�Թϲ�����

Pharmacists and drug wholesalers can import prescription medicines from Canada for up to two years as part of state programs aimed at bringing down drug costs, according to final FDA guidance released Thursday. With President Biden's drug pricing agenda still stalled, the FDA is further clarifying how states could take advantage of lower drug costs abroad without the need to limit prices in the U.S. Both the Biden and Trump administrations embraced limited importation to bring down health costs, though experts view the policy as having limited impact. (Bettelheim, 5/26)

A flurry of innovation in oncology has led to a record number of new cancer drugs launched globally in 2021. But spending on oncology medicines also reached a new high. The world welcomed 30 novel oncology medicines in 2021, IQVIA found in its annual Global Oncology Trends report published Thursday. That’s compared to 104 new rollouts in the past five years. (Liu, 5/26)

India has embarked on an ambitious plan to cut dependence on China for key raw materials as it seeks to become self-sufficient in its quest to be the “pharmacy of the world.” Already the world’s third-largest manufacturer of medicines by volume, India has one of the lowest manufacturing costs globally. About one in three pills consumed in the U.S. and one in four in the U.K. are made in India. However, India’s $42 billion pharmaceutical sector is heavily dependent on China for key active pharmaceutical ingredients or API — chemicals that are responsible for the therapeutic effect of drugs. (Buddhavarapu, 5/26)

A Texas pharmacist's guilty plea in federal court opened a new door into the world of health care fraud in Mississippi. Jada Gilbert, a 51-year-old pharmacist from Liberty County, Texas, pleaded guilty April 29 in U.S. District Court in Gulfport to conspiracy to commit health care fraud. She was accused of filing claims for reimbursement for a number of high-priced scar treatment medications she allegedly purchased from a pharmaceutical company in Ocean Springs. The company, Gulf Coast Pharmaceuticals Plus, was owned by Kenneth Ritchey, an Ocean Springs businessman indicted in 2021 on federal charges of conspiracy and fraud for allegedly purchasing a large supply of personal protection equipment. (Beveridge, 5/26)

As Mirati Therapeutics waits for the Food and Drug Administration to complete a review of its KRAS-targeting lung cancer drug later this year, final results from a clinical trial reported Thursday could both help and hinder the biotech’s efforts to stand apart from a rival Amgen treatment approved one year ago. In its own clinical trial, the Mirati drug, called adagrasib, shrank tumors in 43% of patients with advanced lung cancer — a result that tops the 37% response rate from a study reported by Amgen for its drug, called Lumakras. However, the tumor-shrinking effect of Amgen’s drug may be longer-lasting. Mirati on Thursday said the median durability of treatment response in the adagrasib study was 8.5 months. For Amgen’s own study of Lumakras, the comparable number was 11.1 months. (Feuerstein, 5/26)

Even as interest in psychedelics grows, the lack of formal scientific data on the drugs—and the fact that they’re illegal in most of the world—means businesses entering the market typically seek to create prescription medications for specific ailments. But a handful of companies are trying to sell mind-expanding substances to customers ranging from corporate executives to their blue-collar employees. These upstarts are focusing on jurisdictions where drugs such as psilocybin and ketamine are legal, betting they’ll be able to expand when more places decriminalize or legalize popular substances like ayahuasca and MDMA. Oregon, for example, will introduce licensed therapeutic use of psilocybin next year, and several cities have decriminalized plant-based drugs used for spiritual or religious purposes. (Kary, 5/26)