Sobi™ Discloses Payments to Healthcare Professionals and Healthcare Organisations to Increase Transparency

Sobi™ Discloses Payments to Healthcare Professionals and Healthcare Organisations to Increase Transparency

STOCKHOLM, May 31, 2018 /PRNewswire/ — Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the company has made all payments and transfers of value to healthcare professionals and organisations from 2017 publicly available*. This includes sponsorships to attend meetings, grants and donations, speaker

Impel NeuroPharma Announces Initiation of Phase IIa Study of INP103 in Parkinson’s Disease OFF Episodes

Impel NeuroPharma Announces Initiation of Phase IIa Study of INP103 in Parkinson’s Disease OFF Episodes

Study to Explore the Therapeutic Benefit of Intranasal Levodopa in Parkinson’s Disease OFF Reversal (THOR 201) SEATTLE, May 31, 2018 /PRNewswire/ — Impel NeuroPharma, a Seattle-based, privately-held biotechnology company focused on therapies for the treatment of central nervous system (CNS) disorders, today announced the

Phase I/II Study Design of Birinapant in Combination With Keytruda® to be Presented on June 4 at the ASCO Annual Meeting

Phase I/II Study Design of Birinapant in Combination With Keytruda® to be Presented on June 4 at the ASCO Annual Meeting

STOCKHOLM, May 31, 2018 /PRNewswire/ — Medivir AB (Nasdaq Stockholm: MVIR) today informs that the design of the ongoing phase I/II study of birinapant in combination with Keytruda® (pembrolizumab) in advanced cancer patients will be presented during the 2018 American Society for Clinical

Eisai Receives FDA Priority Review Designation for FYCOMPA® (perampanel) CIII Pediatric Indications Supplemental New Drug Application (sNDA)

Eisai Receives FDA Priority Review Designation for FYCOMPA® (perampanel) CIII Pediatric Indications Supplemental New Drug Application (sNDA)

May 30, 2018 – Designation underscores the need to expand potential treatment options to help certain young patients achieve goal of seizure freedom WOODCLIFF LAKE, N.J., May 30, 2018 /PRNewswire/ — Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA)

IDELVION® Newly Approved 3500 IU Vial to Provide Convenience to Patients Using Larger Volumes

IDELVION® Newly Approved 3500 IU Vial to Provide Convenience to Patients Using Larger Volumes

May 31, 2018 – IDELVION 14-day dosing option for some patients, combined with the larger vial size, will improve convenience with fewer vials and less infusions – New vial option delivers on CSL Behring’s promise to enhance current treatments and provide

Grifols Launches a New Testing Service for Patients Treated with Daratumumab

Grifols Launches a New Testing Service for Patients Treated with Daratumumab

May 31, 2018 – The Daratumumab neutralization testing service from Grifols, will allow improved management of patients under Daratumumab treatment requiring transfusion – Test will be offered at Grifols Immunohematology Center in San Marcos, Texas BARCELONA, Spain, May 31, 2018 /PRNewswire/ — Grifols

Bayer Partners with U.S. Department of Energy to Produce Key Starting Material for Xofigo® (radium Ra 223 dichloride) Injection

Bayer Partners with U.S. Department of Energy to Produce Key Starting Material for Xofigo® (radium Ra 223 dichloride) Injection

Department of Energy’s Oak Ridge National Laboratory to supply actinium-227 WHIPPANY, N.J., May 31, 2018 /PRNewswire/ — Bayer is collaborating with the U.S. Department of Energy’s Oak Ridge National Laboratory, based in Oak Ridge, TN, to produce actinium-227 (227Ac), the key radioisotope used in

New Survey Highlights Lack of Awareness of Neurologic Effects Related to Excessive Sleepiness in Patients with Obstructive Sleep Apnea

New Survey Highlights Lack of Awareness of Neurologic Effects Related to Excessive Sleepiness in Patients with Obstructive Sleep Apnea

May 31, 2018 Survey findings show that while pulmonologists, neurologists and psychiatrists are aware of the negative effects of Excessive Sleepiness (ES) on patients’ quality of life, few are familiar with emerging research linking the condition to brain alterations [1],[2]

Curis Announces FDA Fast Track Designation for Fimepinostat Development in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Curis Announces FDA Fast Track Designation for Fimepinostat Development in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

LEXINGTON, Mass., May 31, 2018 /PRNewswire/ — Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative therapeutics for the treatment of cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the

MEI Pharma and Helsinn Group Announce Successful Interim Analysis of Pracinostat/Azacitidine Phase 2 Combination Study in Higher Risk Myelodysplastic Syndrome (MDS) Patients

MEI Pharma and Helsinn Group Announce Successful Interim Analysis of Pracinostat/Azacitidine Phase 2 Combination Study in Higher Risk Myelodysplastic Syndrome (MDS) Patients

— Predefined Patient Retention Threshold Met: 10% Early Discontinuation Rate Due to Adverse Events Supports Expansion of Patient Enrollment — SAN DIEGO and LUGANO, Switzerland, May 31, 2018 /PRNewswire/ — MEI Pharma, Inc. (Nasdaq: MEIP), a pharmaceutical company focused on leveraging its extensive development and

Cingulate Therapeutics Strengthens Leadership with Two New Board Appointments

Cingulate Therapeutics Strengthens Leadership with Two New Board Appointments

KANSAS CITY, Kan., May 31, 2018 /PRNewswire/ — Cingulate Therapeutics LLC, a clinical stage biopharmaceutical company focused on the development of new and innovative products utilizing its precision timed release drug delivery platform technology, today announced the appointment of Jeff Conroy and Jeff Hargroves to its Board

FDA expedites review of Novartis drug Promacta® for first-line severe aplastic anemia (SAA)

FDA expedites review of Novartis drug Promacta® for first-line severe aplastic anemia (SAA)

May 30, 2018 – Promacta receives FDA Priority Review for first-line treatment of SAA based on data showing 52% complete response rate and 85% overall response rate when added to standard immunosuppressive therapy (IST) – Regulatory action underscores the treatment

TherapeuticsMD Announces FDA Approval of TX-004HR: IMVEXXY™ (estradiol vaginal inserts), the Lowest Dose Vaginal Estrogen Product Approved for the Treatment of Moderate to Severe Dyspareunia, a Symptom of VVA, due to Menopause

TherapeuticsMD Announces FDA Approval of TX-004HR: IMVEXXY™ (estradiol vaginal inserts), the Lowest Dose Vaginal Estrogen Product Approved for the Treatment of Moderate to Severe Dyspareunia, a Symptom of VVA, due to Menopause

May 30, 2018 -IMVEXXY’s applicator-free self-administration was developed with the woman in mind- -TherapeuticsMD will host a conference call at 8:00 AM EDT today- BOCA RATON, Fla., May 30, 2018 /PRNewswire/ — TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced that the United

Sierra Oncology to Present at the Jefferies Global Healthcare Conference in New York

Sierra Oncology to Present at the Jefferies Global Healthcare Conference in New York

– Presentation scheduled for 8:30 a.m. ET on June 7, 2018 – VANCOUVER, May 30, 2018 /PRNewswire/ – Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, today

Oramed Patent Allowed in the US for Oral Administration of Proteins

Oramed Patent Allowed in the US for Oral Administration of Proteins

NEW YORK, May 30, 2018 /PRNewswire/ — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a developer of oral drug delivery systems, announced today that the Company’s patent for its invention, titled “Methods and Compositions for Oral Administrations of Proteins,” has been allowed

Legend Announces FDA clearance of IND application on CAR-T immuno-cell therapy for the Treatment of Multiple Myeloma

Legend Announces FDA clearance of IND application on CAR-T immuno-cell therapy for the Treatment of Multiple Myeloma

LCAR-B38M CAR-T therapy (JNJ-68284528) to be developed as part of strategic partnership between Legend and Janssen PISCATAWAY, N.J., May 30, 2018 /PRNewswire/ — Legend Biotech, a subsidiary of GenScript Biotech Corporation (HKEx: 1548), announced today that the U.S. Food and Drug Administration

BrainStorm Cell Therapeutics to Provide Corporate Update at the BIO International Convention

BrainStorm Cell Therapeutics to Provide Corporate Update at the BIO International Convention

NEW YORK and PETACH TIKVAH, Israel, May 30, 2018 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the Company will present a corporate overview at the BIO International Convention, taking place June

Positive Recommendation of IDMC to Zepsyre® to Continue the Phase III Trial Within Small-cell Lung Cancer (ATLANTIS)

Positive Recommendation of IDMC to Zepsyre® to Continue the Phase III Trial Within Small-cell Lung Cancer (ATLANTIS)

MADRID, May 29, 2018 /PRNewswire/ — PharmaMar (MCE: PHM) has announced today that the Independent Data Monitoring Committee (IDMC) has notified the Company of its recommendation that the Phase III (ATLANTIS) trial currently under way with Zepsyre®(lurbinectedin, PM1183) in combination with doxorubicin

EMD Serono to Present MS Data and Debut New Patient Resources at CMSC 2018

EMD Serono to Present MS Data and Debut New Patient Resources at CMSC 2018

May 29, 2018 – Presentations for investigational Cladribine Tablets include analyses of NEDA and MRI outcomes in patients with relapsing MS – MS in the 21st Century to debut ‘My MS Priorities,’ a new tool to help improve patient-HCP dialogue

Theravance Biopharma Highlights Submission of Regulatory Application in Japan for Once-Daily Single Inhaler Triple Therapy FF/UMEC/VI for Patients with COPD

Theravance Biopharma Highlights Submission of Regulatory Application in Japan for Once-Daily Single Inhaler Triple Therapy FF/UMEC/VI for Patients with COPD

DUBLIN, May 29, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) today highlighted that a regulatory application for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) under the proposed brand name Trelegy Ellipta has been submitted to the Japanese Ministry of Health, Labour

Alexandra Glucksmann Joins REGENXBIO Board of Directors

Alexandra Glucksmann Joins REGENXBIO Board of Directors

Dr. Glucksmann brings 25 years of R&D leadership and operations expertise to the role ROCKVILLE, Md., May 29, 2018 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based

UCB Announces the Approval of CIMZIA® (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis, Representing an Important New Option for Patients in the U.S.

UCB Announces the Approval of CIMZIA® (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis, Representing an Important New Option for Patients in the U.S.

BRUSSELS, May 29, 2018 /PRNewswire/ — The U.S. Food and Drug Administration’s (FDA) approval of CIMZIA® (certolizumab pegol) for use in moderate-to-severe plaque psoriasis marks the entry of UCB into immuno-dermatology CIMZIA Phase 3 psoriasis studies demonstrated significant and clinically meaningful improvements in

Nordic Nanovector Announces PARADIGME Trial Approved to Start in Norway

Nordic Nanovector Announces PARADIGME Trial Approved to Start in Norway

OSLO, Norway, May 29, 2018 /PRNewswire/ — Nordic Nanovector ASA (OSE: NANO) announces that its pivotal PARADIGME Phase 2b trial with Betalutin® (177Lu-satetraxetan-lilotomab) in third-line (3L) follicular lymphoma (FL) patients has been approved by the Regional Committees for Medical and Health Research Ethics

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

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

DUBLIN, May 29, 2018 /PRNewswire/ — 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, 6×28 physicians sample pack, indicated

Halozyme Therapeutics To Participate In Upcoming Healthcare Conferences

Halozyme Therapeutics To Participate In Upcoming Healthcare Conferences

SAN DIEGO, May 29, 2018 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies will participate in two upcoming investor conferences. Dr. Helen Torley, president and chief executive officer will represent Halozyme in a question and answer session