Janssen Biotech Inc., of Horsham, Pa., a unit of Johnson & Johnson, said it submitted a biologics license application requesting approval of an intravenous formulation of anti-tumor necrosis factor-alpha drug Simponi (golimumab) for the treatment of adults with moderately to severely active rheumatoid arthritis...Merck KGgA, of Darmstadt, Germany, said it withdrew its application from the European Medicines Agency seeking to extend the use of cancer drug Erbitux (cetuximab) in non-small-cell lung

Targeted to open in California, Boston, London and China, the centers will serve as regional hubs focused on identifying early stage innovations and establishing collaborations to invest in and speed development of those innovations...The innovation centers, which are set to be operational in the coming months, will house science and technology experts and have local dealmaking capabilities, with flexibility to adapt deal structures to match the early stage opportunity

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

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

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.

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

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

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

Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve delineation of the left ventricular endocardial borders...The FDA determined that additional data analyses recently submitted by Pfizer constituted a major amendment to the application and will require additional time to review

Renaissance Pharma Inc., of Newtown, Pa., acquired the U.S...rights to manufacture, market and sell Denavir (1 percent penciclovir cream) from investment funds managed by Deerfield Management Co...and New American Therapeutics Inc., of Cranford, N.J. Renaissance established a new subsidiary, Prestium Pharma, to commercialize the prescription antiviral indicated for the treatment of recurrent cold sores in adults and children 12 years and older

Sun Pharmaceutical Industries Ltd., of Mumbai, India, will acquire Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., for $39.50 in cash per share paid to shareholders other than Sun Pharma and its affiliates, which currently own about 66 percent of outstanding ordinary shares and 100 percent of founders shares

said its subsidiary Mylan Pharmaceuticals, of Pittsburgh, received FDA approval of its abbreviated new drug application (ANDA) for lithium carbonate extended-release tablets USP, 450 mg, to treat manic episodes of manic depressive illness...Mylan will immediately launch its 100- and 200-mg tablets of modafinil, indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder

Pfizer Inc., of New York, will pay more than $60 million to resolve Department of Justice (DOJ) and SEC investigations into improper payments made by two of its subsidiaries outside the U.S. Pfizer H.C.P. Corp...All the conduct was investigated first by Pfizer, which then voluntarily disclosed it to the U.S