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Aveo Receives CRL from FDA After Stopping RCC Program
A few weeks after the ODAC meeting Aveo's partner Astellas said it didn't intend to submit a marketing authorization application to the European Medicines Agency for tivozanib for the treatment of RCC patients or fund any future trials in RCC under the firms' strategic collaboration inked in February 2011. (See BioWorld Today, May 28, 2013.) RBC Capital Markets LLC analyst Michael Yee wrote in a research note that Astellas' decision to drop the kidney cancer indication was not unexpectedBy Peter Winter | BioWorld Today | Tuesday, June 11, 2013 -
AVEO Terminates RCC Program, Cuts Workforce to Conserve Cash
A few weeks after the ODAC meeting AVEO's partner Astellas Pharma Inc., of Tokyo, said it didn't intend to submit a marketing authorization application to the European Medicines Agency for tivozanib for the treatment of RCC patients or fund any future trials in RCC under the firms' strategic collaboration inked in February 2011. (See BioWorld Today, May 28, 2013.) RBC Capital Markets LLC analyst Michael Yee said in a research note that Astellas' decision to drop the kidney cancer indication wasBy Peter Winter | BioWorld Insight | Monday, June 10, 2013 -
T-VEC Not Top Banana, but Still in the Pudding
Interim OS suggested T-VEC may be "better than the very low expectations" for the company's pipeline and "an incremental revenue opportunity" for Amgen, RBC Capital Markets LLC analyst Michael Yee suggested in a research noteBy Marie Powers | BioWorld Today | Tuesday, June 4, 2013 -
Salix's Topical Budesonide a Hit in Phase III Studies in UC
could help add growth and diversity beyond Xifaxan alone," Malhotra wrote in a research noteBy Jennifer Boggs | BioWorld Today | Thursday, May 23, 2013 -
Xenoport Drops Spasticity Drug, Reboots Horizant
Barrett said Xenoport hopes to obtain Tecfidera for a new arm in the final cohort of a multiple ascending dose study of XP23829, a BG-12 prodrug. (See BioWorld Today, March 28, 2013.) In a research note, RBC Capital Markets LLC analyst Michael Yee said the "big picture Bull case" is that Xenoport is inexpensive, with at a market cap of approximately $300 million and a reasonable chance of moving XP23829 to market in MS or psoriasis, perhaps partnered with a pharma company "to help speed andBy Marie Powers | BioWorld Today | Tuesday, May 21, 2013 -
'JAK'ing Up Myelofibrosis; Sanofi's Phase III Data Solid
Longer-term follow-up beyond the 24 weeks may be needed to tease out any differences," he wrote in a research note, adding that "clear demonstration of a survival benefit" could increase its threat to JakafiBy Jennifer Boggs | BioWorld Today | Monday, May 20, 2013 -
Elan Buying into Theravance, GSK Royalty Stream for $1B
Berenberg analyst Adrian Howd wrote in a research note that Elan appeared to have paid a "fair" priceBy Cormac Sheridan | BioWorld International | Wednesday, May 15, 2013 -
Elan Buying into Theravance, GSK Royalty Stream for $1B
Berenberg analyst Adrian Howd wrote in a research note that Elan appeared to have paid a "fair" priceBy Cormac Sheridan | BioWorld Today | Tuesday, May 14, 2013 -
Isis Peers Beyond Kynamro, Seeks $171M for Pipeline
Jefferies Group LLC analyst Thomas Wei wrote in a research note that the company is valued entirely on Nuedexta sales, but "we could see upside from new indications and await data from ongoing proof-of-concept studies of AVP-923 inBy Marie Powers | BioWorld Today | Friday, May 10, 2013 -
Alexza Banking $40M Up Front in U.S. Adasuve Deal with Teva
In a research note last month, Piper Jaffray analyst Charles Duncan wrote that it "is likely to be something of a moving target in advance of launchBy Jennifer Boggs | BioWorld Today | Thursday, May 9, 2013 -
Arena Yanks MAA, Falls on Belviq Launch Delay in U.S.
Based on a 31.5 percent royalty, we forecast Arena will receive $22 million in Belviq revenues this year and $141 million in 2014," he wrote in a research note...Those data "reinforced our belief that sofosbuvir/GS-5885 will be the dominant all-oral regimen in treatment-naïve G1 HCV," analyst Bret Holley, of Guggenheim Partners, said in a research noteBy Jennifer Boggs | BioWorld Today | Monday, May 6, 2013 -
FDA Gives its Nod to Procysbi; Raptor Ascends
In a research note following the company's 2012 and fourth-quarter earnings call in March, Cowen and CoBy Marie Powers | BioWorld Today | Wednesday, May 1, 2013 -
Amgen Product Sales, Revenues Fall Short of Street Estimates
Amgen indicated that demand trends have not changed," wrote analyst Eric Schmidt, of New York-based Cowen and Co., in a research note, "but that much of the sequential decline in sales was due to late 2012 buy-ins by secondary customers ahead of Q1 price increasesBy Karen Pihl-Carey | BioWorld Today | Thursday, April 25, 2013 -
Other News To Note
and EU regulators," RBC Capital Markets analyst Shibani Malhotra wrote in a research noteBioWorld International | Wednesday, April 24, 2013 -
The Rise and Rise of Biotech: Tracking Progress BIO to BIO
According to Credit Suisse analyst Ravi Mehrotra writing in a research note, "We do not think that we are in a 'biotech bubble,' given that the drivers of the biotech sector's YTD performance are very different from those in '99/'00By Peter Winter | BioWorld Insight | Monday, April 22, 2013 -
Other News To Note
and EU regulators," RBC Capital Markets analyst Shibani Malhotra wrote in a research noteBioWorld Today | Monday, April 22, 2013 -
Theravance Jumps on Briefing Docs for GSK-Partnered Breo
He wrote in a research note that his firm is "marginally more comfortable with the approvability of Breo for COPD in the U.S.," dropping the likelihood of the complete response letter from 60 percent to 50 percent...We believe the totality of the data continue to support a positive outcome for Breo efficacy," Somaiya wrote in a research noteBy Jennifer Boggs | BioWorld Today | Tuesday, April 16, 2013 -
Biogen's Tecfidera Approved as Expected; Launch in 'Days'
analyst Eric Schmidt said in a January research note, "Tecfidera is one thing we do not worry about." (See BioWorld Today, Jan. 29, 2013.) Wall Street also saw a positive omen in the fact that the FDA declined to schedule an advisory committee meeting to discuss Tecfidera's risk/benefit profile, despite public pressure from MS competitor Teva Pharmaceutical Industries Ltd...In a research note on Teva, analyst Shibani Malhotra, of RBC Capital Markets, said he will "wait to see the pick up in theBy Jennifer Boggs | BioWorld Today | Thursday, March 28, 2013 -
Other Omontys Shoe Drops as Affymax Cuts Work Force Deep
Affymax already has proven its candidate noninferior to Epogen, and made publicly known that the price would be competitive, a relief to dialysis providers squeezed by the Centers for Medicare & Medicaid Services bundling rules. (See BioWorld Insight, Dec. 19, 2011, and BioWorld Today, Dec. 8, 2011.) Jim Birchenough, analyst with BMO Capital Markets, wrote in a research note at the time of the FDA panel vote that Omontys price discounts could win Affymax the one-third of the dialysis marketBy Randy Osborne | BioWorld Today | Wednesday, March 20, 2013 -
Aeterna Zentaris Slides on Perifosine Miss in Myeloma
While we are disappointed with the outcome of the DSMB interim analysis, we continue to believe that the potential of Aeterna Zentaris' late-stage products beyond perifosine is not currently reflected by its share price," he wrote in a research noteBy Staff Reports | BioWorld Today | Tuesday, March 12, 2013
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