The FDA will allow pharmacies to offer abortion pills, mifepristone, in the U.S. Pharmacies must complete a form for certification to distribute the abortion pills.
"Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber," the agency said.
If successful, the pharmacies can dispense it directly to patients upon receiving a prescription from a certified prescriber.
Mifeprex was approved in 2000 with restrictions to assure its safe use. Mifeprex was deemed to have, in effect, an approved REMS under the FDA Amendments Act of 2007.
In 2019, when FDA approved the generic version of Mifeprex, the agency approved a single, shared system REMS for mifepristone products (known as the Mifepristone REMS Program).
Under the Mifepristone REMS Program, mifepristone may be dispensed in person or by mail.
Reuters reported that the regulatory change would potentially expand abortion access after they were sharply curtailed by the Supreme Court's decision to overturn the landmark Roe v Wade ruling.
Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Bicycle’s BT8009 monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer. BT8009 is a potential first in class Bicycle Toxin Conjugate (BTC®) targeting Nectin-4, a protein that is highly expressed in urothelial cancer (UC) and other solid tumors.
Geron Corp said on Wednesday its experimental blood cancer drug helped more patients achieve independence from blood transfusions when compared with a placebo in a late-stage trial.
The drug, imetelstat, was being studied in patients with a type of myelodysplastic syndromes (MDS), a difficult to treat family of blood cancers.
Patients with the disease require frequent blood transfusions to manage their anemia, and the only treatment option is a bone marrow transplant.
Nearly 40% of the 118 patients who were on the drug showed independence from transfusion for eight weeks, compared with 15% of the 60 patients on placebo, the company said.
The results suggest that treatment with the drug "may be altering the course of the disease," Chief Medical Officer Faye Feller said in a statement.
Based on the data, the company plans to submit applications for approval in the United States in mid-2023 and in Europe in the second half of 2023, and anticipates commercial launch in 2024.
Geron Corp anticipates a peak market potential of $1.2 billion in the United States and key EU countries, Chief Executive Officer John Scarlett told Reuters.
The drug also met its secondary goal, with 28% of the patients using the drug not needing transfusion for 24 weeks, compared with 3.3% of the patients on placebo.
Adverse effects observed during the late-stage trial were consistent with previous trials, with low count of platelets and white blood among the most common.
The company said these adverse effects were not uncommon.
Geron Corp is also testing the drug for myelofibrosis, a rare type of bone marrow cancer, and expects an interim analysis in 2024. If approved, the drug would compete with Incyte Corp's myelofibrosis drug, Jakafi.
Per federal data, the drug is involved in almost two-thirds of the roughly 102,000 annual overdose deaths nationwide. In the city, it’s over 80% of more than 2,800 OD fatalities for the latest 12 months on record, up 125% since 2016. The national increase of 75% since 2016 has helped drive American life expectancy down to its lowest level in 25 years.
This is a catastrophe, and the forces driving it seem to be strengthening.
Manufactured by Mexican cartels and sent across our porous southern border, fentanyl can kill adults in tiny amounts, even as an additive to “boost” some other drug. (It’s far cheaper and easier to produce at scale than heroin or cocaine.)
And city Special Narcotics Prosecutor Bridget Brennan warns the drug is now “integrated” into our drug supply. Which means the deaths are set to keep climbing from here
Confronted with these numbers, New York’s progressives throw up their hands and spout platitudes about “harm reduction” and how safe-injection sites and testing kits are the only possible remedies.
Bull. The first and most important move is securing the southern border. In 2022, the Drug Enforcement Administration nabbed more than 379 million lethal doses of the drug(including more than 50 million of those fake prescription pills) at the border. Yet the Biden team just shrugs.
On the New York City front, a return to the kind of policing Mayor Eric Adams advocates — focused on fighting recidivism and restoring public order — is also essential.Notcaving to the interests of dealers by enabling addicts. Letting people slowly kill themselves is not compassion.
A bill which allows the state of California to punish doctors over 'false information about Covid-19 vaccinations and treatments' went into effect on January 1st.
Under the new law (AB 2098) which took effect Jan.1, the state's Medical Board would categorize dispensing information - such as the effectiveness of Ivermectin, or the Covid-19 vaccine's rapidly waning efficacy, as unprofessional conduct.
The law was challenged in court by two California doctors, who said that it would restrict their free speech in violation of the first amendment, and that it was "vague" under the Due Process Clause of the Fourteenth Amendment of the Constitution.
However on December 28th, Biden Nominee Judge Fred Slaughter refused to halt the law, ruling that the law trumps free speech claims, and that it falls "within the longstanding tradition of regulations on the practice of medical treatments."
Another lawsuit, brought by Physicians for Informed Consent, was filed in the US District Court for the Eastern District of California in early December. The plaintiffs, physician LeTrinh Hoang and Children's Health Defense, are being represented by Rick Jaffe, Robert F. Kennedy Jr., and Mary Holland, and argues that the state of California has weaponized the vague phrase "misinformation," and thereby has illegally targeted physicians who disagree with the government's public stance on Covid-19.
Expert cardiologist and PIC member Sanjay Verma, M.D., has been tracking and cataloging CDC errors in real time. For the case, he has provided what he calls "a detailed declaration exposing the government's scientific errors and the constitutional dangers of censoring dissent":
"To demonstrate these points of vagueness and the general unsuitability of using 'contemporary scientific consensus' as a disciplinary criterion, I have prepared a detailed overview of public health response to the pandemic broken down into categories such as Masks and Vaccines (transmission, safety, efficacy of natural immunity). I have also included evidence of what [I testify] would be considered misinformation promulgated by the CDC as well as its withholding of information which led to the then 'contemporary scientific consensus' eventually being proven wrong." -KRON4
John Corkins, vice president of the Board of Trustees of the Kern Community College District Board, has a simple solution for those faculty who question diversity, equity and inclusion (DEI) programs: take them to the slaughterhouse. Corkins has since apologized but the Board conspicuously failed to address other glaring problems with his extreme rhetoric.At the meeting, Corkins responded to students and faculty complaining about a racially hostile environment. Faculty opposed to DEI policies were referenced as part of this threat.
Corkins declared that there are “abusive” faculty that “we have to continue to cull.”
He added:
“Got them in my livestock operation and that’s why we put a rope on some of them and take them to the slaughterhouse. That’s a fact of life with human nature and so forth, I don’t know how to say it any clearer.”
Corkins has since apologized and insisted
“My intent was to emphasize that the individuals who spoke during the public comment portion of the meeting have my full support…several African-American faculty, students and statewide representatives … bravely shared their feelings of fear based on the actions of a small group of faculty members and their feelings of disappointment in the district for allowing these actions to continue.”
Notably, however, the video of the Dec. 13 meeting does not give details on the specific racial incidents. There is reference to an ongoing investigation. However, there are references to faculty who have opposed DEI measures.
That would likely include a group called the Renegade Institute for Liberty with history Professors Matthew Garrett and Erin Miller, who teach at Bakersfield College. The group filed a federal lawsuit against the district after they were allegedly threatened with termination for questioning the use of grant money to fund social justice initiatives at their college. They are both tenured.
The opposition to DEI measures has led some to object that the group makes them feel unsafe on campus. That reportedly included calls to terminate faculty who oppose DEI to create a safer environment.
While apologizing for calling for the killing of such faculty, Corkins does not address why faculty should be targeted if they oppose DEI measures. The hearing and the statements made against these faculty members creates a chilling environment for academic freedom. The message is clear that these professors are viewed as a dangerous element on campus.
The Board has an obligation to address this uncertain line. Corkins apologizes for calling for the killing of critics but not why criticism of DEI itself is a matter for action. There may be conduct that is threatening or violent. There is no indication of any criminal complaint, but there is a need to preserve an open and tolerant environment. However, that also includes tolerance for opposing views on issues like DEI.
There is no major campaign to remove Corkins. I am less inclined for such removal as I am interested in greater clarity on the rights of free speech and academic freedom. Everyone makes dumb comments in unguarded moments. I accept that Corkins was carried away by the emotion of the moment. Moreover, Corkins was referencing “abusive” faculty and not necessarily putting all DEI critics in that category. That is precisely what should be clarified.
However, it would likely be a different story if a board member called for the “culling” of DEI supporters or groups on the left. There remains a double standard in how such controversies are handled in academia.
The support enjoyed by faculty on the far left is in sharp contrast to the treatment given faculty with moderate, conservative or libertarian views. Anyone who raises such dissenting views is immediately set upon by a mob demanding their investigation or termination. This includes blocking academics from speaking on campuses like a recent Classics professor due to their political views. Conservatives and libertarians understand that they have no cushion or protection in any controversy, even if it involves a single, later deleted tweet. At the University of North Carolina (Wilmington) one such campaign led to a professor killing himself a few days before his final day as a professor.
The message from this hearing could be viewed by some as affirming that criticism of DEI is now viewed a threatening language. For conservative, libertarian, or contrarian faculty, it is not clear if such views will now be tolerated or viewed as grounds for termination (or a barrier to hiring).
This comes at a time when many faculties have indeed “culled” their ranks of conservatives. A new survey of 65 departments in various states found that 33 do not have a single registered Republican.
In a recent column, the editors of the legal site Above the Law mocked those of us who objected to the virtual absence of conservative or libertarian faculty members at law schools. Senior editor Joe Patrice defended “predominantly liberal faculties” based on the fact that liberal views reflect real law as opposed to junk law. (Patrice regularly calls those with opposing views “racists,” including Chief Justice John Roberts because of his objection to race-based criteria in admissions as racial discrimination). He explained that hiring a conservative academic was akin to allowing a believer in geocentrism (or that the sun orbits the earth) to teach at a university.
It is that easy. You simply declare that conservative views shared by a majority of the Supreme Court and roughly half of the population are invalid to be taught.
It is not limited to faculty. Polls now show that 60 percent of students fear sharing their views in class. Various polls have shown the same fear with some showing an even higher percentage of fearful students. There is a growing orthodoxy taking hold on our campuses with growing intolerance for dissenting faculty and students alike.
There are faculty who have raised concerns over DEI initiatives, land acknowledgment, and other policies. Even with the apology, the Board has allowed the underlying threat to linger. It should state why the opposition of faculty members, including filing in court, could be deemed as threatening or unacceptable viewpoints.