Amarin Corp. plc, of Dublin, didn’t have to wait long for a decision by the U.S. Court of Appeals for the Federal Circuit, which Sept. 3 upheld the March ruling by the U.S. District Court for the District of Nevada in favor of generic firms Dr. Reddy’s Laboratories Inc., of Hyderabad, India, and Hikma Pharmaceuticals plc, of London, in connection with abbreviated NDAs for generic versions of fish oil-derived cardiovascular drug Vascepa (icosapent ethyl). Amarin said it was “extremely disappointed” with the ruling, which came barely a day after the court heard arguments, and is reviewing its legal options, expecting to file within 30 days a petition for an en banc review of the current panel decision by the full panel of active judges. Shares of Amarin (NASDAQ:AMRN), which dropped 30% on the day of the hearing, fell another 9.5% Sept. 3 to close at $4.56.

As part of its preparations for a U.S.-wide rollout of a COVID-19 vaccine this year, the CDC has contracted with McKesson Corp. to distribute vaccines to state and local health departments, medical facilities, doctors’ offices and other vaccine providers. In a letter to state governors, the CDC said McKesson will need business and building permits for new distribution centers throughout the country. Noting that the normal time to obtain the permits could be a significant barrier to the success of the vaccine program, the CDC asked the governors to expedite the applications and, if necessary, waive requirements that would keep the distribution facilities from becoming fully operational by Nov. 1. The requirements that may need to be waived “will not compromise the safety or the integrity of the products being distributed,” according to the letter.

The U.S. Department of Defense (DoD) issued an interim final rule Sept. 3 adding Tricare coverage for COVID-19 treatment with investigational drugs under FDA-authorized expanded access. Tricare will cover both the costs associated with administering an investigational drug under approved expanded access and the drug itself. However, it will not cover the use of investigational drugs in clinical trials. Although the interim rule is limited to the pandemic, DoD said it plans to re-evaluate its normal exclusion that prevents coverage of investigational drugs used under expanded access. To help with that evaluation, DoD said it would like public comment on the potential future coverage of investigational drugs, under expanded access, for people with serious or life-threatening diseases.

In finalizing its inpatient prospective payment system (IPPS) rule for fiscal 2021, the U.S. Centers for Medicare and Medicaid Services included a new diagnosis-related group (DRG) to streamline reimbursements for providers administering CAR T-cell therapies to patients with cancer. “This final rule reaffirms the many benefits transformational therapies – such as CAR T-cell therapy – provide patients and society more broadly,” said Dan Durham, executive vice president for health policy at the Biotechnology Innovation Organization. He encouraged the government to continue building on these steps to ensure seniors benefit from the next generation of innovative cures and treatments. When it released the draft IPPS a few months ago, CMS noted that CAR T therapies Kymriah (tisagenlecleucel, Novartis AG) and Yescarta (axicabtagene ciloleucel, Gilead Sciences Inc.) would no longer qualify for Medicare’s new technology add-on payment because they would have been available for more than three years. That created the need for a DRG, which would help predictably compensate hospitals for their costs in delivering CAR T therapies now and as more become available. The final rule is scheduled for publication in the Sept. 18 Federal Register.

The U.S. Drug Enforcement Administration (DEA) said Jose Francisco Guzman-Cabrera was extradited this week from the Dominican Republic on charges of conspiracy to distribute controlled substances, distribution of controlled substances over the internet and conspiracy to commit money laundering in connection with a large-scale drug distribution operation purporting to be an online pharmacy. The DEA began investigating the Pharmacy Website following the Mach 17, 2017, death of a Boise, Idaho, man that was caused by elevated levels of several prescription opioids and fentanyl. The man’s computer showed that he had repeatedly ordered thousands of dollars’ worth of painkillers from the online pharmacy. The investigation revealed that in some cases, Pharmacy Website customers purchased what were supposed to be prescription drugs such as alprazolam or oxycodone, but instead received pills containing other substances. In 2018, law enforcement agents searched a New Jersey residence used as a distribution center for the online pharmacy and seized about 100,000 pills, including ones containing the fentanyl analogue p-fluoroisobutyryl fentanyl and U-47700, both of which are powerful synthetic opioids with no recognized medical use in the U.S., according to the DEA.

A joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee has been scheduled to discuss an NDA for ALKS-3831 (olanzapine/samidorphan), an Alkermes Inc. candidate for the potential treatment of schizophrenia and bipolar I disorder in adults. The meeting is slated for Oct. 9, ahead of the application's Nov. 15 PDUFA date. The Dublin-based company said it expects the advisory panel to focus on the clinical meaningfulness of ALKS-3831's attenuation of olanzapine-associated weight gain, including the magnitude of weight effect and the impact of the drug on laboratory-based metabolic parameters. The panel will also discuss certain potential clinical risks related to the interaction of the samidorphan component of the medicine, an opioid receptor antagonist, and opioids in the intended patient populations, Alkermes said.

The FDA announced availably of draft guidance for industry, titled "Pharmacokinetics in Patients with Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing." The guidance "is meant to assist sponsors in the design and analysis of studies that assess the influence of impaired renal function on the pharmacokinetics (PK) and/or pharmacodynamics of an investigational drug and how such information can impact dosing," the agency said. The draft guidance replaces the 2010 version, providing updated recommendation on topics including when a dedicated study of a drug's PK in subjects with impaired renal function is recommended and when it may not be needed, among others.

The U.S. SEC suspended trading in Houston-based Oncolix Inc. (OTC:ONCX) through Sept. 15, citing "a lack of current and accurate information about the company" because it hasn't filed certain periodic reports.

Two new guidance documents regarding post-Brexit conduct for drugmakers were published by the U.K.'s MHRA on Sept. 1. From Jan. 1, 2021, the agency will require all holders of a U.K. marketing authorization who sponsor a pediatric study of their product to submit results of the study to the agency within six months of the trial's last day. Separately, the agency published a list of approved countries for batch testing and importation of medicines going forward from New Year's day, aimed at helping U.K. importers and wholesalers.

No Comments