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Tag: biotech


Industry, Vaccines

mRNA booster vaccines may be a good investment in developing countries

May 13, 2022

Via: World Pharma News

Vaccines 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 […]


FDA, Regulations

FDA Approves Radicava ORS (edaravone) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

May 13, 2022

Via: Drugs.com

Mitsubishi 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

FDA tags Editas’ thalassemia cell therapy an orphan drug as it rounds final bend in race to clinic

May 13, 2022

Via: FierceBiotech

Editas 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 […]


News

Ready to go to FDA, can Hengrui’s China-made PD-1 liver cancer immunotherapy change the tides?

May 12, 2022

Via: FiercePharma

After 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

Cellipont Bioservices Expands Cell Therapy Facility

May 12, 2022

Via: Contract Pharma

Cellipont 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. […]


News

Bora Pharmaceuticals Acquires Eden Biologics

May 12, 2022

Via: Contract Pharma

Taiwan-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 […]


FDA, Regulations

Company Hid Problems With COVID Vaccines From FDA

May 10, 2022

Via: Drugs.com

Evidence 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 […]


Mergers and Acquisitions

Pfizer to Acquire Biohaven Pharmaceuticals for $11.6 Billion

May 10, 2022

Via: Contract Pharma

Pfizer 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 […]


FDA, Regulations

With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

May 10, 2022

Via: Biopharma Dive

Over 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

LogicBio’s sun and shares rise again after FDA releases clinical hold on pediatric genome editing therapy

May 9, 2022

Via: FierceBiotech

The 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

Investors take root in Aspen Neuroscience’s customized cell therapy as $147.5M round closes

May 9, 2022

Via: FierceBiotech

Aspen 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 […]


Biotech, Industry

ALSA Ventures, Lonza Partner to Provide Biotech Support & Services

May 9, 2022

Via: Contract Pharma

ALSA 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 […]