Industry News

- Read more about Lilly gets DMC recommendation to continue MONARCH 2 phase 3 trial of abemaciclib without modification
Eli Lilly and Company announced that following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) provided the recommendation to continue the study without modification as the interim efficacy criteria were not met. The MONARCH 2, phase 3 trial compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.
- Read more about Proteostasis Therapeutics complete preclinical milestone in Astellas collaboration
Proteostasis Therapeutics, Inc., a clinical stage biopharmaceutical company developing small molecule therapeutics to treat diseases caused by dysfunctional protein processing, announced that it has successfully completed a key preclinical milestone in its collaboration with Astellas Pharma Inc. (Astellas). The milestone, which triggered an undisclosed payment from Astellas, demonstrated that selective modulation of the Unfolded Protein Response (UPR) pathway in vitro is potentially an effective disease-modifying approach in the treatment of multiple diseases with few or no therapies currently available.
- Read more about Shire launch Vonvendi, a recombinant treatment for adults affected by VWD in US market
Shire plc, a leading global biotechnology company, announced the US launch of Vonvendi [von Willebrand factor (Recombinant)], the only recombinant treatment for adults living with von Willebrand disease (VWD).
- Read more about U.S. FDA Approve Heron Therapeutic’s SUSTOL Extended-Release Injection
Heron Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved SUSTOL® (granisetron) extended-release injection. SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
- Read more about Coherus Biosciences Submits 351(K) BLA To U.S.FDA For CHS-1701
Coherus BioSciences, Inc. announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to U.S. FDA under the 351(k) pathway.

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- Read more about Alkermes Submits sNDA to FDA for Two-Month Dosing Option of ARISTADA
Alkermes plc announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a two-month dosing interval of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
- Read more about Sun Pharma extends Imatinib Mesylate Savings Card program for patients in USA
Sun Pharmaceutical Industries Ltd announced the extension of its Imatinib Mesylate Savings Card programme beyond July 31, 2016. Sun Pharma launched this programme as part of the imatinib mesylate launch in February 2016. The programme is aimed at delivering greater access to the drug by patients who have commercial insurance, but whose out-of-pocket cost may exceed an affordable amount.
- Read more about Intec Pharma initiate clinical development programme of Accordion Pill
Intec Pharma Ltd, a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology, announced the initiation of a new clinical development programme for its Accordion Pill platform with the two primary cannabinoids contained in Cannabis sativa.
- Read more about China FDA accepts Eisai's NDA for anticancer agent Halaven
The China Food and Drug Administration (CFDA) has accepted for review a New Drug Application (NDA) submitted for Eisai's in-house developed anticancer agent eribulin mesylate (eribulin, product name: Halaven) for use in the treatment of patients with locally advanced or metastatic breast cancer in China.
- Read more about Masimo receives CE Marking for pediatric O3 regional oximetry
Masimo announced the CE marking for the pediatric indication for O3 regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, helps clinicians monitor cerebral oxygenation.