Life Technologies Corp., of Carlsbad, Calif., entered a master development agreement with Bristol-Myers Squibb Co., of New York, for current and future companion diagnostics projects. The agreement, the second collaboration between the companies, covers an initial project in oncology and provides for a long-term partnership across a potentially broad range of Life instrument platforms and a wide range of therapeutic areas. Terms were not disclosed. Wockhardt Ltd., of Mumbai, India, received
expanded access program for investigational oncology compound afatinib, which will be available to eligible patients with locally advanced or metastatic non-small-cell lung cancer who have an epidermal growth factor receptor mutation
rights to FDA-approved product Gelclair for treating oral mucositis from the Helsinn Group, of Lugano, Switzerland...DARA plans to launch the topical gel product in the first quarter of 2013...They also appeared to make reciprocal synaptic connectivity with the host rat spinal cord neurons on the gray matter for several segments below the injury
The agency said the resubmission constituted a complete Class 2 response to its July 26 letter and set a PDUFA date of Feb. 28, 2013...Shire plc, of Dublin, Ireland, said the FDA accepted a supplemental new drug application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) capsules for maintenance treatment of attention deficit hyperactivity disorder in children, ages 6 to 17
Pfizer Inc., of New York, said the World Health Organization granted an expansion to the prequalification of Pfizer's pneumococcal conjugate vaccine, Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), to include adults 50 and older against pneumonia and invasive disease caused by the 13 pneumococcal serotypes in the vaccine...The company has invested €75 million (US$96.4 million) in the plant, which is expected to be fully operational by 2014
In othernews, BioLineRx said BL-7010, an oral candidate in celiac disease and gluten sensitivity, was found to be safe and well tolerated in preclinical studies presented at the Better Life for Coeliacs 2012 Conference in Helsinki, Finland...Due to the close relationship among Family B GPCRs, which have proven intractable to small-molecule chemistry, insights from the CRF structure will allow structural models to be generated for the entire family, Heptares said
BioWorld International | Wednesday, September 12, 2012
ALK-Abello A/S, of Horsholm, Denmark, said it inked a co-promotion deal with MSD (known as Merck & Co. Inc., of Whitehouse Station, N.J., in the U.S. and Canada) for Grazax, a fast-dissolving, once-daily allergy immunotherapy for home treatment of grass pollen allergy in France. Under the terms, ALK will book all sales of Grazax, and MSD will receive a co-promotion fee.
Janssen Research & Development LLC, of Raritan, N.J, a unit of Johnson & Johnson, said it submitted a complete response to the FDA for the use of anticoagulant Xarelto (rivaroxaban) to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS), and also resubmitted its supplemental new drug application for Xarelto to reduce the risk of stent thrombosis in patients with ACS...relating to Pfizer's patents covering overactive bladder drug Detrol LA (tolterodine
to collaborate on a Phase III trial testing ASP0113 (TransVax), an investigational vaccine licensed from Vical Inc., of San Diego, for preventing cytomegalovirus (CMV) reactivations in transplant patients...The settlement provides TWi with a license to make, and Anchen a license to market, the generic version of Intuniv in the U.S...Shire also may authorize Anchen to sell generic versions of Intuniv supplied by Shire in exchange for a significant royalty
The drug is intended for patients with chronic, accelerated or blast phase Philadelphia chromosome-positive CML who are resistant to or who cannot tolerate other therapies, including Gleevec (imatinib, Novartis AG...Bosulif is designed to work by blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes...Shire gained rights to Dermagraft through last year's acquisition of Advanced BioHealing Inc., of Westport, Conn. (See BioWorld Today, May 25
Novartis AG, of Basel, Switzerland, said the FDA approved a higher dose of Exelon Patch (rivastigmine transdermal system) for the treatment of people with mild to moderate Alzheimer's disease...A kinase inhibitor, Inlyta is designed to selectively inhibit vascular endothelial growth factor receptors 1, 2 and 3
Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking conditional approval for the use of TMC207 (bedaquiline) as part of combination therapy for pulmonary, multidrug-resistant tuberculosis (MDR-TB...Two months ago, Janssen submitted a new drug application for bedaquiline, under priority review, to the FDA
Abbott, of Abbott Park, Ill., said the European Commission approved Humira (adalimumab) in moderately active Crohn's disease (CD) in adult patients who have not adequately responded to conventional therapy
Armgo Pharma Inc., of Tarrytown, N.Y., said a study published in Cell revealed the underlying role of calcium leak through the ryanodine receptor calcium-release channel on stress-induced cognitive dysfunction – the focus of the company's small-molecule drugs known as Rycals...Piper Jaffray analyst Edward A. Tenthoff said in a research note that the news is "a likely positive" and he continues to expect Cabo approval by the PDUFA date
The acquisition is expected to reduce Hospira's costs, support continuity of supply of antibiotic products and pave the way for future API development...The PDUFA date is expected to occur within six months of the June sNDA submission...In separate news, Janssen said the FDA approved the supplemental new drug application for Nucynta ER (tapentadol) extended-release tablets for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the
The big pharma also reported that its HPS2 THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) study of MK-534A (Tredaptive, niacin/laropiprant) is on track to complete later this year
The FDA approved an abbreviated new drug application for a generic equivalent to Chadds Ford, Pa.-based Endo Pharmaceuticals Inc.'s Lidoderm (lidocaine topical patch 5 percent) by Watson Laboratories Inc., a subsidiary of Watson Pharmaceuticals Inc., of Parsippany, N.J. Watson will launch the product in Sepember 2013 under an agreement with Endo and Teikoku Seiyaku Co...Ltd., of Kagawa, Japan, settling all outstanding patent litigation relating to generic Lidoderm
Glenmark Pharmaceuticals Ltd., of Mumbai, India, said the International Centre for Dispute Resolution ruled in Glenmark's favor on the arbitration claim filed in August 2011 against Napo Pharmaceuticals Inc., of San Francisco, seeking, among other things, a ruling that Glenmark's exclusive rights to develop, commercialize and distribute Crofelemer in 140 countries for treatment of diarrheal diseases includes the exclusive rights to distribute through relief agencies in those countries and an
The letter is in response to opposition from one of Nabi's largest stockholders, Mangrove Partners Fund LP, which last week reached out to shareholders asking them to vote against the proposed merger, arguing that the transaction "fails to return to Nabi's stockholders the underlying value" of the firm
Merck KGaA, of Darmstadt, Germany, said its EMD Millipore division entered definitive agreements to acquire Biochrom AG, a Berlin-based firm that specializes in the production and marketing of cell culture media and buffer solutions
Life Technologies Corp., of Carlsbad, Calif., entered a master development agreement with Bristol-Myers Squibb Co., of New York, for current and future companion diagnostics projects. The agreement, the second collaboration between the companies, covers an initial project in oncology and provides for a long-term partnership across a potentially broad range of Life instrument platforms and a wide range of therapeutic areas. Terms were not disclosed. Wockhardt Ltd., of Mumbai, India, received