STAT

AUGUST 23, 2023

Of the 103 million confirmed cases of Covid-19 in the U.S., an estimated one-third have led to long Covid — a condition that ranges in severity, but can be debilitating. A new study suggests that even more people may be suffering from the post-viral syndrome without having ever received an official diagnosis of Covid-19. The study , published Wednesday in Neurology, Neuroimmunology & Neuroinflammation , was small, examining only 29 patients.

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PharmaVoice

AUGUST 23, 2023

The HeLa cell line’s contributions to medical science were obtained without permission, and now biotechs profiting from its use are answering for it.

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STAT

AUGUST 23, 2023

To most people on the planet, the Covid-19 pandemic is over. But for many scientists who have been tracking the largest global infectious disease event in the era of molecular biology, there is still a step that the virus that caused it, SARS-CoV-2, hasn’t yet taken. It has not fallen into a predictable seasonal pattern of the type most respiratory pathogens follow.

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BioPharma Dive

AUGUST 23, 2023

The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.

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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.

STAT

AUGUST 23, 2023

The Centers for Disease Control and Prevention said Wednesday it’s too early to tell whether a new version of the SARS-CoV-2 virus that has triggered some international concern will actually prove to be disruptive. In a preliminary statement about the BA.2.86 subvariant, the CDC also revealed that updated Covid-19 vaccines should be available across the country as early as mid-September, earlier than previous estimates have placed the start of the fall booster campaign.

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Vaccines 241

The Thyroid Pharmacist

AUGUST 23, 2023

Sometimes we can get stuck on our healing journey. We may be on a seemingly great diet, taking the right supplements, and doing everything in our power to feel better, but still feel like we’re making no progress. But, many times, we’re only one small change away from seeing a huge difference. In my case, I was well on my way to feeling better with Hashimoto’s after changing my diet and incorporating key supplements.

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The Pharmacist

AUGUST 23, 2023

Fish oil supplements provide cardiovascular benefits in randomised trials, but is this benefit undermined by an increased risk of atrial fibrillation and does this risk also apply to eating oily fish? Rod Tucker finds out more, in our Review series Danish researchers first observed how Greenland Eskimos had a fatty acid plasma profile that showed […] The post Does atrial fibrillation risk increase with fish oil supplementation?

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STAT

AUGUST 23, 2023

The number of gender-affirming surgeries taking place in the U.S. nearly tripled between 2016 and 2019, according to new national estimates from a cohort study in JAMA Network Open. Over 48,000 people got some type of gender-affirming surgery between 2016-2020, with a slight decrease in the number of surgeries performed in 2020, likely because of the pandemic.

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BioPharma Dive

AUGUST 23, 2023

Data inadvertently published from a closely watched lung cancer study suggest a drug blocking the protein TIGIT may help extend survival, a finding that boosted shares of other developers.

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STAT

AUGUST 23, 2023

An advisory panel to the Food and Drug Administration delivered a split decision on a surgical system used in a controversial blood pressure treatment called renal denervation.  The panel, whose advice the FDA typically follows, voted that the system developed by ReCor Medical was safe and effective. It voted that the benefits of a system developed by Medtronic, however, did not outweigh the risks.

Hospitals 222

Hospitals 222

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The Pharmacist

AUGUST 23, 2023

The Pharmacist has launched a new and exclusive survey to gather opinions from pharmacists working across community pharmacy and general practice. This will inform our future articles, helping us represent your views and report on issues that matter to you. The Pharmacist editor Carolyn Scott commented that the survey would help shape reporting at a […] The post The Pharmacist launches new summer survey appeared first on The Pharmacist.

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Community Pharmacies 93

STAT

AUGUST 23, 2023

The multibillion-dollar hunt for what many drugmakers hope will be the next big immunotherapy target has had no shortage of twists and tea-leaf- reading. In the wee hours of Wednesday morning, it got another. Roche confirmed it accidentally released interim data from a closely watched clinical trial testing whether blocking that target — a protein on T cells known as TIGIT — can enable non-small lung cancer patients to live longer than standard immunotherapy alone.

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Pharmacy Joe

AUGUST 23, 2023

In this episode, I’ll discuss a case report of enoxaparin overdose. Subscribe on iTunes , Android , or Stitcher A group of authors recently published their experience treating an overdose of 900 mg enoxaparin with a protamine bolus and infusion in the American Journal of Health System Pharmacy. There is little data available on managing large enoxaparin overdoses and inconsistent approaches toward using protamine to reverse enoxaparin so the details of this successful case are of value until mor

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Inpatient 98

STAT

AUGUST 23, 2023

In recent weeks, you may have seen alarming headlines about how leprosy might become “endemic” in Florida. As a physician in Florida who specializes in treating leprosy, also known as Hansen’s disease, this case report was not “news” to us in the field: We have known for some time about endemic cases of leprosy. However, given how rare the disease is in the state, there is no cause for alarm — despite the fearful headline.

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The Pharmacist

AUGUST 23, 2023

Higher staffing levels in primary care are associated with more appointment provision, but not speed of appointment availability, a new study has found. The research paper published in the British Journal of General Practice this week analysed NHS Digital general practice data from August to October 2022, to identify variations in the workforce and in the number of […] The post Increased staffing in primary care ‘unlikely to reduce waiting times’ appeared first on The Pharmacist.

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STAT

AUGUST 23, 2023

Apellis Pharmaceuticals said Tuesday that it had identified “internal structural variations” in a type of needle used by doctors to prepare syringes of its eye disease drug Syfovre as a possible cause of severe eye inflammation reported in patients receiving the treatment — but the company stopped short of definitively linking the needle to the cases.

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BioPharma Dive

AUGUST 23, 2023

The funding for Rapport Therapeutics saw participation from a series of so-called crossover investors, many of which have pulled back from biotech startups in recent years.

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Drug Development 98

STAT

AUGUST 23, 2023

Hello and happy Wednesday from STAT’s London outpost, with Andrew Joseph here filling in for Ed. While you fire up the coffee pot, we’re doing a bit of post-lunch cleanup, but still of course have time to offer you the latest in pharma headlines.  In the wee hours of Wednesday morning, the multibillion-dollar hunt for what many drugmakers hope will be the next big immunotherapy target had its latest twist , STAT details.

Drug Pricing 189

Drug Pricing 189

Pharmaceutical Business Review

AUGUST 23, 2023

The regulator has provided a prescription drug user fee act (PDUFA) date of fourth quarter this year for the review. The sNDA is being reviewed under two initiatives of the FDA , the Real-Time Oncology Review programme and Project Orbis. It is based on data from the multi-national, placebo-controlled, randomised, double-blind Phase III EMBARK trial.

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STAT

AUGUST 23, 2023

The Food and Drug Administration recently approved Opill , the first over-the-counter access birth control pill , in a monumental and long overdue win for reproductive and public health care. This FDA ruling will significantly expand access to high-quality contraception for folks across the country. However, true access will require affordability, too.

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European Pharmaceutical Review

AUGUST 23, 2023

Eli Lilly and Company ’s highly selective and potent RET kinase inhibitor for advanced medullary thyroid cancer (MTC) has demonstrated superior progression-free survival (PFS) compared to approved multikinase inhibitors. These topline results are from an interim efficacy analysis of a Phase III study that compared Retevmo ® (selpercatinib) against multikinase inhibitors (MKIs) cabozantinib or vandetanib.

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Diabetes 94

World Pharma News

AUGUST 23, 2023

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.

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Immunity Immunization Vaccines 91

European Pharmaceutical Review

AUGUST 23, 2023

Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, proposed by the USP Microbiology Expert Committee, is now published as a General Announcement. This is in advance of the official open comment period, according to USP. Comments are welcome from 1 November 2023 to 31 January 2024. The new standard was proposed by the committee earlier in 2023.

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Packaging 92

Pharma Times

AUGUST 23, 2023

The varicella zoster virus that causes shingles and chicken pox is typically present in over 90% of adults globally - News - PharmaTimes

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Vaccines 99

Express Pharma

AUGUST 23, 2023

The company did not disclose the value of the order ABB India on Monday announced that it has secured a major automation contract from Reliance Life Sciences (RLS) to automate its manufacturing plants in Nashik. However, the company did not disclose the value of the order. ABB India has secured a major automation contract from Reliance Life Sciences (RLS) to automate its new manufacturing plants in Nashik, Maharashtra, a company statement said.

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Vaccines 93

BioPharma Dive

AUGUST 23, 2023

The job cuts are meant to preserve enough cash so the nearly three-decade-old company can potentially pursue its first drug approval next year.

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Outsourcing Pharma

AUGUST 23, 2023

With so many advanced therapies on the horizon, the next few years are poised to be one of significant progress for patients with over 2000 cell and gene therapies in active clinical trials globally.

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Express Pharma

AUGUST 23, 2023

The study was performed to understand whether the immunity gained after vaccination or a prior infection was less effective or “leaky” in situations where people are exposed to high levels of the virus High levels of exposure to the SARS-CoV-2 virus may reduce or overcome the protection that COVID-19 vaccination and prior infection provides, according to a study conducted in the US.

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Vaccines Documentation Immunity Immunization 85

Pharma Times

AUGUST 23, 2023

The decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy - News - PharmaTimes

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Vaccines 96

Express Pharma

AUGUST 23, 2023

Nanoscale view of proteins opens window to treat neurodegenerative illness Many diseases affecting the brain and nervous system are linked to the formation of protein aggregates, or solid condensates, in cells from their liquid form condensate, but little is known about this process. This liquid-to-solid transition can trigger the formation of what are called amyloid fibrils.

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Pharmaceutical Technology

AUGUST 23, 2023

Revive has begun the development of a next-generation formulation of Bucillamine to treat public health emergencies.

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National Association of Boards of Pharmacy

AUGUST 23, 2023

Though the coronavirus disease 2019 (COVID-19) public health emergency declarations have officially come to an end, the effect of the pandemic and changes to professional roles and workplace standards will be felt by pharmacists and workers across many industries for years to come. In the post-COVID-19 context, the pharmacy landscape continues to evolve.

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Community Pharmacies Vaccines 73

Pharmaceutical Technology

AUGUST 23, 2023

CROs need to move with the times as artificial intelligence can help deliver more cost-efficient clinical trials.

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PharmExec

AUGUST 23, 2023

Program designed to aid life science organizations in improving go-to-market strategy.

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Pharmaceutical Technology

AUGUST 23, 2023

Celcuity has entered a partnership to use Bayer’s Nubeqa in an upcoming Phase Ib/II prostate cancer trial investigating gedatolisib.

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