This week in the Innovation Partners BioBlog, we look at several top stories including the record-breaking FDA approval rate for generic drugs. Human leveled serious charges against several pharmaceutical firms including Teva for price fixing, alleging up to 1,000% overcharge on some drugs including those treating asthma and breast cancer. These and more are our top stories this week. Read on for more.
School of Pharmaceutical & Biotech Business
10.29.19 Scottsdale, AZ
This program will give pharmaceutical and biotechnology professionals the rare opportunity to view the oncology space, its future and its current operational issues from the provider, advocacy, and payer perspectives.
NCCN Academy for Excellence & Leadership in Oncology – School of Pharmaceutical & Biotech Business will take place on Tuesday, October 29 at The Phoenician in Scottsdale, Arizona.
A judge has denied the Trump Administration’s request to delay repaying hospitals affected by the $380 million in site-neutral payment cuts. U.S. District Court Judge Rosemary Collyer said that the Center for Medicare & Medicaid Services (CMS) hasn’t given sufficient reason for a 60-day stay of her September ruling against the agency’s regulation on site-neutral payments.
Walgreens, Centene Corporation, and pharmacy benefits manager RxAdvance announced this week an agreement to work together on a cloud-based PBM model. The goal is to lower costs and boost transparency. The companies also agreed that a new approach is needed, especially for Medicare patients, to save money. Centene plans to increase their investment in RxAdvance while Walgreens will also add additional funds to the project.
House Speaker Nancy Pelosi’s bill to lower prescription drug prices would save Medicare $345 billion over 10 years, according to a preliminary analysis from the CBO. The greatest savings would come in 2028 at $93 billion, according to the federal agency. The CBO says the lower prices would reduce current and expected revenues for drug companies. Opponents say it will also reduce the incentive for innovation.
The FDA set a new record in 2019 with generic drug approvals. In 2019, the agency cleared 1, 171 generic drugs by the end of fiscal 2019 on September 30. The previous record was 971 set at the end of fiscal 2018. Among the approvals were 125 first-time generics, another important milestone. The first-time generics included an important opioid overdose drug and a drug to treat breast cancer.
Humana filed suit against a dozen drug companies, including Teva Pharmaceuticals, alleging price fixing. The case was filed in the Eastern District of Pennsylvania and alleges a conspiracy of price fixing among the companies, alleging up to 1,000% increases. Two of the alleged price-fixed drugs are those on WHO’s list of essential medicines and include albuterol sulfate, used to treat asthma, and tamoxifen citrate, used in the treatment of breast cancer. The scheme is alleged to have peaked between 2013 and 2015.
Seattle Genetics is ready to file for FDA approval of TKI inhibitor tucatinib thanks to some good news from its trials. The trial tested tucatinib in combination with Roche’s Herceptin and Xeloda in patients with locally advanced unresectable or metastatic HER2-positive breast cancer. Subjects in the control cohort just received the two Roche drugs. All participants had previously taken Herceptin and two other Roche HER2 drugs: Perjeta and the antibody-drug conjugate Kadcyla. The results included a 46% reduction in the risk of disease progression or death, paving the way for FDA filing.