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Cell and Gene Therapy, Industry

Alexion Completes Purchase and License Agreement of Rare Disease Gene Therapy Portfolio from Pfizer

September 21, 2023

Via: Biopharm International

On Sept. 20, 2023, Alexion, AstraZeneca’s rare disease group, completed the purchase and license agreement for a portfolio of preclinical rare disease gene therapy programs and enabling technologies from Pfizer. The acquisition cost AstraZeneca up to $1 billion, with the […]


Cell and Gene Therapy, Industry

Cell therapy developer closes funding round to support diabetes program

September 21, 2023

Via: Biopharma Dive

Like many biotechnology companies, Seraxis has an ambitious aim. The company wants to transform the lives of millions of diabetics who must take insulin every day to control their blood sugar levels. Its approach: use a stem cell line generated […]


News

FDA Wants More Data on Neffy, First Needle-Free Antidote for Severe Allergic Reactions

September 20, 2023

Via: Drugs.com

In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. Approval of the Neffy nasal spray was widely anticipated. An FDA […]


Industry, Vaccines

FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

September 18, 2023

Via: Pharma Times

The updated vaccines more closely target current circulating variants The US Food and Drug Administration (FDA) has granted approval for Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, to tackle currently circulating variants. As previously recommended by the FDA, both vaccines have […]


Industry, Vaccines

NHS bookings for COVID-19 vaccinations open as winter programme starts early

September 18, 2023

Via: PMLiVE

Millions of eligible people in England can now book their vaccine via the NHS website, the NHS app, or by calling 119 for free if they do not have access online. From this week, people aged 65 and over, pregnant […]


Industry, Vaccines

US CDC recommends updated COVID-19 vaccines for autumn/winter season

September 14, 2023

Via: PMLiVE

The recommendation comes after the US Food and Drug Administration (FDA) approved updated COVID-19 vaccines from Pfizer/BioNTech and Moderna, which will be available later this week. Novavax’s protein-based updated COVID-19 vaccine is currently still under FDA review and showed promise […]


Industry, Pharma

Handling New Therapies Moving Through Drug Development at a Rapid Pace

September 13, 2023

Via: Biopharm International

Drug development is inherently costly and time-intensive, with potential attrition a persistent burden on companies’ finances (1). As companies gain a deeper understanding of cell and molecular biology and seek to develop more complex therapeutics for patient populations, they will […]


FDA, Regulations

FDA panel backs Alnylam drug despite doubts over benefit

September 13, 2023

Via: Biopharma Dive

Advisers to the Food and Drug Administration on Wednesday endorsed Alnylam Pharmaceuticals’ drug Onpattro for a rare heart condition, despite questions from agency scientists over the degree of benefit offered by the RNA-based therapy. The advisory committee’s 9-3 vote sets […]


Cell and Gene Therapy, Industry

Novartis stops work on gene therapy acquired in Gyroscope deal

September 11, 2023

Via: Biopharma Dive

Novartis has stopped work on a gene therapy candidate it acquired a little under two years ago, according to an investor in the company the Swiss drugmaker bought. The decision to discontinue research follows a recommendation from a data monitoring […]


Industry, Vaccines

In Good News for U.S., Flu Vaccine Working Well in South America

September 11, 2023

Via: Drugs.com

In a finding that should ease the minds of Americans ahead of another flu season, this year’s vaccines have already cut the risk of hospitalization in half during the South American winter, health officials report. Even better, the flu virus […]


Industry, Vaccines

FDA Approval of New COVID Boosters Could Come by Friday

September 7, 2023

Via: Drugs.com

New COVID-19 booster shots could soon pass the needed hurdles for vaccinations to begin next week. Sources familiar with U.S. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News reported. The U.S. Centers […]


Biotech, Industry

Seagen partners with Nurix to create new kind of cancer drug

September 7, 2023

Via: Biopharma Dive

Seagen is the biotech sector’s leading developer of antibody-drug conjugates, which deliver cell-killing toxins to diseased cells by attaching them to an antibody that seeks out proteins on tumor cells. Its first, Adcetris, is on track to become a blockbuster […]


Cell and Gene Therapy, Industry

Wave readies clinical testing for first RNA editing therapy

September 5, 2023

Via: Biopharma Dive

Success in the clinic would boost the RNA editing field as well as Wave. Broadly speaking, the technology is designed to edit specific sites in an RNA transcript without making permanent changes to a person’s genome. It’s an approach that’s […]


Cell and Gene Therapy, Industry

TherageniX to receive powdered gene therapy grant

September 5, 2023

Via: Pharma Times

The funding will boost the University of Nottingham spinout’s development of bone regeneration treatment TherageniX, a company developing a dry powder gene therapy for bone graft augmentation, and the institution from which it emerged, the University of Nottingham, have been […]


Industry, Vaccines

GSK invests over $270m in vaccine manufacturing ahead of RSV vaccine launch

September 5, 2023

Via: PMLiVE

FEATUREDThe investment follows the launch of the company’s new respiratory syncytial virus (RSV) vaccine, Arexvy. Designed to increase the efficiency of manufacturing processes and reduce environmental impact, the new unit will handle freeze-dried vaccines, including Arexvy, as well as the […]


Cell and Gene Therapy, Industry

BioMarin announces first patient dosed with haemophilia A gene therapy in Europe

August 31, 2023

Via: PMLiVE

Jeff Ajer, BioMarin’s executive vice president and chief commercial officer, said the announcement “represents an important milestone” for the haemophilia community, as well as for patients and physicians around the world seeking access to the therapy. Haemophilia treatment centres in […]


Mergers and Acquisitions

Novo Nordisk acquires Embark Biotech in deal worth over €470m

August 31, 2023

Via: PMLiVE

The transaction gives the Danish drugmaker full rights to develop and commercialise Embark Biotech’s lead asset targeting obesity and other cardiometabolic diseases. In exchange, Embark Biotech will receive an upfront cash payment of €15m and will also be eligible to […]


Pricing, Regulations

5 Things to Know About the New Drug Pricing Negotiations

August 30, 2023

Via: Kaiser Health News

The Biden administration has picked the first 10 high-priced prescription drugs subject to federal price negotiations, taking a swipe at the powerful pharmaceutical industry. It marks a major turning point in a long-fought battle to control ever-rising drug prices for […]


Cell and Gene Therapy, Industry

Bayer and BlueRock announce positive results from Parkinson’s cell therapy trial

August 30, 2023

Via: PMLiVE

The trial results were presented at the International Congress of Parkinson’s Disease and Movement Disorders in Copenhagen, Denmark. Parkinson’s disease is the fastest-growing neurodegenerative disease in the world and causes parts of the brain to become progressively damaged over many […]


FDA, Regulations

Bristol Myers gets key FDA approval for bone marrow disease drug

August 29, 2023

Via: Biopharma Dive

The Food and Drug Administration on Monday approved wider use of a drug important to Bristol Myers Squibb’s future, clearing the medicine for people newly diagnosed with a cancer-like disease of the bone marrow. Called Reblozyl, the drug has been […]