R&D

How AbbVie Is Attacking Tumors at Their Roots

March 30, 2017

A new approach to fighting cancer gets to the origin of solid tumors. By Jim Crumly Just as the body’s normal stem cells renew and sustain organs and tissue, cancer stem cells do the same for tumors. Large cap drugmaker AbbVie (NYSE:ABBV) is taking the lead in developing drugs to go after cancer stem cells, […]

FDA approves Regeneron, Sanofi $37,000 per year eczema drug

March 30, 2017

By Bill Berkrot The U.S. Food and Drug Administration on Tuesday approved Regeneron Pharmaceuticals Inc and Sanofi SA’s drug for moderate-to-severe atopic dermatitis, a product widely seen as the most important future growth driver for the two companies. Sanofi and Regeneron said the drug, Dupixent, will have a list price of $37,000 a year. But […]

Reuters Exclusive – PPD’s private equity owners in talks to sell stakes

March 30, 2017

By Carl O’Donnell and Greg Roumeliotis The two buyout firms that own Pharmaceutical Product Development LLC (PPD) are in advanced talks to sell some of their stakes in the U.S. clinical trials firm at a price that would value the entire company at more than $9 billion (7.23 billion pounds), including debt, people familiar with […]

After 40-year odyssey, first drug for aggressive MS wins FDA approval

March 30, 2017

By Ron Winslow Forty years ago, one of Dr. Stephen Hauser’s first patients was a young Harvard Law School graduate and White House aide with a case of multiple sclerosis that raced like a brush fire through her brain. She quickly lost her ability to speak, swallow, and breathe. She got married in a wheelchair […]

FDA Draft Guidance on Acyclovir Enables Diteba’s Novel IV Approach to Achieve Biowaiver Status, Replacing Clinical Trials

March 30, 2017

Mississauga, Ontario, March 30, 2017 (Business Wire) — Diteba is pleased to announce it has developed a novel in vitro approach to qualify acyclovir cream products for biowaiver status in accordance with the recently released FDA draft guidance on acyclovir. This fully compliant approach combines the extensive acyclovir in vitro release testing (IVRT) and in […]

Worldwide Clinical Trials Selects William “Bill” Hirschman As New Head Of Global Business Development

March 30, 2017

MORRISVILLE, NC, mARCH 30, 2017 – William “Bill” Hirschman has joined the leadership team of Worldwide Clinical Trials (www.worldwide.com), one of the world’s leading, full-service contract research organizations (CROs), as Executive Vice President and head of Global Business Development. Hirschman will lead Worldwide’s growing business development organization, a large global team that includes sales, sales […]

The Pistoia Alliance Calls on the Life Sciences to Support Greater Collaboration to Overcome Technology Challenges

March 30, 2017

Machine learning, deep learning, and pre-competitive data analysis will deliver tangible benefits to patients  The Pistoia Alliance, a global, not for profit alliance that works to lower barriers to innovation in life sciences R&D, is calling upon the industry to improve collaborative efforts to use patient data to its full effect. In a series of […]

Plasticell signs stem cell research collaborations with leading Singapore academic institutions

March 29, 2017

28 March 2017, Stevenage UK: Plasticell, a developer of stem cell technologies and cell-based therapies, has announced that it has signed agreements with the Agency for Science, Technology and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline. “We are delighted to have put together this collaboration which has […]

Positive Results of Phase 2b Clinical Trial of Pharmalink’s Nefecon in Primary IgA Nephropathy Published in The Lancet

March 29, 2017

STOCKHOLM, March 29, 2017 /PRNewswire/ —   Pharmalink AB, a specialty pharma company, announces that positive results and analyses from the completed Phase 2b trial of its oral drug candidate Nefecon® in primary IgA nephropathy (IgAN) patients have been published online in The Lancet (Fellström et al, reference below). This is the first time the […]

ARMO BioSciences Announces First Patient Dosed in Pivotal Phase 3 Trial of Immunotherapy AM0010 for Advanced Pancreatic Cancer

March 29, 2017

REDWOOD CITY, Calif., March 29, 2017 /PRNewswire/ — ARMO BioSciences, Inc., a clinical-stage immuno-oncology company, announced that the first patient has been dosed in the Company’s international Phase 3 pivotal clinical trial to evaluate its lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) in combination with FOLFOX as second-line treatment for patients with advanced pancreatic cancer. […]

Kadmon Presents Preclinical Data Supporting the Therapeutic Potential of ROCK Inhibition in Pulmonary Fibrosis

March 29, 2017

NEW YORK–(BUSINESS WIRE)–Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon”) today announced preclinical data demonstrating the importance of the Rho-associated coiled-coil kinase (ROCK) signaling pathway in the pathogenesis of pulmonary fibrosis, supporting the therapeutic potential of ROCK inhibition to treat the disease. The data will be presented today as a poster at the 2017 Keystone Symposia on Injury, […]

Ligand Announces Licensing Partner Janssen Has Filed an IND for an Antibody Discovered Using the OmniAb® Technology

March 29, 2017

SAN DIEGO–(BUSINESS WIRE)–Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that CNA Development LLC, an affiliate of Janssen Pharmaceuticals, Inc. (Janssen) has filed an IND for an antibody discovered using Ligand’s OmniAb technology. This IND filing results in a $1 million milestone payment to Ligand. “This milestone represents an important step in the development process and is […]

New Data Demonstrate RSV Immunoprophylaxis With SYNAGIS® (palivizumab) May Result in Reduced Overall Costs in Preterm Infants Born at 29-32 wGA Who Are Less Than Three Months of Age

March 29, 2017

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced new results data which evaluated the cost-effectiveness of SYNAGIS® (palivizumab) for respiratory syncytial virus (RSV) in preterm infants 29-34 weeks gestational age compared to those who did not receive SYNAGIS.1 These results, derived from age-specific information on the incidence and cost of RSV hospitalization and cost of SYNAGIS, demonstrated that […]

Lysogene Announces Baseline Data from First International Pivotal Observational Study in MPS IIIA Study will Function as Pivotal Trial Clinical Control and Assist in a Better Understanding of the Disease

March 29, 2017

PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Regulatory News: “We anticipate that this and forthcoming data will represent new learnings in this disease area and we know it will prove extremely valuable as Lysogene prepares for future pivotal studies in MPS IIIA” Tweet this Lysogene (FR0013233475 – LYS), a leading, biopharmaceutical company pioneering in gene therapy technology applied […]

Two Phase 3 Studies of the Tezacaftor/Ivacaftor Combination Treatment Met Primary Endpoints with Statistically Significant Improvements in Lung Function (FEV1) in People with Cystic Fibrosis

March 29, 2017

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from two Phase 3 studies of the tezacaftor (VX-661) / ivacaftor combination treatment that showed statistically significant improvements in lung function (percent predicted forced expiratory volume in one second, or ppFEV1) in people with cystic fibrosis (CF) ages 12 and older who have certain mutations in […]

Acorda Announces Long-Term Safety Data for CVT-301

March 29, 2017

ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced results from two ongoing, long-term safety studies of CVT-301 in people with Parkinson’s that showed no differences in pulmonary function between the group receiving CVT-301 and an observational control group. These results are consistent with previously reported data from Phase 2b and Phase 3 clinical trials. […]

GW Pharmaceuticals Announces Epidiolex® Receives Orphan Drug Designation from the European Medicines Agency for the Treatment of Lennox-Gastaut Syndrome

March 29, 2017

LONDON, March 29, 2017 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to GW’s investigational product Epidiolex® (cannabidiol or CBD) […]

Cytokinetics Announces Start of Second Cohort in Phase 2 Clinical Trial of CK-2127107 in Patients With Spinal Muscular Atrophy

March 29, 2017

SOUTH SAN FRANCISCO, Calif., March 29, 2017 (GLOBE NEWSWIRE) — Cytokinetics, Inc. (Nasdaq:CYTK) today announced that the second cohort of the Phase 2 clinical trial of CK-2127107 in patients with spinal muscular atrophy (SMA), is open to enrollment. This clinical trial is designed to assess the effect of CK-2127107, a next-generation fast skeletal troponin activator […]

CureLab Oncology, Inc. Publishes Results of Phase I/IIa Clinical Trials of Its Anti-Cancer DNA Vaccine, Elenagen™

March 28, 2017

BOSTON, March 28, 2017 /PRNewswire/ — Oncology journal, Oncotarget, has published a pre-print of the research conducted by the Boston based biotech start-up CureLab Oncology, Inc. The paper describes the results of phase I/IIa clinical trials of a novel therapeutic anti-cancer DNA vaccine, Elenagen™. The research demonstrated both the first encouraging evidence of its clinical […]

Icagen Announces Collaboration With Bayer To Develop Novel XRpro® Assays

March 28, 2017

DURHAM, N.C., March 28, 2017 /PRNewswire/ — Today the Target-to-Lead company Icagen announces a collaboration with Bayer to develop new X-ray fluorescence assays using the proprietary XRpro® platform. These assays are designed to help Bayer to progress various early discovery programs in the area of transporter targets.   A major obstacle for validation of transporters […]

Milner Therapeutics Institute announces new partnership with Elysium Health

March 28, 2017

CAMBRIDGE, England, March 28, 2017 /PRNewswire-USNewswire/ — The Milner Therapeutics Institute today announces Elysium Health as a partner to the Milner Therapeutics Consortium. Elysium Health has committed significant investment for collaborative projects with academic researchers in Cambridge over the next four years. This is the first major research investment outside the U.S. for the New […]

Vium Announces Co-Development Partnership with Japan’s CIEA for Humanized Disease Models

March 28, 2017

SAN MATEO, Calif.–(BUSINESS WIRE)–Vium, the first and only Digital Vivarium™ company, today announced a partnership with Japan’s Central Institute for Experimental Animals (CIEA) to co-develop humanized mouse models of disease which Vium will offer as a fee-for-service to clients around the world. The partnership, which will initially focus on developing a humanized mouse model for […]

Blaze Bioscience Announces Tumor Paint BLZ-100 Publication in International Journal of Toxicology

March 28, 2017

SEATTLE–(BUSINESS WIRE)–Blaze Bioscience, Inc., the Tumor Paint Company®, a biotechnology company dedicated to improving the lives of cancer patients, today announced the publication of a peer-reviewed manuscript in International Journal of Toxicology describing the nonclinical safety and pharmacokinetic (PK) profile of Tumor Paint BLZ-100 in animal models. The publication entitled “Nonclinical Profile of BLZ-100, a […]

AstraZeneca Shares Progress on LYNPARZA™ (olaparib) Tablets in the US

March 28, 2017

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for LYNPARZA™ (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. The FDA has also granted priority review status with a Prescription Drug User Fee Act […]

Akebia Announces Publication of Phase 2a Results for Vadadustat in Patients with Anemia Related to Chronic Kidney Disease

March 28, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), today announced the publication of positive results from a Phase 2a study of vadadustat, a once-daily oral HIF stabilizer in development for the treatment of anemia related to chronic […]

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