The FDA usually, but not always, follows the advice of its advisory panels. But the FDA has previously determined it may be appropriate to license biosimilars for additional conditions for which a branded product is approved, even if the biosimilar has not been tested for them. Steven Solga, head of gastroenterology at St. Luke's University Hospital in Bethlehem,...» Read More
On the Pfizer earnings conference call this morning Chairman and CEO Jeff Kindler kicked things off by calling this a "time of great uncertainty in the world economy and capital markets and significant challenges in our industry."
Pfizer Wednesday said quarterly earnings more than doubled on higher sales of its prescription drugs and lower expenses, but its Chantix quit-smoking drug lost more than a third of its U.S. sales amid safety concerns.
GlaxoSmithKline's new chief executive set out plans to make the world's second largest drug maker a broader business with lower costs, but kept a cautious view on short-term prospects that knocked its shares.
German drugs and chemicals company Merck KGaA reported a 15 percent rise in second-quarter operating profit on Wednesday thanks to rising sales of liquid crystals and multiple-sclerosis and cancer drugs.
Recently I blogged about Merck advertising its cervical cancer vaccine Gardasil to a captive audience during trailers for the "Sex and the City" movie.
Yesterday while covering the press conference about the new study on Merck and Schering-Plough's Vytorin I quoted the lead researcher, Dr. Terje Pedersen of Ulleval University Hospital in Oslo, Norway, who said--and this is a direct quote: "However, we had a disturbing finding when we looked at safety."
Boston Scientific quarterly earnings fell 15 percent on declining sales of its drug-eluting stents and charges for acquisitions, divestitures and restructuring.
Schering-Plough, whose shares fell earlier after its Vytorin cholesterol fighter failed another study, said its earnings fell 23 percent but beat forecasts.
Merck on Monday said it was not providing long-time financial forecasts as it assesses the impact of another failed study result for its Vytorin cholesterol fighter, which it produces with Schering Plough.
Vytorin, a cholesterol drug marketed by drugmakers Merck and Schering-Plough, failed to meet the main goals in a new study, released Monday.
The recent spate of takeovers, particularly in pharmaceuticals, represents the first step in what analysts expect to be a busier second half of the year for mergers and acquisitions.
The buyout offer from Swiss drug giant Roche has shares of DNA trading at their highest level in about two-and-a-half years and according to CNBC stock-stat maven, Robert Hum, if they close up at least 8.88% it'll be their biggest one-day percentage gain since April 15, 2005.
You have to wonder at markets and analysts for that matter. They are fickle creatures.
Roche Holdings' $43.7 billion bid to buy the rest of Genentech highlights drugmakers' growing reliance on biotech products.
Merck and Schering-Plough delayed the release of their quarterly financial results so investors could first learn the outcome of a new study of their Vytorin cholesterol fighter, and both drug makers' shares fell on jitters about the impending trial data.
Roche's $43.7 billion offer to buy Genentech may not be the last one, Birgit Kulhoff, pharmaceuticals analyst at Rahn & Bodmer told CNBC Monday.
Swiss drugmaker Roche Holding offered to acquire all outstanding shares in its U.S. partner Genentech for $43.7 billion in cash to reinforce its position in cancer medicines.
arr's Chairman and CEO Bruce Downey told me Teva's CEO Schlomo Yanai made the first move. But it didn't happen in a long-distance phone call from Tel Aviv to New Jersey. They say they were at an industry conference in Palm Beach outside some burger joint when the subject came up.
Teva Pharmaceutical Industries said on Friday it would buy rival generic drugmaker Barr Pharmaceuticals for $7.46 billion to expand its leadership in the U.S. market and fortify its presence in Europe.
Second-quarter net profit at Novartis rose 17 percent to $2.27 billion, helped by the weak U.S. dollar and cost cutting efforts, beating forecasts and boosting its shares.