A large study of Bristol-Myers Squibb Co’s Opdivo treatment has been halted after proving the drug is effective against the most common form of lung cancer, the company said, positioning the medicine for far wider use than its already approved lung cancer and melanoma indications. The U.S. drugmaker on Friday said the study, called Checkmate-057, […]
Leadership representing the 2018 Manny Award agency and network winners and finalists share their views on various healthcare industry trends and developments.
The top pharmaceutical companies are trying to proactively tackle, through shifts in R&D strategy and other tactics, the healthcare demands of the future.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
Current health systems built to evaluate and pay for traditional drugs are going to struggle with gene and other unusual therapies – but manufacturers can take steps before launch to define how manufacturers assess and value these new products.
This yearly review analyzes recent developments, trends and outlooks in the areas of biotechnology, biosimilars, biopharmaceuticals, biologics, biomarkers and biobanks.
A recent study of DTC advertising appearing in the Journal of General Internal Medicine concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.
As more innovative – yet even more expensive – therapies enter the U.S. market, brand marketers will have to find equally new and innovative ways to prove the value of their medicines to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.
On Oct. 28, 2016, my mother, Joan Biamonte, died of complications from metastatic carcinoma of the lung. Despite having her original tumor characterized and going through a regimen of chemotherapy allegedly tailored to her tumor type, her cancer proliferated and spread into her liver and brain.
Pfizer Inc. scored a key victory Friday when it was cleared of liability in the first U.S. trial involving claims that its antidepressant Zoloft can cause birth defects in children born to women who take the drug while pregnant. Plaintiff Kristyn Pesante claimed that Pfizer failed to warn that using Zoloft during pregnancy could […]
An Amgen sign is seen at the company’s office in South San Francisco, California, October 21, 2013. Reuters/Robert Galbraith (Reuters) – U.S. health regulators on Wednesday approved Amgen Inc’s Corlanor to treat patients with chronic heart failure, giving the world’s largest biotechnology company its first cardiovascular product. The Food and Drug Administration approved the use […]
As the waistline of Americans has increased, so has the incidence of Type 2 diabetes. Startling data from the Centers for Disease Control shows that that prevalence of this disease, which is directly related to obesity, now exceeds 9% in the adult population. It was less than half that rate in 1996. Furthermore, there doesn’t […]
Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical trials with the drugs be added to the drugs’ labels. […]
A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. Reuters/Phil Noble (Reuters) – AstraZeneca Plc’s diabetes drug Onglyza and Takeda Pharmaceutical Co.’s rival product Nesina should carry information about the risk of heart failure, an advisory committee to the U.S. Food and Drug Administration said on Tuesday. Heart […]
Soligenix Completes Phase 1 Clinical Study with SGX203 for the Treatment of Pediatric Crohn’s Disease
Princeton, NJ – June 28, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it has enrolled and treated all patients in the Phase 1 Study BDP-PCD-01; the […]
FDA Grants Genentech’s Obinutuzumab (GA101) Priority Review for Previously Untreated Chronic Lymphocytic Leukemia (CLL) Announcement Follows FDA Breakthrough Therapy Designation for GA101 in CLL FDA Decision on the GA101 Biologics License Application (BLA) Is Expected by the End of 2013. South San Francisco, Calif. — July 2, 2013 — Genentech, a member of the Roche […]
HIV Positive Men Show No Signs of HIV after Bone Marrow Transplant and Discontinuation of Anti-Retroviral Therapy Boston, MA – Two Brigham and Women’s Hospital patients with longstanding HIV infections who underwent bone marrow transplants have stopped anti-retroviral therapy and have no detectable HIV in their blood cells. One patient stopped anti-retroviral therapy 15 weeks […]
Novartis Exelon® Patch now FDA approved to treat patients across all stages of Alzheimer’s disease Latest FDA approval based on high dose Exelon Patch 13.3 mg/24h for severe Alzheimer’s; 24-week study showed statistically significant improvement in overall cognition and function compared to 4.6 mg/24h dose Exelon Patch first and only transdermal therapy approved to treat […]