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.

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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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Advaxis has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Advaxis, 2017, DEC 20, 2017, View Source [SID1234522739]).

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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.