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 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.

On December 20, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission (EC) has granted a marketing authorisation for Alecensa (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, DEC 20, 2017, View Source [SID1234522737]). The approval is based on results from the phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 53% (hazard ratio (HR)=0.47, 95% confidence interval (CI): 0.34-0.65, p<0.001) compared to crizotinib. The study also showed that Alecensa reduced the risk of tumours spreading to, or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10-0.28, p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to crizotinib.1

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"Many ALK-positive lung cancer patients see their disease progress within a year on current treatments," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The EU approval of Alecensa heralds a new era for these patients, who now have a treatment option available that halves the risk of disease progression compared with the previous standard of care, crizotinib and is also highly effective against brain metastases."

In addition to today’s first-line approval, the EC also converted the conditional marketing authorisation of Alecensa in crizotinib failure to a standard marketing authorisation. Alecensa has also recently (6 November 2017) been approved by the US FDA, as well as Japan and Turkey as an initial (first-line) ALK-positive NSCLC treatment, and is already approved in Japan as well as in 18 countries in the crizotinib-failure setting.

Results from the phase III ALEX study were simultaneously presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The New England Journal of Medicine. Subsequently, Alecensa was recommended in the US National Comprehensive Cancer Network (NCCN) guidelines as a treatment option for first-line ALK-positive metastatic NSCLC (Category 1, Preferred).2

ALK-positive NSCLC is a distinct form of lung cancer commonly affecting younger people (median age 52), and those with a light or non-smoking history.3 Around 75,000 people are diagnosed with ALK-positive NSCLC every year.4,5,6

On December 20, 2017 Astellas Pharma Inc. reported that the company’s President and CEO Yoshihiko Hatanaka will present at the 36 th Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2018 in San Francisco, Calif (Press release, Astellas, DEC 20, 2017, View Source [SID1234522702]). The presentation will take place at The Westin St. Francis at 9:30 a.m., with a
question and answer session occurring from 10:00 a.m. – 10:25 a.m. PST.

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›At 2:30 a.m., January 10, 2018 with a question and answer session occurring from
3:00 a.m. – 3:25 a.m. in Japan time

To access a live webcast of the presentation, visit JP Morgan Web site at
View Source
Also, the materials will be available at our website after the presentation.
View Source

On December 20, 2017 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective cancer medicines, reported that Drew Fromkin, President and Chief Executive Officer, will present at the 10th Annual Biotech Showcase, occuring January 8-10, 2018 at the Hilton Union Square in San Francisco (Press release, Tarveda Therapeutics, DEC 20, 2017, View Source [SID1234522746]).

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The presentation will take place at 10:00am Pacific Time on Wednesday, January 10 in Franciscan – D.

In the presentation, Mr. Fromkin will address the Company’s Pentarin miniature drug conjugate platform including PEN-221, which is currently in clinical evaluation for the treatment of patients with somatostatin receptor 2 (SSTR2) positive cancers including neuroendocrine and small cell lung cancers, and PEN-866, an HSP90 targeting conjugate, which is being developed for the treatment of patients with a wide range of solid tumors including pancreatic cancer, small cell lung cancer and sarcoma.

About Pentarins
Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell‑killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell‑killing payload inside the cancer cells for efficacy.