Positive Review For Gilead’s Hep C Drug Sofosbuvir

New Drug Approvals



Isopropyl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate

http://www.ama-assn.org/resources/doc/usan/sofosbuvir.pdf  –for cas no

The U.S. Food and Drug Administration (FDA) has issued a positive review for a highly anticipated hepatitis C drug from Gilead Sciences, saying the pill cures more patients in less time than currently available treatments.

The agency posted its review of Gilead’s sofosbuvir online ahead of a meeting Friday where government experts will vote on whether to recommend the drug’s approval.






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hepatitis c


Jun. 7, 2013– Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment…

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Eli Lilly’s Profit Slides, Gets Priority Review for Ramucirumab

New Drug Approvals

Eli Lilly’s third-quarter earnings fell 9 percent compared with last year, when the maker of Cymbalta and Cialis booked a sizeable revenue-sharing payment from a former drug developer partner.

The Indianapolis company beat Wall Street expectations for the quarter and narrowed its earnings forecast for the year.

Lilly also said Wednesday that the U.S. Food and Drug Administration will give its stomach cancer treatment ramucirumab a priority review, which means the drugmaker will learn about its fate inside of eight months rather than a year, which is the norm.

read at


cut paste old article

Eli Lilly and Co. announced that results from the Phase 3 REGARD trial of ramucirumab (IMC-1121B) as a single agent in patients with advanced gastric cancer who have had disease progression after initial chemotherapy were published today in The Lancet. REGARD is the first Phase 3 study with either a single-agent biologic or…

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Actelion wins crucial FDA approval for next-gen lung disease drug Opsumit

New Drug Approvals

File:Macitentan skeletal.svg


N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N’-propylsulfamide, CAS NO  441798-33-0

October 18, 2013 | By John Carroll

Late on Friday the FDA came through with an approval for Actelion’s pulmonary arterial hypertension (PAH) drug Opsumit (macitentan), its next-gen successor to the franchise drug Tracleer.

Read more: Actelion wins crucial FDA approval for next-gen lung disease drug Opsumit – FierceBiotech http://www.fiercebiotech.com/story/actelion-wins-crucial-fda-approval-next-gen-lung-disease-drug-opsumit/2013-10-18#ixzz2i7tDhpZT
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Macitentan (Opsumit® )is a novel dual endothelin receptor antagonist that resulted from a tailored drug discovery process. Macitentan has a number of potentially key beneficial characteristics – i.e., increased in vivo preclinical efficacy vs. existing ERAs resulting from sustained receptor binding and tissue penetration properties. A clinical pharmacology program indicated a low propensity of macitentan for drug-drug interactions.

Macitentan is an investigational drug being studied for the treatment of pulmonary arterial hypertension. It acts as a dualendothelin receptor antagonist and is being developed…

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Improved Continuous Flow Processing: Benzimidazole Ring Formation via Catalytic Hydrogenation of an Aromatic Nitro Compound



Improved Continuous Flow Processing: Benzimidazole Ring Formation via Catalytic Hydrogenation of an Aromatic Nitro Compound

Chemical Process Research and Development, Teva Pharmaceuticals, 383 Phoenixville Pike, Malvern, Pennsylvania 19355, United States
Org. Process Res. Dev., Article ASAP
Publication Date (Web): August 6, 2013 (Article)
DOI: 10.1021/op400179f
 In the development of a new route to bendamustine hydrochloride, the API in Treanda, the key benzimidazole intermediate 5 was generated via catalytic heterogeneous hydrogenation of an aromatic nitro compound using a batch reactor. Because of safety concerns and a site limitation on hydrogenation at scale, a continuous flow hydrogenation for the reaction was investigated at lab scale using the commercially available H-Cube. The process was then scaled successfully, generating kilogram quantities on the H-Cube Midi. This flow process eliminated the safety concerns about the use of hydrogen gas…

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New Drug Approvals


Epratuzumab is a humanised anti-CD22 monoclonal antibody under investigation (clinical development phase III) for its efficacy in SLE. CD22 is a B cell specific surface protein that is considered to be involved in B cell function.

Expected indication Systemic lupus erythematosus
R&D stage Phase 3 ongoing (started in December 2010)
Next milestone Phase 3 results (H1 2014)
Quick facts

Epratuzumab is a humanized monoclonal antibody. Potential uses may be found inoncology and in treatment of inflammatory autoimmune disorders, such as lupus (SLE).[1][2] The manufacturers in August 2009 announced success in early trials against SLE.[3]

Epratuzumab binds to the glycoprotein CD22 of mature and malignant B-cells.

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GSK and Genmab seek alternative approval for leukaemia drug Arzerra

New Drug Approvals


GlaxoSmithKline and Genmab A/S have announced the submission of leukaemia drug Arzerra to the European Medicines Agency (EMA) for a variation in marketing authorisation.

The companies are seeking authorisation for the drug to be used in combination with an alkylator-based therapy for treatment of Chronic Lymphocytic Leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.



Ofatumumab(trade name Arzerra, also known as HuMax-CD20) is a humanmonoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia…

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