Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested.
A U.S. price-slashing Trump-era rule establishing a most-favored nation (MFN) model for part B drugs is officially dead. The death of the interim final rule that originally was scheduled to go into effect Jan. 1, 2021, comes as no surprise. Following court challenges that resulted in a preliminary injunction against the launch of the seven-year mandatory pricing model, the Biden administration proposed a rule rescinding the model in August.
The Russian Ministry of Health issued the 14th version of its guidelines on preventing, diagnosing and treating COVID-19 infections. Released Dec. 28, the latest version includes information about the Omicron variant and provides updates on new therapies, including two new oral drugs: Pfizer Inc.’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s siRNA drug molnupiravir, which will be marketed in Russia as Mir-19.
China’s NMPA has given thumbs up to Cstone Pharmaceuticals Co. Ltd.’s Cejemly (sugemalimab), an anti-PD-L1 monoclonal antibody. It was approved for use in treatment-naïve metastatic (stage IV) non-small-cell lung cancer (NSCLC) patients in combination with chemotherapy.
Biopharma is getting another reprieve, as Canada once again delays the implementation of major changes to its Patented Medicines Regulations. Set to take effect Jan. 1, the implementation of the drug pricing changes has now been pushed back to July 1.
Novartis AG’s FDA go-ahead for Leqvio (inclisiran), the first and only small interfering RNA therapy to lower LDL-C, “should come as a relief, given fears that the pandemic could again limit FDA's ability to conduct manufacturing-site inspections,” Jefferies analyst Peter Welford said. PCSK9-targeting Leqvio’s Dec. 22 approval, which came slightly ahead of the Jan. 1, 2022, PDUFA date, landed after a complete response letter about a year ago, citing unresolved facility inspection-related conditions. The drug is dosed twice per year, unlike competitors in the space.
With licensed Humira (adalimumab) biosimilar competition a little more than a year away in the U.S., Abbvie Inc. is trying to fend off competitors that have not signed an agreement with the North Chicago-based company.
China is making some advances in approving and reimbursing drugs to treat or prevent rare diseases. More than 60 rare disease drugs have been approved for marketing in China, with more than 40 of those included in the national medical insurance system, according to figures released at a national conference on rare diseases held in Beijing Dec. 18.
PERTH, Australia – It’s been a year that Mesoblast Ltd. might like to forget. The company’s stock dropped 17% Dec. 15 on the news that Novartis AG will terminate its licensing agreement with Mesoblast for remestemcel-L.
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