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Zacks News
J&J (JNJ) Gets FDA Nod for Psoriasis Drug -- Guselkumab
by Zacks Equity Research
Johnson & Johnson (JNJ), a healthcare bellwether, announced that the FDA has approved its pipeline candidate guselkumab for the treatment of moderate-to-severe plaque psoriasis. The drug will be marketed by the trade name of Tremfya.
Can Novartis (NVS) Spring a Surprise This Earnings Season?
by Zacks Equity Research
Swiss pharmaceutical company Novartis AG (NVS) is scheduled to report second-quarter 2017 results on Jul 18.
Novartis CAR-T Therapy Drug Recommended by FDA Panel
by Zacks Equity Research
Novartis AG (NVS) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) has unanimously (10-0) recommended the approval of immunocellular therapy candidate CTL019 (tisagenlecleucel).
Can ImmunoGen's Lead Pipeline Cancer Candidate Boost Growth?
by Zacks Equity Research
On Jul 12, 2017, we issued an updated report on ImmunoGen, Inc. (IMGN).
Alnylam (ALNY) Upgraded to Buy on Solid Pipeline Growth
by Zacks Equity Research
On Jul 11, Alnylam Pharmaceuticals Inc. (ALNY) was upgraded to a Zacks Rank #2 (Buy).
Novartis' Cosentyx Superior to Stelara in Psoriasis Study
by Zacks Equity Research
Novartis' (NVS) psoriasis drug Cosentyx got a label update from the Committee for Medicinal Products for Human Use (CHMP) in the EU,
Lilly Gets Favorable Ruling in Alimta Patent Lawsuit in UK
by Zacks Equity Research
Eli Lilly and Company (LLY) announced that it has received favorable ruling from the UK Supreme Court in a patent lawsuit against generic drugmaker, Actavis related to its key cancer drug, Alimta (pemetrexed disodium).
Bristol-Myers Gets FDA Nod for Orencia's Label Expansion
by Zacks Equity Research
Bristol-Myers Squibb Company (BMY) announced that the FDA has approved Orencia for treatment of adults with active psoriatic arthritis (PsA).
Pharma Stock Roundup: MRK's Keytruda MM Combo Studies on Clinical Hold, Bayer to Revise Outlook
by Arpita Dutt
3 studies on Merck's (MRK) Keytruda have been put on clinical hold while Bayer said that it expects to revise its 2017 outlook when it reports Q2 results.
Incyte & Lilly's Olumiant Gets Marketing Approval in Japan
by Zacks Equity Research
Incyte Corporation (INCY) and partner Eli Lilly and Company (LLY) announced that arthritis drug Olumiant got approval in Japan.
Key FDA Events to Watch Out for in Jul 2017
by Arpita Dutt
Will the FDA follow the advice of its advisory panel and give its nod to Puma's (PBYI) neratinib?
Teva's (TEVA) Filing for Biosimilar Rituxan Accepted by FDA
by Zacks Equity Research
Teva Pharmaceutical Industries Ltd. (TEVA) and Korean partner Celltrion, Inc., announced that the FDA has accepted for review their Biologics License Application (BLA) for CT-P10, a proposed biosimilar to Roche Holding AG's (RHHBY) Rituxan (rituximab).
Novartis Gets EC Nod for Lung Cancer Drug's Label Expansion
by Zacks Equity Research
Novartis AG (NVS) announced that the European Commission has approved a label expansion of lung cancer drug drug Zykadia.
Novartis' Erelzi, Biosimilar of Enbrel Approved In Europe
by Zacks Equity Research
Novartis AG (NVS) announced that the European Commission (EC) has approved Erelzi ??? the biosimilar version of Enbrel.
AstraZeneca's Faslodex Recommended by CHMP for 1st Line Use
by Zacks Equity Research
AstraZeneca PLC (AZN) announced that the CHMP of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Faslodex for 1st-line treatment for postmenopausal women with HR+ advanced breast cancer.
Conatus's PSC Candidate Gets Orphan Designation in the U.S.
by Zacks Equity Research
Conatus Pharmaceuticals Inc. (CNAT) announced FDA's grant of Orphan Drug Designation (ODD) to its pipeline candidate IDN-7314 for treatment of primary sclerosing cholangitis.
Roche's (RHHBY) Combination Cancer Remedy Wins FDA Approval
by Zacks Equity Research
Roche (RHHBY) announced that the FDA has granted approval to the subcutaneous injection of its marketed lymphoma drug MabThera/Rituxan as Rituxan Hycela for the treatment of adults with different types of blood cancers.
Novartis Cardiovascular Drug Positive, NSCLC Drug Approved
by Zacks Equity Research
Shares of Novartis AG (NVS) were up after the company announced positive top-line results from the global phase III study, CANTOSon cardiovascular drug.
Epizyme Progressing Well on Two Lead Pipeline Candidates
by Zacks Equity Research
We issued an updated research report on Epizyme, Inc. (EPZM) on Jun 23, 2017.
Regeneron (REGN) Stock on Fire: What's Behind the Surge?
by Zacks Equity Research
Shares of Regeneron Pharmaceuticals, Inc. (REGN) have moved up 14.8% over the last 30 days.
Novartis Announces Positive Results for Cardiovascular Drug
by Zacks Equity Research
Novartis AG (NVS) announced top-line results from the global phase III study, CANTOS on cardiovascular drug.
Ligand Gets Milestone Payment on Partner Drug FDA Approval
by Zacks Equity Research
Ligand Pharmaceuticals Incorporated (LGND) announced receipt of a milestone payment of $1.5 million after its partner Melinta Therapeutics' pipeline candidate Baxdela (delafloxacin) was approved by the FDA.
Novartis Migraine Drug Accepted, AMD Positive in Phase III
by Zacks Equity Research
Novartis (NVS) announced that the EMA accepted its application for migraine candidate AMG 334.
Gilead's (GILD) HBV Drug Vemlidy Receives Approval in Canada
by Zacks Equity Research
Health Canada granted a Notice of Compliance (NOC) for Vemlidy 25mg tablets, a once-daily treatment for adults with chronic HBV infection with compensated liver disease.
Amgen's Xgeva Myeloma Label Expansion sBLA Accepted by FDA
by Zacks Equity Research
Amgen Inc. (AMGN) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) to expand the label of its key drug, Xgeva.