In other news, Biolinerx said it signed an out-licensing agreement with Jiagsu chia-tai Tianqing Pharmaceutical Co...Gentium SpA, of Villa Guardia, Italy, filed the documentation requesting a re-examination of the negative opinion given by the European Committee for Medicinal Products for Human Use (CHMP), regarding the marketing authorization for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

The Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion on granting marketing authorization to Bavarian Nordic A/S, of Kvistgard, Denmark, for Imvanex, a smallpox vaccination for the general adult population, including those with immunodeficiencies...Based on the positive results GSK said it is planning to make regulatory submissions in Europe, the U.S., as well as other regions during the next few

Gentium SpA, of Villa Guardia, Italy, filed the documentation requesting a re-examination of the negative opinion given by the European Committee for Medicinal Products for Human Use (CHMP), regarding the marketing authorization for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy...Horizon Pharma Inc., of Deerfield, Ill., said in an SEC filing that it provided written notice to Mallinckrodt LLC, the

to manufacture, market and sell six dermatology and three antiviral products from GSK...patients to continue to have access to treatments and allows the Stiefel U.S

If approved, Lojuxta will be indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH...The Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion on granting marketing authorization to Bavarian Nordic A/S, of Kvistgard, Denmark, for Imvanex, a smallpox vaccination for the general adult population

turned its attention to other candidates in its pipeline...Isis and Genzyme, a unit of Paris-based Sanofi SA that licensed Kynamro in 2008 for up to $1 .9 billion, continue to pursue approval in Europe, where the European Medicines Agency's Committee for Medicinal Products for Human Use has twice given the drug a thumb's down in HoFH, and in broader cardiovascular indications, including the more common familial hypercholesterolemia, which is being investigated in the 60-week FOCUS FH study under an

The companies opted to withdraw the marketing authorization application amid the Committee for Medicinal Products for Human Use (CHMP) review

Pfizer Inc., of New York, said the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for Xeljanz (tofacitnib citrate) for the treatment of adults with moderate to severe active rheumatoid arthritis...Pfizer intends to appeal the opinion and seek a re-examination by CHMP

Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said the European Committee

In separate news, another Galapagos unit, Argenta, inked a deal with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its respiratory drug discovery services to an undisclosed target within Boehringer's respiratory disease portfolio...In other news, BioInvent said the first patient has been treated in a Phase II study of BI-505 for smoldering multiple myeloma, or asymptomatic myeloma

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

Medigene's partner, Nordic Pharma Group, of Paris, is planning to launch Veregen in the Czech Republic, Poland, Hungary and Slovakia this year, upon conclusion of the reimbursable price-fixing procedure by the responsible authority...The withdrawal is based on a request by the European Committee for Medicinal Products for Human Use/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study...Vanda said it intends to

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

The companies will target development of drugs to treat topical ophthalmic diseases, including ocular allergy, dry eye and other inflammatory eye conditions...Araxes Pharma LLC, of San Diego, said it inked an exclusive arrangement with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to develop first-in-class therapeutics against a certain cancer target

To date, 150 patients out of a total of 200 patients have already been recruited in 16 centers in Germany, Austria and Israel...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections...ProBioGen AG, of Berlin, said another undisclosed global pharma company licensed rights to its GlymaxX ADCC-enhancement technology

The approval will expand Lupin's range of Suprax dosage forms available to treat approved indications in appropriate patients...Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended market approval for Sanofi Pasteur's 6-in-1 pediatric vaccine Hexyon/Hexacima, the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough

In connection, it entered into a loan and security agreement with Biotech Investment Group LLC, relating to the funding of certain tenant improvements, relocation costs, security deposit, portions of rents related to the leased San Diego facility and certain other cash needs...Exelixis Inc., of South San Francisco, partnered with Swedish Orphan Biovitrum AB (Sobi), of Stockholm, Sweden, to distribute and commercialize Cometriq (cabozantinib) for metastatic medullary thyroid cancer in the European

Pursuant to the terms, each of the company's ordinary shares, including shares represented by American depositary shares (ADS), will be cancelled in exchange for the right to receive $2.20 in each per share, or $15.40 per ADS...Due to the oversubscription, the closing unit price was set at NIS3.544 per unit

The EMA's Committee for Medicinal Products for Human Use granted GSK's request for accelerated assessment of the application