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AstraZeneca’s Lynparza gets EU nod as first-line ovarian cancer maintenance treatment

Lynparza was approved as a first-line maintenance treatment for a type of advanced ovarian cancer by the European Commission.

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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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BioMarin’s Hemophilia A Gene Therapy Shows Promise in Clinical Trial

San Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.

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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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Merck buys Peloton, expands kidney cancer treatment portfolio

U.S. drugmaker Merck & Co. Inc. agreed to buy Peloton Therapeutics Inc. for $1.05 billion in cash, gaining access to the privately held company’s lead kidney cancer drug candidate.

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Lilly’s new migraine drug pulls ahead of Amgen in fierce battle for new prescriptions

Eli Lilly and Co. pulled ahead in a three-way race with Amgen Inc. and Teva Pharmaceutical Industries Ltd. in attracting new patients to a new class of migraine drugs, and seeks to build on that advantage by stressing that the company’s therapy can completely prevent headaches in a small percentage of patients.

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Pfizer gets U.S. approval for $225,000 a year heart drug

The U.S. Food and Drug Administration approved Pfizer Inc.’s oral drug tafamidis to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy.

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Novo Nordisk Q1 2019 profit tops forecast

Danish drugmaker Novo Nordisk beat first-quarter 2019 operating profit forecasts, helped by higher sales of the company’s biggest new drug hope, a treatment for type 2 diabetes.

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Gilead to separate Kite cell therapy unit

Gilead Sciences Inc. said Kite Pharma Inc., the cancer-focused cell therapy company acquired in 2017, will become a separate business unit.

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GSK’s 3-in-1 inhalable drug shows promise in asthma study

GlaxoSmithKline Plc said the company’s three-in-one drug Trelegy Ellipta met the main goal of a late-stage asthma study, signaling a possible boost to the British drugmaker’s lung medicines division.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!

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