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Biotech Daily Dose

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Pharma-021618.jpg Today's Daily Dose brings you news about the regulatory catalysts for Akcea; public offering of Amicus' shares; priority review of Agios' Ivosidenib NDA; FDA panel's feedback on the expanded indication for Pacira's EXPAREL, and United Therapeutics' patent litigation with Actavis.

pharma-021518.jpg Today's Daily Dose brings you news about expanded FDA approval for AMAG's Makena and Abiomed's Impella; Bristol Myers' investment in Nektar; Galmed's disappointment over ARRIVE trial, and Vertex Pharma's encouraging results of NaV1.8 Inhibitor VX-150 in a mid-stage trial.

Pharma-021418.jpg Today's Daily Dose brings you news about Tetraphase's disappointing IGNITE3 results; Pain Therapeutics' resubmission of REMOXY NDA; management changes at Arbutus; approval of the second Herceptin biosimilar in Europe; scrapping of yet another potential Alzheimer's drug, and the potential of Exelixis' Cabozantinib in first line treatment for differentiated thyroid cancer.

Pharma-020918.jpg Today's Daily Dose brings you news about Corium's upcoming catalysts; appointment of Bill Lundberg as Head of CRISPR's Scientific Advisory Board; Immunomedics' quarterly financial results; FDA approval of JNJ's prostate cancer drug ZYTIGA for an additional indication; positive results from Madrigal's phase II trial of MGL-3196.

Pharma-020718.jpg Today's Daily Dose brings you news about Gilead's lackluster forecast for 2018; Myriad's rosy outlook; Sangamo's initial safety data from CHAMPIONS trial; Seattle Genetics' revenue target for 2018, and grave findings from Merck Animal Health Veterinary Wellbeing Study.

Pharma-020618.jpg Today's Daily Dose brings you news about commercial launch of leukemia drug VIDAZA in China; promising results of adding XTANDI to androgen deprivation therapy in non-metastatic Castration-Resistant Prostate Cancer; encouraging data from Calithera's early trials of CB-839 in renal cell carcinoma and positive results from Roche's IMmotion151 trial.

Pharma-020118.jpg Today's Daily Dose brings you news about Affimed's data from two early-stage trials of AFM13 in Hodgkin and CD30-Positive Lymphomas; Alnylam's upcoming regulatory catalyst; FDA approval for Allergan's expanded label for superbug antibiotic AVYCAZ; Boxed Warning for Intercept's PBC drug Ocaliva, and MediciNova's encouraging data from mid-stage trial of MN-166 in progressive multiple sclerosis.

IPO-Dollar-sack-020118.jpg Sol-Gel Technologies Ltd., a clinical-stage dermatology company, is all set to debut on the Nasdaq Global Market on February 1, 2018, under symbol "SLGL", offering its shares at a price of $12.00 each.

AMAGPharma-013118.jpg Shares of AMAG Pharmaceuticals Inc. (AMAG) are nearly 43% down from its 52-week high of $25.20 that was recorded on March 8, 2017. With two of the Company's drugs awaiting FDA decision for label expansion, there could be some sharp movement in the level of its stock price in February, depending upon the outcomes.

Pharma-013118.jpg Today's Daily Dose brings you news about Avinger's reverse stock split; FDA clinical hold on Bellicum's BPX-501 trials; Elite's progress with SequestOx and Vical's restructuring.

Pharma-013018.jpg Today's Daily Dose brings you news about FDA's refusal to approve Aradigm's Linhaliq in its present form; Abeona's progress in its clinical trial with EB-101 for a very rare inherited skin disorder; Albireo's stock offering; enrollment data related to Bellerophon's phase III INOvation-1 study; headway in Cellectar's phase II trial of CLR 131 and Diffusion Pharma's progress in INTACT study.

FebruaryCalendar-012518.jpg We are almost one month into the New Year, and it has been a busy month at the FDA. New steps to facilitate efficient generic drug review have been outlined by the U.S. regulatory agency to enhance competition, promote access and lower drug prices. On a more regulatory front, there have been a couple of announcements this month.

Pharma-012218.jpg Menlo Therapeutics Inc., which has priced its initial public offering of shares at $17.00 each, is expected to begin trading under the ticker symbol "MNLO" on January 25, 2018. The Company's lead drug candidate is Serlopitant, and phase III trials for the treatment of pruritus associated with prurigo nodularis are expected to be initiated in the first half of 2018.

Pharma-012418.jpg Today's Daily Dose brings you news about an update on Amarin's REDUCE-IT cardiovascular outcomes study; Cerus' SPARC study; Corindus' preliminary revenue results; futility analysis of MacroGenics' breast cancer study and Puma's disappointment over negative "trend" vote for Neratinib.

Pharma-012318.jpg Today's Daily Dose brings you news about Amgen's LIBERTY migraine study; positive interim futility analysis of Anthera's phase III clinical study of Sollpura; FDA approval of Baxter's Bivalirudin; positive overall survival results from ChemoCentryx's pancreatic cancer trial and Nymox Pharma's encouraging 5-year results of its prostate cancer study.

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