Senator Rand Paul (R-Ky.) and Dr. Anthony Fauci  clashed once again during a contentious faceoff on Capitol Hill Thursday as the senator pressed the National Institute of Allergy and Infectious Diseases (NIAID) director on whether it is necessary to continually boost young children with the experimental COVID-19 vaccines. Paul also demanded transparency from Fauci regarding the millions of dollars of royalties National Institutes of Health’s (NIH) scientists receive from certain entities.

The COVID-positive Fauci, 81, joined the Senate Health Committee hearing virtually, while CDC Director Dr. Rochelle Walensky, FDA Commissioner Dr. Robert Califf, and Assistant Secretary for Preparedness and Response Dawn O’Connell appeared in person to call on Congress to approve emergency supplemental funding for the government’s response to the COVID-19 pandemic.

Pointing out that the government now recommends that everybody over age five get boosted, Paul asked Fauci if he was aware of any studies that show reduction in hospitalization or death for children who do so.

Fauci, Joe Biden’s Chief Medical Advisor, admitted that there has not been enough “data accumulated” to make that case.

“Americans should know this,” Paul declared. “There are no studies on children showing a reduction in hospitalization or death with taking a booster.”

The Kentucky senator continued: “The only studies that were presented were antibody studies. So they say—’if we give you a booster, you produce antibodies.’ Now, a lot of scientists would question whether or not that’s proof of efficacy of a vaccine.”

Paul, a former ophthalmologist, then set Fauci up with a trick question.

“If I give you ten, or if I give a patient ten mRNA vaccines and they make protein each time, or they make an antibody each time, is that proof that we should give ten boosters, Dr. Fauci?” he asked.

“No, I think that is somewhat of an absurd exaggeration, Senator Paul,” Fauci shot back.

“Well that is the proof that you used! – your committees used that!” the senator responded, adding, “that’s the only proof you have to tell children to take a booster is that they make antibodies, so it’s not an absurdity.”

Paul continued roasting Fauci, and the regime’s failed vaccine policies.

“You’re already at like five boosters for people. You’ve had, you know, two or three boosters. It’s like – where is the proof?” Paul demanded.

NIAID announced on Wednesday that Fauci, who is reportedly fully vaccinated and twice boosted, tested positive for COVID-19.

Paul went on to note that there are serious risk factors for children getting the mRNA injections.

“The risk of myocarditis with the second dose for adolescent boys 12-24 is about 80 in a million,” Paul said. “This is both from the CDC, and the Israeli study. It’s also in the VAERS study, remarkably similar.  So there are risks, and you’re telling everyone in America to just blindly go out there because we made antibodies,” he added.

Paul told Fauci that the government should not be making public health policies based on conjecture rather than science.

“You’re not willing to be honest with the American people,” Paul chastised.

The senator pointed out that 75 percent of children have had the disease, and asked why the Centers for Disease Control and Prevention (CDC) is not including this variable in the data.

“What is the incidence for hospitalization and death for children who’ve been infected with COVID subsequently going to the hospital and dying. What is the possibility if your kid has had COVID—which is 75 percent of them—what is the chance that the kid is going to the hospital and dying?”

Fauci told the senator that studies have shown that “the optimal degree of protection when you get infection is to get vaccinated after infection,” although many dissenting medical experts strongly disagree with that notion.

Paul argued that the number of children who have died after already having had COVID could be zero, but we’ll never know that because the CDC won’t release the data.

He pointed out that when the CDC released data regarding the efficacy of taking a booster, they purposefully left out the the age cohort of 18 to 49 because, as we eventually discovered, there was no health benefit.

The senator then pivoted to the subject of alleged graft at the National Institutes of Health (NIH).

“The NIH continues to refuse to voluntarily divulge the names of scientists who receive royalties and from which companies,” he said. “Over the period of time from 2010 to 2016, 27,000 royalty payments were made to 1,800 NIH employees. We know that not because you [voluntarily] told us but because we forced you to through the Freedom of Information Act. Over $193 million was given to these 1,800 employees. Can you tell me that you have not received a royalty from any entity that you ever oversaw the distribution of money in research grants?” the Republican asked.

Fauci tried to obfuscate by discussing the definition of “royalties,” but Paul interjected to demand that he answer the question.

“Have you ever received a royalty payment from a company that you later oversaw money going to that company?” he demanded.

Fauci said he didn’t know the answer as a fact, but said he doubted it.

“Well, here’s the thing, why won’t you let us know? Why don’t you reveal how much you’ve gotten and from what entities?” Paul asked.

He noted that the NIH has refused to disclose the information, and instead sends heavily redacted responses to the query.

Paul said it would be good to know if scientists on the vaccine approval committees are receiving money from people who make the vaccines.

“Can you tell me that?” he demanded.

Fauci answered that according to the regulations, people who receive royalties are not required to divulge them even on their financial statements.

A Food and Drug Administration (FDA) advisory panel on Wednesday cleared the Pfizer and Moderna COVID-19 shots for children as young as six months, greasing the skids for  emergency use authorization of the experimental jabs in the coming days.

The back-and-forth Thursday was just the latest in a string of clashes between the two since the start of the pandemic on a range of issues, including lockdowns, masks, the funding of gain-of-function research, and the Wuhan lab leak.

Fauci has repeatedly denied that the NIH knowingly funded gain-of-function research on viruses that could have created Covid-19, and maintained that it is impossible for the coronaviruses that were studied in the Wuhan Lab to turn into COVID-19.

He reiterated this position on Thursday, telling the committee that the coronavirus likely resulted from a “natural occurrence” rather than a lab leak in Wuhan, China.

He said that, based on the evidence, the virus jumped from “an animal host, perhaps through an intermediary host, into a human species which then spread throughout the human population.”

https://amgreatness.com/2022/06/16/rand-paul-presses-dr-fauci-on-covid-booster-shots-for-children-graft-at-nih/

Trans Exec Order A Blight on the Presidency and the Nation

 Yesterday, President Biden signed an executive order instructing his administration to examine what steps it could take to end “conversion therapy” for minors who identify as transgender. According to the White House press release:

President Biden is charging HHS with leading an initiative to reduce the risk of youth exposure to this dangerous practice. HHS will explore guidance to clarify that federally-funded programs cannot offer so-called “conversion therapy.” HHS will also increase public awareness about its harms, provide training and technical assistance to health care providers, and expand support for services to help survivors. President Biden is also encouraging the Federal Trade Commission to consider whether the practice constitutes an unfair or deceptive act or practice, and whether to issue consumer warnings or notices.

The order itself sweeps much broader than pediatric gender medicine, but that is surely its most controversial element. It should put to rest any remaining doubts over whether the medical scandal of deforming and sterilizing children in order to validate their “internal sense of gender” goes all the way to the top of the American power structure. It undoubtedly does.

The term “conversion therapy” was initially used by gay rights advocates to describe efforts by mental health professionals to make same-sex attracted people heterosexual. In recent years, transgender activists have appropriated the term to target the use of psychotherapy as a measure of first resort for helping minors with gender-related distress to feel comfortable with their bodies. Critics of this approach argue that the only ethical treatment for “gender dysphoria” is “affirmation”—that is, agreeing with a minor’s self-diagnosis. They insist that any effort to explore whether a teenager’s transgender self-identification might result from some other factors—say, a combination of past sexual abuse and depression—is scientifically proven to be deeply harmful. “I have no room in my heart for hatred and I have no time for intolerance,” said HHS Assistant Secretary for Health Rachel Levine, who is transgender, “but we don’t live in a world where everyone feels that way, and this administration understands that more action is needed.”

The idea that it is unscientific and unethical to use psychotherapy as the default treatment for gender dysphoria is demonstrably wrong. The original Dutch Protocol, which laid the foundations for pediatric gender transition, insisted on lengthy psychological prescreening of candidates before prescribing them puberty-blocking drugs. What the Dutch experts knew then, and what researchers know now with even greater confidence, is that minors seeking transition tend to have extraordinarily high rates of mental-health problems, including anxiety, depression, attention-deficit and eating disorders, and autism. The intuition here is simple: if kids are going to give consent to puberty blockers and cross-sex hormone injections, they should first be determined to be mentally stable and competent. The psychological co-morbidities clinicians across the West are used to seeing in (mostly female) teenagers who show up for gender-transition procedures typically precede cross-gender identification and are thought to be in themselves the main causes of suicidality—the dreaded outcome that proponents of the affirm-only approach believe justifies allowing minors to consent to life-altering medical interventions. Existing studies provide no evidence that affirming reduces suicidality, and a new study shows limited evidence that it might worsen the problem.

Affirm-only advocates like to say that their approach has the endorsement of “all major medical associations.” As critics have pointed out, however, the statements of these associations against psychotherapy are based on an egregious misreading of the evidence. For example, when the American Academy of Pediatrics denounced non-affirming approaches as “conversion therapy” in 2018, it based that conclusion entirely on studies done on homosexuality and omitted all relevant studies on youth gender dysphoria. It even interpreted one study as supporting the affirm-only approach, despite the fact that that study explicitly recommended “watchful waiting” (psychotherapy). No one with even superficial familiarity with the politics of gender medicine can take seriously the claim that there is an evidence-grounded consensus in favor of affirmation.

Not only that, but over the past two years medical authorities in Australia, Finland, France, the U.K., and Sweden have recommended severe limitations on affirming therapy, insisting that the evidence for this approach is tenuous at best. The Biden administration is strengthening its commitment to affirming therapy at precisely the moment when the world’s most progressive welfare states are becoming more restrained about the practice.

It’s perhaps no coincidence that on the same day the Biden administration made its announcement, the New York Times Magazine ran a long article acknowledging, for the first time, that affirm-only therapy is controversial among medical experts. The article was by no means as rigorous or as fair as it could have been. Its author, Emily Bazelon, characterizes all opposition to affirming therapy as “right wing,” even as objections have come from feminists, gay rights advocates, and even transgender activists themselves. She acknowledges the role that “social influence” might play in shaping teen identity but vastly underestimates the findings of recent years in regard to “social contagion.” She also understates the growing skepticism within the research community over the safety and reliability of “social transition” and puberty blockers.

Still, Bazelon’s article marks a welcome departure from the newspaper’s previous approach, which framed the debate over pediatric transition as one between enlightened experts and knuckle-dragging bigots. It emphasizes that the World Professional Association for Transgender Health (WPATH) is slated to revise its Standards of Care this summer by adding, among other things, a requirement for psychological prescreening of adolescents prior to giving them puberty blockers. Because the premise of the affirm-only approach is that prescreening means questioning the veracity of a minor’s identity, even the WPATH seems to be moving to the right of the White House.

The sense of betrayal over the Times piece among gender-affirming trans activists is palpable—and revealing. These activists regard dissemination of their ideology by the nation’s leading public opinion organs as an entitlement; they have zero tolerance for dissent. As Bazelon reports, when transgender doctor Erica Anderson voiced concerns about how the affirm-only approach is driving “sloppy, dangerous care” and agreed to speak to Abigail Shrier, author of Irreversible Damage, the U.S. branch of WPATH censured her and imposed a month-long moratorium on speaking to the “lay press” (read: those who are not mouthpieces for the gender-affirming cohort). In preparation for her article, Bazelon sought an interview with Jack Turban, a medical doctor, zealous partisan of affirm-only, and author of two (largely debunked but still widely cited) studies purporting to show that puberty blockers are suicide-prevention measures. Turban declined, however, claiming through his spokesperson that he “didn’t have time to talk.”

Twenty-four states now ban or limit “conversion therapy,” effectively requiring mental-health experts to affirm, affirm, affirm. In California, and probably other places, parents whose teenage daughters suddenly and unexpectedly declare themselves trans and seek virilizing hormones have virtually no option to see a non-affirm-only therapist unless they go out of state. Therapists like Miriam Grossman and Stephanie Winn who disagree with the affirm-only approach believe that their field has ceded almost all grounds to affirm-only activist-practitioners—despite the absence of any evidence that affirm-only is superior to “watchful waiting” (the Dutch Protocol). The WPATH’s proposed revisions are themselves efforts to get medical experts to withhold affirming until a more robust psychological assessment can take place. Regardless, measures restricting gatekeeping for gender transition in state law tend to get smuggled in by grouping “gender identity” with “sexual orientation”—a reflection of trans activism’s deliberate effort to piggyback off the public’s warming attitudes toward homosexuality. The acronym “LGBT,” never mind its more elaborate extensions (the Biden order uses “LGBTQI+”), is surely one of the most successful marketing ploys by political entrepreneurs in recent decades.

The Biden administration’s move is supposedly a reaction to Republican states trying to ban pediatric transition, investigate parents who put their children through transition procedures, and limit government coverage of transition costs. It is possible that HHS will take a more reasonable course of action, for instance by focusing on pushing back against Texas’s parental-investigation initiative (currently held up in the courts), which may do more harm than good. But that is not likely. The president himself, as I have written, seems utterly clueless when it comes to the details of this complicated issue. Like many (but by no means all) Democrats, he seems guided more by unchecked compassion and cues from the party’s activist wing than by reason and common sense. Perhaps he is simply deferring to young progressive staffers or to HHS’s Admiral Levine, who seems intent on using federal power to ensure that every last American agrees with her that she is a woman. Whatever the reason, Biden’s executive order is a blight on his presidency and on the nation.

Leor Sapir is a fellow at the Manhattan Institute.

https://www.city-journal.org/bidens-blighted-executive-order-on-pediatric-gender-medicine

Romney accuses White House of ‘patently false’ information about Covid-19 funds

 Mitt Romney, a prominent Republican senator who spearheaded failed Covid-19 response funding negotiations, on Thursday accused the White House of misleading Congress about the urgency of the situation.

In a striking monologue during a congressional hearing, Romney expressed anger that he spent months negotiating with his colleagues to craft a $10 billion funding package, when the Biden administration earlier this month announced that it had repurposed existing funding to pay for $10 billion in vaccines and therapeutics purchases in the absence of congressional action.

Romney called the administration’s claims earlier this year that it was unable to buy more therapeutics, vaccines, and antiviral treatments without more funding “patently false,” and said he “wouldn’t have worked as hard” to secure a bipartisan deal if he had known that other funds could be repurposed. The claims were made in a letter sent to Romney from Health and Human Services Secretary Xavier Becerra on March 7, which was first published by STAT in May.

“I hope that there’s an appreciation that for the administration to say they could not purchase these things, and then after several months, divert some funds and then purchase them is unacceptable, and makes our ability to work together and have confidence in what we’re being told very much shaken to the core,” Romney said.

The White House declined to comment on Romney’s statements.

The $10 billion bipartisan deal Romney helped craft stalled in Congress amid a dispute over immigration policy. Without Romney, a moderate Republican who has an unusual willingness to buck his party, the Senate is unlikely to pass any additional funding.

Romney isn’t the only moderate Republican who expressed skepticism about offering the federal government more funds.

Sen. Richard Burr (R-N.C.), who has been more supportive of funding for pandemic preparedness than many of his GOP colleagues, on Thursday called the administration’s appeals for more Covid aid “the most well-orchestrated event I’ve seen in the 28 years since I’ve been here.”

“This was designed to pressure Republicans to open a checkbook, sign the check, and let the administration fill in the balance,” Burr said.

https://www.statnews.com/2022/06/16/romney-accuses-white-house-of-patently-false-information-about-covid-19-funds/

With 1 Month Until Launch of 988, Experts Wonder if States Are Ready

 With the 988 number set to replace the current 10-digit number for the National Suicide Prevention Lifeline in mid-July, stakeholders discussed ways to ensure that the rising number of Americans seeking mental health support can access the help they need, during a webinar hosted by the Bipartisan Policy Center on Wednesday.

According to the Substance Abuse and Mental Health Services Administration (SAMHSA), "a trained crisis counselor will answer the phone, listen to the caller, understand how their problem is affecting them, provide support, and share resources if needed. If the local crisis center is unable to take the call, the caller will be automatically routed to a national backup crisis center."

Every 11 minutes, a person in the U.S. dies by suicide, according to the CDC. The COVID-19 pandemic has exacerbated the mental health crisis, particularly among young people. In a nationwide survey, more than a third of high school students reported poor mental health during the pandemic.

"Nationally, more than half of parents express concern over their children's mental health and well-being," said Andrea Palm, the deputy secretary for HHS.

Furthermore, one in five older adults will experience a mental illness at some point in their lifetime, Palm added.

Answering the Call

Anita Everett, MD, director of the Center for Mental Health Services at SAMHSA, offered an anecdote to illustrate the agency's vision for 988.

She described a mother hearing her son crying, who goes to his room and finds a noose fashioned out of an item of clothing lying on his bed. The mother calls a friend, who tells her about 988. She phones the hotline and, together with the operator, assesses the urgency of the situation. Initially, the child seems to calm down and the mother is relieved, but an hour later the child gets angry. The mother calls 988 again, and this time a mobile crisis unit responds.

"It's not a policeman with a red flashing light ... [or] an ambulance that all the neighbors are going to see," Everett noted, but "an interventionist," a trained individual accustomed to these problems.

If necessary, the child may be taken to an emergency department or a "crisis receiving unit," staffed with professionals who have been trained to help stabilize individuals in a mental health crisis. After the visit, the mother will either bring her son home with a tight discharge plan or seek inpatient care.

"We know from experience in various states that systems that have these three elements built out -- someone to talk to, a place for someone to respond, and a place to go -- really reduce avoidable hospitalizations and the stress that's associated with hospitalization," Everett said.

The goal for the hotline is to mirror 911 in its ability to link individuals to the right level of care sooner, she explained.

However, the panelists acknowledged that many states are not prepared for the launch of 988.

Fewer than half of the public health officials responsible for rolling out the hotline in their states felt confident that their jurisdiction was prepared, according to a June 2 report from the RAND Corporation.

Just under half of those surveyed said their jurisdictions had short-term crisis stabilization programs, and only 28% had urgent care units for mental health.

One advantage to 988 is that callers are supposed to be able to call, text, or chat online with an operator, but fewer than half of the officials surveyed said their states offer text communication and even fewer offer the option to chat online -- an essential option, researchers stressed, given the high rates of suicide among adolescents and young adults.

Federal Preparedness

Asked what the federal government is doing to help states prepare, Everett said that SAMHSA has taken steps to address challenges, including bolstering the existing infrastructure of the National Suicide Prevention Lifeline by expanding call center staff in anticipation of increased volume.

The volume of contacts is expected to "nearly double" to 6 million, or even to as many as 12 million, in the first full year after transitioning to 988, a SAMHSA spokesperson told MedPage Today, citing modeling data from SAMHSA's 988 Appropriations Report.

Approximately $177 million of the Biden administration's $282 million investment in 988 has been dedicated to expanding the existing Lifeline operations, including telephone infrastructure, chat/text response, backup center capacity, and special services, such as a "sub-network" for Spanish speakers.

That investment also includes $105 million in grant funding to 54 states and territories as part of the American Rescue Plan, which will be used to improve response rates; build capacity; and route calls to local, regional, or state crisis call centers, noted the spokesperson.

SAMHSA is encouraging states to take advantage of the opportunity for grant funding "to build up crisis systems," Everett said.

"The Lifeline network of nearly 200 crisis call centers has been massively underfunded and under-resourced since it began in 2005," John Palmieri, MD, acting director of SAMHSA's 988 and Behavioral Health Crisis Coordination Office, told MedPage Today. "While this administration has significantly increased funds to support the Lifeline, states must do their part to rev up investments too."

Recommendations for Transitioning to 988

In conjunction with Wednesday's webinar, the Bipartisan Policy Center also released a report detailing recommendations for transitioning to 988.

To date, state and local governments have received "limited federal guidance" on how to effectively implement and utilize crisis response services across the care continuum, the report's authors noted.

"The federal government should establish federal standards for a coordinated state and local crisis response beyond the 988 call centers," they added. Specifically, CDC and SAMHSA should issue "joint guidance to states to support state-level crisis response systems more effectively."

The report also called for developing a national score card, an idea Mary Giliberti, JD, chief public policy officer for Mental Health America, applauded. "Mental health services at times have been traumatizing to people and sometimes even dehumanizing. So, we've got to gather that data on what is the experience in a standardized way," keeping in mind any disparities in demographics, she said.

Former Surgeon General Jerome Adams, MD, suggested that standardizing services across the continuum of care with a score card would help to "tackle disparity" by enabling "state-to-state comparisons," which would help to identify those states that need more support.

The report also recommended that HHS task SAMHSA with developing a "988 communications strategy" to help raise awareness about the hotline itself and trust in the services it provides.

"There are communities of color that are scared to call 911," Adams said, noting that friction exists between some African-American communities and law enforcement, and that EMS and law enforcement are "ill-equipped" to address mental health issues in some situations.

"988, if launched properly, can be a real lifeline to many communities out there that currently don't have one," he added.

Finally, the Bipartisan Policy Center urged HHS to link crisis response service administrators and supervisors with peer-support specialists -- people with lived experience of mental or behavioral health challenges.

"The evidence actually shows how effective peer-support [specialists] are, especially for people in crisis in reducing hospitalization and high-cost [emergency department] visits, connecting people to housing and other supports, decreasing stigma ... increasing confidence, and being able to help their loved ones feel less alone, less stigma and shame," noted Keris Jän Myrick, co-director of the Mental Health Strategic Impact Initiative.

988 is set to launch on July 16.

https://www.medpagetoday.com/psychiatry/generalpsychiatry/99327

Clovis Pulls Third-Line PARP Inhibitor Approval in Ovarian Cancer

 Clovis Oncology has voluntarily withdrawn the indication for rucaparib (Rubraca) as a third-line treatment in BRCA-mutated ovarian cancer after an overall survival (OS) analysis showed a signal for potential harm, according to a filing with the Securities and Exchange Commission (SEC).

"Based on further discussions with the FDA following submission of ARIEL4 OS data previously disclosed, the Company elected to voluntarily withdraw the approval for Rubraca in the U.S. as treatment of BRCA-mutated ovarian cancer after two or more chemotherapies," Clovis wrote in its filing.

"This withdrawal became effective as of June 10, 2022 and does not affect other indications for Rubraca," Clovis noted. The PARP inhibitor also carries indications as a maintenance therapy in recurrent ovarian cancer and as a later-line treatment in metastatic prostate cancer for patients with germline or somatic BRCA mutations.

Primary results from ARIEL4 reported last year showed that third-line rucaparib led to a median progression-free survival (PFS) of 7.4 months versus 5.7 months with chemotherapy in ovarian cancer patients with BRCA-mutant disease.

At that time, however, OS data were immature. In an earlier SEC filing, Clovis reported a 31% higher risk of death for the rucaparib group in an intent-to-treat (ITT) analysis of ARIEL4 (HR 1.31, nominal P=0.0507), which appeared largely driven by the platinum-resistant subgroup (HR 1.51, nominal P=0.0251).

The negative OS signal may potentially derail the company's bid for approval as first-line maintenance in platinum-sensitive ovarian cancer based on findings from the phase III ATHENA-MONO trial. The study showed a doubling in median PFS with the PARP inhibitor versus placebo for both the ITT population (20.2 vs 9.2 months) and for the subgroup with homologous repair-deficient (HRD) tumors (28.7 vs 11.3 months, respectively). OS was a secondary endpoint and data are immature.

According to Clovis, the FDA said the company should not submit for approval in the first-line maintenance setting until OS data from the trial are at least 50% mature or "expect the FDA to require a discussion" with its Oncologic Drugs Advisory Committee.

Currently, the OS data are approximately 25% mature and Clovis estimates that 50% maturity won't be reached for another 2 years.

https://www.medpagetoday.com/hematologyoncology/ovariancancer/99328

Rhythm Pharma Higher After FDA Approves Supplemental NDA

 Rhythm Pharmaceuticals Inc. shares continued to make gains for a second day, recently up 17% at $4.56 after the company received federal approval for a supplemental new drug application.

The commercial-stage biopharmaceutical company after the bell Thursday said the U.S. Food and Drug Administration approved the supplemental new drug application for Imcivree in patients with Bardet-Biedl syndrome.

With the approval, Imcivree is indicated for chronic weight management in adult and pediatric patients 6 years and older with monogenic or syndromic obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency, or BBS. BBS is a rare genetic disease that affects approximately 1,500 to 2,500 people in the U.S. People living with BBS may experience insatiable hunger.

Stifel analysts in a research report note the approval expands the addressable market.

"We are positive on the uptake for 3 reasons: 1) lack of approved therapies, 2) inclusive label (includes patients with severe renal impairment), and 3) possible jumpstart in commercial activities with 350+ patients identified/diagnosed," the analysts said.

Rhythm Pharmaceuticals also said Thursday it has entered into a revenue interest financing agreement with HealthCare Royalty Partners for a total investment amount of up to $100 million. Rhythm will receive an initial investment of $37.5 million with the FDA approval in BBS. Rhythm will get an additional $37.5 million following European Commission marketing authorization for Imcivree for BBS, which is seen in the second half of 2022. The final investment amount of $25 million will be payable upon Rhythm's achievement of sales milestones in 2023.

"All eyes will now be focused on the important BBS launch. We model $16.5M...in 2022 WW sales, but are slightly lowering our 2023+ estimates," Needham analysts Joseph Stringer and Ben Ricard said in a note.

https://www.marketscreener.com/quote/stock/RHYTHM-PHARMACEUTICALS-I-37977152/news/Rhythm-Pharma-Higher-After-FDA-Approves-Supplemental-NDA-40754133/

Codexis Publishes Data on Chemoenzymatic Site-Selective Bioconjugation of Native Peptides

 Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company enabling the promise of synthetic biology, today announces the publication with Merck, known as MSD outside the United States and Canada, of a paper in the peer-reviewed journal Science, detailing the development of a suite of enzymes and their application for site-selective synthesis of insulin bioconjugates.

“Our ongoing agreement with Merck has produced multiple scientific breakthroughs in the enzyme engineering field. This work described in Science is another great example of how scientific collaboration can effectively address challenges facing the biotech industry,” said John Nicols, Codexis’ President and CEO. “The development of this toolbox of enzymes opens opportunities for generating new clinical leads not before possible.”

The publication describes the development and optimization of enzymes using Codexis’ proprietary CodeEvolver® technology platform. Each enzyme has unique specificity and was evaluated for its ability to modify insulin. The described work highlights how enzymes can be engineered to functionalize peptides in a targeted fashion beyond that possible with conventional chemical approaches.

https://finance.yahoo.com/news/codexis-announces-publication-research-demonstrating-120000920.html