Swiss drugmaker Roche said Wednesday the Food and Drug Administration will make a decision on its leukemia drug obinutuzumab by Dec. 20. Roche's Genentech unit is developing obinutuzumab as a treatment for chronic lymphocytic leukemia. Genentech said the FDA will conduct a priority review, meaning it will make a decision in six months instead of the usual 10 months.
Univ. of Adelaide research has produced a potential new antibiotic which could help in the battle against bacterial resistance to antibiotics. The potential new antibiotic targets a bacterial enzyme critical to metabolic processes. The compound is a protein inhibitor which binds to the enzyme (called biotin protein ligase), stopping its action and interrupting the lifecycle of the bacteria.
Scientists at the Univ. of East Anglia are developing a new class of anti-cancer drugs that are not only powerful but also circumvent a primary cause of resistance to chemotherapy. The work is inspired by nature’s fungus farmer, the leaf cutter ant.
A free trade pact being negotiated by the U.S. and 11 Asia-Pacific nations will impose aggressive intellectual property rules that will restrict access to affordable medicines in developing nations, health activists warned Wednesday. The 12 countries will start an 18th round of talks in Malaysia on July 15 and hope to complete negotiations by October.
Scientists at Brookhaven National Laboratory have identified two promising candidates for the development of drugs against human adenovirus, a cause of ailments ranging from colds to gastrointestinal disorders to pink eye. A recently published paper describes how the researchers sifted through thousands of compounds to determine which might block the effects of a key viral enzyme they had previously studied in atomic-level detail.
Opioids are still the most effective class of painkillers, but they come with unwanted side effects. Designing new drugs of this type involves testing them on their corresponding receptors, but access to meaningful quantities of these receptors that work in experimental conditions has been a limiting factor. Now, researchers have developed a variant of the mu opioid receptor that has several advantages when it comes to experimentation.
Deals between pharmaceutical corporations and their generic drug competitors, which government officials say keep cheaper forms of medicine off the market, can sometimes be illegal and therefore can be challenged in court, the Supreme Court said Monday. The justices voted 5-3 to allow the government to inspect and challenge what it calls "pay-for-delay" deals or "reverse payment settlements."
Eli Lilly and Co. will pay Canadian drug developer Transition Therapeutics Inc. $7 million and take over the development of a potential diabetes treatment heading into mid-stage clinical testing. Transition said Monday it also could receive up to $240 million in additional payments, plus royalties if the treatment is eventually approved and sold.
Bacteria in the gut that are under attack by antibiotics have allies no one had anticipated, a team of Harvard Univ. Wyss Institute scientists has found. Gut viruses that usually commandeer the bacteria, it turns out, enable them to survive the antibiotic onslaught, most likely by handing them genes that help them withstand the drug.
French drugmaker Sanofi said Monday the Food and Drug Administration approved a new version of its flu vaccine Fluzone that is designed to prevent four types of the virus. Sanofi said Fluzone Quadrivalent is designed to protect against two types of influenza A and two types of influenza B. Fluzone is the only flu shot recommended in the U.S. for infants and very young children.
A cancer drug developed at the Advanced Photon Source may be following a local tradition and going for a Chicago Bulls-like three-peat. The drug Votrient, or Pazopanib, was approved in 2009 to fight advanced kidney cancer and in 2012 to fight advanced soft tissue sarcoma. Now, according to a New York Times article, a new study shows the drug may delay ovarian cancer relapses.
New research raises fresh questions about which cancer patients benefit from Avastin, a drug that lost its approval for treating breast cancer nearly two years ago. Two studies found that Avastin did not prolong life when used as a first treatment for people with brain tumors like the one U.S. Sen. Edward Kennedy died of several years ago. Side effects also were more common with Avastin.
The Christopher & Dana Reeve Foundation and Capstone National Partners are pleased to announce a $2 million grant from the United States Department of Defense (DOD) to further support the expansion of translational research to find treatments for individuals living with spinal cord injury, including servicemen and women.
Alexion Pharmaceuticals Inc. said Tuesday that regulators have designated its experimental drug asfotase alfa as a breakthrough therapy for a rare metabolic disease that can cause progressive damage to vital organs. The FDA gives breakthrough therapy status to speed the development of drugs that treat serious or life-threatening illnesses if the new medication could be a major improvement over existing treatments.
Specialty drugmaker Biogen Idec said Tuesday it submitted a new injectable multiple sclerosis drug to the Food and Drug Administration for U.S. market approval. The drug, called Plegridy, is intended to treat patients with relapsing forms of multiple sclerosis.
Shares of XenoPort Inc. sank Monday after the drug developer said a potential treatment for multiple sclerosis patients failed in late-stage clinical testing, and it will stop developing the drug. The Santa Clara, Calif., company said the treatment, labeled arbaclofen placarbil, failed to show a statistically significant improvement for patients taking it compared to a fake drug.
Global CROs are no longer the obvious choice for companies looking to run international clinical trials. The motion is towards locally based CROs that are connected internationally to drive down R&D costs and leverage local know-how and quality.
Aerospace conglomerate United Technologies Corp. says it's donated $3 million to establish an endowed professorship at the Yale Cancer Center in New Haven. Lieping Chen will be the first United Technologies Corp. Professor in Cancer Research and is known for research leading to clinical trials of new cancer drugs that harness the body's immune system to fight cancer.
Eli Lilly and Co. said Friday it will stop development of an experimental cancer drug after it failed in a late-stage clinical trial. The company was studying enzastaurin as a treatment for diffuse large B-cell lymphoma, a cancer that affects a type of white blood cell. Lilly said patients who were treated with enzastaurin did not survive longer than patients treated with a placebo.
State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications. The head of the National Association of Boards of Pharmacy told Senate lawmakers that his group welcomes FDA action against pharmacies.
Bristol-Myers Squibb Co. said Friday that U.S. regulators expanded approval of its HIV drug Sustiva to children as young as three months old. The capsule-based drug was first approved in 1998 to treat HIV-infected children who are age three and older and weigh at least 22 pounds. The new approval expands the drug's use to children age three months to three years who weigh at least 7.7 pounds.
U.S. health officials are making a high-tech screening device available to African authorities to help spot counterfeit malaria pills in hopes that the technology may eventually be used to combat the fake drug trade worldwide. The FDA announced Wednesday that regulators in Ghana will begin using a federally developed handheld device to screen for fake or diluted versions of two common malaria pills.
Observing the evolution of a particular type of antibody in an infected HIV-1 patient has provided insights that will enable vaccination strategies that mimic the actual antibody development within the body. Spearheaded by Duke University, the multi-institution study included analysis from Los Alamos National Laboratory and used high-energy X-rays from the Advanced Photon Source at Argonne National Laboratory.
Vertex Pharmaceuticals Inc. said Friday it will work with Bristol-Myers Squibb Co. to study a potential hepatitis C treatment regimen that includes Bristol-Myers Squibb's drug daclatasvir and Vertex's VX-135. Both drugs are taken orally. Vertex said it will start a clinical trial of the once-per-day regimen during the second quarter.
BIND Therapeutics said Wednesday that Pfizer Inc. has agreed to pay it $160 million per drug as part of a collaboration to develop targeted medicines using nanotechnology which use particles measured in billionths of a meter. BIND is developing an experimental group of targeted, programmable...