Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate
Valneva SE, a specialty vaccine company, and Pfizer Inc. reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned...
Ardelyx Continues Battle to Secure Approval for Chronic Kidney Disease Drug
Ardelyx announced the U.S. Food and Drug Administration's Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), provided an interim response to the company's second level of appeal for tenapanor. The OND indicated that more input from the...
Biogen Gives Up on EU Approval of Aduhelm Following CHMP Opinion
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval after regulators hinted the Alzheimer’s drug did not have sufficient enough data to support potential approval. The Boston-based company disclosed the result of a meeting with the...
AI in Healthcare: Leveraging Patient Data Translations to Tackle Health Inequalities
As advanced AI models continue to transform our abilities to collect, manage, and expedite health data analysis, applying this innovative technology to address health inequalities is emerging as an important focus for patient-centered care and an important application...
Servier On Cusp on New Indication with Robust Data in IDH1-mutated AML
Servier is poised to go to market with a new indication after the Phase III trial of a trial of its leukemia drug in IDH1-mutated acute myeloid leukemia (AML) closed with positive results. The global Agile trial ended with Tibsovo (ivosidenib tablets) in combination...
FDA’s Cancer Advisory Committee to Evaluate Safety of PI3K inhibitors
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers. Dysregulated PI3K signaling helps malignant lymphocytes...
Axsome and Aytu’s Positive Day with the FDA
Amid government crackdowns on pharmaceutical companies and increasingly strict federal guidelines, two companies received positive feedback today on their treatments for depression and Vascular Ehlers-Danlos Syndrome (VEDS). The FDA proposed some postmarketing...
The case for testing Pfizer’s Paxlovid for treating long COVID
Reports of two patients who found relief from long COVID after taking Pfizer Inc's (PFE.N) antiviral Paxlovid, including a researcher who tested it on herself, provide intriguing evidence for clinical trials to help those suffering from the debilitating condition,...
FDA Issues New Guidance to Increase Minority Representation in Clinical Trials
Ethnic diversity in clinical trials has been lacking for years. Multiple companies have recognized this lapse and have made changes accordingly, but less has been done on a larger regulatory scale. Now, the U.S. Food and Drug Administration is urging drugmakers to...
Merck’s Pneumococcal Vaccine Claims FDA Breakthrough Therapy Designation
The U.S. Food and Drug Administration granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) Breakthrough Therapy Designation. The vaccine is for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia. It is...
U.S. renews COVID-19 public health emergency
The United States on Wednesday renewed the COVID-19 public health emergency, allowing millions of Americans to keep getting free tests, vaccines and treatments for at least three more months. The public health emergency was initially declared in January 2020, when the...
Phanes Therapeutics’ anti-CD73 antibody patent granted in the US
Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and development in immuno-oncology, announced that the company has been granted a patent (Patent No. US 11,299,550 B2) on its anti-CD73 antibodies by the United States Patent and...
It’s Full Speed Ahead for Many Alzheimer’s Players Following CMS Decision
Following the Centers for Medicare & Medicaid Services’ (CMS) decision to limit the coverage of Biogen’s controversial Alzheimer’s drug Aduhelm to individuals participating in clinical trials, the Alzheimer’s community is now waiting in anticipation for other...
Amphastar Receives FDA Approval for Ganirelix Acetate Injection
Amphastar Pharmaceuticals, Inc.,announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application ("ANDA") for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe. Ganirelix acetate injection is...
How Innovative Technology is Reshaping Patient Centric-Communications and the Integrity of Self-Reported Patient Data
As more clinical trials shift toward decentralized models, utilizing methods that enable remote monitoring and self-reported patient data are allowing for a patient-centric drug development process that does not require in-person clinical visits. Nevertheless, many...
Dupixent® (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance...
BeiGene Announces European Medicines Agency Acceptance of Marketing Authorization Applications for Tislelizumab for the Treatment of Patients with ESCC and NSCLC
BeiGene, Ltd., a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that marketing authorization applications (MAA) for tislelizumab,...
Curium Announces FDA Approval of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S.
Curium announced that its generic version of DaTscan (Ioflupane I 123 Injection) was approved on March 30, 2022, by the U.S. Food and Drug Administration (FDA). Ioflupane I 123 Injection is a single-photon emission computed tomography (SPECT) brain imaging agent used...
FDA Action Alert: BioXcel, Alnylam and Merck
After wrapping up March with a flurry of PDUFA dates, the U.S. Food and Drug Administration has a more leisurely calendar for the first three weeks of April, at least in terms of drug approvals. BioXcel Therapeutics, based in New Haven, Conn., has a target action date...
Deliberate infection trial finds COVID symptoms don’t indicate viral shedding
The world's first "human challenge" trial in which volunteers were deliberately exposed to the coronavirus has found that symptoms had no effect on how likely an infected person is to pass the disease on to others. The findings underscore the difficulty in preventing...