Sanofi Net Income Off 26 Percent In Second Quarter
Q2 2018 Change Change at CER H1 2018 Change Change at CER IFRS net sales reported €8,176m -5.7% +0.1% €16,074m -7.2% -0.1% IFRS net income reported €762m -26.2% – €1,778m -73.6%(2) – IFRS EPS reported €0.61 -25.6% – €1.42 -73,4%(2) – Business net income(1) €1,558m -7.9% +0.4% €3,156m -9.4% +0.4% Business EPS(1) €1.25 -6.7% +1.5%…
First-Ever Parkinson’s Biomarker ‘Qualified’ In EU For Clinical Trials
The European Medicines Agency (EMA) has issued a positive qualification opinion on an imaging test, or biomarker, for use as a tool to improve Parkinson’s clinical trials, according to the Tucson, AZ-based Critical Path Institute and its Critical Path for Parkinson’s (CPP) consortium, which hailed the EMA qualification as the first such regulatory designation for a Parkinson’s biomarker. The EMA move follows…
GSK Invests $300M In 23andMe Gene Profiling Service
GlaxoSmithKline (GSK) on Wednesday announced a major advancement in its capability to assess the impact of genetic variation on human disease with the formation of a new collaboration with 23andMe, a leading consumer genetics and research company. GSK agreed to invest $300 million as part of the collaboration. The move offers GSK an opportunity to use 23andMe’s database and…
Summit To Discontinue Development Of Duchenne Muscular Dystrophy Treatment
Summit Therapeutics plc announced that it will discontinue development of ezutromid based on Phase 2 trial results that failed to meet primary or secondary endpoints after 48 weeks of treatment. Ezutromid was under study as a possible treatment for patients suffering from Duchenne muscular dystrophy (DMD). Company stock plummeted nearly 80 percent following the announcement. Summit announced that now it will turn…
Trial Results Are Positive For Two Rare Disease Gene Therapies
Abeona Therapeutics Inc. last week updated clinical data from the Phase 1/2 trial for ABO-102 (AAV-SGSH), the company’s clinical gene therapy for the treatment of Sanfilippo syndrome type A (MPS III A) and from the Phase 1/2 trial for EB-101, a gene-corrected skin graft cell therapy for patients suffering from recessive dystrophic epidermolysis bullosa (RDEB).…
Dupixent Improved Moderate-To-Severe Asthma In Phase 3 Trials
Two Phase 3 trials for the investigational use of Sanofi’s Dupixent (dupilumab) in moderate-to-severe asthma showed that the drug significantly reduced the risk of severe asthma attacks (exacerbations), improved lung function, and reduced dependence on oral corticosteroids (OCS). The detailed findings were published in the New England Journal of Medicine (NEJM). The trials, known as QUEST and VENTURE, are part of the…
FDA Grants Rare Pediatric Disease Designation For Treatment Of Debilitating Skin Disorder
The U.S. Food and Drug Administration (FDA) has granted a rare pediatric disease designation to Castle Creek Pharmaceuticals for diacerein 1% ointment (CCP-020) in the treatment of epidermolysis bullosa (EB), a genetic condition that leads to extremely fragile skin resulting in mild to severe blistering, skin erosion, and peeling of the epidermis layers in response to minor…
M&A Report: 2017 Was A Disruptive Year In Pharma, Biotech, And Other Markets
Mergermarket, an Acuris company, has released its global merger and acquisition trend report for the technology, media, and telecom (TMT) sector for 2017. Findings include M&A activity in the pharmaceutical, biotech, and healthcare industries. Among key findings: · In 2017, global deal making in the TMT sector saw 3,389 deals worth a combined $498.2 billion. Although total deal value fell 26.3…
FDA Grants Final Approval For Epiduo Gel And Estrace Cream Generics
Perrigo Company plc received final approval from the U.S. Food and Drug Administration and has launched an AB-rated generic version of Epiduo (adapalene and benzoyl peroxide) Gel, 0.1%/2.5%, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. The company also received final FDA approval for the generic version of Estrace Cream…
FDA OKs New Clinical Trial For Sernova’s Cell Pouch System In The U.S.
The Food and Drug Administration will allow regenerative medicine tech developer Sernova Corp. to begin a new U.S. clinical trial of its proprietary Cell Pouch System for treatment of type 1 diabetes in individuals with hypoglycemia unawareness. The Cell Pouch is a scalable, implantable macroencapsulation device for the long-term survival and function of therapeutic cells, which then release proteins and/or hormones…
Sandoz Biosimilar Pegfilgrastim Matches Amgen’s Neulasta In Study
Sandoz announces new Phase I data showing proposed biosimilar pegfilgrastim matches reference medicine. Sandoz, a division of Novartis, confirmed that its biosimilar pegfilgrastim in a Phase I study matches the Amgen Inc. reference biologic Neulasta*1 in terms of the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity profiles1. Neulasta is used to fight infection in cancer patients. According to the Amgen’s…
Efforts On Prostate And Breast Cancer Tests May Prompt New Drug Development
Genomic Health’s research collaboration with Janssen Pharmaceuticals will evaluate the Oncotype DX Genomic Prostate Score test for potential drug development. Genomic Health, Inc. today announced a multi-year research collaboration agreement with Janssen Pharmaceuticals to evaluate the Oncotype DX Genomic Prostate Score (GPS) test for their prostate cancer drug pipeline. As part of the agreement, Genomic Health…
Janssen Biotech To Pay $230M In Hypertension Deal With Idorsia
The Janssen Biotech, Inc. unit of Johnson & Johnson has exercised its option to enter into a collaboration agreement with Idorsia Ltd. to jointly develop and commercialize Idorsia’s hypertension drug aprocitentan and its derivative compounds or products. Idorsia will receive a one-time milestone payment of $230 million that will be reflected in its Q4 2017 financial results. Aprocitentan…
Metastatic Melanoma Treatment Granted Fast Track Designation
U.S. FDA grants Fast Track designation for Idera Pharmaceuticals’ IMO-2125 in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma. The Food and Drug Administration (FDA) has placed Idera Pharmaceutical’s lead development candidate IMO-2125 on the fast track for the treatment of anti-PD-1 refractory metastatic melanoma in combination with ipilimumab. IMO-2125 received orphan drug designation…
Success Reported During Phase III Trial For Neurological Disorder Treatment
Pharnext: Successful intermediate analyses for PLEO-CMT Phase III clinical trial in Charcot-Marie-Tooth disease Type 1A. Pharnext SA, a biopharmaceutical company working on a new approach for the development of drugs based on the combination and repositioning of known therapies, announced successful intermediate analyses for its Phase III clinical trial, PLEO-CMT, in Charcot-Marie-Tooth Disease Type 1A (CMT1A).…
Oxford Genetics Licenses Expression Vectors To CA-Based Twist Bioscience
Oxford Genetics, a provider of synthetic biology-based technologies for biologics discovery, development, and delivery has signed a new licensing agreement with Twist Bioscience Corporation, a company that offers rapid, high-quality synthetic DNA. Under the arrangement, Oxford Genetics will supply Twist Bioscience with its SnapFast technology platform to provide a broad range of application-specific expression vectors, which Twist will use to clone…
MDA Awards $3.5M In New Research Grants
The Muscular Dystrophy Association has awarded 13 new research and development grants totaling $3.5 million to accelerate the development of treatments for life-threatening diseases, incuding muscular dystrophy and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The latest awards bring the MDA 2017 grant total to $13.7 million. According to the association, the goal is to make progress in numerous areas…
Abeona’s Global Sanfilippo Syndrome Trial Gains Ground In Spain
Abeona enrolls first subject in Spain in ongoing phase 1/2 clinical trial in MPS IIIA, also known as Sanfilippo syndrome. Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company, has enrolled the first patient in its ABO-102 Phase 1/2 clinical trial in Spain in the fight against Mucopolysaccharidosis type III (MPS IIIA), more commonly known as Sanfilippo syndrome. The…
The Biggest Trends In Pharma
Serialization and drug prices remain the top issues for executives up and down the pharmaceutical pipeline in 2018. Although the U.S. Food and Drug Administration (FDA) has issued a one-year delay for enforcing the first-phase of Drug Supply Chain Security Act (DSCSA) requirements, companies, especially those that were well behind in their plans to meet…
Generic Versions Of Copaxone Take Toll On Teva 3Q Results
Merck Plans To Eliminate 840 Sales Jobs In Cost-Cutting Strategy
Two Drugs Can Be Better Than One
By combining already established drugs in lower doses, PLEOTHERAPY shows promise in improving targeted therapy and reducing costs. Pharnext, a clinical-stage biopharmaceutical company that develops therapeutics for neurodegenerative diseases for which there currently are no cures and existing therapies available, has pioneered a new paradigm called PLEOTHERAPY. It centers on a blending of drugs previously…
