ALTO-101 demonstrated a favorable pharmacokinetic and tolerability profile; novel transdermal formulation delivered significantly greater drug exposure and fewer adverse events typically associated with PDE4 inhibitors –
– First-in-human achievement of target exposure with proprietary transdermal patch formulation developed in partnership with MEDRx –
– Proof-of-concept study in cognitive impairment associated with schizophrenia (CIAS) to be initiated in the first half of 2024 –
French drugmaker Sanofi has asked banks to pitch for roles on the separation of its consumer-health business, according to people familiar with the matter, one of the biggest deals likely to happen in Europe this year.
Banks recently submitted their responses to the request for proposals, the people said, asking not to be identified because the information is private. Sanofi could pick advisers in the coming weeks, the people said.
The Sanofi unit sells over-the-counter remedies including Gold Bond skin lotions, Phytoxil cough syrups and Icy Hot pain relief gels. Sanofi is considering both a spinoff as well as an outright sale of the operation, and no decision has been made yet, the people said.
A representative for Sanofi declined to comment on the request for proposals.
“As announced in October 2023, Sanofi is reviewing potential separation scenarios,” the spokesperson said in a statement. “The most likely path would be through a capital markets transaction, at the earliest in Q4 2024, and by creating a listed entity headquartered in France.”
Sanofi tapped Rothschild & Co. for advice on a separate listing of the business, which could be valued at more than $20 billion, Bloomberg News reported in November, adding that the company could bring on more advisers later.
Buyout firms including Advent International and Blackstone Inc. have been circling the Sanofi unit, people with knowledge of the matter have said. It has also attracted early interest from CVC Capital Partners, KKR & Co. and Clayton Dubilier & Rice, according to the people.
First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
RAPNO LGG overall response rate (ORR) of 51%
Day One receives rare pediatric disease priority review voucher
Conference call and webcast to be April 24, 8:30 a.m. Eastern Time
Day One will host a conference call and webcast tomorrow, April 24 at 8:30 a.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Investors & Media page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days following the event.
Approval based on NETTER-P trial in which Lutathera demonstrated a consistent safety profile and comparable drug exposure between pediatric (ages 12-17) and adult patients
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are a rare cancer that is often unresectable and commonly diagnosed in the late stages of disease
Novartis, a leader in radioligand therapy (RLT), is investigating a portfolio of RLTs to treat a broad range of cancers, including GEP-NETs, lung, prostate, breast, colon, brain and pancreatic cancers
Neurocrine Biosciences, a drugmaker focused on the brain and nervous system, said Tuesday that one of its experimental medicines succeeded in a clinical trial evaluating it as a treatment for major depression.
The medicine hit the Phase 2 trial’s main goal as well as “key secondary endpoints,” according to Neurocrine, which plans to meet with the Food and Drug Administration to discuss a path to late-stage testing. If positive results continue to pile up, the medicine could become the first of its kind to secure an approval.
Eiry Roberts, Neurocrine’s chief medical officer, called the newly released data “very encouraging” and reflective of the medicine’s potential to alleviate many of the symptoms associated with major depressive disorder. In the study, which pitted a low and a high dose of the oral drug against a placebo, those given one of the doses experienced significant changes on a well-known scoring system clinicians use to assess depression symptoms.
Four weeks into the study’s testing period, the scores of patients on that dose had declined 4.3 points more than what researchers observed in the placebo arm. And at eight weeks, the difference had grown to 7.5 points. Notably, Neurocrine didn’t specify which dose this was. The other dose “demonstrated a trend toward improvement” but was not significantly better than a placebo.
According to Neurocrine, patients generally tolerated its medicine well. The side effect profile of both doses was “comparable to placebo,” with headaches being the most common adverse event seen in the trial. No deaths or serious adverse events occurred, and few participants dropped out of the study.
Neurocrine said additional data will be shared at a future scientific meeting.
Shares of the company ticked up about 5% Tuesday morning, to trade just under $141 apiece.
In a note to clients, Paul Matteis, an analyst at the investment firm Stifel, wrote how investors had “very low” expectations for Neurocrine’s medicine. Placebo-controlled depression studies are notoriously difficult to succeed in, as patients in the control arms often do better than drugmakers anticipate. Many promising depression treatments have failed important experiments over the years.
Neurocrine’s tablet works differently than currently available depression therapies. It’s designed to amplify a protein involved in the transmission of glutamate, a chemical that’s abundant throughout the brain and nervous system. Glutamate is vital to cognition, memory and mood, and is found at lower levels in people with depression.
Newlyunsealed documentsin Donald Trump's classified documents case reveal thatthe Biden White House colluded with the National Archives (NARA) and the FBI to concoct a case against the former president.
Journalist Julie Kelly has been all over this:
What's more, Special Counsel Jack Smith sought to conceal this - telling Judge Eileen Cannon in February that Trump's counsel isn't entitled to discovery on documents between the White House and NARA, that the court should toss requests for evidence of the alleged coordination, and that the court should deny Trump's request for evidence related to secure facilities at his residences. Further, Trump's request for unredacted discovery of materials should be denied.
As the Epoch Times notes further, the trove of unsealed filings also revealed that the Federal Bureau of Investigation’s (FBI) code name for its investigation into President Trump’s presidential records was “[Redacted] Plasmic Echo.”
A key exhibit included with a motion to compel filed in January was an FBI case file labeled “[Redacted] PLASMIC ECHO; Mishandling of Classified or National Defense Information.”
The defense has argued that the emails unsealed on Monday indicate communication between NARA officials, the Biden administration, and the DOJ regarding President Trump’s records, alleging coordination in targeting the former president since 2021.
One email from NARA’s general counsel to the national archivist discussed drafting a letter to U.S. Attorney General Merrick Garland concerning “missing Trump records.” Subsequent emails revealed coordination between NARA and the Biden White House counsel’s office regarding the handling of these records.
The Sept. 1, 2021, email revealed that NARA’s general counsel, Gary Stern, had been in touch with both the DOJ and the Biden White House “about this issue.” A subsequent email on Sept. 30, 2021, reveals that the White House counsel’s office “is now ready to set up a call to discuss the Trump boxes.”
This email came after Mr. Stern emailed Deputy White House Counsel Jonathan Su two days earlier to “check back in to see when and how you want to proceed re [sic] meeting with [redacted], [redacted], [redacted], and NARA to discuss the Trump boxes?”
Furthermore, the defense highlighted instances where NARA officials didn’t disclose certain actions to Trump representatives, suggesting bias in the investigation process.
The defense alleged that Mr. Su didn’t disclose to a Trump representative that NARA had already drafted a DOJ referral letter when contacting them to discuss access to notes “from the Trump administration relating to records handling.”
* * *
More from Epoch:
The unsealed emails show that NARA took into consideration the Democrat-led January 6 Committee’s investigation when considering the timing of reporting to Congress on their issues of getting access to President Trump’s posts on Twitter (now X).
On Oct. 5, 2023, Mr. Stern wrote in an internal NARA email that the release of a letter to Congress “can be timed with our public release of the Trump social media records ... as well as our release to the 1/6 Committee of responsive tweets on the day of January 6.”
Mr. Stern noted that NARA had “issues” getting President Trump’s “social media records” because the Trump White House didn’t “capture them through the use of third-party archiving tools.”
Documents seized during a raid by the FBI of former President Donald Trump's Mar-a-Lago estate in Palm Beach, Fla., on Aug. 8, 2022. (FBI via The Epoch Times)
“I do not think that these problems are something that the AG/DOJ can deal with, but it could be appropriate to report them to Congress, especially since the January 6 Committee has specifically requested Trump’s Tweets from the day of January 6,” Mr. Stern wrote in the email.
Mr. Stern adds that the Biden White House counsel “is now also aware of this issue, and has asked that I keep them in the loop to the extent that we make any reference to the White House Office of Records Management.”
Another email shows Mr. Ferriero saying that he had run “out of patience” amid back-and-forth communications with Trump representatives regarding “missing boxes” that, according to a draft email to the attorney general, were reported as having been “possibly destroyed.”
‘Matters of Public Record’
The defense, along with a coalition of news media, asked the court to unseal these exhibits, arguing that the court filings are “matters of public record.”
The defense has accused the prosecution of withholding potentially exculpatory evidence and alleged bias in the investigation.
The filings made public on Monday revealed previously sealed information while limiting the redactions to keeping secret the names of government witnesses.
They were included as exhibits in a motion to compel the prosecution to produce discovery material. In the Jan. 16 motion, they argued that the office of Special Counsel Jack Smith has engaged in discovery violations and has disregarded fundamental fairness in its pursuit of prosecuting President Trump.
The disclosures come amid a protracted battle over court documents, with Judge Aileen Cannon having reminded both parties in various court filings of the “strong presumption of public access” in the criminal proceedings, showing a preference for making public as much as possible. In January, she ordered that no unclassified material be sealed unless there were clear risks to personal safety or national security.
