APIs and Excipients

Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.

Other indications for which the Sanofi treatment has been approved include atopic dermatitis, asthma, and chronic rhinosinusitis.

LenioBio and Labscoop's new strategic partnership is aimed at increasing access to scalable cell-free protein synthesis technology across North America.

This acquisition will give AbbVie acces to Celsius Therapeutics' lead drug candidate, CEL383, a potential first-in-class anti-TREM1 antibody for treating IBD.

Johnson & Johnson gets two bispecific antibodies in early phase development for immune-mediated diseases through its Proteologix acquisition.

Key information is needed for excipients and their potential impact on continuous manufacturing processes.

Syngene's new production platform offers rapid protein synthesis with lower risk.

Lilly’s investment increase is intended to boost manufacturing capacity at its Lebanon, Ind., site for APIs used in the production of tirzepatide and other pipeline drug candidates.

FDA granted priority review to Sanofi's sBLA for Sarclisa in combination with VRd in treating transplant-ineligible patients who are newly diagnosed with multiple myeloma.

Johnson & Johnson will gain NM26, a bispecific antibody targeting atopic dermatitis, via the acquisition of a wholly owned subsidiary of Numab Therapeutics.

The partnership aims to provide end-to-end development and manufacturing for biopharmaceutical drug substance and drug product.

With the acquisition, Biogen gains felzartamab, HI-Bio's lead investigational mAb candidate being developed for the treatment of a range of immune-mediated diseases.

The new facility will be the company’s first to offer full manufacturing processing for antibody drug conjugates.

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

The use of appropriate taste-masking and appearance technologies can facilitate patient compliance.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

Genmab's acquisition of ProfoundBio will boost its clinical and preclinical pipeline of ADCs for targeted cancer treatment.

FDA granted fast track designation to nipocalimab, which J&J is developing for helping alloimmunized pregnant adults treat FNAIT, a rare disease that poses risk to the fetus or newborn.

FDA has approved AstraZeneca's Ultomiris, marking the first and only long-acting C5 complement inhibitor for patients with NMOSD.

Mapp Biopharmaceutical will use ProBioGen’s GlymaxX technology for the development of an afucosylated antibody against Marburg virus infection

EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

Johnson & Johnson’s $2 billion acquisition of Ambrx boosts its pipeline of next-generation ADCs for cancer treatment.

Under a global license and collaboration agreement, AbbVie and OSE Immunotherapeutics will aim to develop OSE-230, a mAb for treating chronic inflammation.

Nona Biosciences and Boostimmune will collaborate to develop ADCs against novel targets using Nona’s proprietary platform technology.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

Continuous manufacturing and a quality-by-design development approach are a natural fit.

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

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

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.

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