The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.
According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.
The new guidance, Rare Diseases: 2 Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.
Clovis Oncology and Lonza celebrated the grand opening of a dedicated production train at Lonza’s Visp, Switzerland site for manufacturing Rubraca (rucaparib).
The company’s planned investment in its alkoxylation facility in the United States Gulf Coast will also expand production capacity for its polyethylene glycols.
The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.
The company was awarded for excellence in innovation for Parteck MXP Excipient and modified amino acids.
Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).
A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.
Pharmaceutical Technology's In the Lab eNewsletter
The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.
Biotechnology developers should be aware of subtle differences between the way that European and United States patent authorities approach monoclonal antibodies.
Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).
The new facility will include comprehensive mammalian process development and manufacturing capabilities.
This year’s awards attracted more than 250 entries, which included innovations in products and service offerings from across the bio/pharmaceutical supply chain and honored companies and individuals driving the industry forward.
Cost and IT practices may be holding back progress.
A stick-pack laminate packaging film from Amcor uses Pylote’s antimicrobial packaging technology to eliminate the need for preservatives in the liquid pharmaceutical contents.
The investment includes an upgrade and expansion of the company’s packaging and softgel encapsulation capabilities at its facility in Aprilia, Italy.
The company’s three acquisitions over the last 12 months have increased its global presence, expanding its European footprint and bringing new localized services in Asia-Pacific and the west coast of the United States.
The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.
The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.
Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.
At CPhI Worldwide 2018, Tom Wilson, vice president of Contract Manufacturing Operations for Pfizer Global Supply and Pfizer CentreOne Contract Manufacturing, will discuss best practices for meeting manufacturing challenges of compliance as requirements shift.
Audits by independent experts promise to ease the burden that customer audits can have on suppliers, while ensuring drug manufacturers that ingredients meet strict cGMP standards.
The UCL-Pall Biotech Centre of Excellence will address industry challenges and provide workforce training.
Bormioli Pharma, a provider of integrated glass and plastic containers, closures, and accessories for packaging, will showcase products at CPhI Worldwide 2018 at booth 4C20, from Oct. 9–11, 2018.
Syngene International’s Jegadeesh Thampi will discuss the significance of engineering data generation to develop robust, safe, and reproducible processes on Oct. 11, 2018 at CPhI Worldwide.
At this year’s CPhI Worldwide congress in Madrid, Spain, Archer Daniels Midland Company (ADM) will present its range of products spanning probiotics and microbiome solutions to highly purified, injectable-grade vegetable oils.
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario.
Advances in biologic drug development require increased methodological and technological innovation from the biopharma industry. Learn more at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.
The new bioLIVE event, launching this year with CPhI Worldwide 2018, will explore innovation in bioprocessing and manufacturing with a focus on the roles of innovative methods and technology for biopharma continuous manufacturing.