On January 30, 2019 Novartis reported strong sales growth with core margin expansion, building leading advanced therapy platforms and focusing the company in 2018 (Press release, Novartis, JAN 30, 2019, View Source [SID1234532959])·

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Full year net sales up 5% (cc1, +6% USD) driven by strong performance of growth drivers:

o Pharmaceuticals BU grew 7% (cc) driven by Cosentyx USD 2.8 billion (+36% cc) and Entresto USD 1.0 billion (+102% cc)

o Oncology BU grew 9% (cc) driven by AAA2 (USD 0.4 billion) including Lutathera, Promacta/Revolade USD 1.2 billion (+35% cc) and Tafinlar + Mekinist USD 1.2 billion (+31% cc)

· Full year core1 operating income grew 8% mainly driven by higher sales and gross margin expansion

· Net income was USD 12.6 billion (+64%) including a USD 5.7 billion net gain from the divestment of OTC JV. Operating income declined 5% mainly due to M&A transactions and restructurings

· Free cash flow1 grew 12% to USD 11.7 billion driven by strong operating cash flows

· Focused the company with transformational deals during 2018:

o Consumer healthcare JV stake divested to GSK for USD 13.0 billion

o Announced proposal to spin-off Alcon Division3; on track for H1 2019

o Sandoz began transformation with reshaping the portfolio4, geographic focus and a leaner cost structure

· Built leading advanced therapy platforms:

o Gene therapy – Acquired AveXis and in-licensed Luxturna

o Radioligand therapy – Acquired AAA and Endocyte

o Cell therapy – Expanding Kymriah global manufacturing including multiple collaborations

· Four additional products reached blockbuster status in 2018; Lutathera, Aimovig and Kymriah for DLBCL were launched; additional ten key launches on track by 2020

· Alcon sales grew 5% (cc, +6% USD) and core operating income grew 10%; expanding core margin

· Sandoz sales down -3% (cc, -2% USD) due to US price pressure; Biopharmaceuticals grew 24% (cc)

· Dividend of CHF 2.85 per share, an increase of 2%, proposed for 2018

· 2019 Group guidance5:

o New focused medicines company6 – Net sales expected to grow mid single digit (cc); core operating income expected to grow mid to high single digit (cc)

o Current Group structure7 – Net sales expected to grow low to mid single digit (cc); core operating income expected to grow mid single digit (cc)

On January 30, 2019 Eli Lilly and Company (NYSE: LLY) has reported that revised the date for its fourth-quarter and full-year 2018 financial results announcement (Press release, Eli Lilly, JAN 30, 2019, View Source [SID1234532960]). The company will now announce results on Wednesday, February 6, 2019, one week earlier than previously scheduled. Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On January 30, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that Drug Design, Development and Therapy has published an article titled, "Targeting the A3 Adenosine Receptor to Treat Cytokine Release Syndrome in Cancer Immunotherapy (Press release, Can-Fite BioPharma, JAN 30, 2019, View Source [SID1234532976])." The article presents data from numerous studies that show adenosine’s role in inhibiting inflammatory cytokine production. Can-Fite’s Piclidenoson, a Phase III drug candidate, and Namodenson, a Phase II drug candidate, both target the A3 adenosine receptor (A3AR), which the Company believes may treat cytokine release syndrome (CRS) while also promoting an anti-cancer effect.

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CRS is a potentially life threatening side effect of cancer immunotherapies including CAR-T. The market for CAR-T drugs is estimated to reach approximately $5.4 Billion in 2024 according to Evaluate Pharma.

"While CAR-T and other cancer immunotherapies are saving lives, as their use increases, there is growing concern about the drugs’ life threatening side effects including the high incidence of CRS. With the publication of this article in Drug Design, Development and Therapy, we are advancing the scientific community towards delivering immunotherapies that offer a high degree of efficacy with a greater degree of safety for the patient. Our platform technology, through Namodenoson, has already displayed its anti-cancer effects in humans, and therefore it is a candidate to not only protect patients from CRS, but to also boost the body’s fight against cancer," stated Dr. Pnina Fishman, Can-Fite’s CEO. "We look forward to implementing our development strategy for our drugs in the treatment of CRS."

Can Fite’s platform technology selectively targets A3AR, which plays a central role in mediating the mechanism of inflammation by reducing elevated levels of pro-inflammatory cytokines such as IL-6, IL-1β, NF-Kβ, TNF-α, and more.

On January 30, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported that the Company’s Chairman, CEO and Chief Scientific Officer, Charles J. Link, Jr, MD, will participate in the Immuno-Oncology 360° Conference (IO360°) being held February 6 – 9, 2019 at the Crowne Plaza Times Square in New York, New York (Press release, NewLink Genetics, JAN 30, 2019, View Source [SID1234532961]).

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Dr. Link’s presentation, "IDO Changes the T-cell Balance in the Tumor Microenvironment," will occur on Wednesday, February 6th, at 9:15 AM ET, and will include a discussion of immune regulation in the tumor microenvironment and how indoximod’s mechanism of action lends itself to counter multiple elements of immune regulation.

Additional information may be found on the IO360°website. The presentation slides will be available on the NewLink Genetics website at www.newlinkgenetics.com in the "Investors & Media" section under "Events & Presentations" once the presentation has begun.

On January 30, 2019 BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on degenerative diseases, reported that its affiliate company, OncoCyte Corporation (OncoCyte) (OCX), a developer of novel, non-invasive tests for the early detection of cancer, has reported positive results from an R&D validation study of DetermaVu, a non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis (Press release, BioTime, JAN 30, 2019, View Source;p=RssLanding&cat=news&id=2385346 [SID1234532977]). As outlined in OncoCyte’s announcement, the R&D validation study demonstrated a sensitivity of 90% (95% CI 82%-95%) and specificity of 75% (95% CI 68%-81%) of DetermaVu on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators. A 95% confidence interval (CI) suggests that there is a 95% chance that test performance will be within the stated range.

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According to OncoCyte, these results indicate that DetermaVu significantly exceeds the critical parameters necessary for use in lung cancer diagnosis and clearly outperforms reported results from competitors’ tests and other clinical models. OncoCyte believes that the potential U.S. market opportunity for DetermaVu is $4.7 billion. OncoCyte intends to make DetermaVu commercially available in the second half of 2019.

"As the largest shareholder of OncoCyte, we wish to congratulate the entire team on obtaining positive results from the validation study of DetermaVu which were announced yesterday morning," stated Brian M. Culley, Chief Executive Officer of BioTime, Inc. "BioTime owns approximately 36% of Oncocyte’s outstanding common stock and we look forward to the commercial launch of DetermaVu which OncoCyte expects to occur later this year."

DetermaVu is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is being developed as a confirmatory test for presence or absence of lung cancer to reduce the need for unnecessary invasive biopsies when suspicious lung nodules are detected by imaging modalities such as x-rays or other scans. DetermaVu is a trademark of OncoCyte Corporation.