China has blocked British drugmaker GSK plcGSK.Lfrom participating in its national drug procurement programme from Oct. 31, 2022 to April 29, 2024, state television CCTV reported on Monday.
CCTV said authorities had decided to do so after a batch of dutasteride soft capsules supplied by GSK failed a recent quality check by the National Medical Products Administration.
GSK did not immediately respond to a request for comment.
Beijing runs a national scheme where global pharmaceutical companies and Chinese generic drugmakers vie to sell their products in bulk at public hospitals.
As a physician, a public health professional and a parent of a teenage girl, I’ve been following news about aFlorida school district’s decisionto digitize kids’ school athletic records with interest – and with concern.
What should be a simple decision about medical best practice has been turned into a Gordian knot of not just health, but also policy, politics, technology and bodily autonomy.
Being active is obviously important for kids, in general. We should do everything we can to encourage all youth to engage in physical activity, whether through organized sports or informal activity. Although, traditionally, women were less likely to be competitive athletes, the number of US high school athletes who identify as female has increased more than 10-fold over the last five decades. This growth deserves to be supported.
For kids of all genders to safely participate in competitive sports, a consortium of medical organizations have agreed on astandardized pre-sports physical screening and exam. The exact rules and regulations differ between states, but the overarching goal of a pre-sports physical is to allow physicians (or other appropriate clinicians) to identify and then mitigate potential harms from youth sports participation.
The pre-sports evaluation form used by the Florida High School Athletic Association, and by extension the Palm Beach County School District, includes screening for everything from family history of cardiac disorders to concussions, depression and eating disorders. These questions are included for good reason. Competitive athletes of all genders are prone to energy deficiency, whether due to disordered eating or due to excessive energy use during practices. This energy deficiency can cause long-lasting harm, especially for adolescents.
When the energy deficiency is accompanied by amenorrhea (lack of a period), it is particularly worrisome, as the metabolic and endocrine side-effects can weaken athletes’ bones, increase the risk of stress fractures and increase the risk of long-term osteoporosis. It is, therefore, medically appropriate to ask athletes about signs of disordered eating, amenorrhea, and other signs of physical danger when deciding whether an athlete is safe to practice and compete. This is also the reason the screening form also includes four questions for “females only” about menstruation.
However, there is a big difference between a physician or other trained healthcare professional asking these questions in private, as part of a clinical assessment, and the physician sharing all the details with third parties.
That some states may share the full physical and screening exam – including information about youth athletes’ menstrual cycles – with school districts, state officials and third-party digital record-keeping companies is, to me, deeply worrisome. The strictures of the post-Dobbs world, the reality of today’s tech world and the suggestive examples of other instances where these intersections have left women and girls vulnerable could put parents and doctors in an untenable position.
From a purely medical perspective, the pre-participation exam forms approved by the American Academy of Family Physicians, American Academy of Pediatrics, American College of Sports Medicine, American Medical Society for Sports Medicine, American Orthopaedic Society for Sports Medicine, and American Osteopathic Academy of Sports Medicine, specify that only the final decision (e.g., whether or not a patient is cleared for sports, and whether there are restrictions) should be shared with a school district. They specifically comment that the medical exam and screening questions should remain with the evaluating clinician or physician.
This guidance reflects the tremendous importance of protecting the privacy of the patient-physician relationship. The confidentiality of clinical discussions is important in general, but all the more so for adolescents. And reproductive and gynecologic care, including discussions about menstruation, are appropriately considered to be even more private than, say, a lung or heart or knee exam.
But my concern about the reported sharing of data goes beyond fears of impairing the patient-physician relationship. The current social, political and technological environment creates a perfect storm for this information-sharing to endanger youth in a myriad of ways.
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First, laws regarding reproductive health, gender and abortion are quickly being rewritten nationwide. In Texas and Oklahoma, those states effectively offer a bounty to anyone who reports a suspected abortion. In other states, being transgender can result in exclusion from organized sports. One could easily imagine a world in which – if school officials or coaches are expected to follow an athlete’s menstrual cycle – some youth would be reported up the chain (accurately or inaccurately) for missed periods. For some youth, this reporting could result in inappropriate and invasive gynecologic exams. For other youth, this could result in them and their parents being charged with a crime. And knowing about a kid’s periods potentially puts schools in a position of liability.
Second, the security of a third-party software system (such as that being used by districts in Florida) is often dubious. While I can’t judge the level of security particular software program being used in Florida, many of us have previously discussed our concerns about poorly designed, poorly protected “period tracking apps.” Cyber-hacking of electronic health records is on the rise. Even the largest, most security-conscious health care organizations are at risk, and data from reproductive health organizations has been specifically targeted and shared. As soon as we share menstrual data with a digital application, we must also worry about its being accessed by those with nefarious intentions.
I doubt that most school systems are ready for these legal and security risks.
Finally, as a mother of a teenager (and a former high school athlete, myself) I cringe at the thought of a coach – even with the best of intentions! – following a child’s menstrual cycle for signs of missed periods. Even in my state (which protects abortion as healthcare, albeit with parental consent), this kind of tracking would be embarrassing at best and invasive at worst. And my worries would be far greater if I were in a state that limited my own and my children’s reproductive rights.
I am glad that Palm Beach County has reconsidered this dangerous policy and asked that questions about menstrual history be removed from Florida’s pre-sports evaluation form. Here’s hoping the Florida High School Athletic Association listens and does what’s right for the sake of kids, parents, coaches and schools.
Megan Ranney, MD, MPH, is the deputy dean at the School of Public Health at Brown University and a professor of emergency medicine at the University’s Warren Alpert Medical School.
CytoDyn has withdrawn an approval application for leronlimab in a specific HIV indication, the latest installment in the troubled biotech’s ongoing saga to get the monoclonal antibody to market.
Despite the CCR5 antagonist meeting its primary endpoint in a phase 2b/3 trial, the biotech blamed “systemic issues” with the quality of data captured by the CRO overseeing the study for the decision to pull its application for leronlimab as a combination therapy in people living with HIV who have resistance to highly active antiretroviral therapy.
An ongoing legal battle led to CytoDyn obtaining an order for the release of the trial data, which the CRO had been withholding, according to the biotech. CytoDyn commissioned three audits of the data from independent regulatory quality firms, and their feedback was enough to make the drug developer drop its application for the HIV indication, the company said in a premarket release Monday.
Resolving the issues raised with the trial data so that the approval would stand a chance with the FDA would require “significant additional investment,” the biotech concluded. The dispute with the CRO isn’t over, either, with the biotech filing a claim for damages.
It’s only the latest in an ever-growing catalog of woes for leronlimab. The company first submitted an application in this HIV indication back in July 2020, but the FDA refused to accept it, citing a lack of necessary information. CytoDyn has since resubmitted nonclinical and manufacturing sections of the application, which the agency had been reviewing.
In March, the FDA slapped a partial clinical hold on the biotech's HIV program and a full clinical hold on its COVID-19 program for the same drug. At the time, the company sought out partners to rescue key programs, but to no avail.
The biotech said today the data it now has are sufficient to complete and submit its responses to the FDA for the removal of the clinical hold on the HIV program. CytoDyn also plans to publish the safety and efficacy data from the phase 2b/3 trial in a peer-reviewed journal, the company added.
This latest chapter is far from the end for CytoDyn’s hopes for leronlimab. The ever-optimistic biotech reaffirmed its commitments to pursuing other underserved HIV indications as well as nonalcoholic steatohepatitis and metastatic triple-negative breast cancer, where it has already secured a fast-track tag from the FDA.
“We plan to reenter the clinic in those indications and believe these steps will allow us to further build on the strong signals we have seen in these indications,” CytoDyn President Cyrus Arman, Ph.D., said in a release. “I am very excited and quite optimistic about these opportunities, which are what ultimately attracted me to leronlimab and CytoDyn.”
Another potential indication for leronlimab that has already fallen by the wayside is COVID-19, following a failed trial last year. CytoDyn insisted at the time that its drug could treat patients with severe disease, but the FDA publicly disagreed and called out the company for cherry-picking data to suggest the therapy was a success. After the agency blasted the company, the Department of Justice and the Securities and Exchange Commission subpoenaed CytoDyn and its executives.
Even CytoDyn’s senior leadership hasn’t been immune to the chaos. The biotech continues to search for a permanent CEO in the wake of Nader Pourhassan’s departure in January, following a memorable press conference in which he begged investors to stop trashing the FDA.
Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating certain inflammatory and oncological conditions, today announced it has engaged SC&H Capital, an affiliate of SC&H Group, to advise Humanigen on exploration of strategic options. SC&H is an investment banking and advisory firm providing merger and acquisition (M&A), financial restructuring and related business advisory solutions to emerging and growing companies.
Humanigen's board of directors has not set a timetable for the conclusion of its review of strategic alternatives, and there can be no assurance that this process will result in any transaction.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage company developing targeted immunotherapeutic drugs, announced today a collaboration agreement with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, wherein vitroandin vivoefficacy of SON-1010 (IL12-FHAB), SON-1210 (IL12-FHAB-IL15) and SON-1410 (IL18-FHAB-IL12) will be evaluated in combination with certain Janssen proprietary cell therapy assets. The agreement was facilitated by Johnson & Johnson Innovation.
Sonnet shall supply the three referenced compounds for use in head-to-head studies. If successful and subject to provisions of the agreement, Sonnet could seek an expanded collaboration.
