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Category: Industry


Cell and Gene Therapy, FDA, Industry, Regulations

FDA Lifts Partial Clinical Hold on PRS-343 Phase 1 Studies

January 19, 2021

Via: BioSpace

Pieris, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced that the U.S. Food and Drug Administration (FDA) has lifted the previously announced partial clinical […]


Cell and Gene Therapy, Industry, News

Ixaka (formerly Rexgenero) Launches as an Integrated Cell and Gene Therapy Company

January 18, 2021

Via: BioSpace

Ixaka Ltd, an integrated cell and gene therapy company focused on the natural power of the body to cure disease, launches today. The Company’s shareholders have funded the business with over £40 million in financing. Previously Rexgenero Ltd, a UK-based […]


Industry, Vaccines

World on the brink of ‘catastrophic moral failure’ due to unfair vaccine rollouts, WHO chief says

January 18, 2021

Via: CNBC

The head of the World Health Organization said Monday the equitable distribution of coronavirus vaccines is at “serious risk.” Warning of a “catastrophic moral failure,” WHO’s Director-General Tedros Adhanom Ghebreyesus said “the recent emergence of rapidly-spreading variants makes the rapid […]


Cell and Gene Therapy, Industry

Cell and Gene Therapies Shatter Prior Records, with Continued Growth Expected

January 15, 2021

Via: BioSpace

Cell and gene therapies achieved record growth in 2020, surpassing prior high points in terms of financings and approvals. Janet Lambert, CEO of the Alliance for Regenerative Medicine (ARM), painted a rosy picture despite a few challenges at the 2021 […]


Industry, Vaccines

AHA News: What Heart and Stroke Patients Should Know About COVID-19 Vaccines

January 15, 2021

Via: Drugs.com

Experts have a simple answer for heart and stroke patients questioning whether they need a COVID-19 vaccination. That answer: yes. “People with all kinds of cardiovascular risk factors and disease should definitely get vaccinated to protect themselves and their families […]


Cell and Gene Therapy, Industry

Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma

January 13, 2021

Via: Drugs.com

Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. […]


Industry, Vaccines

Governor explains how West Virginia became a top state for Covid vaccine administration

January 11, 2021

Via: CNBC

West Virginia Gov. Jim Justice on Monday touted the state’s coronavirus vaccine distribution strategy, particularly its emphasis on ensuring elderly residents were granted the highest priority. “We don’t have vaccines in a warehouse sitting on a shelf,” Justice said on […]


FDA, Industry, Regulations, Vaccines

FDA chief encourages states to open Covid vaccines to older Americans, other groups

January 8, 2021

Via: CNBC

The head of the Food and Drug Administration said Friday he is urging states to begin vaccinating lower-priority groups against Covid-19 as U.S. officials try to pick up the pace after a slower-than-expected initial rollout. FDA Commissioner Dr. Stephen Hahn […]


Industry, Vaccines

Delaying second Covid vaccine shots can be ‘very risky,’ says former FDA director

January 7, 2021

Via: CNBC

It’s “very risky” to delay the second dose of Covid-19 vaccines because efficacy data was based on a specific dosing schedule, a former FDA director told CNBC on Thursday. His comments came after the U.K.’s decision to administer second shots […]


Industry, Vaccines

Allergic Reactions to COVID Vaccines Are Rare, Resolved on Site: CDC

January 6, 2021

Via: Drugs.com

Cases of anaphylactic shock caused by COVID-19 vaccines are very rare, based on numbers from the first week and a half of vaccinations in the United States, federal public health officials said Wednesday. There have been 21 cases of anaphylaxis […]


Cell and Gene Therapy, Industry

The Discovery Labs as a Cell and Gene Therapy Superstore

January 5, 2021

Via: Genetic Engineering and Biotechnology News

Just northwest of Philadelphia in King of Prussia, PA, academic scientists, startups, and big pharma can explore an array of analytical bioprocessing assays at The Discovery Labs. Dana Cipriano, vice president of testing and analytical services, describes The Discovery Labs […]


Cell and Gene Therapy, Industry, News

Biogen, ViGeneron Enter Gene Therapy Collaboration

January 5, 2021

Via: Contract Pharma

ViGeneron GmbH, a gene therapy company, has announced a global collaboration and licensing agreement with Biogen Inc. to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. The companies will use ViGeneron’s […]