Digital Pharmacist
AUGUST 21, 2023
As we gear up for the upcoming flu season of 2023-2024, it’s important to reflect on the lessons of the previous year , and understand how the coming year may look different. In this article, we’ll delve into a comprehensive breakdown of the past season’s dynamics and provide valuable insights to equip you for the challenges and opportunities that lie ahead.
STAT
AUGUST 25, 2023
With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different. In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention and the Food and Drug Administration detailed the various countermeasures available to combat Covid-19, RSV, and influenza, and discussed the expected timing on the rollout
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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.
Pharma Times
AUGUST 24, 2023
The drug is the first to be approved in Japan to treat children and adolescents with& generalised myasthenia gravis - News - PharmaTimes
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.
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.
STAT
AUGUST 24, 2023
In Igbo-Nigerian culture, new moms receive exquisite care from their own mothers, mothers-in-law, or surrogate mothers for the first few months postpartum. After each of my daughters was born, I was blessed to participate in this tradition, called omugwo, which allowed me to be nurtured by the mothers who came before me. They cooked and cleaned. Massaged my belly and taught me how to breastfeed.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
FDA Law Blog: Biosimilars
AUGUST 24, 2023
Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.
Pharmaceutical Technology
AUGUST 25, 2023
The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.
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.
PharmaVoice
AUGUST 22, 2023
How a pediatric neurologist is advocating for herself and the disabled community in a legal battle with the Howard Hughes Medical Institute.
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BioPharma Dive
AUGUST 22, 2023
Billing itself as both a scientific and investment partner, Foundery aims to provide research grants and drug development support to researchers developing new immunotherapies.
PharmExec
AUGUST 25, 2023
The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval.
STAT
AUGUST 21, 2023
MEXICO CITY — Kellogg’s is waging a war here over Tigre Toño and Sam el Tucán. A 2019 policy requires companies that make unhealthy foods to include warning labels on the front of any boxes they sell in Mexico to educate consumers about things like excess sugar and fat. Any food with a warning label — like Kellogg’s Fruit Loops or its Frosted Flakes, which typically contain more than 37 grams of added sugar in a 100-gram serving — is also banned from
PharmaVoice
AUGUST 21, 2023
The depression space recently got a stinging FDA rebuke — but Brii thinks it can break through with improved formulations.
BioPharma Dive
AUGUST 25, 2023
According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.
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.
STAT
AUGUST 21, 2023
The Food and Drug Administration on Monday approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people in the latter part of pregnancy. The vaccine, Abrysvo, has also been approved for use in adults 60 and older to protect them against respiratory syncytial virus.
PharmaVoice
AUGUST 24, 2023
New variants drive a need for another round of shots, and biopharma companies are stepping up to the plate.
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.
Pulses
AUGUST 22, 2023
By : Victoria L. Williams, PharmD, BCCCP “Dr. Williams, what do I have to do if I want to pursue a career in academia? ” a curious student asked me after class. As a clinical faculty member with 50% of my appointment dedicated to direct patient care and the other 50% to teaching, research/scholarship, and service, my answer started off strong with tried-and-true advice on pursuing residency training to prepare for the practice component of my role.
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.
PharmaVoice
AUGUST 21, 2023
Using real-time data, patient centricity and personalized medicine to accelerate clinical trials.
Quality Matters
AUGUST 22, 2023
Industry examining FDA guidance on nitrosamines Nitrosamine impurities in pharmaceutical products have been making major headlines recently, as this year has marked the fifth anniversary since they were first detected at unacceptable levels in some blood pressure medications and – even more importantly – due to a flurry of new regulatory activity taking place around the globe this summer, including by the U.S.
Community Pharmacy
AUGUST 24, 2023
This summer has been one of the hottest ever recorded and with these extreme temperatures comes serious risks like heat exhaustion—and its more serious and advanced form—heat stroke. A heat stroke occurs when the body can no longer regulate its internal temperature within safe limits. As a result, essential physical and mental faculties rapidly decline, and if left unchecked, a stroke can leave victims with loss of consciousness, seizures, and in particularly severe cases, death.
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.
Drug Patent Watch
AUGUST 21, 2023
Loss of exclusivity (LOE) doesn’t have to spell doom for branded drug revenue streams. In the face of impending patent expirations, pharmaceutical companies can adopt key approaches to preserve meaningful… The post Strategies to Maximize Product Value Amid Loss of Exclusivity in the Pharmaceutical Industry appeared first on DrugPatentWatch - Make Better Decisions.
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
Pharmaceutical Business Review
AUGUST 22, 2023
These therapies include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Talvey recently received the US Food and Drug Administration’s approval for the same indication in adults who received at least four prior lines of therapy. It is a bispecific antibody that targets T-cell CD-3 receptors and G protein-coupled receptor class C group 5 member D (GPRC5D).
STAT
AUGUST 23, 2023
Executives from the shuttered digital health company Pear Therapeutics are launching a new VC firm, offering early access to new startups formed by serial biotech entrepreneur Bob Langer. Former Pear CEO Corey McCann and former licensing head Michael Langer formed the new firm, T.rx Capital, earlier this year, according to three people with knowledge of the firm and documents reviewed by STAT.
BioPharma Dive
AUGUST 22, 2023
The pharma’s suit, which claims Medicare’s new power to negotiate certain drug prices is unconstitutional, comes days before the agency will reveal the first 10 medicines to be included under the plan.
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?
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.
STAT
AUGUST 25, 2023
A group of Nigerian, British, and U.S. doctors have discovered a genetic variant that increases the risk of Parkinson’s disease in people of African and mixed-African descent and is not seen in those with European ancestry, a finding that could improve treatment of the movement disorder in a vastly underserved population. “It could be a major mechanistic basis of Parkinson’s disease in African populations,” the researchers said in their paper , published this week in
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.
PharmExec
AUGUST 21, 2023
In this exclusive Q&A with Pharmaceutical Executive, Janice Chang, CEO of TransCelerate BioPharma, provides an inside look into her career journey, her work at the company, how the industry has changed in the last 10 years, as well as her thoughts on where the industry should put its efforts in clinical trials.
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