May 13, 2022
Via: World Pharma NewsVaccines based on inactivated SARS-CoV-2 virus are commonly used in developing countries due to their low cost. New research from Karolinska Institutet in Sweden shows that a booster shot of mRNA vaccine to individuals who have received two doses of […]
May 13, 2022
Via: Drugs.comMitsubishi Tanabe Pharma Corporation (MTPA) today announced the U.S. Food and Drug Administration (FDA) has approved Radicava ORS (edaravone), the oral form of edaravone, for the treatment of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease that currently has no cure […]
Cell and Gene Therapy, Industry
May 13, 2022
Via: FierceBiotechEditas Medicine has picked up more regulatory privileges for its ex vivo gene-edited medicine, securing FDA orphan-drug designation in beta thalassemia ahead of the start of a clinical trial in the indication. The candidate, EDIT-301, is in development as a […]
May 12, 2022
Via: FiercePharmaAfter two FDA rejections against China-made cancer immunotherapies this year, another Chinese pharma hopes it has the data to crack the agency’s doors open. But one major uncertainty remains. Thursday, Jiangsu Hengrui Medicine said a global phase 3 trial of […]
Cell and Gene Therapy, Industry
May 12, 2022
Via: Contract PharmaCellipont Bioservices, a cell therapy contract development and manufacturing organization (CDMO), unveiled plans to expand its development and manufacturing facility at its Poway, CA location. The expansion will enable Cellipont to increase capacity for process development and Phase I/II programs. […]
May 12, 2022
Via: Contract PharmaTaiwan-based contract development and manufacturing organization (CDMO) Bora Pharmaceuticals recently announced the establishment of Bora Biologics Co., Ltd., to focus on the development of bio-pharmaceuticals. Bora Biologics has investors Taishin Healthcare Limited Partnership and Dr. Allen Chao, founder of Tanvex […]
May 10, 2022
Via: Drugs.comEvidence of quality control problems was hidden by a company contracted by the U.S. government to produce hundreds of millions of COVID vaccine doses, a new House committee report shows. It noted that Emergent BioSolutions didn’t disclose the issues at […]
May 10, 2022
Via: Contract PharmaPfizer and Biohaven Pharmaceuticals have entered into an agreement under which Pfizer will acquire Biohaven, the maker of NURTEC ODT, a dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults. Pfizer will pay approximately […]
May 10, 2022
Via: Biopharma DiveOver the past few years, the Food and Drug Administration has come increasingly under scrutiny for its program to grant speedy approvals to drugs that show early signs of benefiting patients with life-threatening diseases. These so-called accelerated approvals have ushered […]
Cell and Gene Therapy, Industry
May 9, 2022
Via: FierceBiotechThe sun and shares are rising again at LogicBio after the FDA lifted a clinical hold on a genome editing therapy for children with a rare disorder. Shares of the Lexington, Massachusetts-based biotech were sent skyward by 60% as the […]
Cell and Gene Therapy, Industry
May 9, 2022
Via: FierceBiotechAspen Neuroscience, a biotech developing the first autologous neuron replacement for Parkinson’s disease, is seeing double, as investors have flooded the company’s series B with $147.5 million following an initial $70 million round two years ago. The private neurodegenerative disease […]
May 9, 2022
Via: Contract PharmaALSA Ventures, a London based European biotech investment firm, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, have entered a collaboration agreement to help develop and manufacture biologics and small molecule drug candidates […]
April 21, 2022
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