Boehringer Ingelheim and CANbridge Life Sciences announced that both parties have signed an agreement for the manufacture of CAN-017, an ErbB3 (HER3) inhibitory antibody to treat esophageal squamous cell cancer (ESCC), CANbridge plans to initiate a Phase IIa clinical trial for the treatment of ESCC in Greater China. ESCC is the most prevalent form of…
NIH Uses Needle-Free Device in DNA Vaccine Clinical Trial for Zika
PharmaJet, the maker of innovative, needle-free injection technology, announced that the National Institutes of Health will use the PharmaJet Stratis® needle-free device in a DNA vaccine clinical trial for the Zika virus. DNA vaccines are the way of the future. Unlike traditional vaccines, like for flu or measles, that contain whole viruses, DNA vaccines contain…
Phase 3 Trial Results of Merck’s Opioid Dependence Treatment for Patients with HCV
Intec Pharma to Develop Cannabinoid Pills
Intec Pharma Ltd., a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill™ platform technology, announces the initiation of a new clinical development program for its Accordion Pill platform with the two primary cannabinoids contained in Cannabis sativa. Intec Pharma plans to formulate and test cannabidiol (CBD) and tetrahydrocannabinol (THC), or AP-CBD/THC, for the treatment…
Vaxart Initiates Clinical Development of First Oral Norovirus Vaccine
Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, announced the initiation of a Phase 1 clinical trial of the first oral norovirus tablet vaccine. “The start of the norovirus Phase 1 study is another important milestone for Vaxart’s oral vaccine platform,” said Wouter Latour,…
Pfizer Acquires Bamboo Therapeutics, Leads the Way in Gene Therapy
Bristol-Myers Squibb & Janssen Collaborate on Lung Cancer Treatment
Bristol-Myers Squibb Company announced a new clinical research collaboration with Janssen Biotech, Inc. to evaluate Bristol-Myers Squibb’s Immuno-Oncology (I-O) agent Opdivo (nivolumab) and Janssen’s Live Attenuated Double–Deleted (LADD) Listerial monocytogenes cancer immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in patients with non-small cell lung cancer (NSCLC). Opdivo is a human antibody designed to alleviate immune suppression. JNJ-64041757 is designed to induce the…
3Scan Raises $14M To Usher In New Era Of Computational Pathology
3Scan, the computational pathology services platform, announced today that it has raised $14 million in Series B financing. The automated pathology approach pioneered by 3Scan reduces uncertainty in basic and applied research by shedding light on previously inaccessible and important dimensions of diseased tissue, utilizing high throughput robotic microscopes and computer vision. This new round…
Merck & Pfizer Initiate Phase 3 Trial for Ovarian Cancer Treatment
Merck and Pfizer announced the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of avelumab* in combination with, and/or as follow-on (maintenance) treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease (Stage III or Stage IV) with previously untreated epithelial ovarian cancer. JAVELIN Ovarian 100 is…
Biogen & AbbVie’s Injectable Approved in EU for Treatment of MS
The European Commission (EC) has granted marketing authorization for ZINBRYTA™ (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), Biogen and AbbVie announced. ZINBRYTA is a once-monthly, self-administered, subcutaneous injection. “Clinical data showed ZINBRYTA significantly reduced relapses, 24-week confirmed disability progression and new brain lesions for up to three years compared to AVONEX ®…
Bristol-Myers Squibb & PsiOxus Evaluate Potential Drug Combination
Bristol-Myers Squibb Company and PsiOxus Therapeutics, Ltd. (PsiOxus) announced an exclusive clinical collaboration agreement to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus’ enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with Bristol-Myers Squibb’s Immuno-Oncology (I-O) agent Opdivo (nivolumab) to treat a range of tumor types in late-stage cancer patients. Enadenotucirev is designed to have immune stimulating effects while Opdivo is…
Pfizer Completes Acquisition of Anacor
Pfizer Inc. announced that it has completed its acquisition of Anacor Pharmaceuticals, Inc. Under the terms of the transaction, each outstanding share of Anacor common stock has been converted into the right to receive $99.25 net in cash (without interest but subject to required withholding of taxes). “Now that Anacor is part of Pfizer, we can…
China Approves Drug Marketing Authorization Holder Pilot Plan, Impacting CMOs
China’s State Council issued an effective notice dated May 26, 2016, formally authorizing a trial plan for a new Drug Marketing Authorization Holder (MAH) System for ten provinces: Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, and Sichuan. Pharmaceutical research institutions and individual researchers in these provinces can submit application for clinical trials or Marketing Authorization…
AHF Launches Ad Campaign: “Gilead Scandal: Gay Men, We Don’t Care About Your Kidneys and Bones”
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, has launched a new advertising campaign to draw attention to Gilead Sciences, Inc. following a recent and blistering LA Times article that exposed the pharmaceutical giant’s patent manipulation of its best-selling HIV drug. The ad headline reads “Gilead Scandal: Gay Men, we don’t care about your kidneys and bones, only the…
Biogen’s Alzheimer’s Disease Treatment Accepted into EMA’s PRIME Program
Biogen announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was accepted into the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program. PRIME aims to bring treatments to patients faster by enhancing the EMA’s support for the development of investigational medicines for diseases without available treatment or in need of better treatment options. “Alzheimer’s…
AHF Calls on FDA, Congress to Investigate Gilead Sciences Over HIV/AIDS Drug Patent Manipulation
AstraZeneca’s Asthma Treatment Achieves Primary Endpoint in Phase 3 Trials
Biogen & University of Pennsylvania Partner for Gene Therapy Research
Sanofi Genzyme Partners with Johns Hopkins for MS Research
Biogen Reports First Quarter 2016 Revenues of $2.7 Billion
Biogen Inc. reported first quarter 2016 financial results, including: Total revenues of $2.7 billion, a 7 percent increase versus the same period in the prior year. Growth was driven by a 15 percent increase in worldwide TECFIDERA® revenues as well as increased revenues from ELOCTATE® and ALPROLIX®. Revenues were partially offset by a decrease in worldwide interferon sales.…
Global Heparin Market Expected to Take Off
Celgene to Develop and Commercialize Drug without Juno
Celgene Corporation and Juno Therapeutics, Inc. announced that Celgene exercised its option to develop and commercialize the Juno CD19 program outside North America and China. With the exercise of this option, Celgene will pay Juno a fee of $50 million and the companies will now share global development expenses for products in the CD19 program. Celgene…
Pfizer & IBM’s Parkinson’s Disease Research Collaboration
Pfizer Inc. and IBM announced a first-of-its-kind research collaboration to develop innovative remote monitoring solutions aimed at transforming how clinicians deliver care to patients suffering from Parkinson’s disease. The experimental approach will rely on a system of sensors, mobile devices, and machine learning to provide real-time, around-the-clock disease symptom information to clinicians and researchers. The ultimate goal…
Incyte Acquires Commercialization Rights & Amends Agreement with Novartis
Phase 3 Study Results for Pfizer’s Investigational Lipid-Lowering Drug
Pfizer Inc. announced that the Phase 3 SPIRE-AI (AutoInjector) trial of the investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) bococizumab administered with a pre-filled pen met its co-primary endpoints: percent change from baseline in low-density lipoprotein cholesterol (LDL-C) reduction at 12 weeks compared to placebo and proportion of patients successfully operating the pre-filled…