Published: Mar 11, 2021 By Alex Keown
Saniona, a rare disease-focused company based in Sweden, received feedback from the U.S. Food and Drug Administration (FDA) on a path forward for its hypothalamic obesity (HO) drug Tesomet. Based on guidance from the regulatory agency, Saniona is planning a Phase IIb study in this indication in the first half of this year.
“There is currently no medicine approved for hypothalamic obesity, a rare disease secondary to hypothalamic injury, characterized by intractable weight gain and complicated by uncontrollable hunger,” Rudolf Baumgartner, Chief Medical Officer and Head of Clinical Development at Saniona said in a statement. “We are encouraged by this feedback from the FDA and look forward to continuing a constructive dialogue with them as we prepare to initiate our Phase IIb clinical trial with Tesomet.”
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Published: Feb 04, 2021 By Alex Keown
China’s JW Therapeutics, which was co-founded by Juno Therapeutics and Wuxi AppTec, forged a partnership with Thermo Fisher Scientific to ensure non-exclusive
commercial access to Thermo Fisher’s Gibco CTS Dynabeads CD3/CD28. The exclusive agreement will be used to support JW’s clinical development programs for CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China. The deal includes JW Therapeutics’ lead product relmacabtagene
autoleucel (relma-cel), which is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory B-cell lymphoma. The therapy’s new drug application has been accepted by China s National Medical Products Administration. Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
Published: Dec 24, 2020 By Alex Keown
The European Union (EU) authorized
ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) in conjunction with Janssen’s Edurant (rilpivirine tablets) for the treatment of HIV-1 infection in adults who are virologically suppressed. Vocabria is intended for adults who are virologically suppressed on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. The approval of ViiV’s treatment is the first time HIV-1 patients in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase.