Otsuka Pharmaceutical Co Ltd has lost a lawsuit challenging the U.S. Food and Drug Administration’s decision to allow generic versions of the company’s antipsychotic drug Abilify. At the end of April, the FDA approved applications to make Abilify by several generic drugmakers, including Teva Pharmaceutical Industries Ltd, which immediately announced it would launch its own […]
Artificial intelligence generated plenty of chatter amongst the pharma marketing intelligentsia in 2018. Will 2019 be the year when the industry fully embraces it as more than just a tactic?
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
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.
Pharma companies have long demonstrated that they will employ questionable marketing and sales tactics to boost sales, no matter what the impact is on patients’ health. Now Amarin, a small drug maker that sells the prescription drug Vascepa, hopes to bolster its bottom line by suing the Food and Drug Administration, claiming that the company’s […]
Amarin Granted Summary Judgment Motion in Suit Against FDA Seeking New Chemical Entity Market Exclusivity for Vascepa(R) (Icosapent Ethyl) Capsules
BEDMINSTER, NJ and DUBLIN, IRELAND–(Marketwired – May 28, 2015) – Amarin Corporation plc (NASDAQ: AMRN), announced today that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin’s motion for summary judgment in the company’s lawsuit against the United States Food and Drug Administration (FDA) seeking an order […]
New data to be released this weekend should help deepen the understanding of how broadly new drugs that unleash the body’s immune system to fight cancer can be used. Results from key clinical trials will be presented starting Friday in Chicago at the annual meeting of the American Society of Clinical Oncology. These will include […]
Actavis Receives FDA Approval for VIBERZI (eluxadoline) for the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults
DUBLIN, May 27, 2015 /PRNewswire/ — Actavis plc (NYSE: ACT) announced today that VIBERZI™ (eluxadoline) was approved by the Food and Drug Administration (FDA) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). VIBERZI (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, […]
U.S. health regulators approved new irritable bowel syndrome drugs from Actavis Plc and Valeant Pharmaceuticals International Inc on Wednesday, validating big investments both companies made to acquire the products. The Food and Drug Administration approved eluxadoline, to be sold under the brand name Viberzi, which Actavis obtained with its $1.1 billion acquisition last year of […]
Vanda Receives Innovation Award from the National Organization for Rare Disorders for Development of HETLIOZ
WASHINGTON, May 26, 2015 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that it has received the 2015 Industry Innovation Award from the National Organization of Rare Disorders (NORD) in recognition of Vanda’s work in developing HETLIOZ® (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). This award was presented to Vanda at the […]
Research and Markets: Global Hemophilia Market Report: 2015 Edition: Market is Intense Among Large Players like with Baxter International, Novo Nordisk and Pfizer
DUBLIN–(BUSINESS WIRE)–Research and Markets (http://www.researchandmarkets.com/research/j63nc2/global_hemophilia) has announced the addition of the “Global Hemophilia Market Report: 2015 Edition” report to their offering. Hemophilia is an inherited or acquired bleeding disorder that prevents blood from clotting. People with hemophilia lack, either partially or completely, an essential clotting factor needed to form stable blood clots. People with hemophilia […]
Pliability, Elasticity Of Skin Increase Following Wrinkle Treatment With Botox Skin pliability and elasticity improved after treatment with onabotulinum toxin (Botox) for mild facial wrinkles and the effect lasted for up to four months, according to a report published online by JAMA Facial Plastic Surgery. Human skin has three biomechanical features: strength, pliability (the ability […]
European Medicines Agency Issues Positive Opinion, Recommends Full Approval of IMBRUVICA® (ibrutinib) to Treat Waldenstrom’s Macroglobulinemia
SUNNYVALE, Calif., May 22, 2015 /PRNewswire/ — Pharmacyclics, Inc. (NASDAQ: PCYC) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for IMBRUVICA® (ibrutinib) in the European Union to indicate the treatment of adult […]