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Biosimilar makers take a win; EMA recommendations include Ozempic


Essential IR Insights Newsletter Fall - 2023

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Biosimilar makers take a win; EMA recommendations include Ozempic

Top news

* Drug innovators cannot use state laws to force biosimilar makers through injunctions to disclose details about their products, the U.S. Court of Appeals for the Federal Circuit said in a new ruling, declaring that federal law pre-empts such activities.

* Novo Nordisk A/S received a positive opinion for Ozempic, or semaglutide, from the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP. The U.S. FDA approved the drug Dec. 5.

A total of seven drugs were approved by CHMP this month, including Celltrion's biosimilar Herzuma for gastric and breast cancer. Herzuma is a biosimilar form of Roche Holding AG's Herceptin.

* The U.K.'s National Institute for Health and Care Excellence, or NICE, recommended Johnson & Johnson's Imbruvica for use within the National Health Service as a second-line treatment for adults with relapsed or refractory mantle cell lymphoma.

M&A and capital markets

* Perrigo Co. plc plans to bid for Merck KGaA's $4.7 billion consumer health unit, Reuters reported, citing anonymous sources.

* Pfizer Inc. gave the pricing terms of its private offers to exchange and repurchase its outstanding £1.5 billion 6.500% notes due 2038.

* Takeda Pharmaceutical Co. Ltd. acquired a strategic equity stake in newly launched Izana Bioscience, as part of a licensing agreement. Izana is a clinical-stage translational medicine company initially focused on ankylosing spondylitis, a type of arthritis that affects the spine.

Drug and product pipeline

* Merck & Co. Inc.'s phase 3 trial of Keytruda as a second-line treatment for a certain advanced gastric cancer failed to meet its main goal of overall survival.

* Pfizer Inc. said the U.S. Food and Drug Administration approved Xeljanz to treat certain patients with active psoriatic arthritis.

* Merck KGaA plans to seek the U.S. FDA's approval for its multiple sclerosis treatment Mavenclad in the second quarter of 2018, Reuters reported, citing Belen Garijo, the head of the healthcare division.

* The U.S. FDA allowed Kitov Pharmaceuticals Holdings Ltd. to use the brand name Consensi for marketing its drug KIT-302.

* BeyondSpring Inc.'s plinabulin helped limit a chemotherapy-induced reduction in certain white blood cells, meeting the primary goal of the phase 2 portion of a phase 2/3 trial.

Operational activity

* Mylan NV said the U.S. Patent and Trademark Appeal Board initiated inter partes review proceedings on two patents owned by France-based Sanofi for its diabetes drug Lantus.

* Pfizer Inc. is evaluating strategic options for its second Remicade-biosimilar, Ixifi, and does not plan to launch the medicine in the U.S. despite the FDA's approval, FiercePharma reported, citing a company spokesperson. Remicade is Johnson & Johnson's medicine for rheumatoid arthritis.

* So far, only five patients have received Gilead Sciences Inc.'s breakthrough treatment Yescarta, a CAR-T therapy approved by the U.S. FDA for certain types of lymphoma in October, though there are more than 200 patients on waiting lists, Bloomberg News notes. Doctors at the cancer hospitals are blaming delayed payments by the U.S. government health programs Medicare and Medicaid and certain insurers.

Our features

* CAR-T race gets crowded at hematology meeting: This week, gene therapies from Novartis AG, Gilead Sciences Inc. and Juno Therapeutics Inc. took center stage at the American Society of Hematology conference in Atlanta. The treatments, known as chimeric antigen receptor T-cell, or CAR-T cell, therapies, work by manipulating a patient's own disease-fighting T-cells and then infusing them back into the body to fight blood cancers.

Other features

* Bloomberg Businessweek features Vitae Industries Inc. 's AutoCompounder, a 3-D printer that makes pills in about 10 minutes, one-third of the time required to fill gel capsules by hand.

* Short bursts of radiation used to stabilize heart rhythms in cardiac patients is being seen as a "game changer" and a "paradigm shift" from the current standard of care, The New York Times notes. The experimental technique needs to be studied in larger patient populations for a longer period of time.

* The New York Times also discusses a report by the Centers for Disease Control and Prevention of the cerebral development of certain two-year-olds born with brain damage caused by the Zika virus.

The day ahead

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

In Asia, the Hang Seng slipped 1.09% to 28,848.11, and the Nikkei 225 dropped 0.62% to 22,553.22.

In Europe, around midday, the FTSE 100 was up 0.03% to 7,450.49, and the Euronext 100 slid 0.41% to 1,034.23.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.