STAT

NOVEMBER 4, 2022

New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday. The companies said the levels of neutralizing antibodies that target the BA.4 and BA.5 subvariants of the SARS-CoV-2 virus were four-fold higher in people aged 55 and older who received the bivalent booster than in similarly aged people who recei

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Vaccines Immunity Immunization 346

PharmaVoice

NOVEMBER 1, 2022

Leaders at Veeva believe the wording around decentralized trials has been exaggerated, and that a bigger-picture outlook is important as the pandemic winds down.

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Pharmaceutical Technology

OCTOBER 31, 2022

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic. However, recent data from GSK’s sub-unit vaccine, GSK-3844766A, have pushed the candidate to the top, with the highest efficacy demonstrated in a pivotal trial to date.

Vaccines 135

Vaccines Immunity Immunization 135

pharmaphorum

NOVEMBER 2, 2022

Digital therapeutics are rapidly coming into the foreground to treat a variety of conditions. Ben Hargreaves discovers how chronic pain could be a key area for digital therapeutics, as they offer non-addictive and effective relief from the condition. The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium.

Dosage 132

Dosage 132

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

NOVEMBER 3, 2022

The journal Nature published today global consensus recommendations to end Covid-19 as a public health threat. It took a panel of almost 400 independent-thinking scientists, doctors, and representatives of community groups from more than 100 countries (we were among the co-chairs) some 14 months to develop and agree on these recommendations. There have been times when we wondered if it was worth the effort.

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PharmaVoice

NOVEMBER 2, 2022

Charged with bridging the 100-year-old research center to its future mission of holistic patient cancer care, Mesara is bringing decades of experience in communications and culture creation.

Communication 246

Communication 246

pharmaphorum

OCTOBER 31, 2022

Verge Genomics has joined a select group of biotechs who have taken a drug discovered and developed using artificial intelligence into human testing. The small-molecule PIKfyve inhibitor – called VRG50635 – has been administered to the first subject in the phase 1 trial involving healthy volunteers, according to the San Francisco-based biotech, which was founded in 2015 by Alice Zhang and Jason Chen.

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Compounding Drug Development 131

STAT

NOVEMBER 3, 2022

T he first time I remember hearing the words “biology’s century,” it was a sales pitch. I was standing by the Long Island Sound in Sachem’s Head, Conn., in the shadow of an 11-foot-tall granite Stonehenge replica built by Jonathan Rothberg, a biotech entrepreneur, as he talked up his newest gadget, a tabletop DNA sequencer.

Drug Development 323

Drug Development 323

PharmaVoice

NOVEMBER 3, 2022

Toxoplasmosis is carried by about a third of the world’s population, but effective drugs are lacking — now researchers have discovered a key infection element that could lead to better treatment.

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Pharmaceutical Technology

NOVEMBER 2, 2022

Pfizer has reported a 6% decline in revenue to $22.6bn in the third quarter (Q3) of 2022 as against $24bn in the same quarter last year. In the quarter, revenues rose 2% operationally on omitting contributions from Covid-19 therapies, Paxlovid and Comirnaty. Reduction in revenues from Comirnaty outside the US and reduced revenues for some Comirnaty-linked manufacturing works carried out on behalf of BioNTech, Xeljanz and Sutent worldwide were the key drivers that contributed to the revenue dec

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Pharmacy Management

pharmaphorum

NOVEMBER 4, 2022

To address the supply chain vulnerabilities of the pharma industry, an innovative, collaborative blockchain-based system could help to keep track of drugs in transit and ensure they are stored in the correct conditions. The pace of technological advancement and focus in this area suggests that such a solution could be coming soon. While most supply chains were impacted by the Covid-19 pandemic, the demands it placed on pharmaceutical and medical supply chains were immense and underlined the impo

Pharmaceutical Companies 107

Pharmaceutical Companies Pharmaceutical Companies Vaccines 107

STAT

NOVEMBER 3, 2022

Since the late ’90s, Kathy Wallace has been battling major depression with a series of drugs — first Prozac, then three others, and back again to Prozac. But in the last six months, nothing seemed to be helping. So her psychiatrist recommended something new: Spravato, a nasal spray approved in 2019 that delivers a drug similar to the hallucinogen ketamine.

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Labelling 293

PharmaVoice

NOVEMBER 2, 2022

Inflationary pressures and rising energy costs could further expedite the movement of generics manufacturing from Europe to Asia if governments don’t step in.

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Pharma Times

NOVEMBER 4, 2022

Treatment will assist young people and children with symptoms of mild-to-moderate anxiety

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pharmaphorum

NOVEMBER 2, 2022

One of the highlights of Eli Lilly’s third-quarter results was the rapid uptake of new type 2 diabetes therapy Mounjaro, which added more than $97 million in US sales alone in what has been described as “viral” take-up by the drugmaker. Lilly’s head of diabetes, Mike Mason, said on the company’s results call that the rollout of Mounjaro (tirzepatide) was “really unprecedented” for a new diabetes therapy in the US, and had been driven by “tremendous

Diabetes 104

Diabetes 104

STAT

NOVEMBER 2, 2022

Editas Medicine’s new leadership team on Wednesday reiterated a promise to deliver clinical updates on two CRISPR-based treatments before the end of the year — data the troubled biotech hopes will ease investor doubts about its gene-editing technology. Other CRISPR companies command multibillion-dollar valuations, but Editas, one of the originals, trades below its IPO price after years of management upheaval and clinical delay.

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PharmaVoice

NOVEMBER 1, 2022

The Bill & Melinda Gates Medical Research Institute’s clinical development leader talks about its new licensing deal with Merck.

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European Pharmaceutical Review

NOVEMBER 1, 2022

Bristol Myers Squibb (BMS) has announced Reblozyl ® (luspatercept-aamt), the first erythroid maturation agent, showed improvement in red blood cell transfusion independence (RBC-TI) and haemoglobin (Hb) increase in severely anaemic adults with very low, low or intermediate-risk myelodysplastic syndromes (MDS). Reblozyl is a first-line therapy that promotes late-stage red blood cell maturation in animal models.

Labelling 100

Labelling 100

Digital Pharmacist

NOVEMBER 1, 2022

November is Lung Cancer Awareness Month. Lung Cancer is the leading cause of cancer deaths in the US, and about every 2 and a half minutes, someone learns they have this disease. Many organizations are working together to defeat lung cancer and during the month of November, it’s critical to raise awareness. Background. Lung cancer is the second most common cancer in men and women and the leading cause of cancer death.

Pharmacy Management 98

Pharmacy Management 98

STAT

NOVEMBER 4, 2022

When Tamiya Griffin was expecting her first child in 2014, she had what she thought was a straightforward plan: deliver at the hospital down the road, the same place her mother gave birth to her. But when Griffin, then a 22-year-old senior in college, went into labor a few weeks early, she had to undergo an emergency C-section.  “And that was not a part of my plan.

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Hospitals 269

PharmaVoice

OCTOBER 31, 2022

The Inflation Reduction Act helps support American families by lowering prescription drug prices and reducing overall healthcare costs.

Drug Pricing 246

Drug Pricing 246

pharmaphorum

NOVEMBER 3, 2022

In an encouraging development for the fight against antimicrobial resistance (AMR), GSK’s novel antibiotic gepotidacin has shown efficacy in two phase 3 trials, setting up regulatory filings. If approved, gepotidacin (GSK2140944) could become the first drug in a new class of oral antibiotics for uncomplicated urinary tract infections (UTIs) in more than 20 years, according to the pharma group, which plans to submit the data to the FDA in the first half of next year.

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Pharmaceutical Technology

OCTOBER 30, 2022

Concept: Massachusetts Institute of Technology (MIT)’s Computer Science and Artificial Intelligence Laboratory (CSAIL) researchers have developed a system called ‘series elastic end effectors’ (SEED) that enable robots to use grabbed tools correctly and successfully. It was developed in partnership with the American Toyota Research Institute (a technology research unit of Toyota).

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STAT

NOVEMBER 1, 2022

A Food  and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates pulse oximeters, calling for clearer labeling and more rigorous testing of the devices. The widely used instruments monitor blood oxygen levels and have been shown to work less well on patients with darker skin, possibly exacerbating health disparities in many racial and ethnic groups.

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Labelling 262

PharmaVoice

NOVEMBER 3, 2022

The company’s distinct amyloid-beta target, which just won a fast track designation, could give it an edge over the competition.

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pharmaphorum

NOVEMBER 1, 2022

In January 2020, the financial conglomerate Visa announced it was acquiring a relatively unknown startup, Plaid, for $5.3 billion. Corporate acquisitions like these are not uncommon, but someone at the United States Department of Justice took notice of this announcement. Visa had established a stranglehold on financial transactions. The Justice Department moved to stop the acquisition on grounds that Plaid posed “a threat to this monopoly: it has been developing an innovative new solution that w

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HIPAA Insurance Coverage and Processing Specialty Pharmacies Communication 98

PhRMA

OCTOBER 31, 2022

Since the 1980s, October has been recognized as National Breast Cancer Awareness Month — an opportunity for us to unite as a community to honor those who have had breast cancer and raise awareness about progress biopharmaceutical researchers have made towards treating the disease.

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STAT

NOVEMBER 4, 2022

The open enrollment season for health insurance is gearing up at a time when more people in the United States have health insurance than ever before. Yet millions of Americans who enroll this fall still won’t be able to easily afford the health care they need or will be hit with medical bills they can’t pay. Why? Because whether you have health insurance through an employer, the individual market, or even through Medicare, high health care costs and coverage exclusions are making i

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PharmaVoice

OCTOBER 31, 2022

How new tools are helping companies find and keep cancer patients in clinical studies.

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European Pharmaceutical Review

NOVEMBER 4, 2022

A new report in the New England Journal of Medicine for the largest-ever trial observing the effects of psilocybin in patients with treatment-resistant depression, found participants reported reduced depressive symptoms three weeks after being given 25mg of psilocybin (COMP360) in combination with psychological support. The multi-centre, Phase IIb trial observed the severity of depression in 233 individuals over 12 weeks in 22 sites and 10 countries across Europe (Czech Republic, Denmark, German

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Pharma Times

NOVEMBER 2, 2022

The study evaluated the safety, efficacy and immunogenicity of AELIX’s HIV vaccine

Vaccines 128

Vaccines 128

STAT

NOVEMBER 1, 2022

In the years since the onset of the Covid-19 pandemic, many health care professionals have turned to Twitter as a way to share news and advice about public health. But Elon Musk’s takeover of Twitter, which closed last week, is raising concerns that the self-described “ free speech absolutist ” could change the social-media platform in ways that promote, rather than curb, the spread of mis- and disinformation.

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PharmaVoice

NOVEMBER 4, 2022

How companies can work to include people with disabilities into broader equity aims.

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European Pharmaceutical Review

NOVEMBER 3, 2022

GSK has announced the European Medicines Agency (EMA) has validated a marketing authorisation application (MAA) under accelerated assessment for its respiratory syncytial virus (RSV) vaccine for adults above 60. If approved, the vaccine could be the first vaccine to prevent RSV lower respiratory tract disease (LRTD) in older adults. Accelerated assessment?

Vaccines 93

Vaccines 93

Pharmaceutical Technology

NOVEMBER 4, 2022

Last week, after a tumultuous 45 days under Liz Truss’s control , the role of the UK’s Prime Minister (PM) was passed on to Rishi Sunak , in a bid to restore balance to the British economy. During her short reign, Truss’s cabinet had promised a £45 billion ($51.59 billion) mini-budget that included unfunded tax cuts for the rich, enacted a U-turn on an energy price freeze, and oversaw the largest drop in value for the British pound against the US dollar.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 93