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The Pulse of the Pharmaceutical Industry

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GSK wins U.S. shingles vaccine approval

GlaxoSmithKline won U.S. approval for a new and improved shingles vaccine, the second of three key products the drugmaker expects approval for in 2017.

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FDA approves Gilead cancer gene therapy

U.S. regulators approved a new therapy for a type of lymphoma, which was developed by Gilead Sciences Inc.’s Kite Pharma.

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Novo Nordisk wins U.S. backing of new diabetes drug

Novo Nordisk will take aim at Eli Lilly in the growing diabetes market after an advisory panel to the U.S. FDA gave the green light to its semaglutide drug.

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Alecensa wins EU panel’s nod against lung cancer

Swiss drugmaker Roche’s Alecensa was recommended for approval in Europe as a first-line treatment for mutated lung cancer.

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FDA Responds to Antares Pharma’s Xyosted NDA

The U.S. FDA identified unnamed deficiencies in Antares Pharma’s NDA for Xyosted that halted discussion of labeling and postmarketing requirements.

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FDA panel backs gene therapy for rare blindness form

Spark Therapeutics Inc.’s experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded, paving the way for the first U.S. gene therapy for an inherited disease.

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FDA rejects AcelRx Pharma’s opioid painkiller

Shares of AcelRx Pharmaceuticals plunged more than 60 percent after the U.S. Food and Drug Administration declined to approve its opioid painkiller Dsuvia.

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2017 Annual Report: Top 50 Companies – The Corner Turned

For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.

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Janssen Files Apalutamide NDA with FDA

Janssen Biotech filed a New Drug Application to the U.S. FDA for apalutamide for men with non-metastatic castration-resistant prostate cancer.

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Flexion’s knee pain drug gets FDA nod

Flexion Therapeutics Inc.’s injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration, sending the drug developer’s shares soaring to a record high in regular trading.

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FDA approves Mylan’s Copaxone copy

Mylan received long-awaited U.S. approval for its generic version of rival Teva’s blockbuster multiple sclerosis treatment Copaxone.

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EU drugs head fears delays, health hazards as agency uprooted

Access to new medicines and safety checks on existing treatments will be jeopardized if politicians pick a new home for Europe’s London-based drugs regulator that is unacceptable to staff, its executive director told Reuters.

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FDA moves to smooth path for complex generics

The U.S. FDA announced measures designed to speed to market generic versions of complex drugs in an effort to address the rising costs of pharmaceuticals.

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FDA approves fast-acting insulin Fiasp

The U.S. Food and Drug Administration approved Novo Nordisk’s fast-acting insulin to treat diabetes.

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Roche’s Perjeta regimen gets FDA priority review

The U.S. FDA granted priority review for Roche’s Perjeta in combination with Herceptin and chemotherapy for treating HER2-positive early breast cancer after surgery.

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Eli Lilly wins U.S. approval for breast cancer drug

The U.S. Food and Drug Administration approved an Eli Lilly and Co. drug to treat advanced breast cancer that has progressed following prior treatment.

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CSL hemophilia A drug approved in Japan

Global biotherapeutics leader CSL Behring announced that Japan’s Ministry of Health, Labor and Welfare approved Afstyla [lonoctocog alfa] for hemophilia A.

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EU approves Sanofi and Regeneron’s dupilumab in eczema

The European Commission approved Regeneron Pharmaceuticals’ and Sanofi’s key biologic treatment dupilumab for moderate-to-severe atopic dermatitis, the two companies said.

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U.S. FDA joins Interpol crackdown on illicit online pharmacies

Authorities from a record 123 countries, including the U.S. FDA, have taken action against hundreds of businesses suspected of illegally selling medicines over the internet, officials said.

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FDA declines to approve opioid painkiller

The FDA declined to approve Intellipharmaceutics International ‘s long-acting opioid painkiller in its current form.

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