STAT
AUGUST 16, 2023
The nation’s health faces a dual threat — one anticipated, the other, self-inflicted. Covid-19 has not gone away; the Centers for Disease Control and Prevention reports that infections are showing signs of a late summer wave. The new strain, EG.5 , spreads easily and is more resistant to neutralizing antibodies but does not, to date, seem to be more virulent.
ALiEM - Pharm Pearls
AUGUST 16, 2023
Exposure to which of the following could produce the pictured results? Carbon monoxide Lead paint Morphine Oral analgesic gel Reveal the Answer 4 – Oral analgesic gel Oral analgesic gel contains benzocaine, which is an oxidizing agent and a common cause of methemoglobinemia. The pictured cyanosis and classic “chocolate” blood are seen with this condition.
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STAT
AUGUST 16, 2023
In mid-July, Kristen Secrist hopped on a call with her 5-year-old son’s doctor, who had urgent news: The first gene therapy had been approved for Duchenne muscular dystrophy. Her son, Hiram, would be a perfect candidate — if, she added, they could get him dosed in time. The treatment was approved only for 4- and 5-year-olds. Hiram turned 6 in three weeks.
PharmaTech
AUGUST 16, 2023
FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
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 16, 2023
Sarah Evans considers herself a lucky ovarian cancer patient, though she is dealing with the second recurrence of the disease since she was first diagnosed in February 2018. She is grateful that, even by her third round of chemo in March of this year, her cancer was still responding to carboplatin treatment — the most common first line of treatment for ovarian cancer, and one Evans tolerates without unbearable side effects.
The Pharmacist
AUGUST 16, 2023
Places are available for up to 840 pharmacy technicians to apply for new fully funded training launching in September. The training aims to enable community pharmacy technicians to take on responsibility while more pharmacists train as independent prescribers. Pharmacy technicians will be trained in consultation skills, therapeutics, clinical decision making and assessment skills as well […] The post New training for pharmacy technicians to launch in September appeared first on The Pharmac
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
Drug Patent Watch
AUGUST 16, 2023
Annual Drug Patent Expirations for REMODULIN Remodulin is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are nine patents… The post New patent for United Therap drug REMODULIN appeared first on DrugPatentWatch - Make Better Decisions.
STAT
AUGUST 16, 2023
U.S. regulators on Wednesday approved the first treatment for an ultra-rare disease that causes people to grow bone where it otherwise shouldn’t be, extending an option to patients who have been advocating for access to the medicine. The treatment, an oral medication that will be marketed as Sohonos, faced some questions about the quality of its data, and was rejected earlier this year by European regulators.
Pharmacy Joe
AUGUST 16, 2023
In this episode, I’ll discuss the pharmacist’s role in predicting the need for intubation. Episode 844: Why A Pharmacist Should Learn to Predict the Need for Intubation Subscribe on iTunes , Android , or Stitcher Because of how drug delivery systems are set up in most US hospitals with medications stored in automated dispensing cabinets, there can be a considerable delay between the time a physician makes a decision to intubate a patient until the time the team is ready with medications to
STAT
AUGUST 16, 2023
In March, Philips recalled more than 73,000 ventilators that absorbed dust and dirt into breathing tubes. This week, the Food and Drug Administration reported that the issue has been associated with at least one death and two injuries. The recall impacts Philips’ Trilogy Evo ventilators, which are used primarily in hospital settings to support breathing for pediatric and adult patients.
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BioPharma Dive
AUGUST 16, 2023
The decision stands in contrast to the agency’s plans for a would-be rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics that is also under a regulatory review.
STAT
AUGUST 16, 2023
Figuring out the right medical diagnosis for patients can be a tricky process. The recent case of a woman who became sick with a life-threatening disease shortly after giving birth shows how many factors had to align to offer clinicians new insights into a rare complication that had never before been documented. A letter published Wednesday in the New England Journal of Medicine highlights the circumstances of the unusual case that occurred at University of Colorado Hospital.
The Pharmacist
AUGUST 16, 2023
An independent review has found some support for the idea of non-medical prescribers taking the Prescribing Safety Assessment (PSA), as more professionals including pharmacists gain prescribing qualifications. And it recommended a prescribing safety assessment should become standardised and compulsory for all medics practicing in the UK, with regulatory oversight from the General Medical Council (GMC). […] The post Prescribing pharmacists should take prescribing safety assessment, review s
STAT
AUGUST 16, 2023
For only the fifth time, the U.S. Food and Drug Administration recently threatened to fine a company or clinical trial investigator for failing to post study results on a federal government database. And transparency advocates say this is the latest proof that the agency needs to step up enforcement. In a July 19 letter , the FDA warned Light Sciences Oncology about its failure to post study results about a prostate treatment to the database, ClinicalTrials.gov.
FDA Law Blog: Biosimilars
AUGUST 16, 2023
By Douglas B. Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. He talked about regulatory discretion being exercised for drug manufacturing facilities with serious compliance problems, about how firms should respond to FDA inspectional observations, and about an upcoming guidance that will be of
STAT
AUGUST 16, 2023
Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today is butter pecan, a household favorite — and get started. Meanwhile, do keep us in mind if you hear anything interesting.
European Pharmaceutical Review
AUGUST 16, 2023
Sandoz has announced positive results from the MYLIGHT Phase III study for its biosimilar aflibercept, for patients living with wet macular degeneration. The confirmatory efficacy and safety study ( NCT04864834 ) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®. The study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar a
STAT
AUGUST 16, 2023
First Opinion , STAT’s platform for opinion and perspective essays, welcomes submissions about the biopharma industry, medical science and health care, and other topics related to the life sciences writ large.
Pharma Times
AUGUST 16, 2023
The collaboration will focus on multiple enzyme cargoes modified using Aliada's modular delivery platform - News - PharmaTimes
BioPharma Dive
AUGUST 16, 2023
The struggling biotech also plans to offload other cell therapy assets, including a multiple myeloma therapy, and focus exclusively on gene editing medicines.
Eye on FDA
AUGUST 16, 2023
In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This past June FDA posted an Untitled Letter , the first regulatory action letter in a year, reported on here regarding a website communication.
Express Pharma
AUGUST 16, 2023
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) Tacrolimus Ointment, 0.03%, the generic version of Protopic Ointment, 0.03%, of Leo Pharma AS. Glenmark’s Tacrolimus Ointment, 0.03%, will be distributed in the US by Glenmark Pharmaceuticals, US. According to IQVIA sales data for the 12-month period ending June 2023, the Protopic Ointment, 0.03% market achieved annual sales of approximately $15.4 million*.
European Pharmaceutical Review
AUGUST 16, 2023
Amicus Therapeutics has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for Pombiliti ® (cipaglucosidase alfa) + Opfolda ® (miglustat) for adults living with late-onset Pompe disease. Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat (an enzyme stabiiser) for adults with the rare disease.
Pharmaceutical Technology
AUGUST 16, 2023
The proportion of cases found in migrants to Florida has decreased significantly since 2002 while cases in US residents has risen.
Express Pharma
AUGUST 16, 2023
Researchers from the Indian Institute of Technology Guwahati (IITG), under the leadership of Dr Rajkumar Thummer, in collaboration with scientists from Christian Medical College, Vellore, have reported a method to convert regular human skin cells into pluripotent stem cells. Dr Thummer, Assistant Professor, Department of Biosciences & Bioengineering, IIT Guwahati, said, “The human body is made of many kinds of cells – nerve cells, heart cells, liver cells, pancreatic cells, and so on, with u
Pharmaceutical Technology
AUGUST 16, 2023
Bluebird bio eyes hattrick of gene therapy approvals, with a PDUFA date for sickle cell disease therapy lovo-cel set in December.
Express Pharma
AUGUST 16, 2023
Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.09%, to market a generic equivalent of Bromday Ophthalmic Solution, 0.09%, of Bausch & Lomb Inc. This product will be manufactured at Lupin’s Pithampur facility in India. Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of $11 million in the US (IQVIA MAT June 2023).
Pharmaceutical Technology
AUGUST 16, 2023
Several companies are developing robotics to automate cell and gene therapy manufacturing, but some challenges persist.
Pharma Times
AUGUST 16, 2023
The new vaccine is an alternative to injected versions and no medical training is needed to deliver it - News - PharmaTimes
The Pharmacist
AUGUST 16, 2023
Pressure on primary care teams, including the impact of diabetes medication shortages, is preventing diabetes patients from receiving the recommended routine care they expect, a UK diabetes charity has warned. Diabetes UK also called for medication supply to be ‘drastically improved’ and staff resource to be increased before the winter, when NHS resources will come […] The post ‘Vital’ to improve diabetes medication supply and staff resource before winter appeared first on The Pharmacist.
Outsourcing Pharma
AUGUST 16, 2023
OSP discussed going beyond industry sponsors and how to support both patients and centers through clincal trial design with Erin Leckrone, senior director, clinical trials and Kathleen Kane, senior manager, clinical operations, at Be The Match BioTherapies.
pharmaphorum
AUGUST 16, 2023
A new approach to drug design: Restoring the effectiveness of antibiotics Mike.
PharmaTech
AUGUST 16, 2023
Gilead and Tentarix established three multi-year collaborations to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases.
Welltopia Pharmacy
AUGUST 16, 2023
Discover how melatonin, known for sleep regulation, doubles as a powerful antioxidant, effectively preserving the freshness of fruits. Learn about its mechanism and impact on extending shelf life.
Express Pharma
AUGUST 16, 2023
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) Tacrolimus Ointment, 0.03%, the generic version of Protopic Ointment, 0.03%, of Leo Pharma AS. Glenmark’s Tacrolimus Ointment, 0.03%, will be distributed in the US by Glenmark Pharmaceuticals, US. According to IQVIA sales data for the 12-month period ending June 2023, the Protopic Ointment, 0.03% market achieved annual sales of approximately $15.4 million*.
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