Development

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews an esteemed panel of experts from IPEC Americas about excipient grades.

The annual industry report of the Pharmapack Europe event suggests there will be significant innovation in inhaled pulmonary and intranasal drug delivery in 2024.

The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.

Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

Through the acquisition of Harpoon Therapeutics, Merck will gain an investigational delta-like ligand 3-targeting T-cell engager under development for cancer treatment.

Webinar Date/Time: Wed, Mar 6, 2024 2:00 PM EST

Webinar Date/Time: Wed, Feb 28, 2024 11:00 AM EST

Webinar Date/Time: Wed, Feb 7, 2024 10:30 AM CET (4:30 AM EST)

Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.

Nanoform has completed the First Subject First Visit in a trial evaluating the relative bioavailability of its nanotechnology-enhanced enzalutamide.

In a deal worth up to $1.4 billion, GSK aims to acquire Aiolos Bio and gain an expanded pipeline of biologic-based respiratory therapeutic candidates.

Webinar Date/Time: Tue, Jan 30, 2024 9:00 AM EST

Webinar Date/Time: Thu, Jan 25, 2024 11:00 AM EST

Webinar Date/Time: Tue, Jan 30, 2024 11:00 AM EST

MediWound has been granted an additional $6.7 million by the DoD to advance NexoBrid as a non-surgical field care solution for the US military.

Under the collaboration, Boehringer Ingelheim and Ribo will develop RNA-based therapeutics to treat NASH/MASH.

AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.

Novel molecular glues are transforming targeted protein degradation.

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.

Through Syena, its oncology-focused product company, Replay will develop and manufacture T-cell receptor and natural killer cell therapies with the NIH and Miltenyi Biotec.

Tome Bioscience is facilitating the transition in biology from the editing phase to the cut-and-paste phase.

Under a collaboration, Daiichi Sankyo and Depixus will use Depixus’ MAGNA technology to accelerate drug discovery efforts of RNA-targeted therapeutics.

Bristol Myers Squibb and SystImmune plan to co-develop and co-commercialize lead ADC candidate for cancer treatment in US.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

AstraZeneca will utilize Absci’s AI antibody drug creation platform to create an AI-designed antibody.

Matching excipients to API properties is essential.

Collaboration is a key component to achieving long-term success with genetic medicines.

Exagamglogene autotemcel seen as synechdoche.