All
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.
Drug Shortage Survey Points to Pharma’s Supply Chain Management Weaknesses
Research by Pew Charitable Trust and ISPE suggests that inability to forecast internal demand, and poor partner alignment are among the reasons for drug shortages
Inadequate Cleaning Validation Cited in FDA Warning Letter
FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation
Austrian Centre of Industrial Biotechnology and GE Healthcare Form Cell Line Engineering Pact
This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.
Nemaura Pharma Receives Funding to Develop Biologic Micropatch System
The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.
Catalent Predicts More Demand than Capacity in the Next Five Years
On a recent call, Catalent revealed that it has reached more than 90% of its current capacity and discussed how tax policy changes could affect the outsourcing industry.
ISPE Announces 2017 Facility of the Year Award Winners
The International Society for Pharmaceutical Engineering (ISPE) and its Facility of the Year Awards program announced its 2017 category award winners.
FTC: Shire ViroPharma Filed Bogus Petitions to Delay C. Diff Generic
Aggressive petitioning by ViroPharma kept a generic equivalent to Vancocin off the market for more than two years.
Amgen's PCSK9 mAb Shown to Protect Against Heart Attack and Stroke
According to results from the FOURIER trial, Repatha significantly reduced the risk of cardiovascular events and death in patients with atherosclerotic cardiovascular disease.
FDA Issues Warning Letter to Facta Farmaceutici S.p.A.
The warning letter cited GMP violations for finished drug products.
Pharmapack Europe Announces 2017 Award Winners
Companies were recognized for their innovative packaging technologies.
Pharma Companies Join Drug Safety Research Project
The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.
Pfizer Reacts to Trump’s Comments and Discusses Pipeline in Its Q4 Earnings Call
A change in the tax code could help the company create more jobs in the United States, while fewer FDA regulations could help reduce drug prices, according to Pfizer CEO Ian Read.
Does Pharma Really Want to Overhaul FDA?
In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.
