Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted a breakthrough therapy designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD...The company expects to repurchase about $7.5 billion of common stock over the next 12 months, financed through a

Addex Therapeutics SA, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments

to formulate CytoDyn's PRO 140 bulk drug substance through a fill-and-finish process for clinical-ready vials to advance two National Institutes of Health (NIH)-funded Phase IIb studies...Pfenex Inc., of San Diego, awarded Glide Pharma, of Oxford, UK, a subcontract to develop a solid formulation containing the recombinant protective antigen (rPA) from Bacillus anthracis expressed in Pfenex Expression Technology, suitable for delivery with the Glide SDI (solid dose injector

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...The other company, Theravance Biopharma, will be a biopharmaceutical company focused on discovery

flutemetamol to help select patients for a Phase I trial testing Eisai's E2609, a BACE inhibitor for the potential treatment of Alzheimer's disease...Lambrolizumab is Merck's investigational antibody therapy targeting programmed death receptor that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types...The Antimonopoly Committee of Ukraine gave approval to Valeant Pharmaceuticals International Inc., of Laval, Quebec, for its proposed acquisition of

Addex Therapeutics, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...Those and other data were presented at the European Association for the Study of the Liver meeting in Amsterdam, the Netherlands...Tranzyme Pharma Inc., of Research Triangle Park, N.C., and Ocera Therapeutics Inc., of

Merck currently markets Noxafil oral suspension for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 and older, at high risk of developing those infections due to being severely immunocompromised...PeptiDream Inc., of Tokyo, and Ipsen SA, of Paris, entered a research collaboration and license option agreement to discover, evaluate, potentially develop and launch therapeutic peptides to treat serious medical conditions in areas of therapeutic focus for Ipsen

Acceleron Pharma Inc., of Cambridge, Mass., said the FDA granted orphan designation for ACE-536 for the treatment of beta-thalassemia and for the treatment of myelodysplastic syndromes...Other candidates currently undergoing tests required for investigational new drug applications with the FDA include an undisclosed iBioLaunch-produced monoclonal antibody and vaccines for anthrax, malaria and yellow fever...The agreement aims to identify inhibitors of a kinase that plays a key role in tissue

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

AMRI, of Albany, N.Y., signed a license agreement with Chai Therapeutics LLC, an affiliate of Bessor Pharma LLC, of Framingham, Mass., to develop its tubulin inhibitor, ALB109564, which is in Phase I testing...Celgene expects Revlimid to be available to patients late in the second quarter of 2013...Teva opted to make a one-time payment of $880,000 in lieu of future payments

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations...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

Afatinib is under review for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer with an epidermal growth factor receptor mutation as detected by an FDA-approved test

Public biopharmaceutical companies, which had a great year, by and large were not able to fully leverage their increased stock valuations, successful clinical results and product approvals into follow-on and other financings...The company paid $350 million in cash, with the remainder made up of milestones: $195 million related to the development and regulatory approval of Bruton's tyrosine kinase (Btk) inhibitor AVL-292, and up to $380 million in potential payments contingent upon the development

The company paid $350 million in cash, with the remainder made up of milestones: $195 million related to the development and regulatory approval of Bruton's tyrosine kinase (Btk) inhibitor AVL-292, and up to $380 million in potential payments contingent upon the development and approval of candidates generated from Avila's Avilomics platform. (See BioWorld Today, Jan. 27, 2012.) On the other side of the coin, Medicis was acquired by Canada's largest specialty pharma Valeant Pharmaceuticals

NovaDel Pharma Inc., of Bridgewater, N.J., said it signed a preliminary agreement to sell its NovaMist technology to Australian public pharmaceutical company Suda Ltd...The company said it is now free to commercialize or enter into commercialization agreements for its oral BDP suite of products with other parties without limitation

GlaxoSmithKline plc, of London, and the Fred Hutchinson Cancer Research Center entered a partnership to develop therapeutics to treat an inherited form of muscular dystrophy...The goal of the agreement is to develop a small-molecule-based medicine to potentially reverse facioscapulohumeral muscular dystrophy by inhibiting the activity of a protein that is incorrectly expressed by the DUX4 gene in people with the disease

In other news, Bayer said its BAY 86-6150 is being investigated in a Phase II/III study, dubbed TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete...In other news, Viralytics is offering shareholders up to $15,000 worth of shares at 30 cents each in a new underwritten share purchase plan to fund the company's intravenous cancer trial and the continued clinical research and development of Cavatak, its lead oncolytic virus candidate

Astellas Pharma Inc., of Tokyo, said it submitted a supplemental new drug application seeking approval of Tarceva (erlotinib) in first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have EGFR-activating mutations as detected by an approved test

Astellas Pharma Inc., of Tokyo, said it submitted a supplemental new drug application seeking approval of Tarceva (erlotinib) in first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have EGFR-activating mutations as detected by an approved test