Roche Hldg Ltd Spons (RHHBY) 32.3600 $RHHBY
Roche Asthma Drug Xolair Gets FDA Nod for Label Expansion
Zacks Equity Research - Zacks Investment Research - Fri Jul 08, 5:23PM CDT
Roche Holding AG (RHHBY) announced that the FDA has approved a label expansion of respiratory drug, Xolair.
JNJ: 122.85 (+0.34), PFE: 36.12 (+0.35), NVS: 82.13 (+0.33)
Puma (PBYI) Stock Up, Phase II Data on Neratinib Published
Zacks Equity Research - Zacks Investment Research - Fri Jul 08, 10:28AM CDT
Puma Biotechnology (PBYI) reported the publication of phase II study (I-SPY 2) data on neratinib for the neoadjuvant treatment of breast cancer.
INVA: 11.64 (+0.26), PFE: 36.12 (+0.35), PBYI: 34.88 (+2.73)
FDA Approves Genentech's Xolair(R) (omalizumab) for Allergic Asthma in Children
BusinessWire - Thu Jul 07, 3:40PM CDT
--Asthma is one of the most common long-term diseases in children(1), affecting about 6.3 million people younger than 18 in the U.S.(2 )
Galena (GALE) Stock Falls on Discontinuation of NeuVax Study
Zacks Equity Research - Zacks Investment Research - Thu Jun 30, 7:17AM CDT
Galena (GALE) has discontinued evaluating NeuVax in the phase III PRESENT study for the prevention of breast cancer recurrence in the adjuvant setting.
PFE: 36.12 (+0.35), GALE: 0.46 (-0.05), BMY: 75.28 (+1.20)
Roche's Multiple Sclerosis Drug Under Review by FDA, EMA
Zacks Equity Research - Zacks Investment Research - Wed Jun 29, 2:20PM CDT
Roche Holding (RHHBY) announced that the FDA has accepted its BLA for Ocrevus for review as the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
JNJ: 122.85 (+0.34), PFE: 36.12 (+0.35), BMY: 75.28 (+1.20)
Puma (PBYI) Submits Neratinib Marketing Application in EU
Zacks Equity Research - Zacks Investment Research - Tue Jun 28, 8:00AM CDT
Puma (PBYI) announced that it has submitted a Marketing Authorisation Application (MAA) in the EU for its lead pipeline candidate, neratinib.
PFE: 36.12 (+0.35), BMY: 75.28 (+1.20), PBYI: 34.88 (+2.73)
FDA Grants Priority Review for Genentech's OCREVUS(TM) (ocrelizumab) Biologics License Application
BusinessWire - Tue Jun 28, 12:00AM CDT
--OCREVUS is the first investigational medicine seeking marketing authorization for both relapsing and primary progressive forms of MS
Epizyme Teams Up with Roche's Genentech for Tazemetostat
Zacks Equity Research - Zacks Investment Research - Thu Jun 23, 7:32AM CDT
Epizyme (EPZM) announced that it has entered into a collaboration agreement with Roche's (RHHBY) Genentech to evaluate tazemetostat, in combination Tecentriq.
ANIP: 56.51 (-1.61), PFE: 36.12 (+0.35), EPZM: 10.31 (+0.39)
Roche Presents Encouraging Data on Actemra and Tecentriq
Zacks Equity Research - Zacks Investment Research - Mon Jun 06, 3:49PM CDT
Roche Holding AG (RHHBY) announced positive results from the phase III study, GiACTA, on arthritis drug, Actemra/RoActemra.
PFE: 36.12 (+0.35), BMY: 75.28 (+1.20), EXEL: 8.15 (+0.01)
Phase III Study Shows Genentech's Actemra(R) (tocilizumab) Maintained Steroid-Free Remission in People With Giant Cell Arteritis (GCA)
BusinessWire - Mon Jun 06, 11:53AM CDT
--There have been no new treatments for GCA in more than 50 years
Genentech's Cancer Immunotherapy TECENTRIQ(TM) (Atezolizumab) Shrank Tumors in People with Previously Untreated Advanced Bladder Cancer
BusinessWire - Sun Jun 05, 6:30AM CDT
--TECENTRIQ is the first and only cancer immunotherapy approved to treat bladder cancer
Promising Lupus Drug From XTL Biopharmaceuticals Could Be Life Changer In Projected $4 Billion Market
ACCESSWIRE - Thu Jun 02, 8:01AM CDT
NEW YORK, NY / ACCESSWIRE / June 2, 2016 / Lupus - invisible, silent; an autoimmune disease where the body's defenses mistakenly attack its own cells and living with lupus is never ending. Up to 5 million people, mainly women of childbearing age, suffer progression of this disorder because of diagnostic confusion. Most present with fever, malaise and facial skin rash suggesting to internists other unrelated health problems. A capricious disease, lupus strikes in skin, joints, kidney, heart, pancreas, colon, eyes, blood...the list continues and flare-ups are sporadic. If organ damage is severe, lupus can be fatal.
XTLB: 1.05 (-0.12), TEVA: 50.89 (+0.37), GSK: 43.38 (+0.04)
Roche's Subcutaneous Formulation of MabThera Gets EU Nod
Zacks Equity Research - Zacks Investment Research - Tue May 31, 9:10AM CDT
Roche (RHHBY) announced that the EC has approved the subcutaneous formulation of MabThera (rituximab) for the treatment of patients suffering from previously untreated and relapsed/refractory CLL.
BIIB: 251.30 (+4.03), PFE: 36.12 (+0.35), BMY: 75.28 (+1.20)
Watch for Roche Holding to Potentially Pullback After Gaining 3.64% Yesterday
Comtex SmarTrend(R) - Fri May 27, 1:36PM CDT
Roche Holding (NASDAQ:RHHBY) traded in a range yesterday that spanned from a low of $33.20 to a high of $33.41. Yesterday, the shares gained 3.6%, which took the trading range above the 3-day high of $32.15 on volume of 795,000 shares. Often times after large one-day gains, short term traders will seek to take profits and, as such, investors should be cautious.
Genentech's Gazyva(R) Showed Superior Progression-Free Survival Compared to Rituxan(R) in People with Previously Untreated Follicular Lymphoma
BusinessWire - Fri May 27, 12:00AM CDT
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the pivotal Phase III GALLIUM study in people with previously untreated follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin's lymphoma (iNHL). The study compared the efficacy and safety of Gazyva(R) (obinutuzumab) plus chemotherapy (CHOP, CVP or bendamustine) followed by Gazyva alone, head-to-head with Rituxan(R) (rituximab) plus chemotherapy followed by Rituxan alone. Results from a pre-planned interim analysis showed that Gazyva-based treatment significantly reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) compared to Rituxan-based treatment. Adverse events with either Gazyva or Rituxan were consistent with what was seen in previous clinical trials when each was combined with various chemotherapies. Data from the GALLIUM study will be presented at an upcoming medical meeting and submitted to health authorities for approval consideration.
Novartis Filing for MabThera Biosimilar Accepted in the EU
Zacks Equity Research - Zacks Investment Research - Tue May 24, 4:20PM CDT
Novartis (NVS) announced that the EMA has accepted its generic arm Sandoz's MAA for its proposed biosimilar of Roche's (RHHBY) MabThera.
ABT: 41.89 (+0.53), JNJ: 122.85 (+0.34), NVS: 82.13 (+0.33)
Roche Gets Accelerated Approval for Immunotherapy Drug
Zacks Equity Research - Zacks Investment Research - Thu May 19, 4:48PM CDT
Roche Holding (RHHBY) announced that the FDA has granted accelerated approval to its cancer immunotherapy drug, Tecentriq (atezolizumab),
ABT: 41.89 (+0.53), JNJ: 122.85 (+0.34), PFE: 36.12 (+0.35)
Phase III Study of Genentech's Alecensa(R) (Alectinib) Showed Superior Efficacy Versus Crizotinib in Japanese People With a Specific Type of Lung Cancer
BusinessWire - Wed May 18, 4:00PM CDT
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Alecensa(R) (alectinib), an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression-free survival, PFS) by 66 percent compared to crizotinib in Japanese people with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC) (hazard ratio [HR]=0.34, 99 percent CI: 0.17-0.70, p<0.0001). Median PFS was not reached in people who received Alecensa (95 percent CI: 20.3 months-not reached) versus 10.2 months median PFS (95 percent CI: 8.2-12.0) in people who received crizotinib. The results were from a pre-specified interim analysis from the Phase III J-ALEX study in people who had not received prior treatment with an ALK inhibitor. There were fewer adverse events (AEs) in the Alecensa arm versus the crizotinib arm. Alecensa demonstrated a safety profile consistent with that observed in previous studies with no new or unexpected AEs.
FDA Grants Genentech's Cancer Immunotherapy TECENTRIQ(TM) (atezolizumab) Accelerated Approval for People with a Specific Type of Advanced Bladder Cancer
BusinessWire - Wed May 18, 12:22PM CDT
--- First FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years -
Roche Asthma Drug Xolair Gets FDA Nod for Label Expansion
Zacks Equity Research - Zacks Investment Research - Fri Jul 08, 5:23PM CDT
Roche Holding AG (RHHBY) announced that the FDA has approved a label expansion of respiratory drug, Xolair.
JNJ: 122.85 (+0.34), PFE: 36.12 (+0.35), NVS: 82.13 (+0.33)
Puma (PBYI) Stock Up, Phase II Data on Neratinib Published
Zacks Equity Research - Zacks Investment Research - Fri Jul 08, 10:28AM CDT
Puma Biotechnology (PBYI) reported the publication of phase II study (I-SPY 2) data on neratinib for the neoadjuvant treatment of breast cancer.
INVA: 11.64 (+0.26), PFE: 36.12 (+0.35), PBYI: 34.88 (+2.73)
FDA Approves Genentech's Xolair(R) (omalizumab) for Allergic Asthma in Children
BusinessWire - Thu Jul 07, 3:40PM CDT
--Asthma is one of the most common long-term diseases in children(1), affecting about 6.3 million people younger than 18 in the U.S.(2 )
Galena (GALE) Stock Falls on Discontinuation of NeuVax Study
Zacks Equity Research - Zacks Investment Research - Thu Jun 30, 7:17AM CDT
Galena (GALE) has discontinued evaluating NeuVax in the phase III PRESENT study for the prevention of breast cancer recurrence in the adjuvant setting.
PFE: 36.12 (+0.35), GALE: 0.46 (-0.05), BMY: 75.28 (+1.20)
Roche's Multiple Sclerosis Drug Under Review by FDA, EMA
Zacks Equity Research - Zacks Investment Research - Wed Jun 29, 2:20PM CDT
Roche Holding (RHHBY) announced that the FDA has accepted its BLA for Ocrevus for review as the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
JNJ: 122.85 (+0.34), PFE: 36.12 (+0.35), BMY: 75.28 (+1.20)
Puma (PBYI) Submits Neratinib Marketing Application in EU
Zacks Equity Research - Zacks Investment Research - Tue Jun 28, 8:00AM CDT
Puma (PBYI) announced that it has submitted a Marketing Authorisation Application (MAA) in the EU for its lead pipeline candidate, neratinib.
PFE: 36.12 (+0.35), BMY: 75.28 (+1.20), PBYI: 34.88 (+2.73)
FDA Grants Priority Review for Genentech's OCREVUS(TM) (ocrelizumab) Biologics License Application
BusinessWire - Tue Jun 28, 12:00AM CDT
--OCREVUS is the first investigational medicine seeking marketing authorization for both relapsing and primary progressive forms of MS
Epizyme Teams Up with Roche's Genentech for Tazemetostat
Zacks Equity Research - Zacks Investment Research - Thu Jun 23, 7:32AM CDT
Epizyme (EPZM) announced that it has entered into a collaboration agreement with Roche's (RHHBY) Genentech to evaluate tazemetostat, in combination Tecentriq.
ANIP: 56.51 (-1.61), PFE: 36.12 (+0.35), EPZM: 10.31 (+0.39)
Roche Presents Encouraging Data on Actemra and Tecentriq
Zacks Equity Research - Zacks Investment Research - Mon Jun 06, 3:49PM CDT
Roche Holding AG (RHHBY) announced positive results from the phase III study, GiACTA, on arthritis drug, Actemra/RoActemra.
PFE: 36.12 (+0.35), BMY: 75.28 (+1.20), EXEL: 8.15 (+0.01)
Phase III Study Shows Genentech's Actemra(R) (tocilizumab) Maintained Steroid-Free Remission in People With Giant Cell Arteritis (GCA)
BusinessWire - Mon Jun 06, 11:53AM CDT
--There have been no new treatments for GCA in more than 50 years
Genentech's Cancer Immunotherapy TECENTRIQ(TM) (Atezolizumab) Shrank Tumors in People with Previously Untreated Advanced Bladder Cancer
BusinessWire - Sun Jun 05, 6:30AM CDT
--TECENTRIQ is the first and only cancer immunotherapy approved to treat bladder cancer
Promising Lupus Drug From XTL Biopharmaceuticals Could Be Life Changer In Projected $4 Billion Market
ACCESSWIRE - Thu Jun 02, 8:01AM CDT
NEW YORK, NY / ACCESSWIRE / June 2, 2016 / Lupus - invisible, silent; an autoimmune disease where the body's defenses mistakenly attack its own cells and living with lupus is never ending. Up to 5 million people, mainly women of childbearing age, suffer progression of this disorder because of diagnostic confusion. Most present with fever, malaise and facial skin rash suggesting to internists other unrelated health problems. A capricious disease, lupus strikes in skin, joints, kidney, heart, pancreas, colon, eyes, blood...the list continues and flare-ups are sporadic. If organ damage is severe, lupus can be fatal.
XTLB: 1.05 (-0.12), TEVA: 50.89 (+0.37), GSK: 43.38 (+0.04)
Roche's Subcutaneous Formulation of MabThera Gets EU Nod
Zacks Equity Research - Zacks Investment Research - Tue May 31, 9:10AM CDT
Roche (RHHBY) announced that the EC has approved the subcutaneous formulation of MabThera (rituximab) for the treatment of patients suffering from previously untreated and relapsed/refractory CLL.
BIIB: 251.30 (+4.03), PFE: 36.12 (+0.35), BMY: 75.28 (+1.20)
Watch for Roche Holding to Potentially Pullback After Gaining 3.64% Yesterday
Comtex SmarTrend(R) - Fri May 27, 1:36PM CDT
Roche Holding (NASDAQ:RHHBY) traded in a range yesterday that spanned from a low of $33.20 to a high of $33.41. Yesterday, the shares gained 3.6%, which took the trading range above the 3-day high of $32.15 on volume of 795,000 shares. Often times after large one-day gains, short term traders will seek to take profits and, as such, investors should be cautious.
Genentech's Gazyva(R) Showed Superior Progression-Free Survival Compared to Rituxan(R) in People with Previously Untreated Follicular Lymphoma
BusinessWire - Fri May 27, 12:00AM CDT
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the pivotal Phase III GALLIUM study in people with previously untreated follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin's lymphoma (iNHL). The study compared the efficacy and safety of Gazyva(R) (obinutuzumab) plus chemotherapy (CHOP, CVP or bendamustine) followed by Gazyva alone, head-to-head with Rituxan(R) (rituximab) plus chemotherapy followed by Rituxan alone. Results from a pre-planned interim analysis showed that Gazyva-based treatment significantly reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) compared to Rituxan-based treatment. Adverse events with either Gazyva or Rituxan were consistent with what was seen in previous clinical trials when each was combined with various chemotherapies. Data from the GALLIUM study will be presented at an upcoming medical meeting and submitted to health authorities for approval consideration.
Novartis Filing for MabThera Biosimilar Accepted in the EU
Zacks Equity Research - Zacks Investment Research - Tue May 24, 4:20PM CDT
Novartis (NVS) announced that the EMA has accepted its generic arm Sandoz's MAA for its proposed biosimilar of Roche's (RHHBY) MabThera.
ABT: 41.89 (+0.53), JNJ: 122.85 (+0.34), NVS: 82.13 (+0.33)
Roche Gets Accelerated Approval for Immunotherapy Drug
Zacks Equity Research - Zacks Investment Research - Thu May 19, 4:48PM CDT
Roche Holding (RHHBY) announced that the FDA has granted accelerated approval to its cancer immunotherapy drug, Tecentriq (atezolizumab),
ABT: 41.89 (+0.53), JNJ: 122.85 (+0.34), PFE: 36.12 (+0.35)
Phase III Study of Genentech's Alecensa(R) (Alectinib) Showed Superior Efficacy Versus Crizotinib in Japanese People With a Specific Type of Lung Cancer
BusinessWire - Wed May 18, 4:00PM CDT
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Alecensa(R) (alectinib), an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression-free survival, PFS) by 66 percent compared to crizotinib in Japanese people with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC) (hazard ratio [HR]=0.34, 99 percent CI: 0.17-0.70, p<0.0001). Median PFS was not reached in people who received Alecensa (95 percent CI: 20.3 months-not reached) versus 10.2 months median PFS (95 percent CI: 8.2-12.0) in people who received crizotinib. The results were from a pre-specified interim analysis from the Phase III J-ALEX study in people who had not received prior treatment with an ALK inhibitor. There were fewer adverse events (AEs) in the Alecensa arm versus the crizotinib arm. Alecensa demonstrated a safety profile consistent with that observed in previous studies with no new or unexpected AEs.
FDA Grants Genentech's Cancer Immunotherapy TECENTRIQ(TM) (atezolizumab) Accelerated Approval for People with a Specific Type of Advanced Bladder Cancer
BusinessWire - Wed May 18, 12:22PM CDT
--- First FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years -
