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Janssen Halts Phase III Kidney Disease Trial Early After Endpoints Were Met

Janssen Pharmaceuticals halted the company’s Phase III chronic kidney disease trial for Invokana early due to the fact that the SGLT2 diabetes drug had already achieved pre-specified efficacy data.

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Dermavant Bags GSK Phase III-Ready Psoriasis Treatment in $330 Million Deal

Months after tapping GlaxoSmithKline dermatology division executive David Rubenstein as its new chief scientific officer, Vivek Ramaswamy’s Dermavant Sciences returned to the pharma giant to acquire a Phase III-ready psoriasis treatment.

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BioNTech and Genevant Forge mRNA Therapeutics Development Agreement

BioNTech AG and Genevant Sciences entered into a strategic partnership to develop five therapeutics to treat rare diseases with high unmet medical need using a mRNA drug discovery platform.

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Seattle Genetics and Astellas Announce Progress in Enfortumab Vedotin Urothelial Cancer Clinical Development Program

Seattle Genetics Inc. and Astellas Pharma Inc. announced completion of enrollment for the enfortumab vedotin EV-201 pivotal phase 2 clinical trial cohort of patients with locally advanced or metastatic urothelial cancer who have been previously treated with both platinum chemotherapy and a checkpoint inhibitor (PD-L1 or PD-1).

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Europe Approves Expanded Indication for Sprycel

The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.

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FDA Grants Priority Review to Merck’s Supplemental BLA for Keytruda in Combination with Chemo as First-Line Treatment for Metastatic Squamous NSCLC

The U.S. FDA accepted for review Merck’s supplemental Biologics License Application for the anti-PD-1 therapy Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression.

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Lilly’s Taltz Hits Endpoints in AS Study

Eli Lilly announced the results of the company’s COAST-W Phase III clinical trial of Taltz (ixekizumab) to treat ankylosing spondylitis. The study met both primary and major secondary endpoints.

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Opposites attract: Blurring the lines between small and large molecule manufacturing

This whitepaper assesses the current state of the large molecule sector, and how it may be able to learn from the small molecule industry in terms of its supply chain support infrastructure, as well as its acquisition of staff and the adoption of PAT.

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Amgen Announces Top-Line Results From Phase 3 Study Of ABP 710, Biosimilar Candidate To Infliximab

Amgen announced results from a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with Remicade (infliximab) in patients with moderate-to-severe rheumatoid arthritis.

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AstraZeneca, Merck eye $1 billion boost from cancer drug success

AstraZeneca’s oncology business received a boost as results of a clinical trial showed the company’s drug Lynparza helped women with ovarian cancer live longer without their disease worsening when given as a first-line treatment.

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Vertex Tops EvaluatePharma World Preview With Phase III Cystic Fibrosis Drug

An experimental triple combination treatment for cystic fibrosis landed Vertex Pharmaceuticals at the top of EvaluatePharma’s “World Preview 2018” list.

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European Commission Approves Gilead’s Biktarvy

The European Commission granted Marketing Authorization for Gilead Sciences Inc.’s Biktarvy as a once-daily single tablet regimen for the treatment of HIV-1 infection.

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Novo’s pioneering diabetes pill beats Victoza, Januvia in tests

Novo Nordisk’s experimental diabetes pill, which the company hopes will transform the diabetes market, has proved superior to both Merck & Co.’s Januvia and its own best-selling injectable treatment Victoza in tests.

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Novartis Receives FDA Approval For New Prescribing Information For Blockbuster PsA Treatment Cosentyx

FDA approved inclusion of new evidence that Cosentyx significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active psoriatic arthritis (PsA).

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Lilly’s lupus treatment succeeds in mid-stage trial

Eli Lilly and Co. said the company’s drug to treat the autoimmune disease lupus met the main goal of a mid-stage trial, positioning the drugmaker to begin a larger study in 2018.

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Lilly-AstraZeneca abandon Alzheimer’s drug trials

Eli Lilly and AstraZeneca discontinued late-stage trials testing their Alzheimer’s treatment, the latest among a slew of drugmakers to stop developing treatments for the memory-robbing disease.

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Biomarker Development: Unlocking the Promise of Cancer Immune Therapy

Emboldened by 2017’s back-to-back FDA approvals of the first drugs that use genetically engineered patient immune cells – Kymriah (tisagenlecleucel) to treat leukemia and Yescarta (axicabtagene ciloleucel) to combat large-B-cell lymphomas – immunotherapy researchers are continuing to revolutionizing cancer treatment. But uneven patient response rates and the side effects often associated with immunotherapies are putting high priority on accurately identifying which patients would benefit most from particular treatment options.

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Esketamine Shows Promise in Depression Studies

Janssen, part of Johnson & Johnson, announced results from two long-term Phase III trials of esketamine nasal spray in patients with treatment-resistant depression.

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Novo Nordisk’s oral diabetes drug beats Jardiance in study

Novo Nordisk said data from a large final-stage study of a pill the company hopes will transform the diabetes market proved better at lowering blood sugar levels than Eli Lilly and Boehringer Ingelheim’s established Jardiance.

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Pfizer’s Xalkori Snags Breakthrough Therapy Designation for Two New Indications

Pfizer’s Xalkori, the first drug approved in the United States for patients with ALK-positive and ROS1-positive non-small cell lung cancer, secured Breakthrough Therapy Designation from the U.S. FDA for two new indications.

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