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

The design of the trial later will be adapted, enabling it to separate into three separate personalized arms to test AZD0424 in different combinations alongside standard or other experimental treatments in specific patient populations...In other news, Boehringer Ingelheim said it enrolled the first patients in its Phase III interferon-free (IFN-free) program, HCVerso, testing its IFN-free polymodal regimen combining faldaprevir (BI 201335), a next-wave once-daily protease inhibitor, and BI 207127

The drug is expected to launch in Canada in the second quarter...Pfizer Inc., of New York, said the Committee for Medicinal Products for Human Use of the European Medicines Agency offered a positive opinion on the conditional marketing authorization of bosutinib in the European Union (EU) in chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia patients previously treated with one or more tyrosine kinase inhibitors and for whom imatinib

Gentium SpA, of Villa Guardia, Italy, said it submitted responses to the second list of outstanding issues to the European Committee for Medicinal Products for Human Use in connection with the company's marketing authorization application for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

Vanda Pharmaceuticals Inc., of Rockville, Md., said the European Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion recommending against approval of Fanaptum (oral iloperidone tablets) for the treatment of schizophrenia in adult patients...Vanda said it intends to appeal the opinion and request a re-examination of the CHMP decision

Those and other data are set to be presented at the American Society for Hematology meeting in Atlanta next month...Should the trial hit the predefined overall survival endpoint, the company said it expects those data to support marketing applications for AlloStim in the U.S., European Union and other jurisdictions...Under the terms, Nordic Pharma will commercialize the product in those areas, with Medigene receiving milestone payments and double-digit royalties on sales, as well as certain payments

Friday's positive news does not trigger any milestone payment from Sanofi to Copenhagen, Denmark-based Zealand, but it can still take in $215 million in development and commercial milestones, including $40 million for a depot formulation of Lyxumia...Its safety and tolerability profile appears similar to other members of its class, with transient nausea, vomiting and diarrhea among the most common side effects...Other safety issues, according to the EMA, including hypoglycemia when Lyxumia was