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Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.

Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities.

FDA postpones routine domestic facility inspections due to the COVID-19 pandemic.

The deal is expected to close during the first half of 2021.

Under the agreement, Takeda will divest the rights, title, and interest to 18 over-the-counter and prescription products sold in Brazil, Mexico, Argentina, Colombia, Ecuador, Panama, and Peru.

The acquisition will give Gilead access to Forty Seven’s investigational lead product candidate, magrolimab, a monoclonal antibody in clinical development for the treatment of numerous cancers.

With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.

The decision was made after it was determined that many of the event’s largest stakeholders would be unable to travel to the conference due to the novel coronavirus outbreak.

Through the agreement, Lilly will expand its immunology pipeline with lebrikizumab, Dermira’s novel, investigational mAb designed to bind interleukin-13 with high affinity.

Ongoing coronavirus outbreak prompts date change to ensure safety of trade show participants.

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.

Under the agreement, Roche will have access to Promedior's lead product candidate, PRM-15, a recombinant form of human pentraxin-2 that can possibly treat a range of systemic fibrotic diseases.

Catalent builds on its investment in cell and gene therapy development and manufacturing with the acquisition of MaSTherCell Global.

Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.

The new facility, to be operated under the newly formed CDMO, The Center for Breakthrough Medicines, will be located in King of Prussia, PA, and will increase manufacturing capacity for cell and gene therapies.

The facility will produce parenteral products and delivery devices and is set to create 460 new jobs.

Tina Morris will be taking on the role of executive director for AAPS.

The amount was the third highest year recorded and investment has increased more than 400% since 2012.

The agreement centers around the development of new stem-cell derived allogeneic T-cell therapies for the treatment of cancer.

Through the agreement, Eli will expand its immunology pipeline with lebrikizumab, Dermira’s novel, investigational, monoclonal antibody designed to bind interleukin-13 with high affinity.

The new business unit, as well as a new leadership team formed by AbbVie, will be effective upon closing of the acquisition in the first quarter of 2020.

The deal was approved by the Federal Trade Commission following a 10-month investigation.

Through the acquisition, Merck will gain access to ArQule’s lead investigational candidate, ARQ 531, a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase II dose expansion study for the treatment of B-cell malignancies.

The acquisition boosts Sanofi’s pipeline of immuno-oncology product candidates with a lead candidate in development for treating solid-tumor-type cancers.

The acquisition aids in the expansion of the Astellas Focus Area approach, which involves the creation of medicines for diseases with high unmet medical needs by identifying combinations of biology, therapeutic modality and technology based on emerging science.

The acquisition of The Medicines Company and its investigational cholesterol-lowering therapy extends Novartis’ cardiovascular pipeline.

The companies will work to discover and develop therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna’s proprietary GalXC RNAi platform technology.

Alkermes plans to advance its investigational new drug-enabling capabilities for lead preclinical assets in the Rodin development candidate portfolio.