Aerie Pharmaceuticals Announces U.S. Launch of Rhopressa® (netarsudil ophthalmic solution) 0.02%

DURHAM, N.C.–(BUSINESS WIRE)–Apr. 30, 2018– Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma and other diseases of the eye, today announced that it has

FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

TARRYTOWN, N.Y. and PARIS, April 30, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma

AbbVie and Rice University establish K.C. Nicolaou Research Accelerator to advance therapies in oncology

NORTH CHICAGO, Ill. and HOUSTON, April 30, 2018 /PRNewswire/ — AbbVie, a research-based global biopharmaceutical company, and Rice University today announced they have entered into a joint research collaboration to establish the K.C. Nicolaou Research Accelerator. The research at the Accelerator will focus on synthesizing novel cytotoxic

Amgen Receives Positive CHMP Opinion To Add Overall Survival Results From The Phase 3 ASPIRE Study To KYPROLIS® (carfilzomib) Label

KYPROLIS is the First and Only Relapsed or Refractory Multiple Myeloma Treatment to Demonstrate Overall Survival in two Phase 3 Studies THOUSAND OAKS, Calif., April 30, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines

FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

Paris and Tarrytown, NY – April 30, 2018 – The U.S. Food and Drug Administration (FDA) has accepted priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients

Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanoma

Tafinlar + Mekinist is the first oral targeted adjuvant combination therapy to demonstrate significant clinical benefit in patients with a BRAF V600 mutation, following complete surgical resection Tafinlar + Mekinist significantly reduced the risk of disease recurrence or death compared

J&J: Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Filing supported by data from MERIT-1 trial evaluating OPSUMIT in adults with inoperable CTEPH which showed significant improvements in pulmonary vascular resistance and six-minute walk distance (6MWD) compared with ongoing background therapy CHERRY HILL, NJ, AND ALLSCHWIL, SWITZERLAND – April 30,

FDA Grants Priority Review to Merck’s sBLA for KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed (ALIMTA®) and Platinum Chemotherapy Based on Results from Phase 3 KEYNOTE-189 Trial as First-Line Treatment of Metastatic Nonsquamous NSCLC

U.S. FDA Has Set a PDUFA Date of Sept. 23, 2018 Monday, April 30, 2018 6:45 am EDT KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration

Dawn Rogers Appointed Executive Vice President of Pfizer Worldwide Human Resources

NEW YORK, N.Y., April 30 – Pfizer Inc. (NYSE:PFE) today announced that Dawn Rogers will become Executive Vice President of Worldwide Human Resources, effective June 1, 2018. She is currently Senior Vice President of Human Resources for the Chief Operating

Gilead and Verily Announce Scientific Collaboration to Identify and Understand Immunological and Molecular Drivers of Inflammatory Diseases

— Verily to Deploy Its Immunoscape™ Platform to Generate Insights from Gilead Clinical Trials — FOSTER CITY, Calif. & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Apr. 30, 2018– Gilead Sciences, Inc. (Nasdaq: GILD) and Verily Life Sciences LLC, an Alphabet company, today announced a scientific collaboration using

Celgene Corporation Announces Appointment of Jennifer Dudinak to Senior Vice President of Global Regulatory Affairs

SUMMIT, N.J.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ:CELG) today announced the appointment of Jennifer Dudinak, Pharm.D., as Senior Vice President, Global Regulatory Affairs, reporting to Jay Backstrom, M.D., Chief Medical Officer, effective April 30, 2018. Jennifer will be responsible for regulatory strategy and execution across Celgene’s portfolio

TAVALISSE™ (fostamatinib disodium hexahydrate) Phase 3 Data Published in the American Journal of Hematology Describes Pivotal Data and Overall Response Rate Versus Placebo

SOUTH SAN FRANCISCO, Calif., April 30, 2018 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the American Journal of Hematology has published positive results from the Fostamatinib in Thrombocytopenia (FIT) Phase 3 clinical program of TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of adults with chronic

Ultragenyx and Kyowa Kirin Announce Crysvita® (burosumab-twza) Now Launched in the U.S. for the Treatment of X–linked Hypophosphatemia (XLH) in Children and Adults

First FDA-Approved Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease UltraCare™ Program in Place to Provide Ongoing Patient Support NOVATO, Calif., TOKYO and LONDON, April 30, 2018 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel

Tagrisso receives positive EU CHMP opinion for 1st-line treatment of EGFR-mutated non-small cell lung cancer

Recommendation based on FLAURA trial data showing unprecedented median progression-free survival of 18.9 months for Tagrisso versus 10.2 months compared with current standard of care The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has

Amgen Receives Positive CHMP Opinion To Expand Use Of Prolia® (denosumab) To Patients With Glucocorticoid-Induced Osteoporosis

Treats Bone Loss in Patients Using Glucocorticoid Medications who are at Increased Risk of Fracture THOUSAND OAKS, Calif., April 27, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive

350 Years of Merck: Company Looks Ahead to the Future

Merck held its 23rd Annual General Meeting today. The company’s 350th anniversary was one of the overriding themes. 27 APR 2018 | DARMSTADT, GERMANY 23rd Annual General Meeting in Frankfurt am Main A look back at business developments and strategic moves in

CHMP recommends EU approval of Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence

In the large phase III APHINITY study, the combination of Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death by 19% compared to Herceptin and chemotherapy alone in the overall study population In the

J&J: Real-World Study Shows INVOKANA® (canagliflozin) 300mg Demonstrates Better Blood Glucose Control Than Farxiga® (dapagliflozin) 10mg in Patients with Type 2 Diabetes

First Real-World Study Comparing Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) Therapies Also Showed Patients Taking INVOKANA® 300mg Were Significantly Less Likely to Discontinue Treatment or Switch to Another Diabetes Medicine TITUSVILLE, NJ, April 27, 2018 – The Janssen Pharmaceutical Companies of Johnson &

European CHMP Adopts Positive Opinion for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide)

– In Clinical Trials, Biktarvy Demonstrated High Efficacy and Zero Resistance Through 48 Weeks – FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 27, 2018– Gilead Sciences, Inc.(NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency(EMA),

Lilly to Participate in Bank of America Merrill Lynch Health Care Conference

INDIANAPOLIS, April 27, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) will participate in the Bank of America Merrill Lynch 2018 Health Care Conference on Wednesday, May 16, 2018. Christi Shaw, senior vice president and president of Lilly Bio-Medicines will participate in a fireside chat at 8:00 a.m. PDT(11:00 a.m.

ACADIA Pharmaceuticals Issues Statement Reaffirming Benefit/Risk Profile of NUPLAZID

– Concurrently, the Company Has Issued a Press Release Announcing the Presentation of Clinical Experience Data for NUPLAZID at the American Academy of Neurology (AAN) Annual Meeting SAN DIEGO–(BUSINESS WIRE)–Apr. 27, 2018– ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today issued the following statement: NUPLAZID® (pimavanserin) is

ACADIA Pharmaceuticals Announces Presentation of Clinical Experience Data for NUPLAZID (Pimavanserin) at 2018 American Academy of Neurology (AAN) Annual Meeting

Two Independent Data Sets Confirm NUPLAZID Is Well-Tolerated and Efficacious in Treating Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis SAN DIEGO–(BUSINESS WIRE)–Apr. 27, 2018– ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines

Teva Presents New Long-Term Data Demonstrating Efficacy and Safety of COPAXONE® (glatiramer acetate injection) 40 mg/mL

Apr. 27, 2018 Up to 7-year efficacy, safety and tolerability results from the GALA open-label extension study presented at the 70th Annual Meeting of the AAN Over seven years, COPAXONE® 40 mg/mL provides consistent, long-term efficacy and safety JERUSALEM–(BUSINESS WIRE)–Apr. 27, 2018– Teva

Zogenix Announces Initial Quality of Life and Cognitive Function Data From Phase 3 Trial of ZX008 in Dravet Syndrome

ZX008 Patients Experienced Significant Improvements on Select Measures of Quality of Life and Executive Function Compared to Those on Placebo Data Presented During Emerging Therapies Plenary Session at 2018 American Academy of Neurology Annual Meeting EMERYVILLE, Calif., April 27, 2018 (GLOBE NEWSWIRE) — Zogenix, Inc. (NASDAQ:ZGNX),

Allergan Announces Second Positive Phase 3 Clinical Trial for Ubrogepant — an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine

– ACHIEVE II study demonstrates efficacy, safety and tolerability –– Study meets co-primary endpoints at 50 mg ubrogepant in second of two phase 3 studies –– Allergan plans US NDA filing in 2019 –— Allergan hosting a Conference call and