Oramed Pharmaceuticals Inc. is discontinuing oral insulin clinical work in treating type 2 diabetes (T2D) after ORMD-0801 failed to hit its phase III study’s primary and secondary endpoints. The company stock (NASDAQ:ORMP) had lost about three-quarters of its value at midday as shares were going for about $2.50 each. Top-line results for the placebo-controlled, randomized, double-blind, multicenter study showed ORMD-0801 failed to improve glycemic control as assessed by the mean change from baseline at 26 weeks, which was the primary endpoint. The missed secondary endpoint was the mean change from baseline in fasting plasma glucose also at 26 weeks. The therapy had long shown promise. As recently as late November, ORMD-0801 hit its primary endpoint in a phase II study of participants with T2D and nonalcoholic steatohepatitis.

Shy of the prior year, deals reach $206B in 2022; M&As fall behind by 36%

While it made a sturdy effort as biopharma companies opted for licensing deals over M&As in 2022, the year did not surpass 2021 in deal values, falling about 3.5% short. Lackluster M&A values dropped to their lowest levels in all recent years and were down by 35.6% compared with 2021. In total, there were 1,532 biopharma deals, including licensings, joint ventures and collaborations, in 2022, and they were worth a combined $206.18 billion. While the amount is down from 2021, it is up 4% from 2020 and represents the second highest deal value in at least the last six years. M&A values, on the other hand, reached only $77.7 billion through 114 completed transactions, well below each of the three prior years.

Push for better PCVs includes Vaxcyte as well as big pharma players

The U.S. FDA’s rubber stamp Jan. 5 of breakthrough therapy status for Vaxcyte Inc.’s VAX-24, a 24-valent pneumococcal conjugate vaccine (PCV) candidate, underlined efforts to come up with a more broadly effective product in the space. VAX-24 is designed to prevent invasive pneumococcal disease. Busy in PCV are such major names as GSK plc and Merck & Co. Inc.

First round of US price negotiations to center on Price D drugs

Although the U.S. Inflation Reduction Act charges the Centers for Medicare & Medicaid Services (CMS) with negotiating prices of the Part B and D drugs with the highest Medicare spend, the first round of negotiations will focus solely on Part D drugs, which are dispensed through pharmacies. According to a CMS timeline released yesterday, the 10 Part D drugs selected for negotiations will be published by Sept. 1. However, biopharma companies likely have a pretty good idea already whether their drugs will be on that list, given the criteria laid out in the law.

Common network found across multiple psychiatric disorders

A psychiatric disorder rarely comes alone. More than half of all individuals who meet the diagnostic criteria for any psychiatric disorder are diagnosed with more than one condition. That high degree of comorbidity is often viewed as a consequence of the heterogeneity of psychiatric disorders – and as evidence that psychiatric diagnoses poorly reflect the underlying brain biology. Data published in Nature Human Behaviour on Jan. 12, 2023, has identified another likely contributor to the high degree of overlap between different psychiatric disorders.

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Aclaris, Alvotech, Aprea, Avillion, Bexion, Bio4t2, Bioxcel, Eisai, Eton, Glaukos, Grifols, Hemab, Hightide, Innovent, Intellia, Lipella, Medivir, Nascent, Neurelis, Opgen, Palvella, Panbela, Pheno, Prokidney, Revive, SFA, Takeda, Union, Zenas