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News Breaks
February 7, 2013
10:16 EDTLLY, PFE, ELN, JNJFDA offers new guidance on developing drugs for Alzheimer’s disease
The U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer’s disease, before the onset of noticeable dementia. The draft guidance titled, “Guidance for Industry, Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease,” explains the FDA’s current thinking about the way researchers can identify and select patients with early Alzheimer’s disease, or those who are at risk of developing the disease, for participation in clinical trials. For drugs designed to treat patients with overt dementia, the FDA currently requires that treatments not only show an effect on abnormal thinking, but also how well patients function. The goal for these trials is to ensure that any beneficial effect on thinking is associated with a clinically meaningful outcome for the patient, e.g., improvement or lack of decline in how patients feel or function. However, because patients with early Alzheimer’s disease have little-to-no impairment of global functioning, it is difficult to assess changes in function in these patients. This can make it difficult to determine if a given treatment’s effect is clinically important. FDA said it is seeking public comment on the draft guidance for 60 days. Bapineuzumab, an experimental treatment for Alzheimer’s disease, is being developed jointly by Pfizer (PFE) and Johnson & Johnson (JNJ) and Elan (ELN) also has a financial stake in the drug. Eli Lilly (LLY) is also developing solanezumab, an antibody against beta amyloid, a suspected underlying contributor to the disease's development.
News For PFE;JNJ;ELN;LLY From The Last 14 Days
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January 16, 2015
08:12 EDTJNJJohnson & Johnson forms Ebola vaccine development consortia
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January 15, 2015
16:08 EDTJNJJ&J unit sells U.S. Nucynta license rights to Depomed for $1.05B
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16:08 EDTJNJDepomed to acquire U.S. rights to NUCYNTA franchise for $1.05B from Jansen
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16:05 EDTJNJDepomed to acquire U.S. rights to NUCYNTA franchise for $1.05B from Jansen
12:10 EDTJNJJohnson & Johnson volatility elevated into Q4 and outlook
Johnson & Johnson January weekly call option implied volatility is at 22, February is at 16, April is at 15; compared to its 26-week average of 15 according to Track Data, suggesting large movement into the expected release of Q4 results on January 20.
11:20 EDTPFE, JNJ, LLYGoldman cuts J&J to sell citing competitive pressures
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10:00 EDTJNJOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: American Campus (ACC) downgraded to Sell from Neutral at Goldman... Apple (AAPL) downgraded to Neutral from Buy at Mizuho... Archer Daniels (ADM) downgraded to Neutral from Buy at Goldman... Barrick Gold (ABX) downgraded to Underweight from Equal Weight at Barclays... CNOOC (CEO) downgraded to Underperform from Hold at Jefferies... CSC (CSC) downgraded to Underweight from Neutral at JPMorgan... Computer Programs (CPSI) downgraded to Market Perform from Outperform at William Blair... D.R. Horton (DHI) downgraded to Neutral from Buy at UBS... DDR Corp. (DDR) downgraded to Neutral from Overweight at JPMorgan... Dominion Diamond (DDC) downgraded to Equal Weight from Overweight at Barclays... EVERTEC (EVTC) downgraded to Neutral from Overweight at JPMorgan... Education Realty (EDR) downgraded to Sell from Neutral at Goldman... Franco-Nevada (FNV) downgraded to Underweight from Equal Weight at Barclays... General Cable (BGC) downgraded to Neutral from Buy at Longbow... Green Dot (GDOT) downgraded to Neutral from Overweight at JPMorgan... Greif (GEF) downgraded to Neutral from Buy at BofA/Merrill... Grupo Simec (SIM) downgraded to Neutral from Buy at Goldman... Hecla Mining (HL) downgraded to Hold from Buy at BB&T... Host Hotels (HST) downgraded to Hold from Buy at MLV & Co.... Ingredion (INGR) downgraded to Sell from Neutral at Goldman... Insulet (PODD) downgraded to Market Perform from Outperform at Raymond James... Johnson & Johnson (JNJ) downgraded to Sell from Neutral at Goldman... Magna (MGA) downgraded to Hold from Buy at TD Securities... Molson Coors (TAP) downgraded to Neutral from Buy at Goldman... Nuverra Environmental (NES) downgraded at Roth Capital... Omnicom (OMC) downgraded to Hold from Buy at Evercore ISI... PetroChina (PTR) downgraded to Underperform from Hold at Jefferies... Philip Morris (PM) downgraded to Sell from Neutral at Goldman... Precision Castparts (PCP) downgraded to Hold from Buy at KeyBanc... Rio Tinto (RIO) downgraded to Neutral from Outperform at Macquarie... STAG Industrial (STAG) downgraded to Neutral from Overweight at JPMorgan... Silicon Laboratories (SLAB) downgraded to Equal Weight from Overweight at Barclays... Sinopec (SNP) downgraded to Underperform from Hold at Jefferies... Sky (SKYAY) downgraded to Neutral from Outperform at Exane BNP Paribas... Teledyne (TDY) downgraded to Underweight from Hold at KeyBanc... Woodward (WWD) downgraded to Underweight from Hold at KeyBanc... Xilinx (XLNX) downgraded to Equal Weight from Overweight at Barclays.
10:00 EDTLLYOn The Fly: Analyst Upgrade Summary
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07:59 EDTPFEAmerican Society of Clinical Oncology to hold a symposium
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07:07 EDTLLYEli Lilly upgraded at Goldman
As previously reported, Goldman upgraded Eli Lilly to Neutral from Sell. The firm upgraded shares based on new product launches and pipeline assets, and cost reductions. Price target is $70.
07:06 EDTJNJJohnson & Johnson downgraded at Goldman
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06:44 EDTJNJJohnson & Johnson downgraded to Sell from Neutral at Goldman
06:44 EDTLLYEli Lilly upgraded to Neutral from Sell at Goldman
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January 14, 2015
09:51 EDTJNJJohnson & Johnson unit says study shows consistent Xarelto safety
Johnson & Johnson unit Janssen announced that a new post-marketing study evaluating the safety of once-daily Xarelto shows, in patients with non-valvular atrial fibrillation, rates and patterns of major bleeding in routine clinical practice are generally consistent with those observed in Phase 3 clinical trials used to approve the medicine for this indication. The fifteen-month results, published today in Clinical Cardiology, represent initial findings from an ongoing, five-year, observational study of patients using Xarelto daily over the course of their lives.
January 13, 2015
16:00 EDTJNJOptions Update; January 13, 2015
iPath S&P 500 VIX Short-Term Futures up 66c to 34.42. Option volume leaders: AAPL JNJ CELG WFM TSLA TWTR AMZN GILD according to Track Data.
12:40 EDTLLYAmgen off highs after Express Scripts CEO talks PCSK9 costs
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10:00 EDTJNJJanssen Biotech announces license agreement with Vedanta Biosciences
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08:08 EDTLLYEli Lilly, Merck enter collaborationa greement to evaluate Keytruda, compounds
Merck (MRK) and Eli Lilly and Company (LLY) announced an oncology clinical trial collaboration to evaluate the safety, tolerability and efficacy of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Lilly compounds in multiple clinical trials: Merck will conduct a Phase 2 study examining the combination of pembrolizumab with pemetrexed in first-line non-squamous, non-small cell lung cancer. This study is currently enrolling. Lilly will conduct a multiple-arm Phase 1/2 study examining the combination of ramucirumab with pembrolizumab in multiple tumors. This study is anticipated to begin in 2015. Lilly will conduct a Phase 1/2 study examining the combination of necitumumab with pembrolizumab in NSCLC. This study is anticipated to begin in 2015. The agreement is between Lilly and Merck, through a subsidiary. Additional details of the collaboration were not disclosed.
08:05 EDTLLYBristol-Myers Eli Lilly enter clinical collaboration pact for Opdivo combo
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07:45 EDTJNJFierce Biotech to hold a breakfast meeting
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