Bio/Pharma News

FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.

The transaction, announced June 20, follows Bora’s purchase of Minnesota-based Upsher-Smith Laboratories earlier in 2024.

Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.

Yimmugo, which was introduced in Europe at the end of 2022, could be on the market in the US within months.

The research collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.

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.

Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

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

The partnership will create therapeutic assets and new discovery platforms and potentially reshape drug discovery.

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 company is collaborating with the Access to Oncology Medicines Coalition to expand patient access to immuno-oncology therapy Opdivo.

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

At CPHI NA, Rachel Harris, AstraZeneca, spoke on her work at BioPhorum to enable industry consensus and action for sustainability with drug delivery devices.

The company’s presentation at ASGCT includes preliminary data results for a child who received the gene therapy.

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 two companies will combine their cell therapy platforms to develop convertibleCAR programs targeting solid tumors.

The collaboration will combine N4’s nanoparticle delivery system with SRI’s molecular guidance system.

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance.

Zevtera has been approved to treat three types of bacterial infections and has been granted Priority Review and Fast Track and Qualified Infectious Disease Product designations.

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.

Dr. Reddy’s has gained exclusive rights to promote and distribute Sanofi’s vaccines in India.

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

The Landos acquisition adds a lead asset in autoimmune and inflammatory disease to AbbVie's portfolio, while the company's ADC, ELAHERE, gets full FDA approval.

AstraZeneca’s acquisition of Amolyt Pharma includes eneboparatide, a Phase III therapeutic peptide for the treatment of hypoparathyroidism.

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

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

In a new manufacturing pact, Chime Biologics will produce DT-7012, Domain Therapeutics' antibody candidate for treating cancer that will soon be entering Phase I studies.

The Cell Shuttle platform will manufacture cell therapies for its first clinical trials by the end of the year.