Clinical development is an integral part of launching new drugs to market, and is comprised mainly of conducting clinical trials and submitting the data for approval.
NovaDigm Therapeutics announced the presentation of positive data for its NDV-3 vaccine program in a second Phase 1 study.
Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S announced results from a Phase 3 clinical trial evaluating aripiprazole for the treatment of adults with schizophrenia.
Ventrus Biosciences Inc. reported positive results from its Phase 3 clinical trial of diltiazem hydrochloride cream in patients with anal fissures.
Promethera Biosciences has treated its first two patients with its innovative treatment based on allogeneic adult liver stem cell technology, HepaStem.
AesRx LLC has begun a Phase 1/2a clinical trial of Aes-103 in patients with sickle cell disease. This trial is part of an ongoing collaboration with the National Institutes of Health.
A team of bioethics experts has created ELSI 2.0, an international "collaboratory" to better respond to the global aspects of the ethical, legal and social implications (ELSI) of modern genomics.
TapImmune Inc. has announced that following recent IRB approval a Phase 1 clinical trial on a novel set of HER2/neu Class II antigens will start at Mayo Clinic.
Federal health advisers said that a first-of-a-kind drug from Pfizer appears to be safe and effective for patients with rheumatoid arthritis.
GTx Inc. announced that regulators are allowing it to restart clinical testing of its prostate cancer drug Capesaris. The company said it will start a new mid-stage trial of Capesaris during the third quarter of 2012.
Macrocure has achieved positive results for a Phase 4 trial of its lead product, CureXcell, for the treatment of hard-to-heal ulcers in a community care setting.
Halo Therapeutics LLC announced that the European Commission has granted orphan medicinal product designation to HT-100 for the treatment of Duchenne muscular dystrophy.
A second experimental cholesterol medicine in a once-promising class of drugs meant to replace blockbusters such as Lipitor has failed in testing.
Compounds found in curry are being investigated as a way of improving drug response in patients with advanced bowel cancer in a new study.
Genentech announced that the SUMMACTA study met its primary endpoint, showing comparable efficacy of subcutaneous Actemra to intravenous Actemra.
The world's largest drugmaker, Pfizer, halted a late-stage study of its second-best selling drug, Lyrica, as a possible treatment for a nerve pain in HIV patients.
The first randomized controlled trial to assess the effectiveness of memantine, a drug prescribed for Alzheimer's disease, showed the drug does not ease clinically significant agitation in patients.
A Phase 2 study has compared a combination of ficlatuzumab and gefitinib to gefitinib monotherapy in previously untreated Asian subjects with non-small cell lung cancer.
Gilead Sciences Inc. announced that the first patient has been dosed in a Phase 3 clinical trial evaluating the efficacy and safety of GS-1101.
Quotient Clinical has received approval of the final patent for its Enterion technology. This completes a portfolio of eight granted patents across North America and Europe.
EMD Millipore introduced the Strat-M membrane for screening compounds and formulations via in vitro diffusion studies. The synthetic membrane can be used in place of human or animal skin.
Shire plc announced positive top-line results from a Phase 2 study to evaluate the safety and efficacy of Vyvanse in adults with binge eating disorder.
Quark Pharmaceuticals Inc. it has amended an existing exclusive licensing agreement with Pfizer in order to perform a Phase 2a clinical trial of PF-655 on patients with open-angle glaucoma.
A JMP Securities analyst has upgraded Idenix Pharmaceuticals Inc. stock after Idenix reported new data on its experimental hepatitis C drugs.