Phathom Pharmaceuticals Inc. won U.S. FDA approval of Voquezna (vonoprazan), a potassium-competitive acid blocker at 10-mg and 20-mg doses for all grades of erosive gastroesophageal reflux disease (GERD), maintenance of healing of all grades of the condition, and relief of associated heartburn. The drug was tested in GERD when compared with proton pump inhibitor (PPI) lansoprazole. Officials at Phathom said the product likely will be prescribed to patients who have tried one PPI inhibitor without satisfactory results. Shares (NASDAQ:PHAT) were trading at $8.54, down $1.07, or 11%.

ASH preview: Among the flood of abstracts, Arcellx’s phase I data move its stock

Abstracts for the upcoming American Society of Hematology (ASH) annual conference were released earlier today. Among them, Arcellx Inc.’s phase I study of CART-ddBCMA in patients with relapsed or refractory multiple myeloma caught investor attention at midday as the company’s stock (NASDAQ:ACLX) jumped 17% upward to $40.29 per share. The BCMA-specific CAR-modified T-cell therapy’s study showed that all the 38 evaluable patients with a median follow-up of 22 months had a 100% response rate. ASH noted that more than 5,000 abstracts are submitted each year for the annual meeting and more than 3,000 are accepted. ASH’s 65th annual meeting will be held in San Diego on Dec. 9-12.

Stelara price negotiations an overhang for Wezlana launch?

Instead of the two-step process that’s been the typical path for interchangeables in the U.S., Amgen Inc.’s Wezlana got a greenlight from the FDA this week as both a biosimilar and interchangeable to Johnson & Johnson’s inflammatory disease drug, Stelara (ustekinumab). While the approval is good news for Amgen, there’s still the hurdle of launching the follow-on, especially since Stelara is one of the 10 drugs involved in the first round of price negotiations with Medicare. Health and Human Services Secretary Xavier Becerra welcomed the competition, crediting the Inflation Reduction Act (IRA) with removing “some of the incentives for drug companies to block biosimilar and generic drugs from entering the market.” However, he said nothing about how the negotiations mandated by the IRA could affect the launch of follow-ons to the selected drugs.

OMB memo on AI suggests need for more IT capacity at US FDA

As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget has promulgated a memorandum directing federal government agency use of AI. One of the features of this memorandum is that agencies need to ensure that they have the IT infrastructure needed to accommodate this hardware-stretching category of software, something the FDA may struggle with in the absence of additional taxpayer dollars. 

Ausbiotech 2023: Investors riff about bridging gaps in Aussie biotech ecosystem

What’s it going to take for Australia’s biotech industry to be more self-sufficient? Although Australia is far away from the rest of the world, no one is an island when it comes to biotechnology, Ausbiotech CEO Lorraine Chiroiu said during the Ausbiotech 2023 conference held in Brisbane Nov. 1-3. Investors gathered to riff about what they were looking for in Australian biotech investments and what needs to change for the sector to be sustainable. All agreed that the science in Australia is top-notch but that the ecosystem needs more investment to be competitive.

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