R&D

Merck’s KEYTRUDA(R) (pembrolizumab) Significantly Improved Overall Survival and Progression-Free Survival as First-Line Treatment in Combination with Pemetrexed and Platinum Chemotherapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (KEYNOTE-189)

January 16, 2018

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed (Alimta®) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary […]

Foundation Medicine and Pfizer Announce Broad Partnership to Develop Companion Diagnostics for Pfizer’s Oncology Portfolio

January 16, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the company has entered into a broad partnership with Pfizer Inc. (NYSE: PFE). The partnership focuses on development, regulatory support and commercialization of companion diagnostics (CDx) that will be included in updates to FoundationOne CDx™. FoundationOne CDx is Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay […]

Centrexion Therapeutics Announces Fast Track Designation Granted by FDA to CNTX-4975 for Treatment of Knee Osteoarthritis Pain

January 16, 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 U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975 for the treatment of pain associated with knee osteoarthritis. CNTX-4975, Centrexion’s Phase 3 ready lead therapy, is a synthetic, ultra-pure […]

Constellation Pharmaceuticals Announces Initiation of Phase 1b/2 Study of CPI-1205 in Combination with Checkpoint Inhibitors

January 16, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing tumor-targeted and immuno-oncology therapies based on its pioneering research and development in cancer epigenetics, today announced it has initiated a Phase 1b/2 clinical trial to evaluate CPI-1205, a small-molecule inhibitor of Enhancer of Zeste Homolog 2 (EZH2), combined with checkpoint inhibitor ipilimumab (marketed as YERVOY® […]

Ophthotech Announces First Patient Enrolled in the Phase 2b Clinical Trial of Zimura®, Complement C5 Inhibitor, for the Treatment of Autosomal Recessive Stargardt Disease (STGD1)

January 16, 2018

NEW YORK–(BUSINESS WIRE)–Ophthotech Corporation (NASDAQ:OPHT) announced today that the first patient has been enrolled in the Phase 2b randomized, double-masked, sham-controlled clinical trial assessing the efficacy and safety of Zimura® (avacincaptad pegol), complement C5 inhibitor, in patients with autosomal recessive Stargardt disease (STGD1). STGD1 is an inherited orphan retinal disease causing vision loss during childhood […]

Midatech and UCSF receive IND approval for DIPG treatment MTX110

January 16, 2018

Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the international specialty pharmaceutical company focused on developing and commercialising products in oncology, today announces approval of the investigational new drug (IND) application from the US Food and Drug Administration (FDA) to conduct a study of MTX110, an investigational nano-inclusion product, for the treatment of the fatal childhood brain […]

Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA

January 16, 2018

Holzkirchen, January 16, 2018 – Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira®*. “When patients are dealing with a chronic […]

Novartis new data reinforces superiority of Cosentyx® versus Stelara®* in achieving skin clearance for psoriasis patients

January 16, 2018

Basel, January 16, 2018 – Novartis announced today results from the head-to-head CLARITY study demonstrating the superiority of Cosentyx® (secukinumab) compared to Stelara®* (ustekinumab) in delivering clear and almost clear skin in adults with moderate-to-severe plaque psoriasis at 12 weeks. The study results show 66.5% and 72.3% of patients treated with Cosentyx (p < 0.0001) […]

Science Exchange Partners with Lab Launch to Help its Startups Advance Scientific Innovations

January 15, 2018

Science Exchange, the world’s leading and most secure enterprise platform for outsourced research and development (R&D), teamed up today with Lab Launch, a nonprofit working to provide affordable and high-quality laboratories to biotech startups. This partnership with Science Exchange allows Lab Launch’s resident companies to easily supplement and complement their in-house resources with external research […]

Cour Pharmaceuticals Receives FDA Fast Track Designation for TIMP-GLIA – A Novel Treatment for Celiac Disease under Clinical Development

January 15, 2018

Cour Pharmaceuticals Receives FDA Fast Track Designation for TIMP-GLIA – A Novel Treatment for Celiac Disease under Clinical Development TIMP-GLIA is designed to enable patients to develop tolerance to gluten Phase 1 program studying potential of new treatment option for people living with Celiac Disease   CHICAGO, Wednesday, January 10, 2018 Cour Pharmaceuticals today announced […]

Meditraq launches to simplify serialisation data challenge

January 15, 2018

A new serialisation implementation partner has formed to assist the increasing number of companies needing to meet the data requirements of looming global regulation changes. With the pharmaceutical industry struggling to meet serialisation requirements in over 55 countries, Meditraq supports its customers with the deployment of serialisation software solutions. Part of the Tjoa Group, together […]

TiGenix announces publication in Gastroenterology of 52-week results of the Phase III ADMIRE-CD trial of Cx601

January 15, 2018

Leuven (BELGIUM) – January 15, 2018, 07:00 CET – TiGenix NV (Euronext Brussels and NASDAQ: TIG), an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop novel therapies for serious medical conditions, announces today that the 52-week results of the Phase III ADMIRE-CD trial investigating Cx601 (darvadstrocel) […]

Japanese pharma: No longer ‘lost in translation’

January 15, 2018

Amsterdam, 15th January 2018: A New Year report from CPhI forecasts 2018 will be a transformative year for Japanese pharma as the market evolves towards growth in generics, biosimilars and increased internationalisation. The CPhI Japan 2018 report – released ahead of what is likely to be the largest ever CPhI Japan (18-20 April, 2018) – has identified that demographic pressures […]

Just-In-Time Enrollment for Oncology Trials: Get to First Patient In Faster & Mitigate Non-Enrolling Sites

January 12, 2018

Despite scientific advances, oncology clinical trials are still challenged by delayed trial timelines, slow site activation and poor patient enrollment. To overcome these barriers, we need to redefine the enrollment paradigm. A new trial methodology has been developed that addresses these challenges and provides sponsors with the enrollment and budget solution needed to more effectively […]

Eurocine Vaccines Obtains Authorization to Conduct the Next Study with Immunose™ FLU

January 12, 2018

STOCKHOLM, Jan. 11, 2018 /PRNewswire/ — Eurocine Vaccines today announced that the company has received authorization to conduct a phase I/II clinical study on the quadrivalent influenza vaccine candidate Immunose™ FLU, a novel nose drop formulation based on the company´s technology Endocine™ and inactivated split antigens.   Eurocine Vaccines submitted applications to the Swedish Medical […]

Renova Therapeutics to present key components of FLOURISH gene therapy trial for the treatment of heart failure at Keystone Symposium

January 12, 2018

SAN DIEGO, Jan. 11, 2018 /PRNewswire/ — Renova™ Therapeutics, a biotechnology company developing gene and peptide-based treatments for cardiovascular and metabolic diseases, announced today that it will present an overview of its RT-100 AC6 gene transfer Phase 3 clinical trial in a poster session at the Keystone Symposium on Heart Failure on January 14-18, 2018, […]

Xcede Hemostatic Patch Clinical Trial Dossier Submitted to Groningen-based Medical Ethical Review Committee (MREC) in Anticipation of First-in-Human Clinical Trial

January 12, 2018

SEATTLE, Jan. 11, 2018 /PRNewswire/ — The Xcede Patch clinical trial dossier was submitted today to the Medical Ethical Review Committee (MREC) Universitair Medisch Centrum Groningen (Netherlands), in anticipation of a first-in-human clinical trial. The clinical trial, which outlines the treatment of up to 30 patients undergoing various types of liver resection, will take place […]

Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-121 Acne Treatment In Lotion Form

January 12, 2018

LAVAL, Quebec, Jan. 12, 2018 /PRNewswire/ — Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) (“Valeant”) , today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application for IDP-121 (tretinoin 0.05%) lotion (ALTRENO™1) with a PDUFA action date of Aug. 27, 2018. If […]

FDA Grants Fast Track Designation to Concert Pharmaceuticals’ CTP-543 for the Treatment of Alopecia Areata

January 12, 2018

LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543, a novel, oral Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair […]

Aradigm Reports Results of FDA Advisory Committee Meeting on Linhaliq

January 12, 2018

HAYWARD, Calif., Jan. 11, 2018 (GLOBE NEWSWIRE) — Aradigm Corporation (NASDAQ:ARDM) (the “Company”) today announces that the Antimicrobial Drugs Advisory Committee (ADAC) of the US Food and Drug Administration (FDA) did not recommend approval for Linhaliq™ as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung Pseudomonas aeruginosa infections. The Advisory Committee voted […]

BioIVT Launches Scientific Advisory Board, Expands Drug Development Expertise

January 12, 2018

New SAB members include a Nobel Laureate, modeling and simulation guru, pediatric oncologist, and bioanalytical operations and infectious disease experts     BioIVT, a leading provider of biospecimens and related services, today announced the launch of its BioIVT Scientific Advisory Board (SAB). BioIVT’s eminent and world-renowned SAB members will provide the company with scientific and […]

Forty Seven Inc. to Collaborate on a Novel Immuno-Oncology Combination for Leukemia and Bladder Cancer

January 11, 2018

MENLO PARK, Calif., Jan. 11, 2018 /PRNewswire/ — Forty Seven Inc., a clinical-stage company focused on developing the next generation of transformational immuno-oncology treatments to enable patient’s immune systems to defeat their cancer, today announced an agreement with Genentech Inc., a member of the Roche Group., for Genentech to sponsor two clinical trials combining Forty […]

Forty Seven Inc. to Collaborate with Merck KGaA, Darmstadt, Germany, on a Novel Immuno-Oncology Combination for Ovarian Cancer

January 11, 2018

MENLO PARK, Calif., Jan. 11, 2018 /PRNewswire/ — Forty Seven Inc. a clinical-stage company focused on developing the next generation of transformational immuno-oncology treatments to enable a patient’s immune system to defeat their cancer, today announced an agreement with Merck KGaA, Darmstadt, Germany to conduct a Phase 1b clinical trial combining Hu5F9-G4 with avelumab* in […]

Roche and GE Healthcare Plan ‘Industry First’ Digital Platform

January 11, 2018

Roche and GE Healthcare are joining forces to develop clinical decision support software that they say will be the first of its kind.   The digital health platform will combine data from Roche’s biomarker, tissue pathology, genomics and sequencing portfolio with that from GE’s medical imaging and monitoring equipment.   The advanced analytics tying this […]

Regeneron Forms Consortium of Leading Life Sciences Companies to Accelerate Largest Widely-available ‘Big Data’ Human Sequencing Resource With UK Biobank

January 11, 2018

TARRYTOWN, N.Y., Jan. 8, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), along with new collaborators AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer Inc., today announced the formation of a major ‘pre-competitive’ consortium to fund the generation of genetic exome sequence data from the 500,000 volunteer participants who make up the UK Biobank health resource. […]

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