Protocols

AbbVie scores speedy review for RA drug upadacitinib; Merck KGaA wins CRISPR patent

→ AbbVie $ABBV has high hopes, projecting peak potential sales of $6.5 billion, for its oral JAK1 inhibitor upadacitinib for rheumatoid arthritis, which is up against well-entrenched rivals. On Tuesday, the drugmaker said FDA had rewarded the drug — which is also under EU review — priority review, and that the US health regulator is expected to makes its decision by the third quarter of 2019.

Pfizer has nabbed the European green light for its Avastin copycat — its second oncology biosimilar in the continent— in a slate of cancer indications from carcinoma of the colon or rectum to non-small cell lung cancer. The launch of Zirabev would follow a trail blazed by Amgen and Allergan with Mvasi, which was approved by the EU last year and by the FDA a few months prior.

→ While the CRISPR IP landscape is as contentious as ever with the customary players battling it out, Germany’s Merck has swooped in with a patent for proxy-CRISPR, an improved version of traditional CRISPR that makes the gene-editing technique “more efficient, flexible and specific by opening the genome for modification of DNA.”

In other CRISPR news, Gamida Cell $GMDA has joined forces with Editas Medicine $EDIT to edit NAM-NK cells — natural killer cells that have been expanded using Gamida Cell’s nicotinamide-based, or NAM, technology — to improve the treatment of blood cancers and solid tumors. The financial terms of the deal were not disclosed. Gamida Cell’s NAM-NK immunotherapy is currently under development in Phase I trials for use patients with refractory non-Hodgkin lymphoma and multiple myeloma.

Simon Moroney

German cancer drugmaker MorphoSys $MOR is losing one of its founders. CEO Simon Moroney, who has led the company for 27 years, has told the company’s board he intends to retire. Moroney will step down when his current contract expires on June 30, 2020, or when a successor is appointed, whichever comes sooner. In 2017, Tremfya, sold by J&J $JNJ for use in plaque psoriasis, became the first drug based on MorphoSys’s antibody technology to receive regulatory approval.

Israeli biotech Bioblast Pharma $ORPN has sold its Trehalose clinical development programs to Seelos Therapeutics $SEEL for $3.5 million in two installments, and up to $17 million in milestone payments.

Apart from Aradigm $ARDM and Immune Pharmaceuticals $IMNPPernix Therapeutics $PTX has also filed for Chapter 11 to undertake its restructuring and sale process, which it hopes to conclude by May.

→ Gilead’s $GILD CAR-T therapy Yescarta has notched another approval, this time in Canada for relapsed or refractory large B-cell lymphoma in adult patients who have undergone at least two systemic therapies.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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