Bio/Pharma News
Finch and Takeda Collaborate on IBD Therapies
The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.
Janssen Signs Deal with PeptiDream
Janssen will have access to PeptiDream’s proprietary Peptide Discovery Platform System technology, which will be used to identify peptides against multiple metabolic and cardiovascular targets.
FDA Approves Teva’s Deuterated Drug for Chorea Associated with Huntington’s Disease
Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade.
Dipharma Strengthens Pipeline with Stable, Fast-Dissolving Carglumic Acid Tablets
Carglumic acid is used in the management of rare, life-threatening inborn metabolic disorders affecting the urea cycle.
EMA Grants Orphan Drug Designation to Epidiolex for Treatment of Lennox-Gastaut Syndrome
GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.
Novartis Receives FDA Priority Review for CAR-T Therapy
The company received priority review for its investigational CAR-T therapy to treat leukemia.
FDA Approves First Treatment for Primary-Progressive Forms of Multiple Sclerosis
The mAb is the first approved treatment that targets the progressive form of the disease.
Plasticell Collaborates with Singaporean Institutions on Stem Cell Research
The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.
FDA Approves Dupixent for Atopic Dermatitis
FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.
Novimmune Opens Branch Office in Basel
The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.
FDA Approves Avelumab for Rare Skin Cancer
FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.
Lilly Invests $850 Million in US Manufacturing Operations
The company said it plans to expand diabetes manufacturing facilities in the United States.
Sanofi and Regeneron File Suit Against Amgen in Patent Case
Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.
BMS and CytomX Expand Collaboration
The companies will be expanding their collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.
SpacePharma Successfully Completes In-Orbit Experiment
The company said that it has successfully completed its first in-orbit experiment using its miniature end-to-end space laboratory.
Allergan Enters into CRISPR Territory with Editas Partnership
Under the agreement, Allergan will receive exclusive access to five of Editas’ ocular programs.
Chairman of Senate Judiciary Committee Raises Questions Over Auvi-Q Price Tag
Senator Chuck Grassley sent a letter to the Kaléo CEO questioning the drugs high listing price.
FDA Grants Clearance for Clinical Development of UCART19
The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.
MedImmune and Sanofi Pasteur Strike Deal
The companies have entered into an agreement to develop and commercialize a mAb for the prevention of lower respiratory tract illness in young children.
BeiGene and GDD Build Biologics Facility in China
BeiGene and the Guangzhou Development District have established a joint venture to build a biologics manufacturing facility in China.
Study Dismantles PhRMA’s Long-Standing Argument on Drug Pricing
A blog posted on Health Affairs on March 7, 2017 presents a study that tested PhRMA’s long-standing argument that high prices for drugs fund research and development in the pharmaceutical industry.
Sanofi and Lonza Partner on mAb Cell Culture Facility in Switzerland
Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.
Sarepta Sells Priority Review Voucher to Gilead for $125 Million
Sarepta sold the priority review voucher for Exondys 51, a controversial treatment for Duchenne Muscular Dystrophy, to Gilead.
FDA Grants Pfizer Priority Review for Inotuzumab Ozogamicin
FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.
CellGenix Adds Capacity for Cell Therapy Raw Materials
CellGenix will add R&D, production, and warehouse space in Freiburg, Germany for GMP-grade raw materials for cell therapy, gene-therapy, and tissue-engineered products.
Mereo BioPharma’s Brittle Bone Disease Drug Accepted for EMA’s Adaptive Pathways Program
BPS-804, which is being developed for the treatment of osteogenesis imperfecta (brittle bone disease), has been granted orphan drug designation by both FDA and the European Commission.
GW Pharmaceuticals Announces Results from Cancer Trial
The company announced results from a Phase II trial with its THC:CBD drug for the treatment of glioblastoma multiforme.
Seattle Genetics Strikes Deal with Immunomedics
The companies entered into a license agreement for Immunomedic’s antibody-drug conjugate sacituzumab govitecan.
Biotech Executives Express Concern Over Immigration Order
A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.
Capsugel Announces Commercial Availability of Modular Automated Sampling Technology
Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.
