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The companies will work together to discover and develop new treatments for neurological conditions such as Alzheimer’s and Parkinson’s disease.

The partnership provides Sarepta with capacity and manufacturing slots for GMP-grade plasmid production for its micro-dystrophin Duchenne muscular dystrophy gene therapy program, as well as plasmid capacity for future gene therapy programs.

In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.

Drug pricing and reimbursement concerns will continue to hinder industry growth in 2019, according to data and analytics company GlobalData.

The Massachusetts site, formerly associated with an affiliate of Shire, is Rentschler Biopharma’s first facility in the US.

AbbVie and immunotherapy company Tizona Therapeutics will join forces to develop and commercialize CD39-targeted therapeutics to treat cancer.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.

Merger cites combined strengths in oncology, immunology and inflammation, and cardiovascular disease.

The company has brought a second stream of high-throughput GMP peptide manufacturing online.

Core functions and those funded by fiscal year 2018 user fees are continuing, and 59% of the agency’s staffers are being retained.

The agency sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.

A report from GlobalData, a data and analytics company, reveals the predicted role of immuno-oncology drug development and personalized medicine in the pharmaceutical industry in 2019.

The $2.1-billion acquisition strengthens Novartis’ position in nuclear medicine and radioligand therapy for treating cancer.

The proposed $12.7-billion deal includes the spinoff of GSK and Pfizer consumer brands to a new UK-listed company.

The STERIS ProKlenz ONE alkaline cleaner now has a label performance claim for biofilm removal, in addition to the product’s existing label as a disinfectant and virucide.

Agilent and other partners are funding development of Tapestri, a single-cell sequencing platform designed to help predict cancer relapse in individual patients and show the efficacy of gene-editing experiments.

The use of artificial intelligence creates growth opportunities in novel therapeutics development by leveraging multi-sourced data, according to experts at research and consulting firm Frost & Sullivan.

Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

The UK Pharma Industry has emphasised the need for the government to avoid a 'no-deal' Brexit in response to the prime minister delaying the deal vote.

The merged companies will provide histopathology services in the research and pre-clinical therapeutics markets.

According to research from staffing firm, Kelly Services, 14% of life science professionals based in the UK may move abroad if Brexit results in negative changes to economic conditions.

A new facility in California will expand Orchard Therapeutic’s capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells.

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

The $62-billion acquisition of Shire by Takeda Pharmaceutical was approved by both sets of shareholders.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

New FDA guidance developed to identify lapses in data integrity and promote best practices.

The agency is looking to leverage real-world health data to support drug development.

The company is investing approximately $14 million to expand biologics packaging capabilities and capacity at its biologics manufacturing facility in Bloomington, IN.

The company will use GE Healthcare’s off-the-shelf KUBio biologics factory, which is expected to start operations in 2020, to provide development and manufacturing for early- to late-clinical and early-commercial manufacturing stages.