R&D

PharmaMar’s Lurbinectedin ATLANTIS trial design and data in small-cell lung cancer will be an oral presentation at the IASCLC´s annual meeting

February 21, 2018

MADRID, Feb. 20, 2018 /PRNewswire/ —   Dr Anna Farago, oncologist from the Massachusetts General Hospital and principal investigator of the phase III ATLANTIS clinical trial, will present the potential of lurbinectedin in small-cell lung cancer along with the main clinical data on safety and efficacy. The phase III Atlantis clinical study for recurrent small-cell […]

Cullinan Oncology and MAB Discovery Announce Collaboration to Develop Novel Antibody-Based Therapeutics

February 21, 2018

CAMBRIDGE, Mass. & NEURIED, Germany–(BUSINESS WIRE)–Cullinan Oncology, LLC and MAB Discovery GmbH (MABD), announced today the initiation of a collaboration to develop novel antibody therapeutics based on MABD’s unique discovery platform. “We are excited to enter into this collaboration as the MABD development engine provides us with access to highly differentiated monoclonal antibodies” said Patrick […]

Tetraphase Pharmaceuticals Enters into Exclusive Development and Commercialization Agreement with Everest Medicines for Eravacycline in China

February 21, 2018

WATERTOWN, Mass., Feb. 20, 2018 (GLOBE NEWSWIRE) — Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that it has entered into an exclusive licensing agreement with Everest Medicines Limited (“Everest”), a C-Bridge Capital-backed biopharmaceutical company based in China, to develop and […]

Portola Pharmaceuticals Announces Results of CHMP Oral Explanations for Andexanet Alfa and Betrixaban

February 21, 2018

SOUTH SAN FRANCISCO, Calif., Feb. 20, 2018 (GLOBE NEWSWIRE) — Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a positive trend vote on the Marketing Authorisation Application (MAA) for andexanet alfa, a Factor Xa-inhibitor reversal agent, and a negative […]

Evofem Biosciences Receives Fast Track Designation for Amphora for Prevention of Chlamydia

February 21, 2018

SAN DIEGO, Feb. 21, 2018 /PRNewswire/ — Evofem Biosciences, Inc., (NASDAQ: EVFM) (“Evofem” or the “Company”), a biotechnology company developing innovative products to fill women’s unmet healthcare needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Amphora® (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for […]

Centrexion Therapeutics Announces First Patient Dosed in Phase 3 Trial of CNTX-4975 for the Treatment of Moderate to Severe Knee Osteoarthritis Pain

February 21, 2018

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-steroidal therapeutics for the treatment of chronic pain, today announced that the first patient has been dosed in its Phase 3 VICTORY-1 clinical trial of CNTX-4975, a synthetic, ultra-pure injection of trans-capsaicin, for the treatment of chronic moderate to severe pain due to knee osteoarthritis […]

GSK presents new efficacy data for FLUARIX® QUADRIVALENT (Influenza Vaccine) in children

February 21, 2018

GSK presented today at the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices meeting that FLUARIX® QUADRIVALENT demonstrated 63.2% efficacy against moderate to severe influenza and 49.8% efficacy against influenza of any severity in children 6 months through 35 months of age. These results are based on a randomized, observer-blind, non-influenza […]

TG Therapeutics, Inc. Announces Publication of Clinical Data from the Phase 1 First-in-Human Trial of Umbralisib in The Lancet Oncology

February 21, 2018

NEW YORK, Feb. 21, 2018 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ:TGTX) announced the publication of the results from the Phase 1 first-in-human study of umbralisib (TGR-1202), the Company’s novel once-daily PI3K delta inhibitor, in The Lancet Oncology. The paper includes safety and efficacy information from 90 patients with relapsed or refractory b-cell malignancies, including […]

DrugDev Introduces Consent Engineering, the Clinical Trials Industry’s First Truly SaaS Solution for Creating, Managing and Automating Informed Patient Consent In-House

February 21, 2018

Simple yet robust technology tools are primed to change completely the way pharmaceutical companies and CROs develop, implement and track patient consent across global clinical trial sites Today at the 2018 SCOPE Summit for Clinical Operations Executives, DrugDev (an IQVIA company) unveiled the industry’s first truly SaaS solution for electronic patient informed consent. Consent Engineering, […]

Amneal Introduces Memantine Hydrochloride Extended-Release Capsules, Generic for Namenda XR®

February 21, 2018

Amneal Pharmaceuticals has launched memantine hydrochloride extended-release capsules, the company’s AB-rated equivalent for Namenda XR®, in 7 mg, 14 mg, 21 mg and 28 mg strengths. The product is manufactured here in the United States in the company’s recently expanded Brookhaven, New York facility. Annual U.S. sales of Namenda XR® were $929 million, according to […]

Dynavax’s HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted] Recommended by CDC Advisory Committee on Immunization Practices for the Prevention of Hepatitis B in Adults

February 21, 2018

BERKELEY, Calif., Feb. 21, 2018 (GLOBE NEWSWIRE) — Dynavax Technologies Corporation (NASDAQ:DVAX) today announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously in favor of including HEPLISAV-B on its list of ACIP recommended products for use to vaccinate adults against hepatitis B. HEPLISAV-B was approved by […]

Envigo appoints Lynn Lewis as Senior Vice President of Global Sales

February 21, 2018

East Millstone, NJ, February 21, 2018 – Envigo, a leading provider of nonclinical contract research services and research models, today announced the appointment of Lynn Lewis to the position of Senior Vice President, Global Sales. She brings extensive knowledge in both science and business to the company through her successful career in pharmaceuticals and leadership roles […]

Phoenix Marketing Solutions Transforms to Phoenix Group

February 20, 2018

NEW PROVIDENCE, NJ (February 15, 2018) — Phoenix Marketing Solutions, a recognized leader in full-service medical communications and speakers bureau management, has announced its rebrand and will officially be known as Phoenix Group. The new company name aligns strategically with Phoenix Group’s core and vision — a multidisciplinary group unified with one common purpose: to transform […]

Cedars-Sinai and Emulate, Inc. Advance Precision Medicine With Organs-on-Chips, Stem Cells

February 20, 2018

LOS ANGELES and BOSTON (Feb. 20, 2018) – Scientists at Cedars-Sinai and Emulate, Inc. are pioneering a Patient-on-a-Chip program to help predict which disease treatments would be most effective based on a patient’s genetic makeup and disease variant—a new approach to precision medicine for improving patient care and health. The collaboration leverages innovative stem cell […]

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