R&D

New Data Show Benefit of Tagrisso in Patients with EGFR-mutated Non-small Cell Lung Cancer and Central Nervous System Metastases

November 20, 2017

CAMBRIDGE, England–(BUSINESS WIRE)–AstraZeneca today presented new data from a subgroup analysis of the Phase III FLAURA trial, which explored osimertinib as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Results presented at the ESMO Asia 2017 Congress in Singapore showed that patients with […]

Acorda Discontinues Tozadenant Development Program

November 20, 2017

ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that it is discontinuing its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease, including immediately discontinuing dosing of all participants currently enrolled in its tozadenant studies. The Company made this decision based on new information obtained from the Phase 3 program related to previously […]

FDA Grants Breakthrough Therapy Designation and Orphan Drug Designation to PellePharm for Topical Patidegib in Gorlin Syndrome

November 20, 2017

MENLO PARK, Calif.–(BUSINESS WIRE)–PellePharm, a clinical-stage biopharmaceutical company committed to targeting rare genetic dermatological conditions at the source, today announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy Designation and Orphan Drug Designation to topical patidegib for reduction of the life-long serious clinical morbidity and disease burden of persistently developing […]

U.S. Food and Drug Administration (FDA) Grants Alnylam Breakthrough Therapy Designation (BTD) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis with Polyneuropathy

November 20, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated ATTR amyloidosis (hATTR amyloidosis) with polyneuropathy. BTD is intended to expedite […]

Phase III IMpower150 Study Showed Genentech’s Tecentriq (Atezolizumab) and Avastin (Bevacizumab) Plus Chemotherapy Significantly Reduced the Risk of Disease Worsening or Death in the Initial Treatment of People with a Type of Advanced Lung Cancer

November 20, 2017

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower150 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus chemotherapy (paclitaxel and carboplatin) provided a statistically significant and clinically meaningful reduction in the risk […]

Genentech’s Hemlibra (Emicizumab-kxwh) Significantly Reduced Bleeds in Phase III Study in Hemophilia A

November 20, 2017

SOUTH SAN FRANCISCO, CA — 2017-11-19 00:00:00 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III HAVEN 3 study evaluating HEMLIBRA® (emicizumab-kxwh) in adults and adolescents (aged 12 years or older) with hemophilia A without inhibitors to factor VIII. The study met its primary […]

19th Annual Drug Discovery Summit

November 20, 2017

Join over 300 leading experts for Europe’s most prestigious drug discovery congress at the 19th Annual Drug Discovery Summit, 7-8 June 2018, Berlin, Germany. Bringing you the latest research in drug discovery innovations and strategies, discovery enabling technologies and novel drug targets; our industry renowned speakers will give you the key insights you need to reduce costs […]

Summit Completes Initial 24 Weeks of Dosing of Ezutromid in Patients With DMD in PhaseOut DMD Clinical Trial

November 20, 2017

Oxford, UK, 20 November 2017 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection, announces the completion of the initial 24-weeks of dosing of ezutromid in patients with DMD in the Company’s Phase 2 clinical trial called PhaseOut DMD. […]

Deciphera Pharmaceuticals Reports Data from Ongoing Phase 1 Clinical Study of DCC-2618 at the 22nd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology

November 20, 2017

WALTHAM, Mass., Nov. 20, 2017 (GLOBE NEWSWIRE) — Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced the presentation of data from its ongoing Phase 1 clinical trial of DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, in patients with malignant gliomas. The data were presented […]

Drug Development: Making the impossible possible

November 20, 2017

THE Advancing Drug Development Forum has confirmed a prestigious line-up of leading industry voices to speak at its inaugural event. Taking place on November 30, 2017 in Boston, USA, the forum will see pharmaceutical experts and scientists from across the globe come together to exchange ideas and experiences and conduct a deep dive into the […]

ZIOPHARM Presents Positive Updated Results of Ad-RTS-hIL-12 Study in Brain Cancer at Society for Neuro-Oncology Annual Meeting

November 20, 2017

BOSTON, Nov. 20, 2017 (GLOBE NEWSWIRE) — ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company developing new gene and cell-based immunotherapies for cancer, today announced positive data updates supporting survival benefit and the underlying immune system mechanism for Ad-RTS-hIL-12 plus veledimex, the Company’s controlled human interleukin-12 (hIL-12) gene therapy candidate for brain cancer, at the 22nd […]

Intra-Cellular Therapies Receives FDA Fast Track Designation for Lumateperone for the Treatment of Schizophrenia

November 20, 2017

NEW YORK, Nov. 20, 2017 (GLOBE NEWSWIRE) — Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for lumateperone for the treatment of schizophrenia. The Company requested Fast Track designation […]

Geron Announces First Patient Dosed in Expanded Part 1 of IMerge Clinical Trial in Myelodysplastic Syndromes

November 20, 2017

MENLO PARK, Calif., Nov. 20, 2017 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq:GERN) today announced that the first patient has been dosed in the expanded Part 1 of IMerge, the ongoing Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who are refractory or resistant to treatment […]

New treatments to solve global antibiotic crisis have potential to reach the market as early as 2020

November 20, 2017

[London, 13th November 2017] Helperby Therapeutics (Helperby), a pioneering British biopharmaceuticals company, have developed a novel answer to the clear and present danger of antimicrobial resistance – Antibiotic Resistance Breakers (ARBs) Doctors increasingly rely on last resort antibiotics such as carbapenems and colistin, but as harmful bacteria continue to mutate, this final line of resistance […]

Poor aggregation will see ADC targets fail or face long delays

November 20, 2017

14 November 2017, Wales:ADC Biotechnology (ADC Bio)‘s leading experts warn that best in class ADCs are being overlooked due to critical aggregation control problems. CDMOs are unable to develop products which are capable of working successfully in clinical testing or which are economically viable. The warning comes as more and more full service CDMOs are […]

BioQ Pharma and Sophos Biotech Enter into Strategic Partnership for Post-Operative Analgesia Therapy in Italy

November 20, 2017

ROME and SAN FRANCISCO, Nov. 20, 2017 (GLOBE NEWSWIRE) — BioQ Pharma Incorporated (“BioQ”) and Sophos Biotech S.r.l. (“Sophos”), both specialty pharmaceutical companies, today announced a strategic partnership agreement under which BioQ will supply and Sophos will commercialize a proprietary treatment for post-operative pain management in Italy. The product is a 48-hour opioid sparing post-surgical […]

Quanticate launches statistical monitoring services following the ICH GCP E6(R2) addendum

November 20, 2017

LONDON (UK) – Quanticate, a data-focused clinical research organisation (CRO), has launched its centralised statistical monitoring service (https://www.quanticate.com/centralized-statistical-monitoring) as an extension of its statistical consultancy offering in response to recent amendments to the International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) E6(R2) guidelines. The new service will offer Quanticate’s customers statistical consultancy that incorporates […]

CRF Health’s TrialMax Touch® Selected by Leading Specialty Pharmaceutical Company for Pediatric Rare Disease Phase II Study

November 20, 2017

Plymouth Meeting, PA – November 14, 2017:  CRF Health, the leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, has been selected by a leading specialty pharmaceutical company for its latest pediatric rare disease Phase II study. The trial will utilize CRF Health’s TrialStudio®, TrialMax® and TrialManager® eCOA solutions […]

Oxford Genetics licenses SnapFast™ expression vectors to Twist Bioscience

November 20, 2017

November 16, 2017, Oxford, England and San Francisco, Calif. – Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery, development and delivery, announced today a new licensing agreement with Twist Bioscience Corporation, a company enabling customers to succeed through its offering of rapid, high-quality synthetic DNA. Oxford Genetics will supply Twist Bioscience with its SnapFast™ technology […]

WIRB-Copernicus Group Partners with Veeva Systems Inc.

November 20, 2017

WCG will create a seamless connection between WCG’s MyConnexus™ IRB document management web portal and Veeva Vault eTMF WIRB-Copernicus Group® (WCG™), the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, today announced that it is partnering with Veeva Systems Inc. to improve the speed and accuracy of institutional review […]

Comprehend Systems Appoints New CEO in Response to Surging Demand for Clinical Intelligence Solutions; Enterprise Growth Expert to Scale Company and Expand Partner Ecosystem

November 20, 2017

Redwood City, Calif., November 13, 2017—Comprehend Systems, Inc., the leader in Clinical Intelligence solutions, has named Terry Cunningham CEO.  Cunningham will focus on scaling Comprehend in response to explosive customer demand for solutions that reduce time and risk in clinical trials. Cunningham will also drive expanded partner programs to help sponsors achieve faster, better clinical […]

Amgen, Merck, Roche get in on Syapse’s $30M round

November 16, 2017

by Amirah Al Idrus Syapse picked up $30 million in series D financing, funds it will use to bring its oncology precision medicine software to more healthcare providers. In addition to its oncology software platform, which enables caregivers in large health systems to practice precision medicine consistently, Syapse offers a data-sharing network. This provides physicians […]

Sangamo Announces Treatment of First Patient in Landmark Phase 1/2 Clinical Trial Evaluating In Vivo Genome Editing for MPS II

November 16, 2017

RICHMOND, Calif., Nov. 15, 2017 /PRNewswire/ — Sangamo Therapeutics, Inc. (Nasdaq: SGMO) today announced treatment of the first patient in the Phase 1/2 clinical trial (“the CHAMPIONS study”) evaluating SB-913, an investigational in vivo genome editing therapy for people with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. “For the first time, a […]

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