On December 20, 2017 Vectura Group plc (LSE: VEC) ("Vectura", "the Company"), an industry-leading device and formulation business for inhaled airways products, reported that James Ward-Lilley, Chief Executive Officer, will present at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, on Wednesday, 10 January 2018, at 9:30am PST / 17:30pm GMT (Press release, Vectura, DEC 20, 2017, View Source;customerKey=VecturaIntranet&storyID=13758359 [SID1234522731]).

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A live webcast of the presentation and a copy of the slides will be available on the Company’s website: View Source A recording will be available following the presentation.

Vectura will issue a 2017 pre-close trading update on Thursday 4th January 2018.

– Ends –

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Vectura Group plc

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On December 20, 2017 4SC AG (4SC, FSE Prime Standard: VSC) reported that it received a Pediatric Investigation Plan waiver from the European Medicines Agency (EMA) for resminostat in advanced-stage cutaneous T-cell lymphoma (CTCL) (Press release, 4SC, DEC 20, 2017, View Source [SID1234522733]).

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As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a Pediatric Investigation Plan that outlines the clinical development strategy for studying the investigational product in children. In some instances, a waiver from developing a Pediatric Investigation Plan for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate. CTCL is extremely rare in children and if present, is usually an early stage disease that can be controlled quite well with existing therapies.

"This waiver represents an important milestone in the regulatory process for resminostat, and will allow 4SC to submit a Marketing Authorization Application for resminostat to the EMA following successful completion of the pivotal RESMAIN study without the requirement to conduct additional clinical studies in children before or after approval," said Jason Loveridge, CEO of 4SC.

Resminostat is being evaluated as maintenance therapy in advanced-stage CTCL patients in the pivotal RESMAIN study, which is currently being conducted at more than 50 clinical centers in 11 European countries. Top-line results are expected to be available in the first half of 2019.

On December 20, 2017 Samsung Bioepis Co., Ltd. reported that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptini (trastuzumab) (Press release, Samsung Bioepis, DEC 20, 2017, View Source [SID1234522734]). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the United States (US). If approved, SB3 will be commercialized in the US by Merck, which is known as MSD outside of the US and Canada.

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On 20 December 2017, Idorsia Ltd reported that it has entered into a research collaboration that provides Roche with an exclusive option right to develop and market first-in-class compounds for a promising new approach in the field of cancer immunotherapy (Press release, Hoffmann-La Roche, DEC 20, 2017, View Source [SID1234584171]).

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Martine Clozel, M.D. and Chief Scientific Officer of Idorsia, commented: "The preclinical data we have generated leads us to believe that our approach can translate into significant therapeutic benefits for patients. By joining forces, we are combining our advanced drug discovery program together with the cancer immunotherapy expertise of Roche. I am looking forward to the collaboration with our partner to leverage our research and bring compounds through clinical development as soon as possible."

About the terms of the agreement

The parties will collaborate on the discovery of products through the formation of a joint committee, chaired by Idorsia.

Roche will pay Idorsia an upfront payment of CHF 15 million and will have the option to exclusively license Idorsia compounds and compounds resulting from the collaboration, for a further payment of 35 million, after a pre-determined period. After the exercise of its option right, Roche would have the exclusive worldwide right to develop and commercialize the Idorsia and collaboration compounds.

Idorsia will be eligible to receive one-time development and regulatory milestones of up to CHF 410 million. Idorsia will also be entitled to one-time milestones based on sales thresholds, as well as tiered royalties on annual net sales of all products resulting from the collaboration.

On December 20, 2017 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that Phil Hagerman, CEO and chairman, and Atul Kavthekar, CFO, will present at the upcoming 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Diplomat Speciality Pharmacy, DEC 20, 2017, View Source [SID1234522736]).

(Press release, Diplomat Speciality Pharmacy, DEC 20, 2017, View Source [SID1234522736])

Mr. Hagerman and Mr. Kavthekar are scheduled to present at the conference on Wednesday, Jan. 10, 2018, at 1:30 p.m. PT. A live audio-only webcast of the presentation and related presentation materials will be available on the investor relations section of the Company’s website at diplomat.is. The archived webcast and presentation materials will also be available for approximately 90 days at the same URL.