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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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Avanir Pharmaceuticals Announces FDA Approval of ONZETRA Xsail (AVP-825) for the Acute Treatment of Migraine in Adults

—ONZETRA Xsail is the first breath-powered intranasal medication delivery system for the acute treatment of migraine—   FDA Approves Avanir’s Acute Migraine Treatment for Adults     ALISO VIEJO, Calif., Jan. 28, 2016 /PRNewswire/ — Avanir Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ONZETRA Xsail (sumatriptan nasal powder), formerly known […]

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Spread of Zika alarming, 4 million cases a possibility: WHO

Zika virus – linked to severe birth defects in thousands of babies in Brazil – is spreading “explosively” and could affect as many as four million people in the Americas, the World Health Organization (WHO) said on Thursday. Director-general Margaret Chan told members of WHO’s executive board in Geneva that the spread of the mosquito-borne […]

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A new Sandbox to play in

Former GA Communications Group changes name, teams up to expand operations   After more than 30 years in the pharmaceutical and healthcare advertising arena, GA Communications Group has a new identity and an expanded busines model. The agency is now Sandbox, an entirely new integrated marketing agency built  on the foundation of four firms whose […]

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Roche expects cancer treatments to be spared U.S. pricing curbs

The U.S. Congress may intervene on how much companies can charge for some drugs following a move last year by Turing Pharmaceuticals to ratchet up the price of a treatment for deadly parasite infections by 5,000 percent, Roche’s head of pharmaceuticals said.   Roche’s Dan O’Day is convinced the oncology portfolio at the world’s biggest […]

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Pershing Square’s Bill Ackman Writes Letter of Apology to Investors, Regrets Investing so Heavily into Valeant

In a 13-page letter to clients, Pershing Square Capital Management’s Bill Ackman apologized for the debacle of 2015 and, in a not-quite-a-mea-culpa, takes responsibility for some bad decisions. One of the key mistakes he takes credit for is not selling Valeant Pharmaceuticals International (VRX) stock when its share price rose over $200 in the summer. […]

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Vertex Withholds Specific Sales Guidance for CF Drug Orkambi Due to Lacking Patient Compliance Data

January 28, 2016By Alex Keown, BioSpace.com Breaking News Staff   BOSTON – An issue of patient compliance in taking Vertex (VRTX)’s new blockbuster cystic fibrosis drug Orkambi is at the root of why the company has not issued sales guidance yet, the Boston Business Journal reported this morning. During the J.P. Morgan Healthcare Conference earlier […]

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Investors Grin Over Biogen’s $3.4 Billion Cash Pile and Earnings Report

January 28, 2016 By Mark Terry, BioSpace.com Breaking News Staff   Cambridge, Mass.-based Biogen Inc. (BIIB) announced its 2015 financial and fourth-quarter reporting yesterday, citing $10.8 billion in annual revenues, an increase of 11 percent over 2014. Biogen exceeded analysts expectations, who were predicting a revenue increase of about 9 percent. Net income was $3.6 […]

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FDA approves Neos Therapeutics’ long-acting ADHD drug

Neos Therapeutics Inc’s drug to treat a common type of childhood behavioral disorder was approved by the U.S. Food and Drug Administration, making it the first of its kind to win U.S. approval. The drug, Adzenys XR-ODT, is approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six and older. The […]

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Incyte stops tests on Jakafi to treat colorectal cancer

Incyte Corp said on Wednesday that it would stop a mid-stage study on its combination treatment after it failed to prove to be sufficiently effective to treat metastatic colorectal cancer. The results cast a shadow on the prospects of the drug, Jakafi, which is also being studied in a late-stage trial to treat advanced pancreatic […]

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Massachusetts challenges Gilead’s hepatitis C drug prices

Massachusetts’ attorney general is studying whether the prices of Gilead Sciences Inc’s blockbuster treatments for hepatitis C violate state law, according to a letter the prosecutor sent to the California drugmaker. The letter from Attorney General Maura Healey to Gilead Chief Executive Officer John Martin, dated January 22, asked the biotechnology company to reconsider its […]

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