Sir Pharmalot himself suggested we make a mention of where turkey futures stand this morning, in case anyone is trying to score a last-minute turkey at bargain prices. Instead, we’re more focused on gaming out our oven strategy for the big meal, with a particular priority on the pecan pie we’re on tap for. We are, after all, a former winner of STAT’s pie contest, so we have a reputation to uphold. A few more pieces of wisdom as we head into the holiday: Warm up appropriately for both your turkey trots and turkey feasts — we don’t want any injuries out there. Salads absolutely have a place on the Thanksgiving table (you need something bright and acidic to cut through everything else that’s rich and fatty; cranberry sauce should not have to shoulder that responsibility alone). And finally, no matter how full you get, there’s always room for dessert — and yes, for an extra helping of gratitude. Enjoy the holiday.

The U.S. Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder, STAT writes. The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company. Hemgenix will cost $3.5 million, making it the most expensive drug approved to date. The approval of Hemgenix provides physicians with a new, potentially curative treatment option for patients with severe hemophilia B, a rare bleeding disorder caused by a genetic mutation that prevents the body from producing sufficient quantities of a clotting protein called Factor IX.

Continue to STAT+ to read the full story…

Further, the top court bench comprising the Chief Justice and Justice Hima Kohli has also permitted the State of Uttarakhand to extend the mop up round by three days.

"In this view of the matter and in order to obviate prejudice to the students, we order and direct that the petitioner and similarly placed students who were unable to exercise their options at the end of round 1 of the State counselling shall not be held to be ineligible merely because the State of Uttarakhand combined both rounds 1 and 2 of the counselling rounds. These students will be permitted to withdraw from the seats which have been allotted to them as a "free surrender" without suffering any penalty and would be permitted to participate in the State mop up round which is under way. The State of Uttarakhand shall duly publicize the above directions so that other similarly placed students are made aware of the option which has been granted in terms of the present order," observed the Apex Court bench.

"The State of Uttarakhand is permitted to extend the State mop up round by a further period of three days," it added.

The judgment came while the Court was considering the plea by a PG medical aspirant who after clearing the NEET-PG 2022-2023 examination, appeared in the counselling process.

As per the scheme for counselling which has been prescribed by the National Medical Commission, the counselling authorities at the Central and State level are required to conduct two separate rounds of counselling- i.e. rounds 1 and 2 before the mop up rounds for the All India Quota (AIQ) and the State mop up round take place.

However, the court noted that in case of Uttarakhand, the State Government authorities conducted only one consolidated round of counselling. In case of Uttarakhand, both the first and second rounds have been combined as the main round of counselling.

Issuing a notification in this regard on October 18, 2022, the State Government had notified, "...NEET PG 2022 Candidates participating in Uttarakhand State Centralized Counseling are informed that due to unavoidable reasons of Uttarakhand State Centralized Counseling, the first phase counseling was not conducted, due to which the counseling board decided to do main phase and mop phase. As per the instructions of Government of India /NMC / MCC /, a candidate admitted in the institute after the second stage counseling cannot leave his seat.

In view of the above, the first phase and second phase counseling mentioned in the information brochure issued by the counseling board should be considered as zero and the time table and information for the mop phase counseling will be issued separately."

The bench took note of the fact that because of the deviation by the State of Uttarakhand from the prescribed process, the rights of petitioner and other similarly placed students have been prejudically affected. If there would have been two rounds of counselling, such candidates would have been eligible to exercise the options available at the end of round 1 such as "free exit" and "upgradation". However, since both these rounds have been combined together, the students have been deprived of these options.

In this regard, the bench perused the clause 11.2.7 of the NEET-PG 2022 Information Bulletin issued by the State of Uttarakhand. The concerned clause stated, "If a candidate has withdrawn the admission or left the allotted seat after confirming the admission during the process of round-I counselling. He/she will be eligible for round-II counselling & subsequent rounds of counselling. Instruction for round-II and subsequent round will be uploaded separately."

Taking note of this, the Supreme Court bench also referred to the previous judgment of the Apex Court in the case of Nihila P P v Medical Counselling Committee (MCC) and Others, where the top court had directed that candidates who have joined the allotted seat in round 2 and further rounds of counselling will not be allowed to resign and will also be ineligible to take part in further rounds of any type of counselling. This order had been reiterated in following orders and the Supreme Court had clarified that students who have joined in round 2 of the state quota or round 2 of the All India Quota shall not be eligible to participate in the mop up round for All India Quota.

At this outset, the bench opined that the State's decision of combining two rounds of counselling has affected the PG medical aspirants in Uttarakhand and observed,

"It is plainly apparent that the failure of the State of Uttarakhand to hold two separate rounds of counselling has caused serious prejudice inasmuch as the options which would have been available at the end of round 1 would be foreclosed and would be unavailable."

Therefore, providing relief to the PG aspirants in Uttarakhand, the Court clarified that students like the petitioners who could not exercise their options at the end of round 1 of the State counselling shall not be held to be ineligible just because Uttarakhand government combined two rounds. 

Further, the court has permitted these students to withdraw from the seats as a "free surrender" and participate in the State mop up round. Meanwhile, the State of Uttarakhand has been allowed to extend the State mop up round by a further period of three days.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/supreme-court-free-surrender-191738.pdf

Also Read: SC directs States, UTs to complete 2nd Round of NEET PG Counselling by November 16

More than 55 brand-name blockbuster biologic drugs, each with peak annual sales above $1 billion, are due to come off patent by the end of the decade, according to industry estimates.

Executives from Teva, and Sandoz said they are targeting top-selling biologics such as Humira, AbbVie Inc's top-selling arthritis drug, which came off-patent in Europe and is due to come off-patent in the U.S. next year. But both companies face commercial and regulatory challenges, especially in the U.S., where biosimilars have not resulted in dramatically lower prices for consumers.

Biologics are complex molecules cultivated inside living cells, making it impossible to manufacture exact copies, as is the case with conventional pharmaceuticals made from chemical compounds.

Use of brand-name biologics typically account for an outsize proportion of drug spending in wealthier countries.

One of the biggest makers of generic drugs, Israeli-based Teva said it aims eventually to secure a 10% global market share of biosimilars. The company has been grappling with a heavy debt load since a 2016 acquisition and lawsuits arising from the U.S. opioid epidemic.

Teva currently has three approved biosimilars and 13 in development.

"We are going full blast now," Teva Chief Executive Kåre Schultz said in an interview with Reuters.

He said the company was targeting "80% of what's going off-patent in the next 10 years" including big sellers like the cancer drug Keytruda.

A division of Novartis, Sandoz is currently the second biggest player after Pfizer Inc in the biosimilar market by gross sales globally, per IQVIA data, cited by Sandoz. (Amgen is in third place).

Sandoz has launched eight biosimilar drugs.

"We now have over 15 products in development, and in the next five years we would like to double the value of our marketed portfolio," chief scientific officer Claire D'Abreu-Hayling told Reuters, adding that the biologics they intend to target are "really obvious opportunities".

BLOCKBUSTERS COMING OFF PATENT

Novartis plans to spin off its Sandoz generics business in 2023. The Swiss drugmaker said the unit failed to attract a serious buyer earlier this year as it considered options for the unit's future.

The more than 55 blockbuster biologics coming off patent protection in the United States and Europe over the next decade account for more than $270 billion in expected peak annual sales, according to a McKinsey analysis.

The analysis projected the value of the global biosimilar market could more than triple to an estimated $74 billion by 2030.

Next year could bring a test case in the U.S. market, with the anticipated launch of at least six biosimilars for Humira, which brings in about $15 billion to $20 billion in annual sales and is approved for autoimmune conditions including rheumatoid arthritis, psoriasis and Crohn's disease.

Sandoz and Teva are both working on biosimilars for Humira.

But the crowded field raises a tough question: Should the companies target the biggest selling biologics such as Humira, or aim for smaller brands that will likely attract fewer players, said Barclays pharmaceuticals analyst Emily Field.

Teva aims to ensure it is one of the first three biosimilars on the market for any given biologic, according to Sven Dethlefs, executive VP, North America commercial. He said the company intended to kick off multiple biosimilar development programs but would halt production if it could not make the top three.

While going after Humira, Sandoz is also targeting drugs like Biogen's multiple sclerosis medicine Tysabri, which is used in a much smaller patient population. The company believes no other biosimilar is being actively developed for Tysabri, said Chief Operating Officer Pierre Bourdage.

Creating the only biosimilar in a particular market for a particular drug could be a win, said Joshua Harris, senior VP focused on pharmaceutical patent litigation at Burford Capital, a provider of commercial legal finance. "That's going to be a rare situation," he said.

A typical biosimilar costs $100 million to $300 million to develop and between six to nine years to win approval, according to McKinsey. About half of efforts launched across the U.S., European, and Japanese markets fail at the earliest stages, the report found.

Generics, which can be priced as much as 80% to 90% less than branded pills, barely cost a few million to develop.

Biosimilars are viewed as "better than traditional generics, but nowhere near as good as branded pharma," Field said.

Commercial prospects will also depend on the regulatory environment. While more than 50 biosimilars have been introduced into the European market, the United States has taken longer to set up a regulatory pathway for biosimilars.

European regulators consider all approved biosimilars on par with the original biologic, which has helped boost uptake. Biosimilars have taken the majority of market share from brand-name biologics in Europe and resulted in savings between 75% to 90% off the reference product prices, according to a 2021 report by Duke University's Margolis Center for Health Policy.

In the United States, the Food and Drug Administration (FDA) has approved 39 biosimilars and 22 products have been launched as of October, according to an Amgen analysis.

The FDA typically expects additional trial data before designating a biosimilar as "interchangeable" with the original biologic, which would allow it to be automatically replaced with a biosimilar at the pharmacy counter.

In a note last month, SVB Securities analysts predicted most U.S. payers will likely stick with branded Humira next year, but seriously consider switching patients to interchangeable biosimilars by 2024.

Biosimilars launched in the U.S. have only taken about 20% of the volume share of the biologics they are based on, according to the Duke Report, with knockoffs delivering discounts of about 30% to 40%.

Patent-focused court battles have stymied some launches of biosimilars. Aggressive pricing strategies from branded drug companies also helped neutralize the limited discounts initially offered by biosimilar makers

Read also: Former Sandoz Chief Richard Francis joins Teva Pharma as President, CEO

It can be difficult to stay healthy during the holidays. Thanksgiving is typically celebrated by feasting, followed by seconds, maybe thirds, and topped off with dessert. Of course, then you have the post-feast nap, and then an additional leftover...

mercially available sustained-release treatment for common retinal disease,” he said. “Reintroduction after recall will be a critical time, and we have to work together with each

Medical equipment is still strewn around the house of Rick Lucas, 62, nearly two years after he came home from the hospital. He picks up a spirometer, a device that measures lung capacity, and takes a deep breath — though not as deep as he’d like.

Still, Lucas has come a long way for someone who spent more than three months on a ventilator because of covid-19.

“I’m almost normal now,” he said. “I was thrilled when I could walk to the mailbox. Now we’re walking all over town.”

Dozens of major medical centers have established specialized covid clinics around the country. A crowdsourced project counted more than 400. But there’s no standard protocol for treating long covid. And experts are casting a wide net for treatments, with few ready for formal clinical trials.

It’s not clear just how many people have suffered from symptoms of long covid. Estimates vary widely from study to study — often because the definition of long covid itself varies. But the more conservative estimates still count millions of people with this condition. For some, the lingering symptoms are worse than the initial bout of covid. Others, like Lucas, were on death’s door and experienced a roller-coaster recovery, much worse than expected, even after a long hospitalization.

Symptoms vary widely. Lucas had brain fog, fatigue, and depression. He’d start getting his energy back, then go try light yardwork and end up in the hospital with pneumonia.

It wasn’t clear which ailments stemmed from being on a ventilator so long and which signaled the mysterious condition called long covid.

“I was wanting to go to work four months after I got home,” Rick said over the laughter of his wife and primary caregiver, Cinde.

“I said, ‘You know what, just get up and go. You can’t drive. You can’t walk. But go in for an interview. Let’s see how that works,’” Cinde recalled.

Rick did start working earlier this year, taking short-term assignments in his old field as a nursing home administrator. But he’s still on partial disability.

Why has Rick mostly recovered while so many haven’t shaken the symptoms, even years later?

“There is absolutely nothing anywhere that’s clear about long covid,” said Dr. Steven Deeks, an infectious disease specialist at the University of California-San Francisco. “We have a guess at how frequently it happens. But right now, everyone’s in a data-free zone.”

Researchers like Deeks are trying to establish the condition’s underlying causes. Some of the theories include inflammation, autoimmunity, so-called microclots, and bits of the virus left in the body. Deeks said institutions need more money to create regional centers of excellence to bring together physicians from various specialties to treat patients and research therapies.

Patients say they are desperate and willing to try anything to feel normal again. And often they post personal anecdotes online.

“I’m following this stuff on social media, looking for a home run,” Deeks said.

The National Institutes of Health promises big advances soon through the RECOVER Initiative, involving thousands of patients and hundreds of researchers.

“Given the widespread and diverse impact the virus has on the human body, it is unlikely that there will be one cure, one treatment,” Dr. Gary Gibbons, director of the National Heart, Lung, and Blood Institute, told NPR. “It is important that we help find solutions for everyone. This is why there will be multiple clinical trials over the coming months.”

Meanwhile, tension is building in the medical community over what appears to be a grab-bag approach in treating long covid ahead of big clinical trials. Some clinicians hesitate to try therapies before they’re supported by research.

Dr. Kristin Englund, who oversees more than 2,000 long covid patients at the Cleveland Clinic, said a bunch of one-patient experiments could muddy the waters for research. She said she encouraged her team to stick with “evidence-based medicine.”

“I’d rather not be just kind of one-off trying things with people, because we really do need to get more data and evidence-based data,” she said. “We need to try to put things in some sort of a protocol moving forward.”

It’s not that she lacks urgency. Englund experienced her own long covid symptoms. She felt terrible for months after getting sick in 2020, “literally taking naps on the floor of my office in the afternoon,” she said.

More than anything, she said, these long covid clinics need to validate patients’ experiences with their illness and give them hope. She tries to stick with proven therapies.

For example, some patients with long covid develop POTS — a syndrome that causes them to get dizzy and their heart to race when they stand up. Englund knows how to treat those symptoms. With other patients, it’s not as straightforward. Her long covid clinic focuses on diet, sleep, meditation, and slowly increasing activity.

But other doctors are willing to throw all sorts of treatments at the wall to see what might stick.

At the Lucas house in Tennessee, the kitchen counter can barely contain the pill bottles of supplements and prescriptions. One is a drug for memory. “We discovered his memory was worse [after taking it],” Cinde said.

Other treatments, however, seemed to have helped. Cinde asked their doctor about her husband possibly taking testosterone to boost his energy, and, after doing research, the doctor agreed to give it a shot.

“People like myself are getting a little bit out over my skis, looking for things that I can try,” said Dr. Stephen Heyman, a pulmonologist who treats Rick Lucas at the long covid clinic at Ascension Saint Thomas in Nashville.

He’s trying medications seen as promising in treating addiction and combinations of drugs used for cholesterol and blood clots. And he has considered becoming a bit of a guinea pig himself.

Heyman has been up and down with his own long covid. At one point, he thought he was past the memory lapses and breathing trouble, then he caught the virus a second time and feels more fatigued than ever.

“I don’t think I can wait for somebody to tell me what I need to do,” he said. “I’m going to have to use my expertise to try and find out why I don’t feel well.”

This story is from a reporting partnership that includes WPLN, NPR, and KHN.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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This story can be republished for free (details).

Jamaica's activities are being led by the Pan American Health Organization (PAHO), in conjunction with the Ministry of Industry, Investment and Commerce, Ministry of Agriculture and Fisheries, and the Ministry of Health and Wellness.

WAAW is a World Health Organization (WHO)-led global campaign that is celebrated annually to improve awareness and understanding of antimicrobial resistance and to encourage best practices among the public, as health stakeholders and policymakers all play a critical role in reducing the further emergence and spread of antimicrobial resistance (AMR).

AMR occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines, making infections harder to treat and increasing the risk of disease spread, severe illness and death. As a result of drug resistance, antibiotics and other antimicrobial medicines become ineffective and infections become increasingly difficult or impossible to treat.

According to the WHO, researchers estimated that AMR in bacteria caused an estimated 1.27 million deaths in 2019.

In an interview with JIS News, National PAHO Infection Prevention and Control (IPC)/AMR Consultant Dr Glendee Reynolds-Campbell explained that the main activity for WAAW will be a symposium which will be held under the WAAW theme. The event will take place on Thursday, November 24 beginning at 10:00 at the Regional Headquarters Building, The University of the West Indies.

The other activity for the week will be a webinar hosted by the Ministry of Agriculture and Fisheries, in collaboration with the Ministry of Industry, Investment and Commerce, on Wednesday, November 23.

Diabetes mellitus (DM) is a prevalent health issue in developing world. Lower urinary tract symptoms (LUTS), a hidden and enigmatic morbidity, are widespread in diabetic individuals. Patients with diabetes mellitus (DM) experience LUTS that has a complex pathogenesis. Importantly, LUTS is understood to lead to both mental and physical suffering.

Studies examining risk factors that might lead to LUTS or the prevalence of LUTS among DM patients have not been conducted in Palestine.

Therefore, given the frequency of LUTS and risk factors, the authors set out to investigate the LUTS problem among DM patients visiting primary health care facilities and to determine whether there may be a connection between LUTS and the quality of life of diabetics.

For this purpose, data from 378 diabetic individuals were gathered over a 6-month period, from May 2021 to October 2021, in primary healthcare facilities. Data were gathered using the Incontinence Impact Questionnaire-7 (IIQ-7), Urogenital Distress Inventory-6 (UDI-6), and demographic and clinical parameters. Included were all patients whose laboratory tests revealed they had DM. Patients having a confirmed diagnosis of a urogenital disorder, a background of urological surgery or recurring UTIs, or those suffering from a mental illness were disqualified. (29.9%) were in the age range of (58–67). Females made up 49%. A third of the cohort was obese, and 50% of the group was overweight. 81% had type 2 diabetes. Nearly all of them were receiving medical care. Both single-variate and multiple-variate analyses were conducted.

Key results of the study:

• The UDI-6 scale had a median score of 5.50 (2.00-8.00) and the IIQ-7 scale had a median score of 5 (0.00-10.00).
• Residency (p = 0.038) and regular exercise (p = 0.001) were substantially and negatively associated with the UDI-6 score, according to multiple linear regression models, whereas female gender (p = 0.042), insulin use (p = 0.009), and the presence of comorbidities (p = 0.007) were strongly and positively linked with this score.
• Age and body mass index (BMI) were considerably and favorably correlated with the IIQ-7 score (p = 0.040 and p< 0.001, respectively).

"LUTS is linked to high BMI and inactivity, regardless of the presence or absence of DM. It is also obvious that losing weight and exercising regularly help treat urine incontinence and alleviate LUTS in females. As a result, weight loss and more physical activity not only aid the patient's DM control and prevent serious complications, but also aid the patient's LUTS," asserted Faris Abushamma, Department of Medicine and team.

The findings support the notion that LUTS directly impairs diabetic patients' quality of life. The need for interventions to be implemented at all healthcare levels to identify such issues at an early stage in order to prevent physical and emotional tiredness among DM patients is compellingly demonstrated by this novel concept in Palestine.

REFERENCE

Qasrawi, H., Tabouni, M., Almansour, S.W. et al. An evaluation of lower urinary tract symptoms in diabetic patients: a cross-sectional study. BMC Urol 22, 178 (2022). https://doi.org/10.1186/s12894-022-01133-1 

New Delhi : Through a recent notice, the Medical Counselling Committee (MCC) has released the reporting schedule for mop up round of NEET PG counselling.

Medical counselling committee had published provisional result of Mop Up Round NEET-PG 2022 Counselling on 19.11.2022 on MCC website, following which final Result is published on MCC website.

To view the final result, click here-- https://mcc.nic.in/WebinfoMedical/File/ViewFile?FileId=4761&LangId=P

All the allotted candidates are advised to strictly adhere the counselling schedule as mentioned below:

Allotment Letter for Mop Up Round is now available for Download and Reporting will start as per Notice.

Mop Up Round

Result

Reporting

19th November, 2022

20th November, 2022 to 24th November,

2022

(1-Day)

 (05-Days)

All candidates shall ensure that admission process by allotted college should be made through online reporting portal of intraMCC. Any admission take through offline mode will be treated null & void.

To view the official Notice,Click here :  https://medicaldialogues.in/pdf_upload/notice-for-reporting-of-mop-up-round-pg-counsellin-191557.pdf

MCC is conducting the counselling for the following Institutions/Universities:-

a) 50% All India Quota seats of all states including Union Territory of Jammu & Kashmir, this year onwards. (UT of J&K will also contribute their 50% broad speciality Medical/ Dental seats for the All India Quota counselling conducted by MCC of DGHS).b) 100% seats (All India Quota seats + Institutional Quota seats) of Central Universities (Aligarh Muslim University/ Banaras Hindu University/ University of Delhi/ Central Institutes as per eligibility conditions mentioned in Important Questions related to Scheme of Counselling duly uploaded on MCC website.c) 100% seats of Deemed Universities.d) 50% AIQ P.G seats of colleges under Employee State Insurance Corporation (wards of ESIC insured persons).e) All P.G seats of Armed Forces Medical Services Institutions(only Registration part).f) Central Institutes, VMMC & Safdarjung Hospital, ABVIMS & RML Hospital and ESIC Institute, PGIMSR, Basaidarapur(50% All India Quota seats and 50% seats of I.P University).