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experimental drug 24 articles

Regeneron, Sanofi pay $67.5 million to expedite approval of experimental cholesterol drug

Regeneron Pharmaceuticals and Sanofi are paying $67.5 million to improve the chances of getting their experimental cholesterol-lowering drug on the market before any other drug company with similar cholesterol treatments in development. Regeneron and Sanofi are purchasing a first-of-its-kind voucher that grants expedited review by drug regulators, paving the way for faster Food and Drug Administration (FDA) approval. The voucher was awarded to BioMarin Pharmaceuticals as an incentive for drug companies to invest in drugs for rare childhood diseases. It allows the drug company expedited review of a different drug of its choice. Companies given vouchers can also sell them ... Read More

Drug companies race to win market approval for new alternative to cholesterol-lowering statins

An experimental medication aiming to replace statin drugs as a cholesterol-lowering treatment has cleared nine clinical trials in a race for Food and Drug Administration (FDA) approval. Sanofi and Regeneron Pharmaceutical’s alirocumab reportedly met the goal of lowering bad cholesterol after 24 weeks of treatment more than placebo or other medications, and reducing the rate of heart attack, stroke and death in one test. Previous tests have shown a 47 percent drop in bad cholesterol with alirocumab. Sanofi and Regeneron are racing against drug maker Amgen, Inc., to get new cholesterol treatments on the market. Both drugs are in a ... Read More

FDA allows clinical trials on brain drug for patients with severe TBI to resume

The U.S. Food and Drug Administration (FDA) is allowing Oxygen Biotherapeutics Inc. to resume patient testing on its experimental brain injury drug Oxycyte, nearly six years after the agency suspended clinical trials of the drug due to concerns about its use in patients with severe traumatic brain injuries (TBI). TBIs are caused by a blow to the head or a penetrating head injury and interfere with normal brain functioning. About 52,000 people die from TBI in the United States each year, according to the Brain Trauma Foundation. When someone suffers from a TBI his platelet count significantly drops in response ... Read More

Experimental genital herpes treatment fares well in small clinical trial

Clinical trials are showing promise for an experimental drug to treat genital herpes, a common, highly contagious, and incurable infection usually spread through sexual contact. The drug, called pritelivir, was found to substantially decrease “viral shedding,” which is the amount of time the virus was active and potentially transmissible to sexual partners. Genital herpes is caused by the herpes simplex virus, most often from a strain known as HSV-2. The infection can cause painful sores around the genitals, rectum or mouth, which can be reactivated periodically. Sometimes people experience no symptoms or only mild ones, however the disease can be ... Read More

Experimental drug helps reduce symptoms of tardive dyskinesia

Patients with a movement disorder known as tardive dyskinesia saw a reduction in spasms after taking Neurocrine Biosciences’ experimental drug NBI-98854 for six weeks compared to patients taking a placebo. The drug company says it hopes the promising data will win Food and Drug Administration (FDA) approval to move forward with a late-stage study during the first half of the year. Tardive dyskinesia is a difficult to treat and often incurable neurological disorder that causes involuntary movements such as grimacing, tongue movements, lip smacking and puckering, pursing of the lips, and excessive eye blinking. The condition most often occurs as ... Read More

Trials of experimental cholesterol-lowering drug look promising

An experimental type of cholesterol-lowering drug cut levels of “bad” cholesterol almost in half in a dozen late-stage clinical trials, makers Regeneron Pharmaceuticals and Sanofi announced. The injectable drug, known as alirocumab, is from a new class of medications called PCSK9 inhibitors. Drugs in this class have yet to be evaluated and approved by the Food and Drug Administration (FDA), but several drug makers, including Amgen Inc., are currently testing PCSK9 drugs. The first approved drugs in this class could likely jump to blockbuster status with an estimated $3 billion in sales or more, stealing shares from the widely prescribed ... Read More

Experimental type 2 diabetes drug looks promising in regulating blood sugar, reducing weight

A new drug cocktail combining two medications that mimic naturally occurring hormones appears to work better than single hormone drugs in treating type 2 diabetes and obesity, according to data from a small clinical trial. The breakthrough treatment is a dual-action molecule that targets receptors for hormones known as GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) that play an important role in regulating the body’s metabolism. GLP-1 medications currently marketed in the United States include Novo Nordisk’s Victoza, and Bristol-Myers Squibb and AstraZeneca’s Byetta. GIP is not currently marketed as a drug. Researchers believe that by using the two ... Read More

FDA panel questions safety, efficacy data for proposed COPD treatment

The Food and Drug Administration (FDA) questioned the validity of an experimental drug for the treatment of chronic obstructive pulmonary disease (COPD), cautioning its panel of advisors that the data is incomplete and may not give a clear picture of efficacy and potential adverse reactions. The treatment, called Anoro Ellipta, is a combination of two drugs, umeclidinium and vilanterol, neither of which has been approved by the FDA as a single therapy. Anoro Ellipta is manufactured by GlaxoSmithKline and Theravance Inc. The two companies in May had secured FDA approval for another COPD drug, Breo Ellipta, and had hoped to keep ... Read More

Roche stops development of type 2 diabetes drug because of safety, efficacy concerns

Drug maker Roche has stopped development of the experimental type 2 diabetes treatment aleglitazar because of undesirable side effects and a lack of efficacy. The decision was based on a recommendation by the independent Data and Safety Monitoring Board, which conducted a regular safety review of the aleglitazar AleCardio phase III trail. The drug was being tested in patients with a recent acute coronary syndrome event and type 2 diabetes. Patients reportedly suffered from side effects to the kidneys and the heart. “The safety of patients is our first priority. Roche is working with investigators to support the management of ... Read More

Researchers receive funding for innovative new blood thinner

Researchers have received financial support to develop a new kind of blood thinner they believe may prevent life threatening blood clots without causing major bleeding events, a dangerous side effect to currently marketed anticoagulants. Index Ventures is teaming up with GlaxoSmithKline and Johnson & Johnson to create X01, a new company formed to develop experimental drugs. The new $11 million venture early-stage biotech fund will help fund research into the innovative blood thinner ichorcumab. The drug is still in the very early stages of development with clinical trials not expected for at least another two years. However, financial analysts say ... Read More