News

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.

The companies will work together to develop Ionis-FB-LRx for the treatment of complement-mediated diseases, including Geographic Atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD), in a deal worth $760 million.

Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.

The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.

Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.

According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.

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.

The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.

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).

The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

The new facility will include comprehensive mammalian process development and manufacturing capabilities.

Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).

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.

The UCL-Pall Biotech Centre of Excellence will address industry challenges and provide workforce training.

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.

Insmed’s Arikayce (amikacin liposome inhalation suspension) is the first drug approved under the agency’s Limited Population Pathway for Antibacterial and Antifungal Drugs, established to support development of antibiotics for unmet medical needs.

The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million per program.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

Kangstem Biotech has selected Orgenesis subsidiary, MaSTherCell, as its contract manufacturing partner for the European clinical trial of Furestem-AD.

Researchers who are younger than 35 years with an advanced degree and working within Europe will be able to apply for the award.

The divestiture of the European generic-drug business of Sanofi-Zentiva-to Advent International has been completed.

FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.