The news was hardly unexpected, as the product was nodded through by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in January...In order to acquire something interesting, it's going to be very expensive, and some people are afraid they'll have to pay too high a price...Those and other questions are likely to get a further airing in Brussels Tuesday

In other news, law firm Bronstein, Gewirtz & Grossman LLC, of New York, said it is investigating claims on behalf of purchasers of Spectrum securities, after shares (NASDAQ:SPPI) fell as much as 38 percent on March 13 on news that the company slashed its revenue projections for colon cancer drug Fusilev (levoleucovorin

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch

Inc., of Whitehouse Station, N.J., and Luminex Corp., of Austin, Texas, signed a collaboration and license deal to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck's clinical development program for MK-8931, an oral, beta amyloid precursor protein site cleaving enzyme inhibitor and Merck's lead candidate for Alzheimer's disease...Takeda Pharmaceutical Co., of Tokyo, and the Scripps Research Institute announced plans to expand their

That news "shocked the Street," according to Roth Capital Partners analyst Joseph Pantginis...Investors took the news hard, sending shares of Spectrum (NASDAQ:SPPI) falling $4.64, or 37.3 percent, to close Wednesday at $7.79

Clinigen Group plc, of Burton-on-Trent, UK, and Theravance Inc., of South San Francisco, entered an exclusive commercialization agreement in the European Union and certain other countries located in Europe for Vibativ (telavancin) in nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus, when other alternatives are not suitable...In other news, Elan said its Tysabri (natalizumab) restructuring transaction is

In the same study, ANAVEX 2-73 also blocked apoptosis and oxidative stress, which is believed to prevent the onset of Alzheimer's...CMX001 is a broad-spectrum, oral nucleotide analogue lipid-conjugate designed to block the replication of double-stranded DNA viruses...That cross-border supply approval is in addition to the manufacturing capacity in the UK already developed with partner Kings College London

Celtic Therapeutics Management LLLP, of New York, changed its name to Auven Therapeutics Management LLLP to overcome confusion related to other Celtic entities...Clinigen Group plc, of Burton-on-Trent, UK, and Theravance Inc., of South San Francisco, entered an exclusive commercialization agreement in the European Union and certain other countries located in Europe for Vibativ (telavancin) in nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by

and other affiliates he controls, proposing to acquire outstanding shares not currently owned by the group for $9.56 per American Depositary Share (ADS) or $4.78 per ordinary shares in cash...Simcere's board formed a special committee of independent directors to evaluate the offer

Eisai Inc., of Woodcliff Lake, N.J., reported that the German Federal Joint Committee said it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments...Eisai said it believes the committee "failed to adequately interpret" benefits to patients with the drug, which is indicated as an adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy, age 12 and older

Tecafarin recently completed a Phase III study showing it was safe and effective in patients with prosthetic heart valves in addition to patients with other conditions such as atrial fibrillation or venous thromboembolism, independent of CYP status...In addition to strengthening its balance sheet, Biovest said the move will support ongoing strategies to commercialize its BiovaxID personalized cancer vaccine, including facilitating ongoing partnering/licensing initiatives, as well as enhancing the

The company has also submitted new drug applications to the FDA for canagliflozin and for the fixed-dose combination therapy...The companies will expand their existing collaboration to include joint promotion of Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the U.K. Lundbeck will promote Abilify in Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania...Under the agreement, Lundbeck will have the right to promote all formulations of Abilify currently marketed, sold or

to develop, manufacture and supply commercial quantities of Ofirmev (acetaminophen) injection in flexible plastic bags...According to the terms of an asset purchase agreement jointly executed by the parties, RXi will acquire substantially all of OPKO's RNAi-related assets, including an extensive intellectual property portfolio...Sorrento Therapeutics Inc., of San Diego, signed an exclusive option to acquire Igdrasol Inc., of Fountain Valley, Calif., a private company focused on the development of

As part of the agreement, the company pleaded guilty to a misdemeanor, entered a five-year corporate integrity agreement and agreed to dismiss its lawsuit challenging FDA regulations that criminalize truthful speech about approved drug uses. (See BioWorld Today, Oct. 24, 2011...Roche will provide R&D funding and scientific expertise to BioLamina

The application requests approval to expand the indication beyond the treatment of iron deficiency anemia in adults with chronic kidney disease to also include adults with iron deficiency anemia who have failed or could not take oral iron treatment...The three-year alliance, aiming to develop a drug pipeline targeting cancer metabolism, has been expanded to run to early 2015, adding the possibility of at least two new projects being selected by CRT

Funds will be used to advance development programs across Bionomics' pipeline, including BNC375, Bionomics' drug candidate for the treatment of Alzheimer's disease and other conditions where memory is significantly compromised and Bionomics' cancer stem cell directed drug candidate BNC101...In other news, Biotie and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro (nalmefene), an opioid system modulator, for the

The agreement gives miRagen rights to a discovery made in the course of the collaboration...AstraZeneca gained the right to develop and commercialize alpha4beta2 NNR modulators licensed from Targacept, including AZD1446, in any therapeutic area...The company is planning to begin clinical trials in ischemic stroke and peripheral vascular diseases this year

Janssen said it is evaluating the letter and will respond to the agency's questions

materials to support ongoing commercialization of Brinavess, and oral API is expected to be sufficient for clinical trials...The initial percentage to be paid out directly to shareholders is 20 percent of those royalties. (See BioWorld Today, Feb. 25, 2013