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US FDA approves 1st Eliquis generics; AstraZeneca inhaler wins Chinese approval

Top news

* The U.S. Food and Drug Administration approved the first generic versions of Bristol-Myers Squibb Co. and Pfizer Inc.'s blood thinner Eliquis. The regulator gave the nod to two copies of Eliquis, or apixaban, made by Micro Labs Ltd. and Mylan NV, to reduce the risk of stroke and recurrent blockages in the blood vessels due to clots in patients with nonvalvular atrial fibrillation, a type of irregular heart rhythm.

* AstraZeneca PLC said its triple-combination inhaler therapy PT010 was approved as a maintenance treatment in China for a group of lung diseases called chronic obstructive pulmonary disease.

* Allergan PLC's medicine Ubrelvy was approved by the U.S. FDA to treat migraine with or without aura in adults. Ubrelvy belongs to a group of drugs that work by blocking calcitonin gene-related peptides, or CGRPs, in the body to prevent migraine. Ubrelvy is the first and only orally administered CGRP receptor antagonist approved in the U.S.

M&A and capital markets

* Karo Pharma AB (publ) agreed to acquire anti-hemorrhoid and dermatology products from Danish pharmaceutical company LEO Pharma Inc. for €90 million.

Drug and product pipeline

* BioMarin Pharmaceutical Inc. is seeking U.S. approval for its gene therapy valoctocogene roxaparvovec to treat adult patients with hemophilia A, a type of blood disorder.

Other companies seeking the U.S. FDA's approval for their medicines include Seattle Genetics Inc., which wants to market tucatinib for breast cancer; FibroGen Inc., for its anemia drug Evrenzo; and Zosano Pharma Corp., which wants the regulator's nod for its non-oral migraine therapy Qtrypta.

* Meanwhile, Karyopharm Therapeutics Inc. is seeking the U.S. FDA's accelerated approval for Xpovio to treat patients with a type of blood cancer called diffuse large B-cell lymphoma.

* Progenics Pharmaceuticals Inc. said its imaging agent PyL helped in localizing tumors in prostate cancer patients with biological recurrence of the disease in a late-stage study.

Operational activity

* Gilead Sciences Inc. and Tokyo-based Eisai Co. Ltd. entered an agreement to distribute and co-promote Gilead's rheumatoid arthritis treatment filgotinib in Japan.

* Roche Holding AG agreed to acquire the worldwide rights to Codexis Inc.'s EvoT4, an enzyme that is used to analyze a patient's genetic code and how their cells express their genes as proteins. Financial terms of the deal were not disclosed.

* Elsewhere, Sangamo Therapeutics Inc. transferred SB-525 — a potential treatment for bleeding disorder hemophilia A — to its partner Pfizer which is going to see the medicine through late-stage development. Sangamo received $25 million for the transfer.

* In other licensing news, Pfizer agreed to pay $10 million up front to Theravance Biopharma Inc. for access to the company's Janus kinase, or JAK, inhibitors which are being studied as treatments for skin conditions. Meanwhile, Fortress Biotech Inc. said it was acquiring the exclusive worldwide license to AstraZeneca's experimental nervous system disorders treatment AZD7325.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, the Hang Seng decreased 0.15% to 27,864.21, and the Nikkei 225 was up 0.04% to 23,830.58.

In Europe, around midday, the FTSE 100 was up 0.09% to 7,630.15, and the Euronext 100 climbed 0.13% to 1,154.45.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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