A number of drugmakers have been looking to get drugs across the finish line for approval of first-line use in the treatment of chronic lymphocytic leukemia, and Roche's Genentech and Biogen Idec have gotten there first. The FDA today approved their drug Gazyva, a successor to Roche's Rituxan that it hopes will offset some of massive sales that drug generates when it finally succumbs to biosimilar competition.
GlaxoSmithKline's Advair is hard to copy. Some companies have given up on generic Advair, while others have shied away altogether despite the substantial sales up for grabs. But what if generics makers had some help--and an expedited review process--from the FDA?
Swiss drugmaker Novartis' situation with heart drug Diovan is like some kind of tragicomedy movie. The drugmaker has to keep apologizing for unethical studies of the heart drug in Japan even as it continues to haul in revenue from the drug hand over fist in the absence of generic competition
Mylan CEO Heather Bresch is looking forward to next year. After having red-hot earnings reports last year, the more lackluster results in 2013 have been a disappointment. The company reported a 25% drop in net profit and a 2% falloff in sales for its third quarter. But Bresch promises the generic drugmaker will return to form in 2014, and analysts are taking her at her word.
While other countries are scrambling to understand if they have exposure to a Chinese probe into bribery, Teva Pharmaceutical Industries says it has found it has similar issues elsewhere. The Israeli drugmaker said in a securities filing that its own investigation has turned up suspect practices in Latin America, Eastern Europe and Russia.
A new report starkly illustrates how quickly things can change in the pharma industry, showing how a drug darling becomes a market dud.
Eye drug Eylea and blood thinner Xarelto are pretty good products for any drugmaker to have in its lineup, and Bayer's got them both. Sales of those new stars have been plentiful, and they helped the German company raise earnings 7.7% for the third quarter, the company announced Thursday.
The Swiss drugmaker is wading into research that could top the GLP-1 diabetes-fighting class by adding one of the drugs to another imitation hormone, GIP, for a combination treatment.
There are 29 drugs on the FDA's most recent list of resolved drug shortages. The problem is, there are dozens and dozens more on the list of drugs still in short supply. The FDA has been having success in heading off new shortages but the list of those hard to come by remains stubbornly persistent. The agency is working on a new plan it hopes can provide some relief.
AstraZeneca has a new CFO to replace the departing Simon Lowth: Marc Dunoyer, who joined the company from GlaxoSmithKline earlier this year. He'll have plenty of work on his plate: The company's sales continue to slide on generic competition, it's in the middle of a cost-cutting plan and headquarters move, and more patent expirations are on their way.
In the aftermath of Teva CEO Jeremy Levin's departure announcement yesterday, media reports offer a few puzzle pieces that combine into one picture: Who in the world will the generics giant find to take on the job?
With a respectable sales increase and profits growth that beat Big Pharma's, Novo Nordisk's third-quarter results still fell short of analyst expectations. The reason: Novo's powerhouse diabetes drug Victoza is slowing down a bit.
Tantalized by various megablockbuster projections for the PCSK9 field of cholesterol drugs, Pfizer has mapped out one of the most ambitious late-stage programs in the industry for RN-316. This week, the pharma giant spelled out plans for a massive cardiovascular outcomes trial to prove to regulators and payers alike that the drug not only works as advertised, but delivers real value to patients.
Last year, the FDA came down hard on a Sanofi Pasteur plant in Toronto. The ensuing trouble triggered serious supply problems--and, in turn, a shortage of childhood vaccines in the U.S.
Just a few days ago, we learned that Dendreon is looking to woo a buyer. The question now is whether the struggling drugmaker can find a suitor to take on its baggage.
Sanofi's third-quarter results show emerging markets can be a double-edged sword. Though the company's growth in these fast-growing countries often outclasses that of its peers, this time--for the second quarter in a row, we might add--emerging markets failed to pump up Sanofi's top line. What with generic competition and lagging vaccines sales, the French drugmaker posted a decline in sales and a steeper decline in profits.
Q3 earnings: Gilead excels; Actavis floats; Lupin overcomes price controls; Allergan performs but faces headaches
The third-quarter earnings reports continue to roll in, and good news came in with the tide for some, but not all.
So much for denials. Monday, Teva Pharmaceutical Industries and CEO Jeremy Levin said he wasn't weighing a resignation. Today, the Israel-based company announced his imminent departure. Levin's exit comes in the wake of last week's layoffs announcement--and, so the story goes, amid a behind-the-scenes dust-up between Teva's board and management team.
GlaxoSmithKline has again said it will close a consumer healthcare plant in Clifton, NJ, and move production to a facility in New York.