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Good morning my dear subscribers. This is my last Readout newsletter – just kidding! This is just my last Reading for the next few weeks. I’m going on a three week holiday so you won’t see my name on here for a while. By the way, my colleague Meghana Keshavan will moderate the newsletter.

See you all in December!

What to know this morning

• In order to maintain the company’s dominant position in the field of cancer, Merck he said it would happen Obtaining license for a new cancer drug from LaNova PharmaceuticalsA Shanghai-based firm for $588 million upfront and potential payments of as much as $2.7 billion.

GOP-controlled Congress gives Trump broad power

Now that it is determined that Republicans will have full control of the House and Senate, President-elect Trump will have broad authority to assert his will on health policies.

Major health care issues are potentially at stake, including subsidies for Affordable Care Act plans, Medicaid funding, restructuring of massive federal agencies like the FDA and CDC, access to telehealth, drug broker reforms, drug price negotiations, and China’s rise in biotechnology .

Democrats are in a weak position to push their own preferences on most of these issues, but the arcane rules of Congress and divisions within the GOP have the potential to give the party at least some openings. 60 votes are needed to overcome the filibuster in the Senate, and Republicans are short of that number.

Read more From STAT’s John Wilkerson.

Looking forward to Vertex’s high-risk pain reading

Vertex Pharmaceuticals’ next quest is to transform pain management, and a crucial milestone is fast approaching.

The biotech plans to announce results by the end of the year from a mid-stage trial of an experimental treatment for patients with lumbosacral radicular syndrome, more commonly known as sciatica.

Analysts have viewed this trial as a pivotal moment for the company, and the risks are high. My colleague Jonathan Wosen details the background and design of the experiment, as well as expectations for the results.

Read more.

CDC, FDA officials warn of anti-vaccine implications

Two Biden administration officials — CDC Director Mandy Cohen and FDA’s top vaccine regulator Peter Marks — warned yesterday that there could be serious consequences for the nation’s children if anti-vaccine views prevail.

Comments made at different conferences yesterday focused on who will fill key healthcare positions in the country’s new Trump administration and Robert F. Kennedy Jr. It came at a time when anti-vaccination figures such as were waiting to see how effective they could be.

“The natural consequence of not believing in science or the potential benefit of these vaccines is that we will have unnecessary deaths,” Marks said. “I’m sorry to say this. I hope it doesn’t have to come to that, but it looks like that’s where we’re at.

Read more From STAT’s Helen Branswell and Anil Oza.

Tune Therapeutics to launch HBV gene editing trial

From my colleague Jason Mast: Human testing of its gene editing therapy for hepatitis B will soon begin, Tune Therapeutics announced today. It became the second company to receive regulatory approval for such a study, after Precision Biosciences announced in October that it would begin its first gene-editing therapy trial for HBV.

These efforts come a decade after researchers first suggested that gene editing could eventually provide a cure for a chronic virus that still affects more than 300 million people worldwide. Beyond traditional approaches, the virus evaded other treatment attempts by creating stable DNA loops in liver cells or integrating into human DNA.

Both Intellia Therapeutics and Beam Therapeutics toyed with HBV programs before shelving them. Precision Biosciences is trying to cut a strand of DNA from patients’ livers using a DNA-cutting enzyme found in algae. Tune definitely doesn’t cut DNA. Instead, the company is using an approach called epigenetic editing, which researchers can use to repress or activate certain enzymes without disrupting genes.

Neither Precision nor Tune are starting trials in the United States, where CRISPR companies often complain that regulators are too strict in their preclinical requirements. Tune starts in New Zealand. He decided to study Precision treatment in Moldova. If successful, both are likely to apply to start training in the US

Amgen defends obesity drug amid bone concerns

And to close the loop on this – if you recall, on Tuesday, a research note from Amgen raising potential safety concerns about its leading obesity candidate caused the company’s shares to tumble, wiping $12 billion from its market value.

The memo was based on data found in hidden tabs of a file attached to a publication of early trial results for the drug called MariTide. The tabs included data showing that study participants experienced loss of bone mineral density, the note said.

Amgen’s chief development officer defended the drug at an investor conference yesterday, saying the data tables referenced in the memo had not been finalized and were not subject to standard review, so the company asked the journal to publish a correction and include the final data.

He added that there were overlapping margins of error between the treatment and placebo groups, and leading researchers concluded there was no relationship between MariTide and bone density changes.

Observers have hypothesized that MariTide may carry a risk of bone density loss due to its mechanism of blocking GIP hormone receptors. But the Amgen executive said the company reviewed the genetic data and found no signal that genetic variants associated with reduced GIP receptor activity were linked to decreased bone density or bone diseases.

Read all about this saga Here.

Race to the bottom of neurogen and gene therapy

From my colleague Adam Feuerstein: Forgive the cranky rant, but I believe companies developing genetic drugs for even the rarest and most severe diseases should conduct randomized, placebo-controlled clinical trials. Anything less is scientifically irresponsible and demonstrates a lack of respect for patients and their families. These treatments are irreversible and carry significant risks, so benefits need to be clearly demonstrated.

But at Neurogene, developer of a gene therapy for Rett syndrome, that seems to be the priority. The company is collecting the least amount of data possible from single-arm, open-label studies, which by definition will not provide convincing evidence of efficacy or safety.

Randomized, placebo-controlled studies are the gold standard for definitively determining the benefits and risks of an experimental treatment. But gene therapy developers are making an exception, arguing that asking patients to participate in such scientifically rigorous studies is logistically or ethically too difficult.

Read more from me Here.

Further reading

• Struggling Ginkgo Bioworks says it will move away from the soon-to-open Seaport building. Boston Globe
• Thune, the new Senate Majority Leader, comes from a state that relies on rural hospitals, telehealth and healthcare. STATISTICS
• Moderate GOP senators: Don’t ask me about confirming RFK Jr. STATISTICS