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Tag: featured


Industry, Vaccines

FDA Grants Full Approval to Paxlovid to Treat COVID-19

May 25, 2023

Via: Drugs.com

Americans with COVID-19 have been taking Paxlovid since it was approved under emergency use in late 2021. Today, the U.S. Food and Drug Administration granted full approval to the drug. This approval will allow drugmaker Pfizer to sell the medication […]


Industry, Pharma

FDA approves new antibiotic for hospital-acquired pneumonia

May 24, 2023

Via: Biopharma Dive

Acinetobacter baumannii are a common cause of pneumonia in hospitals, and infections can be life-threatening. Innoviva’s treatment consists of a drug, sulbactam, that’s similarly structured as the antibiotic penicillin, along with another compound, durlobactam, that helps protect it from degradation. […]


Industry, Vaccines

Pfizer’s maternal RSV vaccine candidate backed by FDA advisory committee

May 23, 2023

Via: PMLiVE

The Vaccines and Related Biological Products advisory committee (VRBPAC) voted unanimously that the available data supported the efficacy of RSVpreF in helping to protect against the complications of RSV in infants from birth to six months of age. The committee […]


Clinical Trials, Research and Development

How the digital front door benefits clinical trial patients, clinicians and sponsors

May 22, 2023

Via: Biopharma Dive

Opening the digital front door to clinical trials means creating a great user experience for patients, clinicians and ultimately sites and sponsors. As anyone in healthcare knows all too well, it has historically been much easier said than done. However, […]


Cell and Gene Therapy, Industry

FDA approves Krystal gene therapy for rare wound disorder

May 22, 2023

Via: Biopharma Dive

Dystrophic epidermolysis bullosa is one of four main types of the disorder. Depending on the inheritance pattern, the condition can be severe and disabling, causing blisters anywhere on the skin from minor trauma and friction. The form Vyjuvek is cleared […]


News

Gilead picks former Roche executive to run cell therapy unit Kite

May 17, 2023

Via: Biopharma Dive

Gilead Sciences on Tuesday named former Roche executive Cindy Perettie as the next head of its cell therapy business Kite Pharma, moving quickly to fill the vacancy left by Christi Shaw, who stepped down from the role at the end […]


FDA, Regulations

Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program

May 16, 2023

Via: World Pharma News

Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF). This news […]


Cell and Gene Therapy, Industry

Biotech startup Ray raises $100M for vision-restoring gene therapies

May 16, 2023

Via: Biopharma Dive

Diseases of the eye have been a popular target for gene therapy development, due in part to the potential for efficient delivery via injection as well as the lower risk of dangerous immune responses. Luxturna, the first gene therapy for […]


FDA, Regulations

FDA Approves First Nonhormonal Drug, Veozah, to Ease Menopause Hot Flashes

May 15, 2023

Via: Drugs.com

The U.S. Food and Drug Administration on Friday approved the first nonhormonal medication aimed at easing menopause hot flashes. The new pill, called Veozah (fezolinetant), is a neurokinin 3 (NK3) receptor antagonist. “It works by binding to and blocking the […]


Cell and Gene Therapy, Industry

Life Biosciences, Forge Biologics Partner for Manufacturing to Advance Gene Therapies

May 15, 2023

Via: Biopharm International

Life Biosciences, a biotechnology company, and Forge Biologics, a genetic medicines manufacturing organization, announced on May 8, 2023 that they are in a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to further address aging-related diseases, according […]


Industry, Vaccines

FDA Approves First RSV Vaccine

May 10, 2023

Via: Biopharm International

FDA announced the approval of GSK’s Biologicals’ Arexvy, a respiratory syncytial virus (RSV) vaccine, on May 3, 2023. The vaccine is the first to be approved for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged […]


Mergers and Acquisitions

Gilead Acquires Privately Held Biotech XinThera

May 9, 2023

Via: Contract Pharma

Gilead Sciences, Inc. has acquired all outstanding shares of XinThera, a privately held biotech company in San Diego. The acquisition adds clinical development pipeline assets for well-validated targets in oncology and inflammation. Through the acquisition, Gilead gains rights to a […]


FDA, Regulations

FDA Experts to Consider First Over-the-Counter Birth Control Pill, Opill

May 9, 2023

Via: Drugs.com

As a U.S. Food Drug Administration advisory panel prepares to weigh whether to recommend that a birth control pill be sold over the counter in this country, a coalition of advocates on Monday called attention to the safety and effectiveness […]


Cell and Gene Therapy, Industry

OBiO, Chinagene Sign Gene Therapy Manufacturing Services Agreement

May 8, 2023

Via: Contract Pharma

OBiO Technology Corp., a provider of gene and cell therapy-focused biotechnology, entered into a strategic commercial manufacturing collaboration with Chinagene, a developer of clinical genetic diagnosis, and gene therapy drugs. Under the agreement, OBiO will provide contract development and manufacturing […]


FDA, Regulations

FDA Approves First Monoclonal Antibody Treatment, Librela, for Arthritis in Dogs

May 8, 2023

Via: Drugs.com

Man’s aging best friend has a new treatment to dull osteoarthritis pain as the U.S. Food and Drug Administration (FDA) announced approval Friday of the first monoclonal antibody for dogs. Called Librela, the bedinvetmab shot controls pain from the most […]


Industry, Vaccines

FDA Approves First RSV Vaccine, Arexvy

May 3, 2023

Via: Drugs.com

The first vaccine for respiratory syncytial virus (RSV) has been approved by the U.S. Food and Drug Administration for use in seniors aged 60 and older. Arexvy, manufactured by GlaxoSmithKline (GSK), is expected to help prevent lower respiratory tract infections […]


Cell and Gene Therapy, Industry

Challenges of Expanding CAR-T Cell Therapy into Solid Tumors

May 3, 2023

Via: Biopharm International

Since the first FDA approval in 2017, chimeric antigen receptor T-cell (CAR-T) therapy has garnered excitement as a potentially curative option for hard-to-treat blood cancers (1). In this therapy, T cells are genetically engineered to recognize specific tumor-surface antigens. When […]


FDA, Regulations

FDA Gives Guidance for Decentralized Clinical Trials for Drugs, Devices

May 2, 2023

Via: Biopharm International

FDA released a new draft guidance that provides recommendations aimed at sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. This specific guidance refers to a DCT as a clinical […]


Cell and Gene Therapy, Industry

J&J, building on CAR-T success, strikes another cell therapy deal

May 2, 2023

Via: Biopharma Dive

Once a latecomer to cell therapy research, J&J has established itself as a major player in recent years. A 2017 licensing deal with Chinese drug developer Legend Biotech yielded Carvykti, which has since become one of only two cell therapies […]


Clinical Trials, Research and Development

Flatiron, Sanofi Partner on Efficiency in Clinical Trials

May 1, 2023

Via: Contract Pharma

Flatiron Health is collaborating with Sanofi to redesign the clinical trial experience for sponsors, sites, and patients in the therapeutic area of oncology. The multi-study collaboration will focus on improving clinical trial data acquisition, delivery, and quality through site-facing technology […]