2024

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H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe

STAT

WASHINGTON — Testing conducted by the Food and Drug Administration on pasteurized commercially purchased milk has found genetic evidence of the H5N1 bird flu virus, the agency confirmed Tuesday. But the testing, done by polymerase chain reaction, or PCR, cannot distinguish between live virus or fragments of viruses that could have been killed by the pasteurization process.

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Traditional gene therapies are uber-niche. Ocugen hopes to change that.

PharmaVoice

The biotech is developing a ‘gene-agnostic’ approach to expand the patient pool for gene therapies.

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An open letter: Concerns on electoral bonds and pharma industry

Express Pharma

Chandru Chawla, a pharma veteran writes an open letter to those CEOs of Pharmaceutical companies who have NOT purchased Electoral Bonds and have NOT made political donations through other means Dear Pharma CEO who did NOT make political donations Compliments from an ordinary soon-to-be senior citizen and a consumer of medicines. Recently, ordinary folks like me have been bombarded with this alleged scam being referred to as Chanda Do Dhanda Lo.

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Psychiatry drugs finally have pharma’s attention. Can they keep it?

BioPharma Dive

Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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UK swapped to fatal US blood products to save money, minutes suggest

The Guardian - Pharmaceutical Industry

Exclusive: contaminated blood campaigners say internal 1976 Immuno AG document proves British government negligence Analysis: families hope report will finally apportion blame The British government was willing to risk infecting NHS patients to get “lower-priced” blood products, according to a document that campaigners claim proves state and corporate guilt in one of the country’s worst ever scandals.

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USDA releases H5N1 bird flu genetic data eagerly awaited by scientists

STAT

The U.S. Department of Agriculture, which has been under pressure from scientists both at home and abroad to share more data on the H5N1 bird flu outbreaks in dairy cows, uploaded a large number of genetic sequences of the pathogen late Sunday. Access to the 239 genetic sequences will help scientists assess whether the dangerous virus has acquired mutations that might make it easier for it to spread to and among mammals, and whether additional changes have been seen as it moves from cow to cow a

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STAT+: In a scientific first, researchers use CRISPR base editing to treat liver disease in fetal monkeys

STAT

The ambitious idea of using CRISPR to cure genetic diseases before birth is one step closer to reality. Scientists reported on Monday that they used a form of the technology known as “ base editing ” to alter the DNA of laboratory monkeys in the womb, substantially reducing the levels of a toxic protein that causes a fatal liver disease before the animals had even been born.

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Hospitals largely keep quiet on maternal care since Dobbs, STAT survey finds

STAT

The Supreme Court decision to overturn Roe v. Wade has transformed not just abortion access but maternal health care across the United States, causing physicians in states with restrictive laws to shift treatment of conditions including ectopic pregnancy and miscarriage. The full scale of the impact, though, has been obscured in a polarized political climate where physicians are often afraid to speak out, or are blocked by their hospitals from talking about their experiences post-Dobbs.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Covid ignited a global controversy over what is an airborne disease. The WHO just expanded its definition

STAT

In the chaotic first few months of the Covid-19 pandemic, stores faced shortages of all kinds — toilet paper, canned food, and especially, cleaning supplies. With everyone scrubbing their groceries, mail, even library books, good luck finding antibacterial wipes or disinfectant sprays back then. That’s because public health advice in early 2020 focused on sanitizing surfaces, not protecting against a virus that could be spread through the air.

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Opinion: Former HHS secretaries: Congress should adopt site-neutral payments for health care

STAT

As two former secretaries of Health and Human Services, we are all too familiar with the struggle of finding narrow openings for bipartisanship. Despite our different approaches, we believe that addressing health care costs is a truly bipartisan issue. To be serious about creating access for people to the best possible care, that care must be affordable for patients and taxpayers.

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STAT+: Eli Lilly’s Zepbound eases obstructive sleep apnea in trials

STAT

Eli Lilly reported positive results for its obesity drug Zepbound in obstructive sleep apnea, giving the medication a new edge in the highly competitive obesity market. The results also pave the way for Zepbound to potentially become the first approved treatment for obstructive sleep apnea, or OSA, a common disorder characterized by breathing interruptions during sleep.

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Second-generation mosquito nets prevented 13 million malaria cases in large pilot programs

STAT

The fight against malaria is a test of human intelligence against mosquitoes — and so far, our minuscule winged enemy is winning. But new results shared this week show substantial improvements in one of the most important tools we have to prevent the life-threatening disease: bed nets. Results shared this week by the New Nets Project, an initiative funded by Unitaid and the Global Fund, highlighted a pair of second-generation bed nets tested in endemic areas between 2019 and 2022.

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STAT+: Dana-Farber retracts string of studies in systematic review of data integrity

STAT

An ongoing investigation into data integrity at Dana-Farber Cancer Institute has resulted in a string of retractions, the latest of which is a 2006 Science paper co-authored by institute president and CEO Laurie Glimcher. The retraction notice, published in Science on Thursday, noted that the authors had become aware of discrepancies in key scientific images that led them to lose confidence in key figures in the study, although the study’s lead author opposed the retraction.

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STAT+: Can investing in infectious disease pay off? Vir Biotechnology’s tightrope walk shows it’s a struggle

STAT

Nearly a decade ago, venture capitalist Bob Nelsen called industry veteran Vicki Sato to pitch her on launching a large company dedicated to tackling the world’s worst pathogens. “This is a crazy idea,” Sato said. Nelsen, managing director of ARCH Venture, had made a name and fortune off crazy ideas, but generally it was the science that sounded crazy: engineering cells to cure cancer, finding drugs to slow aging.

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STAT+: Microsoft is selling AI in health care, and helping to set its standards. Is that a problem?

STAT

For a company moving as quickly as possible to build artificial intelligence into everything — including health care — Microsoft spends a lot of time talking about how to regulate it. The tech giant has helped organize four separate coalitions to devise guidelines and technical standards for AI in health care. It supplies these groups — composed of health systems, government regulators, and other health businesses — with top executives to serve on steering committees,

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Opinion: Hospitals that make profits should pay taxes

STAT

As diligent taxpayers breathe a sigh of relief that the hassle of filing their tax forms is over for another year, the Internal Revenue Service continues to let most U.S. hospitals pay nothing in federal taxes. It’s time for Congress to take a hard look at the IRS’s hand in health care. The agency uses a vague “community benefit” standard to liberally grant tax-exempt status to so-called nonprofit hospitals even as many of them are financially taking advantage of sick

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Health disparities and premature deaths run deep, even in best-performing states

STAT

A new analysis of health inequities in the United States shows that every state has deep racial and ethnic disparities in the performance of their health care systems. The report released Thursday by the Commonwealth Fund analyzed 25 indicators that track health outcomes, health care access, and quality of care provided for five racial and ethnic groups.

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Opinion: Free med school tuition won’t solve the shortage of primary care physicians

STAT

Last month, nearly 40,000 medical students were accepted into residency programs on “Match Day.” Surrounded by family and friends, these soon-to-be-physicians opened envelopes revealing where they would begin their careers. This moment marked the culmination of a residency match process that requires medical students to make a series of choices and rankings about which medical specialty to practice and at which health system, along with the various lifestyle factors inherent in suc

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STAT+: UnitedHealth skips hearing in the wake of Change cyberattack, triggering call for subpoena

STAT

In the first federal hearing focused on the massive cyberattack on Change Healthcare , lawmakers had many important questions for UnitedHealth, which owns Change: Did it meet Health and Human Services’ cybersecurity performance goals ? Has UnitedHealth exploited physicians’ cash shortfalls caused by the Change outage to acquire struggling practices?

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Opinion: H5N1 bird flu in U.S. cattle: A wake-up call to action

STAT

The recent detection of H5N1 bird flu in U.S. cattle, coupled with reports of a dairy worker contracting the virus , demands a departure from the usual reassurances offered by federal health officials. While they emphasize there’s no cause for alarm and assert diligent monitoring, it’s imperative we break from this familiar script. H5N1, a strain of the flu virus known to infect bird species globally and several mammalian species in the U.S. since 2022, has now appeared to have bre

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Opinion: Kids can’t wait any longer for social media safety

STAT

When my son Conall took his life at age 17, it was devastating to me and our entire family. Conall was a caring, empathetic, and bright young man, but he had also struggled for many years with anxiety and depression. Like many kids his age, much of his life revolved around social media. While I understand that suicide is complex, with many different factors contributing to someone’s risk for it, I know that social media intensified and fueled Conall’s insecurities and ultimately ha

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$10 billion long Covid ‘moonshot’ is being floated by Bernie Sanders 

STAT

WASHINGTON — Bernie Sanders is pushing for a long Covid “moonshot.” He released a draft legislative proposal this week, a follow up to a milestone hearing in January that sounded the alarm on long Covid as a pressing public health crisis. The pitch calls for $10 billion in mandatory funding over the next decade to establish a new long Covid research program at the National Institutes of Health.

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STAT+: Medicare expects to spend $3.5 billion on new Alzheimer’s drug in 2025

STAT

Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer have projected — according to a document obtained by STAT. Medicare’s actuaries expect the drug Leqembi , made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medica

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STAT+: Animal rights group urges SEC to investigate Charles River over monkey purchases

STAT

A leading animal rights group has asked securities regulators to investigate Charles River Laboratories for allegedly misleading investors about its sales and purchases of long-tailed macaques, which are widely used in clinical research by pharmaceutical companies and universities, among others. The company, one of the largest clinical research organizations, was accused of failing to disclose purchases of thousands of non-human primates that should not have been imported into the U.S. and obtai

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STAT+: When a cancer drug fails, oncologists often fly blind. A precision technique might light the way

STAT

It seemed as if Logan Jenner had the best possible chance for a cure. Diagnosed at age 3 with acute myeloid leukemia, an aggressive blood cancer, Logan happened to have a targetable mutation that occurs in a small minority of childhood AML cases, making it possible for him to receive a precision therapy drug that — with chemotherapy — got him to a point where he could receive a bone marrow transplant.

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STAT+: Cancer vaccines gain momentum, after years of disappointing results

STAT

SAN DIEGO — Cancer vaccines have traveled a potholed road over the last decade. But as researchers from different companies and academic institutions presented promising early data at the American Association for Cancer Research annual meeting in San Diego this week, experts said there’s a collective feeling of turning a corner. “There’s a lot more interest in vaccines” now that the technology is improving, said Roy Herbst, chief of medical oncology at Yale Can

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STAT+: Grocers are pushing legislation they claim would enhance food safety. Advocates say it would gut FDA rules

STAT

WASHINGTON – In the last decade, Americans have been sickened by salmonella from cucumbers, listeria from Mexican-style cheese, and E. coli from romaine lettuce. Now, it would seem that Washington is finally getting serious about making sure the Food and Drug Administration has the power to promptly investigate and respond to foodborne outbreaks.

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STAT+: MassMutual is rolling out free genetic testing for members, a dicey area for life insurers

STAT

One of the country’s biggest life insurers is venturing into genetic testing, an area that’s historically been a minefield for that industry, in a purported effort to keep its members alive longer.  MassMutual announced Tuesday that it’s offering many of its 4.2 million policyholders free genetic risk assessments for eight common diseases, like heart disease, type 2 diabetes, and breast cancer.

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STAT+: How a scientific slip-up caused a pregnant woman to get an untested treatment for preterm birth

STAT

Makena, once the only available treatment to prevent preterm birth, has had its share of controversy. A yearslong debate over the drug’s effectiveness led the Food and Drug Administration to withdraw its approval of the product and demand it be pulled from the market after a confirmatory trial couldn’t replicate the results of a key study.

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STAT+: Did you say 486%? Why one company thinks such a price hike for its drug is justified

STAT

In an era when huge price hikes for prescription drugs are almost guaranteed to draw criticism, is there any circumstance when a 486% increase for a medicine might appear to be justified? A small company called Harrow argues that it can make the case for an injectable eye treatment that has been used to combat several serious conditions. Company executives maintain the medication, which has been largely out of stock for the past few years, requires substantial investment in order to restore a st

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What the noses of mice can tell us about the inheritance of trauma

STAT

In the final year of World War II, Nazi troops starved the Netherlands in a brutal event known as the Dutch Hunger Winter. Some 20,000 people died and millions more suffered from this man-made famine. The survivors went on to have children and even grandchildren with increased rates of metabolic issues like diabetes, hypertension, and schizophrenia.

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Opinion: The time has come for over-the-counter antidepressants

STAT

Anyone can now walk into a pharmacy in the United States and buy oral contraceptives over the counter without a prescription, thanks to the FDA’s approval of norgestrel (Opill). This change reflects the drug’s safety and the public health imperative to ensure wider access to birth control. But another safe class of medicine that addresses a massive public health need remains unavailable except by prescription: the antidepressants known as selective serotonin reuptake inhibitor

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STAT+: Vertex to buy Alpine Immune Sciences for $4.9 billion

STAT

Vertex Pharmaceuticals will buy Alpine Immune Sciences, a maker of protein-based medicines that harness the immune system, for $4.9 billion, the companies announced Wednesday. It is the largest acquisition in Vertex’s history. The acquisition gives Vertex a drug called povetacicept, which has shown promise in treating IgA nephropathy (IgAN), an autoimmune disorder of the kidney that can lead to end-stage renal disease and affects 130,000 people in the U.S.

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