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Dynavax Tumbles on Heplisav Delay; More Safety Data Needed
Hopes for a resubmitted Heplisav application by the end of this year were dashed Monday, after Dynavax Technologies CorpBy Jennifer Boggs | BioWorld Today | Tuesday, June 11, 2013 -
Manufacturing, Marketing And Distribution Agreements Between Biotech Companies: April 1 - May 23, 2013
rights to market Pertyze (pancrelipase) for exocrine pancreatic insufficiency due to cystic fibrosis Terms were not disclosed 5/10/13 Kinex Pharmaceuticals Inc. (Buffalo, N.Y.) Zenith Technology Corp. (Dunedin, New Zealand) ND Collaboration for commercial rights to oncology candidates Oraxol and Oratecan in New Zealand and Australia Zenith affiliate ZenRx will provide an undisclosed up-front payment, milestones and royalties, and Zenith will commit resources to the global development programs 5BioWorld Insight | Tuesday, May 28, 2013 -
Other News To Note
Under the terms of AnaptysBio's contract with the Science and Technology Corp., AnaptysBio will be responsible for delivering anti-ricin antibodies to the Edgewood Chemical and Biological Center, an agency of the U.S. ArmyBioWorld Today | Friday, May 17, 2013 -
Other News To Note
Kinex Pharmaceuticals Inc., of Buffalo, N.Y., executed a collaborative licensing agreement granting Zenith Technology Corp., of Dunedin, New Zealand, through affiliate ZenRx, commercial rights to oncology candidates Oraxol, an oral formulation of paclitaxel, and Oratecan, an oral formulation of irinotecan, in New Zealand and AustraliaBioWorld Today | Tuesday, May 7, 2013 -
Opsona's TLR Biology Will Get a $43M Shot in the Arm
Dynavax Technologies Corp., of Berkeley, Calif., is the most recent casualtyBy Cormac Sheridan | BioWorld International | Wednesday, May 1, 2013 -
Opsona's TLR Biology Will Get a $43M Shot in the Arm
Dynavax Technologies Corp., of Berkeley, Calif., is the most recent casualtyBy Cormac Sheridan | BioWorld Today | Tuesday, April 30, 2013 -
Other News To Note
Medicyte GmbH, of Heidelberg, Germany, said it signed a licensing agreement for the rights to use Lentiviral vector technology from Life Technologies Corp., of Carlsbad, Calif., to develop and market next-generation, cell-based upcyte cell products to the biopharma and academic research marketsBioWorld International | Wednesday, April 3, 2013 -
Appointments and Advancements
Dynavax Technologies Corp., of Berkeley, Calif., appointed David Novack senior vice president of operations and qualityBioWorld Today | Monday, April 1, 2013 -
Collaborations Between Biotechnology Companies And Government/Nonprofit Institutions: Dec. 1, 2012 - March 21, 2013
Company (Location) University/ Nonprofit Type of Agreement Product Area Details Date DECEMBER Biogen Idec Inc. (Weston, Mass.) Several leading academic research centers Research consortium Created a research consortium in collaboration with several leading academic research centers aimed at leveraging a range of scientific techniques and disciplines to identify new approaches to treating amyotrophic lateral sclerosis Each participating lab will undertake a three-year research project, andBioWorld Insight | Monday, March 25, 2013 -
FDA Submissions, Approvals & Other Actions: February 2013
Technologies Corp. (Berkeley, Calif.) Heplisav Vaccine Hepatitis B FDA issued a complete response letter 2/26/13 Idenix Pharmaceuticals Inc. (Cambridge, Mass.) IDX184 A nucleotide polymerase inhibitor Hepatitis C virus infection Elected not to continue its clinical development program after the FDA placed it on clinical hold due to cardiac adverse events 2/6/13 MISCELLANEOUS Hyperion Therapeutics Inc. (South San Francisco) Ravicti Glycerol phenylbutyrate Urea cycle disorders FDA issued anBioWorld Insight | Monday, March 11, 2013 -
Other News To Note
Life Technologies Corp., of Carlsbad, Calif., signed a collaborative research agreement and related license with Harvard University and acquired exclusive rights to develop a panel of characterization assays designed to rapidly evaluate human pluripotent stem cells for their utility in a variety of discovery and translational research applicationsBioWorld Today | Tuesday, March 5, 2013 -
Week in Review
Dynavax Technologies CorpBioWorld Insight | Monday, March 4, 2013 -
No Surprise: FDA Rejects Dynavax Hepatitis B Vaccine
The FDA's complete response letter (CRL) for its Heplisav hepatitis B vaccine was no surprise to Dynavax Technologies Corp., of Berkeley, Calif., as it had extensive behind-the-scenes conversations with the FDA between the November advisory committee meeting and the CRL issued over the weekend...The FDA denied Dynavax Technologies Corp.'s application for approval of Heplisav, which took heavy fire at that advisory panel meeting over its safety profileBy Catherine Shaffer | BioWorld Today | Tuesday, February 26, 2013 -
Biotech-Biotech Collaborations: Modified And Terminated Agreements: Dec. 1, 2012 - Feb. 21, 2013
Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date I. Modified Agreements JANUARY Auxilium Pharmaceuticals Inc. (Malvern, Pa.) BioSpecifics Technologies CorpBioWorld Insight | Monday, February 25, 2013 -
U.S. Public Offering Performance of Biotech Industry by Underwriter: Jan. 1 - Dec. 31, 2012*
Technologies Corp. (DVAX) 5/10/12 $4.25 $2.85 $74.4 -33% Exelixis Inc. (EXEL) 2/10/12 $5.50 $4.57 $69.58 -17% Exelixis Inc. (EXEL) (co-lead)2 8/9/12 $4.25 $4.57 $146.6 +8% Horizon Pharma Inc. (HZNP) (co-lead) 9/20/12 $3.50 $2.33 $74.97 -33% Hyperion Therapeutics Inc. (HPTX) (IPO; co-lead) 7/27/12 $10 $11.28 $57.5 +13% ImmunoCellular Therapeutics Ltd. (OTC QB:IMUC) (lead) 1/11/12 $1.10 $1.92 $10.44 +75% ImmunoGen Inc. (IMGN) 7/12/12 $16 $12.75 $100 -20% MannKind Corp. (MNKD) 2/6/12 $2.40 $2.31BioWorld Insight | Monday, January 28, 2013 -
Other News To Note
Auxilium Pharmaceuticals Inc., of Malvern, Pa., exercised an option under an agreement with BioSpecifics Technologies CorpBioWorld Today | Tuesday, January 8, 2013 -
Biotech/Biotech Collaborations
Zenith Technology CorpBioWorld Snapshots | Friday, January 4, 2013 -
FDA Submissions, Approvals & Other Actions: November 2012
Technologies Corp. (Berkeley, Calif.) Heplisav Toll-like receptor 9 agonist used as an adjuvant for vaccine Hepatitis B virus FDA advisory panel voted against approval based on inadequacy of safety data 11/16/12 Ligand Pharmaceuticals Inc. (San Diego) and GlaxoSmithKline plc (London) Promacta Eltrombopag Thrombo-cytopenia in patients with chronic hepatitis C Received FDA approval to expand its use with interferon-based therapy 11/20/12 Savara Pharmaceuticals Inc. (Austin, Texas) AeroVancBioWorld Insight | Monday, December 10, 2012 -
Venture Capital And Other Investments In Private Biotechnology Companies: November 2012
Total: $610.9M Company Location Amt. (M) Details Date Applied Genetic Technologies CorpBioWorld Insight | Monday, December 3, 2012 -
Biotech Collaborations Between Pharmaceutical & Miscellaneous Companies: Sept. 1 - Nov. 19, 2012
9/25/12 Life Technologies Corp. (Carlsbad, Calif.) Bristol-Myers Squibb Co. (New York) ND Master development agreement for current and future companion diagnostics projects The agreement covers an initial project in oncology and provides for a long-term partnership across a potentially broad range of Life instrument platforms and a wide range of therapeutic areas 9/18/12 Merck KGaA (Darmstadt, Germany) iPS Academia Japan Inc. (Kyoto, Japan) ND Global licensing agreement for induced pluripotentBioWorld Insight | Monday, November 26, 2012
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