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November 4, 2012
14:26 EDTGSK, SNY, MRK, NVS, BMY, PFE, JNJ, AZN, LLY, RHHBYIn new hit for 'big pharma' India revokes patent on Roche drug, Reuters says
India's Intellectual Property Appellate Board, IPAB, revoked a patent granted six years ago on Roche's (RHHBY) hepatitis C drug Pegasys, says Reuters.Reference Link
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November 16, 2015
14:38 EDTJNJGenmab confirms FDA approval of Darzalex
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14:07 EDTAZNClovis plunges after lung cancer drug response rate misses expectations
Shares of Clovis Oncology (CLVS) plunged more than 70% after the drugmaker reported new details regarding its cancer drug candidate rociletinib, with new, confirmed data showing an unexpected drop in effectiveness. SURPRISING DRUG RESULTS: Clovis announced this morning new details regarding its rociletinib drug, which is being studied for the treatment of non-small cell lung cancer. According to the company, the Food and Drug Administration is now requesting additional clinical data on the drug, with a renewed focus on so-called confirmed treatment responses. Clovis explained that previous applications submitted to the FDA -- as well as early data on the drug publicized at medical conferences and elsewhere -- contained some immature and unconfirmed results. Perhaps most notably, the company disclosed that "as the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected," with the current confirmed response rate for rociletinib now standing at 28% for the 500mg dose and 34% for the 625mg group. The primary driver of the low conversion to confirmed responses was due to ineffective tumor shrinkage as well as general disease progression, including brain metastasis, said the company. APPROVAL DELAY: In the wake of this morning's update, Piper Jaffray's Charles Duncan cut his price target on Clovis shares to $28 from $92 while reiterating a Neutral rating. Duncan explained that Clovis had previously reported a 54%-60% unconfirmed response rate for rociletinib, a significant change from today's confirmed numbers. The analyst had previously speculated that rociletinib might further differentiate itself in the market by demonstrating a meaningful impact on brain metastasis, but Monday's commentary from Clovis seems to specifically downplay that possibility. Though the new data "may still ultimately be approvable," Duncan envisions an approval delay of three to six months given what was revealed, and he pushed anticipated first U.S. sales of the drug to the fourth quarter of 2016 while cutting his expected second-line market penetration to just 25% from 45%. RETHINKING CLOVIS: Goldman Sachs analyst Terence Flynn said he views the news as a "significant setback" for rociletinib, especially given that the updated responses rates come in below that of Tagrisso, AstraZeneca's (AZN) recently-approved rival treatment option. As a result, Flynn put his Conviction Buy rating and $123 price target on Clovis "under review." IMMUNOGEN PRESSURED: Weighing in on the news, RBC's Simos Simeonidis speculated that Monday's selloff in ImmunoGen (IMGN) shares could be related to the Clovis update, as investors may be drawing a parallel between the company's IMGN853 and rociletinib. IMGN853 saw a similar drop in efficacy when adjusting data for confirmed responses, but the drug looks outright potent when limiting results to just key patient groups, the analyst contended. Though IMGN853 will still have to prove itself in larger trials, Simeonidis nevertheless sees the current weakness in ImmunoGen as a buying opportunity. PRICE ACTION: Shares of Clovis have dived more than $71, or 71.5%, to $28.35 in afternoon trading, while ImmunoGen has fallen 7% to $11.62. AstraZeneca, meanwhile, is up better than 4%.
13:32 EDTPFECantor helps Moelis clinches advisory role for Pfizer, Reuters reports
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13:09 EDTJNJFDA approves Darzalex to treat multiple myeloma
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11:47 EDTLLYEli Lilly reports 8.4% passive stake in Ignyta
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10:27 EDTAZNGoldman puts Conviction Buy-rated Clovis under review
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10:23 EDTAZNClovis price target cut to $28 from $92 at Piper Jaffray
Piper Jaffray analyst Charles Duncan cut his price target for shares of Clovis Oncology (CLVS) to $28 from $92 after the company announced that rociletinib efficacy data matured and the number of patients with a confirmed response is lower than expected. The updated response rate may still ultimately be approvable, but it further hinders rociletinib's competitive positioning compared to AstraZeneca's (AZN) Targrisso, Duncan tells investors in a research note. The analyst pushed back his first rociletinib sales estimate to Q4 of 2016 and lowered the drug's peak penetration of the second line market from 25% to 45%. He reiterates a Neutral rating on Clovis. The stock is down 67%, or $66.93, to $32.50 in morning trading.
10:00 EDTLLYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Alliant Energy (LNT) upgraded to Outperform from Market Perform at Wells Fargo... AmerisourceBergen (ABC) upgraded to Equal Weight from Underweight at Morgan Stanley... Amphenol (APH) upgraded to Buy from Neutral at Goldman... CA Technologies (CA) upgraded to Neutral from Sell at Citi... Cempra (CEMP) upgraded to Overweight from Equal Weight at Morgan Stanley... Edgewell Personal Care (EPC) upgraded to Neutral from Sell at Goldman... Eli Lilly (LLY) upgraded on improved growth outlook at BMO Capital... MiMedx (MDXG) upgraded to Strong Buy from Buy at Needham... NVIDIA (NVDA) upgraded to Buy from Hold at Canaccord... New York REIT (NYRT) upgraded to Buy from Hold at Evercore ISI... Oracle (ORCL) upgraded to Conviction Buy from Buy at Goldman... Perrigo (PRGO) upgraded to Buy from Neutral at UBS... Semtech (SMTC) upgraded to Buy from Neutral at B. Riley... Tullow Oil (TUWOY) upgraded to Buy from Neutral at UBS... Wabtec (WAB) upgraded to Outperform on valuatoin at Raymond James.
09:59 EDTPFEOmega bought Valeant in Q3, sold some SuneEdison
Leon Cooperman's Omega Advisors gave a quarterly update on its stakes in a filing this morning, disclosing its positions as of September 30. NEW STAKES: Pfizer (PFE), Valeant (VRX) Walgreens Boots Alliance (WBA), TerraForm Global (GLBL), Cigna (CI). INCREASED STAKES: Google Class A (GOOGL), Facebook (FB), Delta Air Lines (DAL). DECREASED STAKES: SunEdison (SUNE), Shire (SHPG), Citi (C), KAR Auction (KAR), LyondellBasell (LYB). LIQUIDATED STAKES: McKesson (MCK), 21st Century Fox (FOXA), General Motors (GM), QEP Resources (QEP), eBay (EBAY).
08:44 EDTLLYEli Lilly upgraded on improved growth outlook at BMO Capital
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08:35 EDTMRKMerck to present Phase 2 hep C therapy data at The Liver Meeting
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08:32 EDTAZNClovis reopens, down 64% after FDA requests added data for rociletinib
AstraZeneca (AZN), which is at work on a drug similar to rociletinib, is up 2.5% in pre-market trading.
07:24 EDTMRKSalomon to hold a conference
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07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.
06:33 EDTPFEPfizer, Allergan deal brings focus on U.S. tax-inversion deals, Reuters says
Pfizer's (PFE) takeover bid for Allergan (AGN) has refocused financial markets over a potential move by the U.S. Treasury Department against tax-inversion deals, Reuters reported Friday. The outlook for such a move remained unclear on Friday, the report says. Reference Link
06:07 EDTLLYEli Lilly upgraded to Outperform from Market Perform at BMO Capital
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05:57 EDTAZNAstraZeneca urges UK for antibiotics investment shake-up, Financial Time says
AstraZeneca has urged the U.K. government to develop a new model for incentivizing investment in antibiotics, reports the Financial Times. In a letter to the Financial Times, the company said it has joined other "leading voices" in the life sciences sectory to implore Britain to go ahead with a new system rather than waiting for an international agreement. The company said a new payment model was needed that would reward companies' investments but without encouraging the over-use of antibiotics. Reference Link
November 15, 2015
18:13 EDTPFEAllergan, Pfizer targeting late November merger deal, FT says
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15:19 EDTMRKMerck reports integrated analysis of six trials of elbasvir/grazoprevir
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15:15 EDTMRKMerck reports Phase 3 data on elbasvir/grazoprevir in patients injecting drugs
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