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J&J’s Duato to replace departing Gorsky as board chair

Johnson & Johnson CEO Joaquin Duato will become chairman of the pharmaceutical company’s board of directors in January, taking over the role from the departing …

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FDA approves first microbiota-based treatment

The Food and Drug Administration on Wednesday approved Ferring Pharmaceuticals’ microbiota-based therapy for a type of debilitating intestinal infection, making it the first drug of …

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Rigel wins US approval of rival drug to Servier leukemia treatment

The Food and Drug Administration has approved a leukemia drug developed by Rigel Pharmaceuticals, giving the 26-year-old biotechnology company its second marketed medicine. The pill, …

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FDA grants speedy review to Sarepta’s Duchenne gene therapy

The Food and Drug Administration has started the first regulatory review of a gene therapy for Duchenne muscular dystrophy, the treatment’s developer, Sarepta Therapeutics, announced …

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Novo Nordisk to boost drug manufacturing in Denmark

Danish drugmaker Novo Nordisk will spend 5.4 billion Danish kroner, or about $744 million, to expand its clinical manufacturing facilities in a suburb near Copenhagen, Denmark. …

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FDA approves first gene therapy for hemophilia B

The Food and Drug Administration on Tuesday approved the first gene therapy for a type of hemophilia, giving people with the inherited disorder a treatment …

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Teva taps Sandoz veteran to take over CEO post from Schultz

Generic drugmaker Teva Pharmaceutical on Monday named former Sandoz head Richard Francis as its next CEO, taking over on Jan. 1 from Kåre Schultz, who …

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Merck to buy blood cancer biotech Imago for $1.35B

Merck & Co. has agreed to acquire Imago BioSciences, a California-based biotechnology company focused on bone marrow disorders, for more than $1 billion in cash. …

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GSK to pull blood cancer drug from US market after study failure

GSK will pull a blood cancer drug from the U.S. market after the treatment failed in a confirmatory clinical trial, the British drugmaker announced Tuesday. …

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Company Profile

Novo Nordisk Pharmatech A/S

Novo Nordisk Pharmatech A/S is a global manufacturer of pharmaceutical ingredients for the biopharmaceutical and pharmaceutical industries. The company specializes in Recombinant Insulin for use …

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Former Rubius CEO to lead buzzy Flagship startup

Just two days after stepping down from his last job, former Rubius Therapeutics head Pablo Cagnoni is again leading a biotech, joining another startup backed …

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FDA panel votes in favor of Ardelyx’s once-rejected kidney disease drug

Dive Brief: A Food and Drug Administration advisory panel on Wednesday backed Ardelyx’s drug for kidney disease patients, lending weight to the company’s appeal of a …

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Biotechs reveal layoffs, research revamps in third quarter earnings

Third quarter earning reports have brought news of layoffs from at least six biotechnology companies this week as a weak market continues to weigh on …

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First-of-its-kind Type 1 diabetes drug wins FDA approval

Dive Brief: One year after an initial regulatory rejection, Provention Bio’s injectable drug teplizumab has won Food and Drug Administration approval for preventive treatment of …

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Festivals
Events

Festival of Biologics USA – San Diego

The Festival of Biologics USA brings together 1800 attendees from pharma, biotech, academia, and regulatory bodies. From discovery through development, clinical trials, and manufacturing the …

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Advanced therapies
Events

Advanced Therapies 2023

14th-15 March 2023 The Advanced Therapies Congress is Europe’s largest cell and gene therapy conference and exhibition. Taking place 14th-15 March 2023 at the ExCel …

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Under FDA pressure, GSK limits use of ovarian cancer drug

GSK will stop selling the drug Zejula for some ovarian cancer patients whose disease is stable after a second line of chemotherapy, the company said …

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FDA declines to review Brainstorm’s ALS therapy

Dive Brief: Brainstorm Cell Therapeutics said Thursday that the Food and Drug Administration has decided not to review an approval application for a cell therapy …

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Biogen names former Sanofi head Viehbacher to replace Vounatsos as CEO

Biogen on Thursday named former Sanofi executive Christopher Viehbacher to replace Michel Vounatsos as its CEO, ending a six-month search for new leadership and putting …

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Seagen picks Novartis, Flagship veteran Epstein as new CEO

Cancer drugmaker Seagen on Thursday appointed longtime Novartis executive David Epstein as its new CEO, ending a search that began when the company’s founder, Clay …

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