Bio/Pharma News

Brian Feth, Jonathan Grinstein, PhD, Beth Willers, and Laks Pernenkil go behind the headlines to discuss major news announcements made during the JP Morgan Healthcare Conference, a wave of new Medicare drug price negotiations, and more.

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

Using splicing technology, the new company aims to innovate safer and more effective RNA therapies for severe genetic diseases.

With the new $94 million (€90 million) funding, the company will develop its pipeline of oral macrocycle drugs, nCycles, against validated biologic targets.

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

Under the agreement, the companies will advance development of IBI3009, Innovent’s ADC candidate, which has received IND approvals in the US, China, and Australia.

FDA's approval of Hikma Pharmaceuticals’ liraglutide injection makes this product the first generic version of Victoza, a GLP-1 receptor agonist.

Results from a Phase IIb study missed the primary endpoint by failing to achieve statistical significance.

The companies will use Orexo’s powder-based drug delivery technology to develop mucosal vaccines in an inhaled formulation.

AbbVie's latest acquisition target is Nimble Therapeutics, which will give AbbVie a lead asset, an oral peptide for treating psoriasis.

With these agreements, the respective parties will work to advance therapeutic candidates for treating fibrotic diseases, osteoarthritis, and Alzheimer’s disease.

With this investment, BioMarin will add a new laboratory to its Shanbally, Co. Cork, Ireland, manufacturing facility.

AbbVie has completed its acquisition of Aliada Therapeutics which includes Aliada’s disease-modifying therapy for Alzheimer’s disease.

Novartis will in-license PTC's PTC518 program, which has the potential become the first oral disease-modifying therapy for Huntington's disease.

Lilly is investing $3 billion to expand its recently acquired manufacturing facility in Wisconsin, while Amgen is investing $1 billion to expand its facility in North Carolina.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

Sanofi will use this investment to increase its antibody bioproduction at its site in Lyon Gerland, France.

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months.

In the collaboration, the new company, Oblenio Bio, has been granted an exclusive option to license LBL-051, a tri-specific T-cell engager antibody, from Leads Biolabs.

The partnership will use ViaNautis’ proprietary polyNaut technology platform to develop genetic medicines that can precisely target tissue types.

The collaboration aims to advance clinical development of a Phase I drug candidate, MRT-6160, and to explore other therapeutic opportunities across multiple indications.

Merck is acquiring the Yale-spinout, which develops direct DNA modification-enabled cancer treatments.

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

The merger will create a specialty company, REGiMMUNE/Kiji TX, for regulatory T cells.

Xiao-Yan Cai, PhD, co-founder and CEO of Accurant Biotech, discussed collaborative efforts that must be undertaken between companies, and across scientific disciplines, to work together on continuing to develop medicines to save lives.

Merck will deploy Mestag’s proprietary RAFT platform to investigate the pathogenic role that fibroblasts play in inflammatory diseases.

The design of the center prioritizes integration of the entire supply chain, with the end goals of accelerating product development and autonomous production capacity in alignment with EU priorities.

The new mechanism of action targets cholinergic receptors instead of the standard dopamine receptors.

The approval of EBGLYSS (lebrikizumab-lbkz) by FDA puts a new biologic treatment for moderate-to-severe atopic dermatitis on the market for patients whose symptoms are not well controlled with topical treatments.