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Aurobindo Receives FDA Approval for Voriconazole Tablets, 50 mg and 200 mg

January 29, 2016   Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Voriconazole Tablets, 50 mg and 200 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Voriconazole Tablets, 50 mg and 200 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference […]

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Race for Zika vaccine gathers momentum as virus spreads

Companies and scientists are racing to create a Zika vaccine as concern grows over the mosquito-borne virus that has been linked to severe birth defects and is spreading quickly through the Americas. Zika is now present in 23 countries and territories in the Americas. Brazil, the hardest-hit country, has reported around 3,700 cases of the […]

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Hawaii Biotech joins race to develop Zika vaccine

Privately owned vaccine developer Hawaii Biotech Inc has joined the race to produce a vaccine for the mosquito-borne Zika virus, a fast-spreading infection which has been linked to severe birth defects in babies. The company initiated a formal program to test a Zika vaccine last fall, as the virus began to gain traction in Brazil, […]

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Gilead’s John C. Martin, PhD to Assume Role of Executive Chairman of the Board; John F. Milligan, PhD to Be Appointed Chief Executive Officer and Director

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced that, effective March 10, 2016, current Chairman and CEO John C. Martin, PhD will assume the role of Executive Chairman of the company. John F. Milligan, PhD, currently President and Chief Operating Officer, will be promoted to CEO and appointed to the company’s Board of Directors. […]

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U.S. Stakeholders in GlaxoSmithKline May Not Have a Voice in Possible CEO Search

RALEIGH, N.C. – Although GlaxoSmithKline (GSK) employs thousands in North Carolina and the United States, it’s unlikely that any U.S. operation will have a say in who the company’s next chief executive officer will be if Andrew Witty leaves the position, the Triangle Business Journal reported this morning.   In recent days, some of the […]

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As Eylea and Praluent Sales Take Off, Regeneron Plans to Expand HQ and Manufacturing Sites

January 29, 2016By Mark Terry, BioSpace.com Breaking News Staff   Tarrytown, N.Y.-based Regeneron Pharmaceuticals, Inc. (REGN) recently filed with the town of East Greenbush, N.Y. to build a second campus in Rensselaer County. East Greenbush is a suburb of Tarrytown, where the company is headquartered. It employs approximately 1,200 people in East Greenbush, which is […]

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FDA Discovers Wockhardt Hid Failed Tests and Deleted Data at Indian Plant

January 29, 2016By Mark Terry, BioSpace.com Breaking News Staff   The U.S. Food and Drug Administration (FDA) sent a report to Mumbai, India-based Wockhardt (WOCKHARDT.BO), indicating that the company intentionally hid and deleted data regarding failed tests at its Shendra facility. Wockhardt has manufacturing facilities in the U.S., UK, Ireland and France, as well as […]

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Dr. Reddy’s Laboratories Ltd. Receives FDA Approval for ZEMBRACE SymTouch (sumatriptan succinate) Injection for the Acute Treatment of Migraines in Adults

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that the U.S. Food and Drug Administration (FDA) has approved ZEMBRACE™SymTouch™ (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment […]

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Can you REALLY manage your own information?

The pharma sector has been thrust into finding alternatives that will enable it to maintain an edge in the face of advancing technology, shifting priorities and evolving expectations.

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FDA approves Merck’s new hepatitis C pill

U.S. regulators on Thursday approved a new once-daily pill for the liver-destroying hepatitis C virus made by Merck & Co Inc, which said it will sell the drug at a lower list price than its competitors. The list price for Zepatier will be $54,600 for a 12-week regimen, which Merck said it expects “to be […]

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