The U.S. FDA has approved the first cell-based gene therapy for treating adult and pediatric patients with beta-thalassemia requiring frequent red blood cell transfusions. The $2.8 million wholesale acquisition cost for the one-time I.V. infusion will make it one of the most expensive drugs in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bridge, Index, Inhibrx, Merck, Roche.
Alain Bouaziz, a French citizen and resident of the United Arab Emirates, pleaded guilty Aug. 12 to one count of lying to the U.S. FDA in an attempt to steal a discontinued Novartis AG weight loss drug. The charge carries a maximum prison term of five years and a fine of up to $250,000, or twice the gain or loss caused by the offense, whichever is greatest.
“It’s now law,” U.S. President Joe Biden said after he signed H.R. 5376 Aug. 16. His signature made Medicare drug pricing negotiations a near-term reality, along with new inflationary rebates, new caps on annual out-of-pocket drug spending and monthly insulin copays for Medicare beneficiaries, and tax changes that could affect the bottom line for several multinational drug and device companies beginning next year.
As expected, the U.S. House of Representatives passed, on a 220-207 party-line vote, a legislative package Aug. 12 that, for the first time, allows Medicare to directly negotiate some prescription drug prices, while imposing severe penalties and an excise tax on companies that refuse to negotiate or don’t comply with the government price.
Moderna Inc. has received conditional authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency for its bivalent COVID-19 booster vaccine mRNA-1273.214 (Spikevax bivalent original/omicron). The conditional approval, which covers adults aged 18 years and older, marks a new phase in the ongoing global effort to curb the COVID-19 pandemic, as the new vaccine represents the first commercial product to incorporate omicron-specific epitopes. It contains 25 micrograms each of the spike proteins of the omicron BA.1 variant and the original Wuhan strain of SARS-CoV-2.
Despite new laws and enforcement efforts, protecting intellectual property (IP) rights in China remains a big challenge for companies based in the U.S. and other countries. A case in point is China’s new patent law that came into effect in June 2021. The law provides for patent term extensions and adjustments, an important consideration for the biopharma industry since the launch of drugs in China could be hampered by long regulatory review times.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Argenx, Astrazeneca, Atyr, Everest, Maat, Menarini.
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
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