The U.K.’s competition watchdog has found that a subsidiary of Pfizer Inc. and a generics firm jacked up the price of a life-saving epilepsy drug by up to 2,600%, fining them a total of £70 million (US$83.72 million). The Competition and Markets Authority’s decision is part of a long-running dispute against subsidiary Pfizer Ltd. and the generics firm Flynn Pharma Ltd.
In a sense, memories are useless without being linked to feelings. Without knowing whether a memory is good or bad, there is no way to seek out good experiences, and avoid bad ones. Now, investigators at the Salk Institute have identified neurotensin as a critical molecule for the assignment of such emotional valence.
Japan’s Kyowa Kirin Co. Ltd. has stopped development of its adenosine A2a receptor antagonist, KW-6356, in Parkinson’s disease. Discovered internally by Kyowa Kirin, KW-6356 was studied in phase II trials in Japan for Parkinson’s disease, with results showing it was “potentially effective in relieving motor and non-motor symptoms both as a monotherapy and in combination with levodopa-containing therapy,” Kyowa said. However, development is now being discontinued after conducting an evaluation of the global regulatory landscape, development hurdles and potential timelines for market entry.
New interim data from Ultragenyx Pharmaceutical Inc. and Genetx Biotherapeutics LLC’s phase I/II study of GTX-102 in Angelman’s syndrome didn’t do much to bolster investor confidence, as Ultragenyx shares sagged considerably July 19. The Novato, Calif.-based company’s stock (NADAQ:RARE) closed 13% downward at $52.89 per share. That is nearly half the price shares fetched in late August. At $102.40 per share, that was the stock’s highest value in the past 12 months.
Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
After filing patents on a decades-old antipsychotic, Aneurotech BV is laying plans for a U.S. phase IIIb trial of the drug as an adjunctive therapy in major depressive disorder. The study will assess the effects of ANT-01, a low dose of pipamperone, a selective antagonist of both the serotonin 5-HT2A and D4 dopamine receptors, which has been on the market in some countries in Europe and elsewhere for more than 40 years.
New and updated preclinical and clinical data presented by biopharma firms at the European Academy of Neurology Congress, including: Bristol Myers Squibb, Horizon, Teva.
Connections, Susan Greenfield told her audience at the 2022 Annual Conference of the European Academy of Neurology, are what the mind is all about. "When you are born, you are born with a fair amount of neurons," she said at the conference's opening plenary on Sunday. But "what characterizes the growth of the brain postnatally is the configurations of connections."
Axsome Therapeutics Inc. and the U.S. FDA appear to be working out their differences. The company said it received the proposed labeling from the agency for AXS-05 (dextromethorphan + bupropion), an oral NMDA receptor antagonist with multimodal activity, for treating major depressive disorder.
Uniqure NV rolled out stock-pleasing safety and biomarker data from 10 patients enrolled in the low-dose cohort of the ongoing phase I/II trial with AMT-130 for the treatment of Huntington’s disease (HD), but investors must wait for details on MRI scans. “We have communicated that we will discuss the MRI findings in the middle of next year,” CEO Matt Kapusta told investors during a conference call. “That’s all I can say.”
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