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The Generic Drug Battle
Wednesday, February 10, 2016 - 9:13am | 480On Tuesday, a U.S. regulatory panel voted in favor of the Food and Drug Administration approving a knockoff arthritis drug that would rival Johnson & Johnson (NYSE: JNJ)'s Remicade. A blow to Johnson & Johnson, the decision was good news for Pfizer Inc. (NYSE: PFE), which holds the license...
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Here's Why Shares Of Vertex Pharmaceuticals Tumbled
Friday, February 5, 2016 - 2:09pm | 224Shares of Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) tumbled by more than 6 percent on Friday after the company confirmed it has received a letter from the U.S. Food and Drug Administration for use of Kalydeco in people with cystic fibrosis. Vertex Pharmaceuticals said that it received...
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Acadia Pharmaceuticals Are Spiking
Monday, February 1, 2016 - 8:55am | 217Shares of ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) were trading higher by nearly 9 percent early Monday morning. Acadia Pharmaceuticals announced after Friday's market close that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration will review data...
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The FDA Just Crushed Sarepta Therapeutics' Hopes Of Releasing A Muscular Dystrophy Drug
Thursday, January 21, 2016 - 11:23am | 490Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) saw a marked decline this week after Food and Drug Administration scientists said studies examining the effects of the firm's latest muscular dystrophy drug were inconsistent. The FDA's review of Sarepta's drug followed a similar dismissal of...
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FDA Delays Decision on Amarin's Vascepa Drug
Friday, December 20, 2013 - 12:46pm | 611The plot deepens regarding the biotech company Amarin (NASDAQ: AMRN) and its controversial cholesterol-controlling drug, Vascepa. As previously reported on Benzinga, Amarin was waiting to hear the results of a Food and Drug Administration ruling. The company had appealed the FDA's October...
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AstraZeneca Spikes on Brilinta Approval Rumor, Continues to Rise Following FDA Confirmation
Wednesday, July 20, 2011 - 4:11pm | 97AstraZeneca (NYSE: AZN) spiked 1% this afternoon following rumors that Brilinta has received FDA approval. Benzinga then spoke with AstraZeneca, which said it had not yet received approval, but expected to soon. Moments later, the company announced that the FDA had now approved its anti-clotting...
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May Catalysts for Biotech and Drug Stocks
Wednesday, May 4, 2011 - 11:32am | 557By Brett Chase After a few months of blockbuster Food and Drug Administration advisory panel meetings, May seems a bit calmer. But there are certainly important dates for drug and biotechnolgy companies. Here are some events to watch for this month. Dates are subject to change. May 3 Vertex...
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Has Star Scientific Found A Cure For Alzheimer's Disease? (CIGX)
Tuesday, March 1, 2011 - 11:45am | 404If Star Scientific's (NASDAQ: CIGX) press release is to be believed, we might be on the precipice of a genuine breakthrough. James Altucher took a moment to translate the confusing and unusually written press release into what he calls “Investor-English.” His conclusion is that Star Scientific has...
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FDA To Review Alzheimer's Brain Scan (LLY)
Wednesday, January 19, 2011 - 8:08am | 315The research of Alzheimer's disease continues as new tests show great promise for the early diagnosis of the illness. According to the New York Times, the Food and Drug Administration will review a newly developed brain scan which purportedly can detect plaques indicative of Alzheimer's disease. A...
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ARNA Intraday Update: Shareholders Exiting (ARNA)
Wednesday, December 22, 2010 - 10:49am | 41Arena Pharma (NASDAQ: ARNA) last price check is $1.89, down 7.35% after the announcement today; the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application.
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Incyte Climbs 8.2% After Its Drug Meets Goals (INCY)
Tuesday, December 21, 2010 - 4:51pm | 242Shares of Incyte Corporation (Nasdaq: INCY) ended the day up 8.2% at $16.43 per share. Incyte Corporation reported after the market closed on Monday that its INCB18424 drug had a response rate of 42% in patients with myelofibrosis (MF), which caused its shares to start Tuesday trading significantly...
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FDA Managers Visit Civil War Battlefield To Learn About Backing Away From “Tough Decisions”
Friday, November 12, 2010 - 9:55am | 192If you think that becoming a Food and Drug Administration consultant would be all food and no fun, think again. The FDA has been paying consultants millions of dollars for management help, including leadership classes held at a Civil War battlefield. However, as an agency that's supposed to be...
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Savient Pharmaceuticals Jumps On FDA's Approval Of Its Gout Drug
Wednesday, September 15, 2010 - 8:14am | 110Shares of Savient Pharmaceuticals Inc (NASDAQ: SVNT) surged in pre-market trading after the approval of its gout drug by the Food and Drug Administration (FDA). SVNT's shares surged 23.31% to $18.20 in pre-market trading. The FDA has approved SVNT's gout drug for adults who were not getting any...
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FDA Considers Genetically Modified Food For Humans
Tuesday, September 7, 2010 - 10:21am | 197In something out of a science fiction movie, the Food and Drug Administration is considering allowing genetically modified salmon to be eaten by humans. Aqua Bounty is the first company being considered for approval, as the FDA wrote that modified fish are as safe to eat as regular fish. The...
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Good News About Arena Pharmaceuticals (ARNA) Weight Loss Drugs
Monday, June 28, 2010 - 9:00am | 345Hapoalim Securities analyst Jon LeCroy reiterated his Buy rating for shares of Arena Pharmaceuticals Inc (Nasdaq: ARNA), with a price target of $6 per share. LeCroy said that Arena Pharmaceuticals (ARNA) presented two pooled analyses at the 2010 ADA meeting that showed that the company's lorcaserin...