Medical

SEC warns pharma companies to be honest about FDA correspondence

The U.S. Securities and Exchange Commission's top enforcement chief warned on Tuesday that too many pharmaceutical companies are failing to accurately portray their dealings with federal drug regulators - a problem that could get them in trouble.


FDA approves new use for Celgene's cancer drug Revlimid

The U.S. Food and Drug Administration has expanded the authorized use of Celgene Corp's cancer drug Revlimid to include newly diagnosed patients with multiple myeloma, the company said on Wednesday.

Sanofi says Cerdelga trial shows promise

French pharmaceutical group Sanofi said on Tuesday a trial treatment with its Cerdelga drug for patients with type 1 Gaucher disease, a rare genetic disorder, showed promise.

FDA approves Eisai's thyroid cancer drug

The U.S. Food and Drug Administration said it approved Japan's Eisai Co Ltd's drug to treat the most common form of thyroid cancer more than two months ahead of the review date.


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Motif Bio, which is working on a range of antibiotics, is planning to raise at least 4 million pounds ($6 million) - and potentially up to 16 million - through a stock market listing in London.
Salix Pharmaceuticals Ltd said it would restate financial statements for all of 2013 and the first three quarters of 2014, adding to the drugmaker's list of woes.
First results from a human trial of an Ebola vaccine from GlaxoSmithKline show it is safe and generates an immune response, scientists said on Wednesday, but larger trials are needed to see if it protects and if a booster is needed.
Medical device maker Abiomed Inc (ABMD.O) raised its full-year revenue forecast and said the U.S. Food and Drug Administration had approved its heart pump, sending its stock nearly 32 percent in extended trading.
Two new tools to fight AIDS should be available by 2030 in the form of a vaccine and new intense drug treatments, ending most cases of a disease that has killed millions in the past 30 years, Bill Gates said.
A steep fall in Ebola cases in Liberia will make it hard to prove whether experimental vaccines work in a major clinical trial about to start in the country, the head of the U.S. National Institutes of Health (NIH) said on Saturday.
The U.S. Food and Drug Administration has approved NPS Pharmaceuticals Inc's drug Natpara to treat a rare hormone disorder, validating a bet by Shire Plc, which recently agreed to acquire NPS for $5.2 billion.
The international charity Medecins Sans Frontieres urged drugmakers GlaxoSmithKline and Pfizer on Tuesday to slash the price of their pneumococcal vaccines to $5 per child in poor countries.
GlaxoSmithKline is feeling the heat from the rapid growth in electronic cigarettes, with enthusiasm for the nicotine delivery devices dampening sales of the British drugmaker's patches and gum, its chief executive said.
The world's biggest drugmakers face a new reality when it comes to U.S. pricing for their products as insurers use aggressive tactics to extract steep price discounts, even for the newest medications.
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