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Pharma Clinical & FDA Action Update: December 2012
Novartis AG (Basel, Switzerland) ACZ885 Canakinumab Systemic juvenile idiopathic arthritis A Phase III trial showed that 84% of patients treated with ACZ885 improved by at least 30% compared to 10% of the placebo group, after 15 days of treatment, and that benefit was sustained after 29 days...another Phase III trial showed that 45% of patients receiving ACZ885 who were taking corticosteriods at the beginning of the study were able to reduce the dosage substantially, and one-third of patientsBioWorld Insight | Monday, January 14, 2013 -
American Society of Hematology: December 2012
Novartis AG (Basel, Switzerland) Tasigna Nilotinib Philadelphia chromosome-positive chronic myelogenous leukemia Phase III data showed that patients achieved significantly deeper molecular responses vs. Glivec (imatinib) 12/12/12 Onconova Therapeutics Inc. (Newtown, Pa.) Rigosertib Multikinase PI3K inhibitor Myelodysplastic syndromes and acute myeloid leukemia Phase I/II data showed that single-agent rigosertib was well tolerated and achieved effects that were in line with previous studies 12/12BioWorld Insight | Monday, January 14, 2013 -
Pharma: Clinic Roundup
Novartis AG, of Basel, Switzerland, said data published in The Lancet showed that patients on mTOR inhibitor Afinitor (everolimus) tablets with noncancerous kidney tumors known as renal angiomyolipomas associated with tuberous sclerosis complex experienced a significant reduction in tumor size and the absence of tumor progressionBioWorld Today | Monday, January 14, 2013 -
Value of Gene-Based Patents in the Eye of the Beholder
To make its case for requiring an adcom evaluation, Teva mentioned safety concerns that cropped up postmarket for other MS drugs, including Biogen's Tysabri (nataluzimab) and Novartis AG's Gilenya (fingolimodBy Mari Serebrov | BioWorld Today | Friday, January 11, 2013 -
Other News To Note
The study tested multiple ascending doses of Somatoprim in healthy male volunteers, administered alone and in combination with Sandostatin (octreotide, Novartis AGBioWorld International | Wednesday, January 9, 2013 -
Clinic Roundup
The study tested multiple ascending doses of Somatoprim in healthy male volunteers, administered alone and in combination with Sandostatin (octreotide, Novartis AGBioWorld Today | Tuesday, January 8, 2013 -
After a Bumpy Road, Can RNA Therapeutics Prosper in 2013?
Novartis AG, for instance, purchased a 19.9 percent equity stake in Alnylam Pharmaceuticals IncBy Brian Orelli | BioWorld Insight | Monday, January 7, 2013 -
Biotech Products Approved 1992-2013
Biotech Products Approved in 2013 | Biotech Products Approved 1982-2012 BIOTECH PRODUCTS 2013 Company Product Marketer Indication (U.S. Approval Date; Month/Day) Theravance Inc. Breo Ellipta GlaxoSmithKline plc Chronic obstructive pulmonary disease (5/13) Genentech Inc. Actemra Genentech Inc. Polyarticular juvenile idiopathic arthritis (5/1) Raptor Pharmaceutical Corp. Procysbi Raptor Pharmaceutical Corp. Nephropathic cystinosis (5/1) Sucampo PharmaceuticalsBioWorld Snapshots | Friday, January 4, 2013 -
Biotech/Big Pharma Collaborations
Boehringer Ingelheim GmbH Target validation deal for OBT to further validate potential targets from its OGAP database of human proteins OBT is getting an up-front payment and research funding and could receive milestones, as well as royalties Oxford BioMedica plc Novartis AG Deal to manufacture clinical grade material using Oxford's LentiVector gene delivery technology and to provide certain process development services Oxford will manufacture several batches of a lentiviral vectorBioWorld Snapshots | Friday, January 4, 2013 -
Biotech - Big Pharma Collaborations: Modified And Terminated Agreements: Nov. 1 - Dec. 27, 2012
Novartis AG (Basel, Switzerland) ND Expanded partnership to include Ylanthia and Slonomics technologies The two companies have agreed to cross-license future improvements, and have waived existing co-development options 11/8/12 IIBioWorld Insight | Wednesday, January 2, 2013 -
Collaborations Between Biotech And Pharmaceutical Companies: Nov. 1 - Dec. 27, 2012
Novartis AG; Basel, Switzerland) $43 Dendreon sold its immunotherapy manufacturing facility in Morris Plains, N.J., to Novartis Novartis paid $43M in cash 12/21/12 Evotec AG (Hamburg, Germany) Janssen Pharmaceuticals Inc. $175 Partnership for Evotec's NMDA antagonist portfolio Deal is worth a potential $75M up to launch, plus milestones payable on further products and/or indications, and $100M in commercial milestones 12/18/12 Genmab A/S (Copenhagen, Denmark) Kyowa Hakko Kirin CoBioWorld Insight | Wednesday, January 2, 2013 -
Other News To Note
Novartis AG, of Basel, Switzerland, said results of two Phase III trials of an investigational compound, ACZ885, for systematic juvenile idiopathic arthritis (SJIA), appeared in the New England Journal of MedicineBioWorld International | Wednesday, December 26, 2012 -
Pharma: Clinic Roundup
Novartis AG, of Basel, Switzerland, said results of two Phase III trials of an investigational compound, ACZ885, for systematic juvenile idiopathic arthritis (SJIA), appeared in the New England Journal of MedicineBioWorld Today | Friday, December 21, 2012 -
Other News To Note
Dendreon Corp., of Seattle, said it sold its immunotherapy manufacturing facility in Morris Plains, N.J., to Novartis Pharmaceuticals Corp., a unit of Basel, Switzerland-based Novartis AG, for $43 million in cash...Trovagene Inc., of San Diego, said it granted Genoptix Inc., a unit of Basel, Switzerland-based Novartis AG, a worldwide, nonexclusive license to incorporate nucleophosmin protein, or NPM1, into research and clinical testing services for acute myelogenous leukemiaBioWorld Today | Friday, December 21, 2012 -
Tasimelteon Tames Circadian Rhythms in Phase III Testing
Vanda also has an FDA-approved product, Fanapt (iloperidone) for schizophrenia, marketed by Novartis AGBy Catherine Shaffer | BioWorld Today | Wednesday, December 19, 2012 -
Vaccines Firm Goes to Vivalis in All-Share Deal Worth $175M
Under Intercell's deal for the Pseudomonas vaccine with Novartis AG, it is entitled either to receive royalties and potential development milestones of €120 million, or to co-develop the product, in which case it will take a share of the profitsBy Nuala Moran | BioWorld International | Wednesday, December 19, 2012 -
Dutalys Gets First Taker for Bispecific Antibody Platform
DuoBodies, the subject of alliances with Novartis AG, Johnson & Johnson and one other unnamed big pharma company, are generated by exploiting a natural Fab-arm exchange process that occurs between IgG4 antibodies in vivoBy Cormac Sheridan | BioWorld International | Wednesday, December 19, 2012 -
Pharma: Other News To Note
Novartis AG, of Basel, Switzerland, said the FDA approved Signifor (pasireotide) injection for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curativeBioWorld Today | Tuesday, December 18, 2012 -
Washington Roundup
The proposed order required Watson and Actavis to sell the rights and assets to 18 drugs to Sandoz International GmbH, a unit of Basel, Switzerland-based Novartis AG, and to Par Pharmaceuticals Inc., of Woodcliff Lake, N.J., and to relinquish the manufacturing and marketing rights to three other drugsBioWorld Today | Tuesday, December 18, 2012 -
Vaccines Firm Goes to Vivalis in All-Share Deal Worth $175M
Under Intercell's deal for the Pseudomonas vaccine with Novartis AG, it is entitled either to receive royalties and potential development milestones of €120 million, or to co-develop the product, in which case it will take a share of the profitsBy Nuala Moran | BioWorld Today | Tuesday, December 18, 2012
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