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Zacks News
3 Pharma & Biotech Pipeline Areas to Keep an Eye on in 2018
by Arpita Dutt
Immuno-oncology was a key focus area in 2017 - will it remain so in 2018 as companies like Juno (JUNO) progress with their pipelines?
Novartis (NVS) Oncology Head Strigini to Step Down by Dec. 31
by Zacks Equity Research
Novartis (NVS) is at a transitional stage as the CEO of its oncology segment will step down by the end of year. The company's CEO is also going to step next year.
Radius Health to Get Third Day-180 List of Outstanding Issues
by Zacks Equity Research
Radius Health (RDUS) will get a third Day-180 List of Outstanding Issues from the CHMP for its marketing authorisation application of abaloparatide-SC leading to a further delay in tentative approval.
Spectrum Pharma Dismisses CEO, Makes Leadership Changes
by Zacks Equity Research
Spectrum Pharma (SPPI) terminates Rajesh Shrotriya and appoints its present COO, Joseph Turgeon, as the new CEO.
Merck's Keytruda Misses Primary End Point for Gastric Cancer
by Zacks Equity Research
Merck's (MRK) anti-PD-1 therapy Keytruda misses the primary endpoint in a phase III study, which analyzed it as a second-line treatment for patients with advanced gastric adenocarcinoma.
Lilly Issues Guidance for 2018, New Drugs to Drive Top Line
by Zacks Equity Research
Eli Lilly (LLY) issues financial guidance for 2018 and also reaffirms the previously issued 2017 projection as well as its long-term expectations.
Intersect ENT (XENT) SINUVA Implant Receives FDA Approval
by Zacks Equity Research
Intersect ENT's (XENT) consistent focus on the chronic sinusitis market is likely to lend the company a competitive edge in the niche space.
Merck's Keytruda Gets FDA Priority Review for Rare Lymphoma
by Zacks Equity Research
Merck (MRK) informs that the FDA grants a priority review to its supplemental biologics license application looking for its marketed drug Keytruda's label expansion for a rare lymphoma indication.
Sanofi Wins FDA Approval for Biosimilar of Lilly's Humalog
by Zacks Equity Research
Sanofi's (SNY) Admelog, a follow-on biologic version of Lilly's Humalog, received FDA approval.
Lilly Reports Mixed Results from Late-Stage Cyramza Study
by Zacks Equity Research
Lilly's (LLY) gastric cancer drug, Cyramza, meets primary endpoint of progression free survival in a phase III study in first-line advanced gastric cancer patients. However, it failed to improve overall survival.
Pharma Stock Roundup: FDA Nod for NVO's Ozempic, Second Indication for Lilly's Taltz
by Arpita Dutt
FDA approval for Novo Nordisk's (NVO) type II diabetes drug, a second indication for Lilly's Taltz, and the approval of the first Herceptin biosimilar were the key highlights this week.
Pfizer Reports Updated Data from Phase III Study on Ibrance
by Zacks Equity Research
Pfizer (PFE) releases impressive new data of a post-hoc analysis from a phase III study on the combo therapy of Ibrance and Femara for the first-line treatment of ER+, HER2- metastatic breast cancer.
Lilly's (LLY) Taltz Gets Approval for Label Expansion in US
by Zacks Equity Research
Lilly (LLY) announced the label expansion of its psoriasis drug, Taltz, for the active psoriatic arthritis indication in the United States.
Why Is ImmunoGen (IMGN) Stock Up More Than 150% This Year?
by Zacks Equity Research
ImmunoGen's (IMGN) shares shoot up in the year so far on rapid pipeline progress plus positive study data and strategic collaborations.
Cancer Space Update: 2 Drugs Receive Regulatory Nod in EU
by Zacks Equity Research
This week the European Commission granted approval to Zejula for ovarian cancer and for label expansion of Tasigna in first-line Ph+ chronic myeloid leukemia.
Here's Why Merck Stock Is Down in 2017 Despite a Rising Industry
by Zacks Equity Research
Shares of Merck (MRK) have declined so far this year compared to an increase witnessed by the industry due to some notable pipeline setbacks.
Lilly Inks Deal to Include Dexcom Products in Diabetes System
by Zacks Equity Research
Lilly (LLY) enters into a development agreement with DexCom to integrate the latter's continuous glucose monitoring into its Connected Diabetes Ecosystem.
DexCom-Lily Partnership to Boost CGM Platform, Customer Base
by Zacks Equity Research
DexCom (DXCM) continues to sign deals to boost CGM platform adoption.
Novartis (NVS) Receives EC Nod for Tasigna Label Expansion
by Zacks Equity Research
Novartis (NVS) oncology portfolio gets a boost with EC's approval for the label expansion of Tasigna for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia.
United Therapeutics PAH Drug's Exclusivity Period Extended
by Zacks Equity Research
United Therapeutics' PAH drug, Adcirca has been granted six months pediatric exclusivity. This will delay generic competition for the drug for an additional six months.
Celldex (CLDX) Initiates Phase II Study on Cancer Candidate
by Zacks Equity Research
Celldex (CLDX) enrolled the first patient in a phase II study on pipeline candidate, CDX-3379, to evaluate it in advanced head and neck squamous cell carcinoma patients.
AstraZeneca's Faslodex Gets FDA Nod for Use With Verzenio
by Zacks Equity Research
AstraZeneca's (AZN) drug Faslodex received FDA approval for a new indication.
Pharma Stock Roundup: FDA Nod for AstraZeneca Severe Asthma Drug, Bayer Signs Deal with Loxo
by Arpita Dutt
Key highlights this week include the FDA approval of AstraZeneca's (AZN) severe asthma drug and Bayer's collaboration with Loxo for cancer.
J&J Presents Positive New Data for Diabetes Drug Invokana
by Zacks Equity Research
Johnson & Johnson (JNJ) puts forth positive data from CANVAS study on its type II diabetes drug, Invokana, showing better renal outcomes.
Pharma ETFs Down Post Q3 Earnings
by Sweta Killa
The string of earnings beat failed to boost pharma ETFs as they saw rough trading over the past one month.