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Roche names Pao head of drugs research and early development

Roche named U.S. cancer expert William Pao head of the Swiss drugmaker’s Pharma Research and Early Development business after John Reed decided to leave for what it called personal reasons.

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Eisai, Merck Enter Strategic Oncology Collaboration

Eisai and Merck agreed upon a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima (lenvatinib mesylate), an orally available tyrosine kinase inhibitor.

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Esperion cholesterol drug succeeds in late-stage study

Esperion Therapeutics Inc. said a late-stage trial of the company’s experimental oral drug met the main goal of reducing cholesterol by 28 percent in patients suffering from, or at a high risk of, an artery-clogging heart disease.

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FDA approves new dosing for Bristol-Myers’ Opdivo

Bristol-Myers Squibb Co. said the U.S. Food and Drug Administration approved a four-week dosing schedule for its cancer drug Opdivo.

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U.S. judge orders ex-drug executive Shkreli to give up $7.36 million

A U.S. judge ordered former drug company exec Martin Shkreli to forfeit $7.36 million following his conviction of defrauding investors.

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FDA to Review Dupixent for Severe Asthma

The U.S. FDA accepted for review the supplemental BLA of Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents with moderate-to-severe asthma.

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Lynparza Receives Positive EU CHMP Opinion in Platinum-Sensitive Relapsed Ovarian Cancer

AstraZeneca and Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending a marketing authorization of Lynparza (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.

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FDA Grants Priority Review for Lanadelumab

Shire plc announced the U.S. Food and Drug Administration accepted the Biologics License Application and granted priority review for lanadelumab (SHP643).

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Merck to Acquire Viralytics for $394 Million

Merck & Co. is driving forward in its quest to develop a premier immuno-oncology pipeline with the acquisition of Australia-based Viralytics Ltd. and its oncolytic immunotherapy treatments.

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Eli Lilly and Hanmi Shutter a Failed Phase II RA Trial

Eli Lilly and its Korean collaborative partner Hanmi Pharmaceutical stopped a Phase II trial on an experimental rheumatoid arthritis treatment after less-than-stellar interim results were examined.

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FDA clears AstraZeneca’s lung cancer immunotherapy

The U.S. FDA granted approval for expanded use of AstraZeneca‘s immunotherapy drug Imfinzi to treat non-small cell lung cancer whose tumors can not be surgically removed.

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FDA Advisory Panel Spurns Pacira’s Request for Expanded Use of Pain Drug Exparel

Shares of Pacira Pharmaceuticals plunged more than 15 percent after the company revealed a U.S. Food and Drug Administration advisory panel recommended against approving expanded use of the company’s pain treatment Exparel.

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Merck KGaA, Pfizer’s immunotherapy fails in lung cancer trial

Merck KGaA and Pfizer Inc. received a setback for their drug Bavencio, which is a late starter in the cancer immunotherapy field.

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EU Approves Celltrion’s Trastuzumab Biosimilar

The EC approved Herzuma for patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have HER2 overexpression or HER2 gene amplification.

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Germany’s CureVac wins new vaccine funding from Gates Foundation

German biotech firm CureVac secured more financial backing for vaccine development projects from its investor the Bill & Melinda Gates Foundation, working on jabs to prevent malaria and influenza.

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Phase II Data Support Potential for Novel Anti-VEGF/Anti-Angiopoietin-2 Bispecific Antibody, RG7716, for People With Diabetic Macular Edema

Genentech announced encouraging results from the Phase II BOULEVARD study. In people with vision loss from diabetic macular edema, treatment with intravitreal RG7716 resulted in clinically meaningful and statistically significant improvements in visual acuity gains compared with ranibizumab alone.

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Janssen Submits MAA for Apalutamide

J&J’s Janssen Pharmaceutical Companies submitted a Marketing Authorization Application to the EMA for apalutamide for non-metastatic castration-resistant prostate cancer.

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Sanofi Abandons Multiple Mid-Stage Drug Programs

As part of the company’s fourth-quarter 2017 earnings report, Paris-based Sanofi released a pipeline update showing it plans to halt several mid-stage drug programs.

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Novartis Receives FDA Approval for Cosentyx Label Update to Include Moderate to Severe Scalp Psoriasis

Novartis announced that the U.S. Food and Drug Administration approved a label update for Cosentyx (secukinumab), the first interleukin-17A antagonist cleared to treat moderate to severe plaque psoriasis, to include data in moderate to severe scalp psoriasis.

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U.S. FDA approves Gilead triple HIV drug

The FDA approved Biktarvy, Gilead’s once-daily, triple-combo tablet for treating HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market.

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