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AbbVie Halts Brain Tumor Late-Stage Study

AbbVie halted the Phase III INTELLANCE-1 trial of depatuxizumab mafodotin in patients with newly diagnosed glioblastoma whose tumors have epidermal growth factor receptor amplification.

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Agios Pharma’s Tibsovo Shows Positive Results in Phase III for Another Cancer Indication

Cambridge, Mass.-based Agios Pharmaceuticals announced that Tibsovo (ivosidenib) hit the primary endpoint in the Phase III ClarIDHy trial in patients with cholangiocarcinoma with an isocitrate dehydrogenase 1 mutation.

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FDA approves first anticoagulant for pediatric patients to treat potentially life-threatening blood clots

The U.S. FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism in pediatric patients 1 month of age and older.

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Gilead and Other HIV Treatment-Making Companies Face Class Action Lawsuit

Gilead Sciences has been accused of withholding safer formulations of its HIV drugs in order to maximize profits on those medications that had already been approved, such as Truvada.

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J&J to submit NDAs for at least 10 new drugs by 2023

Johnson & Johnson expects to file marketing applications for at least 10 new drugs between 2019 to 2023, to strengthen the company’s pharma unit which has been a major growth driver.

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Pfizer’s abrocitinib meets late-stage study goals

Pfizer Inc.’s experimental atopic dermatitis treatment abrocitinib met the main goals in a late-stage study that tested the drug in patients aged 12 and older with moderate to severe forms of the disease.

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Mallinckrodt Completes Enrollment of Phase 3 Terlipressin CONFIRM Trial

Mallinckrodt plc announced that the company achieved target enrollment of 300 participants in the Phase 3 CONFIRM clinical study to evaluate the efficacy and safety of the investigational agent terlipressin in adult patients with Hepatorenal Syndrome Type 1 (HRS-1).

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Pfizer Acquires Rare-Drug Company Therachon for $810 Million

Pfizer announced plans to buy Therachon, a rare disease biotech company based in Basel, Switzerland.

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AstraZeneca-Daiichi breast cancer treatment shows promise in latest study

An experimental breast cancer drug being developed by British drugmaker AstraZeneca and Japan’s Daiichi Sankyo’s met the main goal in a mid-stage study, bolstering the companies’ position in a highly competitive oncology market.

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AstraZeneca Halts Phase III CLL Trial Early After Primary Endpoints Are Met

AstraZeneca’s Calquence (acalabrutinib) hit the mark in a Phase III trial of previously treated patients with chronic lymphocytic leukemia (CLL).

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!

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