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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.
Recipharm Completes Kemwell Acquisition
Recipharm’s addition of Kemwell’s Bengaluru, India facility expands its solid- and liquid-dosage capabilities.
Sartorius and the European Molecular Biology Laboratory Collaborate on Training
Sartorius and EMBL have entered into a corporate partnership program to foster advanced training.
FDA Posts ICH Q11 Q&A Guideline
The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.
SGS Adds to ICP-MS Capabilities
SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.
PhRMA Urges USTR to Ramp Up Patent Enforcement Activities Overseas
PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.
Sterile Manufacturing Deviations Found at Japan Facility
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
FDA Approves Brodalumab for Psoriasis
FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.
The Broad Institute Triumphs in CRISPR Patent Battle
The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the institution to keep patents for its CRISPR-Cas9 gene-editing technology.
Symbiosis Announces Plans to Open US Office
The new commercial site, set to be located in Cambridge, Boston, MA, will serve clients on both the East and West Coast. It will also be the base for reaching new customers in the area.
Catalent Completes Accucaps Acquisition
The acquisition complements Catalent’s global OTC and prescription pharmaceutical softgel capabilities and capacity.
CPhI South East Asia Gathers March 22–24 in Jakarta
South East Asian pharma manufacturers seeking region growth expected to attend CPhi South East Asia.
Preventive and Corrective Maintenance for Rouge in Stainless-Steel Equipment
Process conditions can corrode stainless-steel surfaces, necessitating corrective and preventive maintenance.
EDQM Clarifies the Role of Monographs in Determining Biosimilarity
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
FDA Warns India API Manufacturer Over Contamination Issues
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
Synergy Rx Pharmacy Issues Recall Due to Lack of Sterility
The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
European Commission Approves Once-Daily Tablets for Rheumatoid Arthritis
Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.
Aurobindo Adds Four Biosimilars From TL Biopharmaceutical
Aurobindo has added four cell-culture derived biosimilars to its product line.
GPhA Rebrands as AAM
The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.
Therapeutic Antibodies to Track in 2017, Part II
Evaluate and BioPharm International highlight the antibody-based therapeutics that may have 2017 launch dates in the United States.
Quotient Clinical Expands US Operations
Quotient Clinical’s addition of CDMO QS Pharma increases the company’s footprint in the US an adds high potency molecule capability.
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.
Therapeutic Antibodies to Track in 2017, Part I
EvaluatePharma and BioPharm International highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.
EU’s Post-Authorization Study Register Reaches One Thousand Entries
EMA announces that the European Union’s PAS Register has received its 1000th upload.
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.
A New Location for EMA?
Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.
Exela Pharma Sciences Recalls Ibuprofen Lysine Injection
The company is voluntarily recalling product due to particulate matter.
Dr. Reddy's Expands European Operations
Dr. Reddy’s has expanded its commercial operations in Europe with the introduction of its range of generic drugs in France.
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.
