FDA approves first nonprescription daily oral contraceptive
Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy - the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online. (Source: World Pharma News)
Source: World Pharma News - July 13, 2023 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news
Combination cancer therapies can shrink tumors and improve survival outcomes for patients with advanced non-small lung cancer
While pembrolizumab is an approved treatment for patients with stage III non-small cell lung cancer (NSCLC), only some patients respond to this therapy. Treatment failure, researchers say, is often caused by differences in the tumor microenvironment. An ongoing phase II study (KEYNOTE-495/KeyImPaCT) led by a researcher at Yale Cancer Center reveals that combining pembrolizumab with other treatments reduced the size of target tumors, resulting in a higher response rate for patients with advanced NSCLC. (Source: World Pharma News)
Source: World Pharma News - July 12, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
AbbVie secures positive CHMP opinion for atogepant for the preventive treatment of adults with migraine
AbbVie (NYSE: ABBV) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment spanning both episodic and chronic migraine in the European Union (EU). (Source: World Pharma News)
Source: World Pharma News - July 11, 2023 Category: Pharmaceuticals Tags: Featured AbbVie Business and Industry Source Type: news
Bayer extends partnership with Peking University to foster pharmaceutical innovation in China
Bayer and Peking University (PKU) will collaborate to foster the translation of basic pharmaceutical research into drug discovery and development, while accelerating scientific research on cutting-edge technologies across the pharmaceutical value chain.
The collaboration will focus on selected key areas of interests, such as oncology, cardiorenal, immunology, as well as cell and gene therapy. (Source: World Pharma News)
Source: World Pharma News - July 10, 2023 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news
Fecal transplants show promise in improving melanoma treatment
In a world-first clinical trial published in the journal Nature Medicine, a multi-centre study from Lawson Health Research Institute, the Centre hospitalier de l'Université de Montréal (CHUM) and the Jewish General Hospital (JGH) has found fecal microbiota transplants (FMT) from healthy donors are safe and show promise in improving response to immunotherapy in patients with advanced melanoma. (Source: World Pharma News)
Source: World Pharma News - July 7, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
Unlocking the mystery of long-lasting cancer treatment
New insights explaining why some children have a longer remission than others after having cutting-edge CAR T-cell therapy for leukaemia have been revealed by researchers at UCL, Great Ormond Street Hospital, and the Wellcome Sanger Institute.
The collaborative research project, published in Nature Medicine, combines expertise in novel immune therapy design and state-of-the-art computational analysis to identify a genetic signature of CAR T-cells that will be the most effective in the long term. (Source: World Pharma News)
Source: World Pharma News - July 6, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
Artificial cells demonstrate that " life finds a way "
"Listen, if there's one thing the history of evolution has taught us is that life will not be contained. Life breaks free. It expands to new territories, and it crashes through barriers painfully, maybe even dangerously, but... life finds a way," said Ian Malcolm, Jeff Goldblum's character in Jurassic Park, the 1993 science fiction film about a park with living dinosaurs. (Source: World Pharma News)
Source: World Pharma News - July 5, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
FDA approves Pfizer & #039;s NGENLA ™, a long-acting once-weekly treatment for pediatric growth hormone deficiency
Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. (Source: World Pharma News)
Source: World Pharma News - July 4, 2023 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
AI and CRISPR precisely control gene expression
Artificial intelligence can predict on- and off-target activity of CRISPR tools that target RNA instead of DNA, according to new research published in Nature Biotechnology.
The study by researchers at New York University, Columbia Engineering, and the New York Genome Center, combines a deep learning model with CRISPR screens to control the expression of human genes in different ways - such as flicking a light switch to shut them off completely or by using a dimmer knob to partially turn down their activity. (Source: World Pharma News)
Source: World Pharma News - July 3, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
New approach in cancer therapy with innovative mechanism-of-action for ferroptosis induction
A team of researchers led by Dr. Marcus Conrad from Helmholtz Munich discovered a novel anti-cancer drug, called icFSP1, which sensitizes cancer cells to ferroptosis. Ferroptosis is characterized by the iron-dependent oxidative destruction of cellular membranes, which is counteracted by ferroptosis suppressor protein-1 (FSP1), one of the guardians of ferroptosis. Although FSP1 has been considered as an attractive drug target for cancer therapy, in vivo efficacious FSP1 inhibitors have been lacking. (Source: World Pharma News)
Source: World Pharma News - June 30, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
Proteins predict significant step toward development of diabetes
Scientists have taken an important step forward in predicting who will develop Type 1 diabetes months before symptoms appear.
In a paper published online on June 29 in Cell Reports Medicine, researchers at the Department of Energy's Pacific Northwest National Laboratory and their colleagues identify a set of altered proteins that predict a condition known as islet autoimmunity, a precursor for everyone who will ultimately develop Type 1 diabetes. (Source: World Pharma News)
Source: World Pharma News - June 29, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
Bayer & #039;s new pharmaceutical R & D strategy to accelerate breakthrough innovations
This afternoon at 2 pm CET (8 am EDT), Bayer AG will host its Pharmaceuticals R&D Event 2023 for Investors. The company will present a deep dive on the innovation strategy in its four therapeutic core areas Oncology, Cardiovascular Diseases, Neurology & Rare Diseases and Immunology. The presentations will also include status updates on Bayer Pharmaceuticals' key assets in clinical and preclinical development as well as on its platform companies Asklepios BioPharmaceutical (AskBio), BlueRock Therapeutics (BlueRock) and Vividion Therapeutics (Vividion). (Source: World Pharma News)
Source: World Pharma News - June 28, 2023 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news
FDA accepts Pfizer & #039;s application for hemophilia B gene therapy fidanacogene elaparvovec
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA). (Source: World Pharma News)
Source: World Pharma News - June 27, 2023 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
Higher doses of oral semaglutide improves blood sugar control and weight loss
Diabetes is a progressive disease that affects one's ability to control blood sugar levels. For many patients, the condition becomes more severe over time and blood sugar levels grow more difficult to manage. Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, have granted patients more control in lowering of blood sugar. (Source: World Pharma News)
Source: World Pharma News - June 27, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
FDA approves Pfizer & #039;s LITFULO ™ (ritlecitinib) for adults and adolescents with severe alopecia areata
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata. (Source: World Pharma News)
Source: World Pharma News - June 26, 2023 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
