM) in patients whose prior therapies included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

Belantamab mafodotin is an immunoconjugate comprised of a humanized anti-B cell maturation antigen monoclonal antibody conjugated to a cytotoxic agent called auristatin F via a non-cleavable linker in-licensed from Seattle Genetics (NASDAQ:SGEN).

https://seekingalpha.com/news/3533065-glaxos-balantamab-mafodotin-nabs-accelerated-review-in-u-s-for-mm

BeiGene’s tislelizumab successful in late-stage lung cancer study

A Phase 3 clinical trial evaluating BeiGene’s (NASDAQ:BGNE) PD-1 inhibitor tislelizumab, combined with two chemo regimens, for the first-line treatment of patients with squamous non-small cell lung cancer (NSCLC) met the primary endpoint of progression-free survival (PFS) at the planned interim analysis.

Additional data will be submitted for presentation at an upcoming medical conference.

The company plans to file a supplemental marketing application in China.

The China National Medical Products Administration approved tislelizumab last month for Hodgkin lymphoma patients who have received at least two prior lines of therapy.

https://seekingalpha.com/news/3532989-beigenes-tislelizumab-successful-in-late-stage-lung-cancer-study

Eton Pharma teams up with Xellia Pharma for Biorphen

Eton Pharmaceuticals (NASDAQ:ETON) has entered into a co-promotion agreement with Xellia Pharmaceuticals for the promotion of Biorphen (phenylephrine HCl), an only FDA approved ready-to-use formulation of phenylephrine injection indicated for the treatment of hypotension resulting primarily from vasodilation in the setting of anesthesia.

Xellia’s hospital sales force will immediately begin promoting Biorphen in collaboration with Eton.

The agreement significantly expands Biorphen’s commercial footprint and provides access to institutions that prefer ready-to-use injectable formulations.

Xellia will receive a commission on Biorphen sales realized from certain customer accounts.

https://seekingalpha.com/news/3532996-eton-pharma-teams-up-xellia-pharma-for-biorphen