Drug Pipeline
Halozyme Reports Pancreatic Cancer Study Data
May 16, 2013 4:39 pm | News | CommentsHalozyme Therapeutics Inc. has posted results from an early-stage trial that included its drug PEGPH20 as a treatment for pancreatic cancer. Halozyme said PEGPH20 may make tumors more vulnerable to treatment by depleting their defenses and changing their metabolism.
Oncothyreon Releases Stimuvax Data
May 16, 2013 11:54 am | News | CommentsDrug developer Oncothyreon Inc. announced new clinical trial data about an experimental lung cancer treatment that failed to improve the overall survival rate. Oncothyreon said that it identified some patients who appeared to live longer after treatment with Stimuvax.
FDA Grants Priority Review to Simeprevir
May 15, 2013 12:00 pm | News | CommentsThe U.S. Food and Drug Administration has granted Priority Review to Janssen's New Drug Application for simeprevir, an investigational NS3/4A protease inhibitor administered with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C.
India Developing $1 Vaccine
May 14, 2013 9:21 am | by Ravi Nessman | News | CommentsThe Indian government announced the development of a new low-cost vaccine proven effective against a diarrhea-causing virus that is one of the leading causes of childhood deaths across the developing world. The Indian manufacturer of the new rotavirus vaccine pledged to sell it for $1 a dose.
Lyme Disease Vaccine Shows Promise in Trial
May 13, 2013 1:59 pm | News | CommentsThe results of a phase 1/2 clinical trial in Europe of an investigational Lyme disease vaccine co-developed by researchers at Stony Brook University, Brookhaven National Laboratory and at Baxter International Inc., a U.S. based healthcare company, revealed it to be promising and well tolerated, according to a research paper published online in The Lancet Infectious Diseases.
Lilly Ends Enzastaurin Development
May 10, 2013 2:50 pm | News | CommentsEli Lilly and Co. said 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.
Pfizer Having Second Thoughts on Remoxy
May 10, 2013 11:35 am | by The Associated Press | News | CommentsPfizer Inc. may not pursue further development of Remoxy, an experimental pain drug that has been plagued with delays in regulatory approval. Durect Corp. developed Remoxy and licensed it to Pain Therapeutics Inc. who in turn sublicensed the drug to Pfizer.
Muscular Dystrophy Trial Starting
May 9, 2013 6:15 pm | News | CommentsThe National Center for Neurology and Psychiatry and drugmaker Nippon Shinyaku Co. will start a clinical trial of a drug to treat Duchenne muscular dystrophy, a genetic disease that affects around one in 3,500 boys, aiming to release it for sale in five years.
Alexza Licenses Adasuve to Teva
May 8, 2013 1:30 pm | News | CommentsAlexza Pharmaceuticals Inc. said Teva Pharmaceutical Industries Ltd. will market its agitation drug Adasuve in the United States. The companies said that Teva will be responsible for all U.S. commercial and clinical-related activities, including a required post-approval study.
FDA Reviewing Allergy Therapy
May 8, 2013 12:47 pm | News | CommentsDrugmaker Merck & Co. says the Food and Drug Administration is reviewing its second application to sell a new type of allergy treatment meant to gradually reduce allergic reactions over time, rather than just relieving sneezing, itching and other symptoms temporarily.
Another Setback in Alzheimer’s Fight
May 7, 2013 9:48 am | by Andrew Pollack | News | CommentsBaxter International said that a promising new therapy had failed to halt the mental decline caused by the disease in a late-stage clinical trial. The company said its immunoglobulin therapy did not significantly arrest the decline in either cognition or daily functioning when compared with a placebo.
FDA Approves Merck's Liptruzet
May 3, 2013 5:56 pm | News | CommentsMerck & Co. said that it received U.S. Food and Drug Administration marketing approval for the new combination cholesterol drug Liptruzet, which combines the company's drug Zetia with a generic version of the mega-blockbuster drug Lipitor.
Arena Withdraws Belviq Application
May 3, 2013 7:32 am | News | CommentsDrug developer Arena Pharmaceuticals Inc. announced that it is withdrawing its application for approval of the weight loss drug Belviq in Europe. The San Diego company also said that it is still waiting for a U.S. decision on the status of the drug.
Allergan Pushes Back Eye Drug Trial
May 1, 2013 3:08 pm | News | CommentsAllergan executives announced that are delaying late-stage testing of an experimental eye treatment by one to two years. Allergan was previously expected to launch a study of DARP-in, an experimental drug for macular degeneration, by late 2013.
Actavis Buys Valeant Gel for $55M
May 1, 2013 1:55 pm | News | CommentsActavis has acquired a bacterial vaginosis gel developed by Valeant Pharmaceuticals. Actavis said it agreed to pay Valeant $55 million for its metronidazole gel product, which has not yet received marketing approval. The total includes both an upfront payment and payments related to sales targets.
Daiichi Sankyo Sponsoring Perosphere Trial
May 1, 2013 11:41 am | News | CommentsPerosphere and Daiichi Sankyo have entered into a clinical trial agreement under which Daiichi Sankyo will support and co-sponsor a Phase 1 clinical trial testing the safety, tolerability, and effectiveness of PER977 to reverse the anticoagulant activity of Daiichi Sankyo’s edoxaban.
Molecule Offers Hope for Muscular Dystrophy
April 30, 2013 11:53 am | News | CommentsThere’s hope for patients with myotonic dystrophy. A new small-molecule has been shown to break up the protein-RNA clusters that cause the disease in living human cells, an important first step toward developing a pharmaceutical treatment for the as-yet untreatable disease.
Merck, Pfizer Team Up On Diabetes Pill
April 29, 2013 12:26 pm | News | CommentsMerck & Co. will work with Pfizer Inc. to develop a new combination pill designed to treat Type 2 diabetes. The experimental pill will combine Merck's drug Januvia, Pfizer's experimental pill ertugliflozin, and metformin, an older diabetes drug.
Auxilium Spending $585M on Actient
April 29, 2013 12:10 pm | News | CommentsAuxilium Pharmaceuticals Inc. announced the purchase of Actient Holdings LLC from private equity firm GTCR for $585 million. In the process Auxilium said it will get two testosterone drugs, impotence treatments, and two respiratory drugs.
EMA Panel Recommends Nuedexta
April 26, 2013 10:31 am | News | CommentsA panel that advises the European Medicines Agency recommended that Avanir Pharmaceuticals' Nuedexta be approved as a treatment for pseudobulbar affect. The drug is already approved in the U.S. Being able to sell the drug in Europe would likely increase Avanir's revenues.
European Regulators Reject Xeljanz
April 25, 2013 5:00 pm | News | CommentsPfizer Inc. said that the European Union's committee of medical experts has rejected the company's drug Xeljanz for patients with rheumatoid arthritis. The European Medicines Agency committee recommended against approving the drug because its benefits did not sufficiently outweigh its risks.
Pfizer Aims To Cut Generics Impact
April 25, 2013 3:11 pm | by Linda A. Johnson | News | CommentsPfizer Inc. CEO Ian Read said that continuing expirations of drug patents through 2015 will restrain revenue growth, but the world's largest drugmaker is trying to offset that with launches of several medicines and research to create new ones.
Aubagio Delays Multiple Sclerosis Onset
April 25, 2013 11:33 am | News | CommentsGenzyme announced positive results from a Phase 3 trial of Aubagio designed to assess whether early initiation of the drug in patients who experienced their first neurological symptoms consistent with clinically isolated syndrome can prevent or delay conversion to clinically definite multiple sclerosis.
Tamoxifen Enhanced for Aggressive Cancer Treatment
April 24, 2013 12:04 pm | News | CommentsTamoxifen is a time-honored breast cancer drug used to treat millions of women with early-stage and less-aggressive disease. Now a team of researchers has shown how to exploit tamoxifen’s secondary activities so that it might work on more aggressive breast cancer.
FDA Designates Lambrolizumab a Breakthrough
April 24, 2013 10:54 am | News | CommentsMerck announced that the Food and Drug Administration has designated lambrolizumab as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab's designation as a Breakthrough Therapy is intended to expedite its development and review.
