PhRMA
MARCH 22, 2023
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.
Drug Topics
MARCH 22, 2023
The drug, called Lumisight, is an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection. An NDA has been submitted to the FDA.
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STAT
MARCH 22, 2023
The ongoing Marburg fever outbreak in Equatorial Guinea is significantly larger than has previously been acknowledged, according to new information released Wednesday by the World Health Organization, which warned there may be undetected chains of transmission of the deadly virus in the West African country. The update, the first in nearly a month, shows that the number of confirmed and probable cases has grown from nine to 29, with cases having been reported in three different provinces over a
Drug Topics
MARCH 22, 2023
According to a study, patients are frequently prescribed broad-spectrum antibiotics instead of narrowly tailored antibiotics, which would be more optimized to treat them.
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.
European Pharmaceutical Review
MARCH 22, 2023
In a recent video , pharmaceutical microbiology expert Tim Sandle highlighted areas of concern and attention relating to mycological contamination control in manufacturing. Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms , cold rooms and other controlled areas.
Drug Topics
MARCH 22, 2023
Dupilumab met both its primary and key secondary endpoints in a phase 3 trial, demonstrating efficacy as a potential treatment for atopic hand and foot dermatitis.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
Drug Store News
MARCH 22, 2023
The company's accelerator program, Walmart Start, will choose at least five unique brands to receive access to key resources specific to launch successfully at Walmart.
Fierce Pharma
MARCH 22, 2023
AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17
STAT
MARCH 22, 2023
Five years ago, I donated my “spare” kidney at the Mayo Clinic to a woman I read about in the newspaper. Though living with only one kidney has risks, I was not particularly concerned about my own health. The clinic’s medical evaluation was extremely thorough, and I knew their highly conscientious selection committee would not approve me to be a living donor if they were even the slightest bit concerned the procedure would cause me long-term health problems.
ISPE
MARCH 22, 2023
Message From The Chair: Why Attend The 2023 ISPE Biotechnology Conference Trudy Patterson Wed, 03/22/2023 - 12:08 iSpeak Blog iSpeak Message From The Chair: Why Attend The 2023 ISPE Biotechnology Conference Liz M. Dooley, MSc. 22 March 2023 The Biopharmaceutical industry continues to grow and deliver life-changing medicines to patients as evidenced by the number of drug approvals by the FDA year after year.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
STAT
MARCH 22, 2023
An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients. By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen.
PharmaVoice
MARCH 22, 2023
As experts wrestle with COVID-19’s lab leak versus animal market debate, here’s what experts say are the suspected origins for some of the worst viral outbreaks in the last century.
STAT
MARCH 22, 2023
WASHINGTON — Moderna CEO Stéphane Bancel and Senate health committee Chair Bernie Sanders shook hands amicably before Wednesday’s hearing examining the company’s vaccine pricing strategy began. That’s about where the goodwill ended between the two.
Fierce Healthcare
MARCH 22, 2023
Patients want their medical test results immediately, even when its bad news, survey finds hlandi Wed, 03/22/2023 - 12:13
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STAT
MARCH 22, 2023
CHICAGO — Abdullah Hassan Pratt is giving a tour of a sheep heart that sits, heavy and sodden, in his hand. Dressed all in black, with his Jordans and easy manner, Pratt doesn’t look all that different from his audience: dozens of teenagers from this city’s roughest and poorest neighborhoods. One student raises a tentative hand, utterly confused by how blood travels through the heart.
Fierce Pharma
MARCH 22, 2023
Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD kdunleavy Thu, 03/23/2023 - 01:37
STAT
MARCH 22, 2023
Biotech company 89bio said Wednesday that its experimental treatment improved liver scarring at more than three times the rate of placebo without worsening other symptoms of patients with the fatty liver disease known as NASH. The results met the main goal of a mid-stage clinical trial, with the potential for less frequent injections than a similar experimental treatment being developed by a competing drugmaker.
Drug Topics
MARCH 22, 2023
Evkeeza, which treats a rare form of high cholesterol, is now approved for patients as young of 5 years.
STAT
MARCH 22, 2023
WASHINGTON — The Biden administration said Wednesday it will attempt to break up the network that runs the nation’s organ transplant system as part of a broader modernization effort. More people than ever are getting new organs, with a record 42,888 transplants last year — but that’s not nearly enough to meet the demand. More than 100,000 patients are on the national transplant list, thousands die waiting, and critics have long urged an overhaul to save more liv
European Pharmaceutical Review
MARCH 22, 2023
The 20 th anniversary edition of the CPHI Pharma Awards is open for entries. Three new categories have been created to reflect the surge of innovation sweeping the industry, from new methodologies to sustainability and philanthropic initiatives. The CPHI Pharma Awards 2023 will celebrate global leaders from across 12 categories, including returning categories spanning development and manufacturing of devices and drugs, alongside packaging , supply chain, sustainability, regulatory compliance, an
STAT
MARCH 22, 2023
Health policy circles have erupted in debate over a wonky administrative tool: the quality-adjusted life year ( QALY ) and similar metrics to value and price drugs and other health interventions. Rep. Cathy McMorris Rodgers (R-Wash.) has warned of the potential for these approaches to discriminate, arguing that “All lives are worth living. It’s unconscionable that a health care bureaucracy would so callously determine that someone’s life is worth less,” suggesting tha
Drug Topics
MARCH 22, 2023
How can current Alzheimer disease treatments be used to best treat patients living with the disease?
STAT
MARCH 22, 2023
A potential class-action lawsuit against troubled digital prescribing startup Cerebral raises crucial questions about whether online marketing methods violate legal and ethical standards — an issue with important implications for dozens of other telehealth companies doing largely the same thing , experts tell STAT. For years, Cerebral and other telehealth companies have used free tracking technologies known as “pixels” — provided by big technology companies like
Fierce Healthcare
MARCH 22, 2023
Senate panel advances bill to reform PBMs and bring more FTC scrutiny on industry rking Wed, 03/22/2023 - 14:47
STAT
MARCH 22, 2023
DALLAS — It took just three years, after the tool’s invention, for researchers to devise ways of using CRISPR-Cas9 gene editing to treat mice with Duchenne muscular dystrophy. Since those first 2015 papers, dozens more have been published and multiple startups have launched, spurred by the hope that CRISPR could outperform the gene therapy approaches now nearing approval.
Fierce Pharma
MARCH 22, 2023
After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court kdunleavy Wed, 03/22/2023 - 14:39
STAT
MARCH 22, 2023
Social media use is linked with body image concerns and eating disorders among young people, according to a new review of the scientific literature. But rather than social media being a direct cause of these issues, a “self-perpetuating cycle of risk” could be to blame, with more vulnerable teens and young adults succumbing to online pressures, the authors say.
European Pharmaceutical Review
MARCH 22, 2023
Hovione, a contract development and manufacturing organisation (CDMO) and Laxxon Medical, a pharma-tech company will collaborate to advance 3D screen printing technologies for the pharmaceutical industry. Under the agreement, Hovione will establish Laxxon’s 3D screen printing technology at Hovione’s current good manufacturing practice (cGMP) production sites first in Portugal and later in the US.
STAT
MARCH 22, 2023
Stanford cardiologist Euan Ashley and his research team received a Guinness World Record last year for sequencing a full human genome in just over five hours. He says that’s just the beginning. Ashley is at the forefront of a push by researchers to make more genetic information available to patients facing major health care decisions. Faster sequencing for patients with rare and deadly diseases can help their doctors decide which treatments and surgical procedures to try and which ones to
Drug Store News
MARCH 22, 2023
The new product supports vision health and contains specially formulated vitamins and nutrients, including vitamin A and lutein, the company said.
STAT
MARCH 22, 2023
In a long-awaited decision, the U.S. National Institutes of Health rejected a petition urging the agency to use a controversial provision of federal law to widen access to a cancer drug by forcing the manufacturers to license their patents. The focus of the petition was the cost of the Xtandi prostate cancer drug, which has a list price of between $160,000 and $180,000.
Fierce Pharma
MARCH 22, 2023
US again spurns march-in campaign to slash cost of Pfizer, Astellas' Xtandi fkansteiner Wed, 03/22/2023 - 09:50
STAT
MARCH 22, 2023
SAN FRANCISCO — Mindstrong, a high-profile mental health tech startup, is selling off its assets to the therapy platform SonderMind. The acquisition comes less than two months after Mindstrong laid off most of its employees and permanently shuttered its Menlo Park offices. The deal caps a turbulent time for Mindstrong, which had drawn backing from heavyweight Silicon Valley investors like General Catalyst with its pitch to analyze people’s smartphone use for early signs of mental i
Fierce Healthcare
MARCH 22, 2023
Becerra takes bipartisan hits from senators over Medicare Advantage pay rule as lobbying efforts heat up rking Wed, 03/22/2023 - 16:17
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