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EU approves AstraZeneca lung cancer immunotherapy

AstraZeneca’s immunotherapy drug Imfinzi was approved in Europe for use in lung cancer patients with inoperable disease that had advanced locally but not spread widely around the body.

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Boston Scientific drug-coated stent gets FDA approval

The U.S. Food and Drug Administration approved Boston Scientific Corp.’s drug-coated stent Eluvia to treat narrowed arteries in the leg.

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Takeda lung cancer drug gets European panel nod

Takeda Pharmaceutical Co.’s lung cancer drug Alunbrig received the recommendation of a European Union panel, more than a year after winning U.S. regulatory approval.

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Spark’s blindness therapy gets European panel nod

A European Medicines Agency panel recommended approval of Spark Therapeutics’ gene therapy Luxturna for blindness, a move that also boosts Swiss drugmaker Novartis that bought the rights to one of the world’s costliest treatments outside the United States.

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FDA Issues Statement Reaffirming Positive Benefit-Risk Profile Of Nuplazid For Patients with Hallucinations, Delusions Associated With Parkinson’s Disease Psychosis

Acadia Pharmaceuticals Inc. announced that the FDA completed a postmarketing review and issued a clear statement reaffirming the positive benefit-risk profile of Nuplazid (pimavanserin) for patients with Parkinson’s disease psychosis.

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EU approves fifth copy of AbbVie’s Humira

Europe approved a fifth copy of AbbVie’s $18-billion-a-year biologic Humira – the world’s best-selling prescription medicine – ramping up competition among makers of less-expensive biotech drugs.

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FDA Requests Another Trial for Pharming’s Ruconest Label Expansion

The U.S. FDA issued a Complete Response Letter to Netherlands-based Pharming Group for the company’s supplemental Biologics License Application for Ruconest.

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FDA Lifts Partial Clinical Hold for Mersana’s XMT-1522

Mersana Therapeutics Inc. announced that the U.S. Food and Drug Administration lifted the partial clinical hold on the Phase 1 study of the experimental cancer drug XMT-1522.

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U.S. regulator approves Teva migraine drug, shares rise

Shares of Israeli drugmaker Teva Pharmaceutical Industries rose more than 5 percent after the U.S. Food and Drug Administration approved the company’s new migraine treatment.

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Sun Pharma’s Xelprost Wins FDA Approval

The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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FDA approves AstraZeneca’s drug for rare form of blood cancer

The U.S. FDA approved AstraZeneca Plc’s treatment for hairy cell leukemia, a slow-growing type of blood cancer.

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FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis

Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

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FDA Grants Breakthrough Therapy Designation for Concentric Analgesics’ CA-008 in Post-Surgical Pain

Concentric Analgesics Inc. announced today that the clinical-stage biopharmaceutical company received Breakthrough Therapy designation from the U.S. Food and Drug Administration for CA-008 in post-surgical pain.

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Merck’s Keytruda chemo cocktail wins EU approval

Merck & Co.’s key cancer drug Keytruda was approved for use in Europe in combination with chemotherapy in previously untreated lung cancer patients.

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GSK says U.S. FDA wants more information on pulmonary drug

GlaxoSmithKline said U.S. health authorities asked for more information about the company’s Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).

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Tezepelumab Granted Breakthrough Therapy By FDA

Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.

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J&J to work with India on compensation for recalled hip implants

Johnson & Johnson said the company would work with the Indian government to compensate patients who had suffered from hip implants that were recalled by the U.S. healthcare firm eight years ago after data showed high failure rates.

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Akcea Therapeutics to cut about 10 percent of workforce

Akcea Therapeutics Inc. planned to cut its workforce by about 10 percent after the U.S. health regulator declined to approve the company’s Waylivra drug for treating a genetic disease that causes fat accumulation in blood.

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FDA extends review of Roche’s Tecentriq by 3 months

Roche said the U.S. FDA extended by three months the review period for Tecentriq in combination therapy as a first-line treatment for a form of lung cancer.

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Boost for ‘made in China’ medicine as Chi-Med wins key approval

Hutchison China MediTech won Chinese approval for a closely watched new cancer drug in a significant boost for “made in China” medicine.

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