President Donald Trump signed a bill into law that requires pharmaceutical companies to provide details of biosimilar deals to the Federal Trade Commission for antitrust scrutiny.
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.
Merck & Co. CEO Kenneth Frazier, speaking with the Economic Club of New York, joined a growing list of pharmaceutical chiefs in criticizing the role of middlemen in rising drug prices.
Seattle Genetics and development partner Takeda Pharmaceutical announced stellar Phase III data from the ECHELON-2 clinical trial of Adcetris (brentuximab vedotin) for peripheral T-cell lymphoma.
Dr. Robert Redfield, the new head of the U.S. Centers for Disease Control and Prevention, boldly predicted in April 2018 that the AIDS epidemic can be defeated by 2025. Merck, Janssen and Gilead Sciences all released clinical data for HIV treatments that could make Redfield’s prediction a reality.
Two Americans and a Briton won the 2018 Nobel Prize for Chemistry for harnessing the power of evolution to generate novel proteins.
Frustrated by delays in new medicines reaching their own country, a small but growing number of patients are turning to an online broker that bills itself as a legal version of the Dallas Buyers Club.
Swiss drugmaker Roche is breaking into hemophilia A treatment, a $10 billion global market dominated by rivals who have cultivated close ties to sufferers of the genetic bleeding disorder.
U.S.-listed shares of GW Pharmaceuticals rose 8 percent as the company’s marijuana-based treatment Epidiolex cleared the last hurdle after the Drug Enforcement Administration labeled the drug as having a low abuse potential.
A drug cocktail with Roche’s Tecentriq added two months to small-cell lung cancer patients’ lives, according to a study, aiding the Swiss group’s bid to win approval in a niche disease area before rivals that now dominate the immunotherapy market.
AstraZeneca’s immunotherapy drug Imfinzi cut the risk of death in patients with mid-stage lung cancer by nearly a third in a closely watched clinical study, reinforcing the case for using the drug in earlier disease.
Prescription drug shortages may drive up prices twice as much as they would rise with medicines in abundant supply, adding $230 million a year to U.S. drug costs, a new study estimates.
A European Medicines Agency panel recommended approval of Spark Therapeutics’ gene therapy Luxturna for blindness, a move that also boosts Swiss drugmaker Novartis that bought the rights to one of the world’s costliest treatments outside the United States.
FDA Issues Statement Reaffirming Positive Benefit-Risk Profile Of Nuplazid For Patients with Hallucinations, Delusions Associated With Parkinson’s Disease Psychosis
Acadia Pharmaceuticals Inc. announced that the FDA completed a postmarketing review and issued a clear statement reaffirming the positive benefit-risk profile of Nuplazid (pimavanserin) for patients with Parkinson’s disease psychosis.
Health authorities in England rejected a pricey CAR-T cell therapy from Novartis for adults with blood cancer, two weeks after endorsing Kymriah’s use in children and young people.
The U.S. Senate overwhelmingly supported a new bill aimed at opioid abuse and other addictive drugs.
Head and neck surgery patients in Hong Kong are far less likely to be prescribed opioids than patients undergoing similar surgeries in the U.S., new research shows.
Amgen unveiled data at a multiple myeloma conference for AMG-420, which targets B-cell maturation antigen (BCMA).
Lilly Announces Initiation of IXORA-R Head-to-Head Trial Comparing Taltz and Tremfya in Patients with Moderate-to-Severe Plaque Psoriasis
Eli Lilly and Company announced today the initiation of the IXORA-R head-to-head clinical trial, designed to evaluate superiority between Taltz (ixekizumab) and Tremfya (guselkumab) in adult patients with moderate-to-severe plaque psoriasis.
Roche faces a fresh row over drug pricing in Britain, following a decision by the body responsible for medicine use within the state health service not to approve the company’s drug Ocrevus for treating a highly disabling form of multiple sclerosis (MS).
Roche said the U.S. FDA extended by three months the review period for Tecentriq in combination therapy as a first-line treatment for a form of lung cancer.