* Amicus unlikely to file application this year * Had earlier expected to file application by Q4 * Drug aims to be first oral drug for Fabry disease * Company says European filing on track * Stock slumps as much as 59 pct (Adds details) By Natalie Grover Oct 2 (Reuters) – Amicus Therapeutics […]
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.
Xenoport Inc said it would stop developing on its own a drug that showed high rates of side effects in a study and instead focus on its treatment for restless leg syndrome. The company also said on Thursday that Ronald Barrett, its chief executive since 2001, has stepped down and will be succeeded by Chief […]
The U.S. Food and Drug Administration approved Bristol-Myers Squibb Co’s immunotherapy drug combination to treat a form of skin cancer, setting the tone for other companies developing similar cocktails. This is the first time the FDA has approved a combination of two immuno-oncology drugs, Bristol-Myers said on Thursday, adding that the treatment will be available […]
A group of patients and campaigners has called on Britain’s health minister to over-ride patents protecting Roche’s expensive breast cancer drug Kadcyla to allow for the import or manufacture of cut-price copies. The move shows the growing pricing pressure on drug companies on both sides of the Atlantic, especially in the field of cancer […]
BERKELEY, Calif. – Swiss-based Novartis AG (NVS) struck a deal worth more than $500 million with XOMA Corporation (XOMA) to acquire rights to the company’s anti-transforming growth factor-beta (TGFb) antibody program, Xoma announced this morning. Under terms of the deal, Xoma will receive $37 million in upfront payments, with the remaining $480 million in regulatory […]
Germany’s Merck KGaA said it agreed to return to BioMarin Pharmaceutical Inc the rights to the Kuvan drug against rare genetic disorder PKU as it seeks to focus on cancer, immunology and neurology. Merck in 2005 acquired the rights to Kuvan and Peg-Pal, another PKU treatment, outside the United States and Japan. Under the agreement […]
Everyone with HIV should be given anti-retroviral drugs as soon as possible after diagnosis, meaning 37 million people worldwide should be on treatment, the World Health Organization (WHO) said on Wednesday. Recent clinical trials have confirmed that early drug use extends the lives of those with the AIDS-causing virus and cuts the risk of […]
Teva Pharmaceutical Industries Ltd’s research chief said on Tuesday the drug industry must act responsibly when it comes to pricing medications, given the mounting anger over the high cost of therapies in the United States. Democratic presidential candidate Hillary Clinton brought new attention to the issue last week, proposing to cap patients’ treatment costs, […]
(Reuters Health) – According to a reanalysis of the original data from a 2001 study of paroxetine (Paxil) for teens with major depression, the drug was not effective and led to serious side effects, which is not how the results were presented 14 years ago. “There have been warnings about paroxetine for a long time,” […]
Merck & Co said its Type 2 diabetes drug had been approved in Japan, marking the first approval for the once-weekly drug. The drug, omarigliptin, belongs to the same class of drugs as Merck’s bestseller Januvia, which is to be taken once a day. Both drugs are aimed at lowering blood sugar levels. Januvia had […]