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RegenxBio and Pfizer Partner on Gene Therapy

Rockville, Maryland-based RegenxBio entered a license deal with Pfizer for a gene therapy for Friedreich’s ataxia, the most common hereditary ataxia.

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From Isolation to Anticipation: How technology continues to improve the lives of rare disease families

Working in the rare disease space has never been more rewarding than it is today. Technology is turning what was once thought to be impossible into actual, tangible realities for physicians, patients, and families. There are many exciting advancements happening now – in real time – and even more on the horizon that demand our attention and advocacy to help bring them to light.

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Vertex to file for U.S. approval of CF therapy in 2019

Vertex Pharmaceuticals Inc. will apply for regulatory approval during 2019 for the company’s triple combination of drugs to treat the life-shortening genetic condition cystic fibrosis.

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Shares of BioCryst Fall After Phase III HAE Drug Underwhelms Investors

Shares of North Carolina-based BioCryst Pharmaceuticals were down more than 53 percent after the company released data from a Phase III trial that underwhelmed analysts.

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U.S. Supreme Court could side with Merck over Fosamax lawsuits

U.S. Supreme Court justices appeared sympathetic to Merck & Co. in the company’s bid to fend off hundreds of lawsuits accusing the company of failing to adequately warn patients of the risks of thigh bone fractures associated with the osteoporosis drug Fosamax.

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Sanofi Unloads Programs to Acer Therapeutics and MyoKardia

Acer Therapeutics in-licensed the clinical-stage, selective, non-peptide tachykinin NK3 receptor antagonist osanetant from Sanofi. MyoKardia regained global rights to all the programs that the company had inked with Sanofi.

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Shire’s Takhzyro for rare swelling disorder wins European panel green light

An EMA panel recommended approving a potential blockbuster drug from Shire Plc to treat a rare hereditary disease.

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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 approves Shire drug for rare swelling disorder

The U.S. FDA approved a first-of-its-kind drug from Shire Plc to treat patients aged 12 and older suffering from a rare hereditary disease that causes swelling.

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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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