MERCK: FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy as First-Line Treatment for Metastatic Squamous Non-Small Cell Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. Read More »

MCKESSON CORPORATION: Combination Therapy BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) for the Treatment of BRAF-mutant Melanoma, Available for Order at Biologics, Inc.

Biologics, Inc., a McKesson Specialty Health oncology, neurology and complex care pharmacy services company, has been selected by Array BioPharma, Inc. to be in the limited distribution network for the combination therapy BRAFTOVITM (encorafenib) and MEKTOVI®(binimetinib) for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by a U.S. Food and Drug Administration (FDA) approved test. Read More »

VALEANT PHARMACEUTICALS : FDA Issues Complete Response Letter For DUOBRII™ (Halobetasol Propionate and Tazarotene) Lotion

Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for DUOBRII™1 (halobetasol propionate and tazarotene) (IDP-118) lotion in the treatment of plaque psoriasis. Read More »

MERCK: FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S.Food and Drug Administration (FDA) has approved KEYTRUDA®, the company’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. Read More »

MERCK: FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for GARDASIL®9 in Women and Men Ages 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL ® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. Read More »

CELGENE CORPORATION: Celgene Announces Updated Safety and Efficacy Data from the TRANSCEND Trial of liso-cel (JCAR017) in Patients with Relapsed or Refractory B-cell non-Hodgkin Lymphoma at ASCO

Celgene Corporation (NASDAQ:CELG) today announced updated six-month safety and efficacy data from the TRANSCEND (NHL-001) study of lisocabtagene maraleucel (liso-cel; JCAR017), an investigational CD19-directed CAR T cell therapy, in patients with relapsed/refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL) in a presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Read More »

CELEGENE CORPORATION: Results of Phase III RELEVANCE Study Comparing REVLIMID plus Rituximab (R²) Versus Rituximab Plus Chemotherapy in Patients with Previously Untreated Follicular Lymphoma to be Presented at ASCO 2018

Celgene Corporation (NASDAQ:CELG) today announced additional results from RELEVANCE, a phase III, randomized, open-label, international clinical study conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC), were presented at the 54th Annual American Society of Clinical Oncology Scientific Sessions (ASCO) in Chicago, Illinois on June 1-5, 2018. Read More »

DAIICHI SANKYO, INC: Daiichi Sankyo Presents Preliminary Phase 1 Data for Antibody Drug Conjugate U3-1402 in Patients with HER3-Expressing Breast Cancer at 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that preliminary data from the dose escalation part of an ongoing phase 1/2 study with investigational U3-1402 in heavily pretreated patients with HER3-positive metastatic breast cancer will be presented during a Poster Discussion Session on Monday, June 4 at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (Abstract 2512; 3:00 – 4:15 PM CDT). Read More »

ALLERGAN, INC.: Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Read More »

MERCK: Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival and Progression-Free Survival as First-Line Treatment for Squamous Non-Small Cell Lung Cancer (NSCLC) in Pivotal Phase 3 KEYNOTE-407 Trial

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-407 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC), met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Read More »

NOVO NORDISK INC: Head-to-head pharmacokinetic study demonstrated greater factor IX activity with Rebinyn® versus rFIXFc in people with hemophilia B

A new head-to-head pharmacokinetic study showed that adults with hemophilia B who received a single dose (50 IU/kg) of Rebinyn® [Coagulation Factor IX (Recombinant), GlycoPEGylated] achieved high factor IX activity for longer than those treated with rFIXFc [Coagulation Factor IX (Recombinant), Fc Fusion Protein]. Read More »

DAIICHI SANKYO, INC.: Daiichi Sankyo to Present New Data on Multiple Compounds Including Antibody Drug Conjugates DS-8201 and U3-1402 at 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it will present new data for multiple investigational compounds in the Daiichi Sankyo Cancer Enterprise pipeline at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting from June 1-5 in Chicago. Read More »

VALERITAS, INC:Valeritas Announces Positive Clinical Results Across Two New Studies Evaluating V-Go® Wearable Insulin Delivery Device in Patients with Type 2 Diabetes

Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers V-Go® Wearable Insulin Delivery device, a simple, all-in-one insulin delivery option for patients with diabetes, announced positive results were shared today from two new studies during poster presentations at the American Association of Clinical Endocrinologists Annual Scientific and Clinical Congress held in Boston, Massachusetts. Read More »

VALERITAS, INC:Valeritas’ V-Go® Wearable Insulin Delivery Device Results in Clinical Benefits Sustained Over Time in Patients with Diabetes

Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers patients with diabetes V-Go® Wearable Insulin Delivery device, a simple, affordable, all-in-one insulin delivery option that is worn like a patch and can eliminate the need for taking multiple daily shots, announced today the publication last week of a manuscript titled “Clinical Benefits Over Time Associated with Use of V-Go Wearable Insulin Delivery Device in Adult Patients with Diabetes: a Retrospective Analysis” in Advances in Therapy, an international, peer-reviewed journal. Read More »

VALEANT PHARMACEUTICALS: Bausch + Lomb Launches LUMIFY, The First And Only OTC Redness Relieving Eye Drop With Low-Dose Brimonidine

Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International (NYSE/TSX: VRX), today announced the launch of LUMIFY™ (brimonidine tartrate ophthalmic solution 0.025%), the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate for the treatment of eye redness. Read More »