Sat.Jun 03, 2023 - Fri.Jun 09, 2023

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Opinion: When should hospitals require masks?

STAT

Is the pandemic over ? On the one hand, Covid-19 is clearly still with us. In the U.S., over the past month there was a weekly average of 557 deaths , though the numbers are dropping sharply, from 849 four weeks ago to 208 last week. On the other, for those who are not vulnerable or immune compromised, most facets of life have returned to normal, thanks to high levels of immunity from vaccines, boosters, and past infections.

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How the public health lessons of Covid can help Americans protect themselves from wildfire smoke

STAT

An unusually early and ferocious outbreak of forest fires across Canada has sent unprecedented amounts of smoke pollution to regions of the eastern United States unaccustomed to such hazards. Three years after the onset of the Covid-19 pandemic, the ensuing air pollution has once again put respiratory health at the forefront of many North Americans’ minds.

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JB Pharma: Betting big on India

Express Pharma

Pegged as one of India’s fastest growing pharma companies, JB Pharma’s recently released fourth quarter and year ended March 31, 2023 results continue to beat market growth rates. As per IQVIA MAT March 2023 data, JB Pharma continued to be the fastest growing company amongst the Top 25 in FY23, outperforming the Indian Pharma Market (IPM), growing at 22 per cent versus 8 per cent, aided by the organic business growing at 21 per cent.

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Amgen’s Lumakras data and research shows positive results across CodeBreaK clinical trial program

Outsourcing Pharma

Research has reinforced the efficacy of Lumakras (sotorasib), a small molecule inhibitor in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).

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Position Your Pharmacy for Expansion

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.

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Using twin viruses, startup AAVantgarde aims to extend gene therapy’s reach

BioPharma Dive

The biotech has raised about $65 million to test two ways to deliver larger genes into the body, each of which could help gene therapy treat more diseases.

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Closing ASCO: AstraZeneca’s ‘very special’ meeting, more CAR-T survival data and Pfizer’s PARP play

BioPharma Dive

Dramatically positive trial data for AstraZeneca’s Tagrisso capped an important conference for the British drugmaker, while Gilead built a stronger case for its cell therapy Yescarta.

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Academia’s postdoc system is teetering, imperiling efforts to diversify life sciences

STAT

For young life scientists hoping to land a prestigious faculty job in academia, postdoctoral research is practically a requirement. But it’s not a path equally open to everyone. Freshly minted life science Ph.D. graduates who have started families or have big loans, or are Black or female, say they plan to pursue postdoc positions at lower rates than their peers, according to a STAT analysis that includes previously unreported data from the National Center for Science and Engineering Stat

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FDA Approves First Intravenous Iron Replacement Therapy for Adults With Heart Failure, Iron Deficiency

Pharmacy Times

Treatment with Injectafer significantly improved exercise capacity compared to placebo in a randomized clinical trial in adult patients with heart failure.

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ACMT Toxicology Visual Pearl: The Black Eschar

ALiEM - Pharm Pearls

Which of the following is the most likely explanation for this skin lesion in a worker handling sheep hides? Bacillus anthracis Group A streptococcus Pseudomonas aeruginosa Staphylococcus aureus (Photo credit: CDC/ James H. Steele, Public domain via Wikimedia Commons) Reveal the Answer Answer: 1. Bacillus anthracis This patient has cutaneous anthrax.

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BIO’s CEO digs into the hot-button issues facing the industry

PharmaVoice

Rachel King took the reins at BIO during a rocky time. Now, after steadying the ship, she’s brought the trade association’s focus back to the industry’s most pressing priorities.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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STAT+: FDA panel unanimously endorses Eisai’s Alzheimer’s drug

STAT

Expert advisers to the Food and Drug Administration on Friday voted unanimously in favor of expanding the approval of Leqembi, an Alzheimer’s disease treatment from Eisai and Biogen, further clearing the way for what could be the first widely available medicine that delays the disease’s progress. The group voted 6-0 that an 1,800-patient study of Leqembi confirmed its benefits for patients in the early stages of Alzheimer’s, recommending the FDA widen the drug’s

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J&J sees trial data supporting earlier CAR-T use in multiple myeloma

BioPharma Dive

The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.

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Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Pharmaceutical Technology

Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.

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Yes, biopharma still has a reputation problem. These leaders are looking for solutions

PharmaVoice

Negative news is breaking down the public’s perception of the biopharma industry — but leaders around the industry have some ideas to fix it.

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STAT+: ‘We don’t agree’ on drug pricing policy, FDA chief tells biotech leaders

STAT

BOSTON — The drug industry has spent the past year speaking against new mechanisms that could limit how much governments or insurers pay for certain new medicines. Robert Califf, the Food and Drug Administration chief, walked on stage Wednesday and told a crowd of biotech leaders that drug costs needed fixing. “We don’t agree,” said Califf, referring to a conversation he had backstage with Ted Love , the new chair of the Biotechnology Innovation Organization.

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After years of disappointment, cancer vaccines show new promise

BioPharma Dive

Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.

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Cybersecurity in pharma: Securing the future

Pharmaceutical Technology

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

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Why cancer could be the ideal realm for psychedelic treatments

PharmaVoice

The CEO of Sunstone Therapies said the results of a recent trial testing psilocybin in cancer patients with depression were “remarkable.

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FDA’s letter to medical device maker iRhythm is a warning for the industry

STAT

Heart monitoring company iRhythm is in hot water with the Food and Drug Administration, which issued a stern warning letter to the device maker this week for marketing its product for “high risk” patients and changing its algorithm without seeking the FDA’s permission. The letter highlights FDA’s growing scrutiny of digital health and patient monitoring tools — as well as the grave impacts even small device glitches can have on patients.

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FDA sets decision dates for Vertex, CRISPR gene editing drug

BioPharma Dive

The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

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China grants EUA to Covid-19 vaccine against XBB descendent lineages

Pharmaceutical Technology

WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.

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Janssen reveals data from erdafitinib study

Pharma Times

Erdafitinib boosted survival in patients with certain conditions including metastatic urothelial carcinoma - News - PharmaTimes

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How a now-retracted study got published in the first place, leading to a $3.8 million NIH grant

STAT

The scientific paper inspired international headlines with its bold claim that the combination of brain scans and machine learning algorithms could identify people at risk for suicide with 91% accuracy. The promise of the work garnered lead author Marcel Adam Just of Carnegie Mellon University in Pittsburgh and co-author David Brent of the University of Pittsburgh a five-year, $3.8 million grant from the National Institute of Mental Health to conduct a larger follow-up study.

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FDA panel backs full approval for Eisai, Biogen Alzheimer’s drug

BioPharma Dive

In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

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How do we foster high functioning teams in the classroom?

Pulses

By: Melissa Mickley 2023 PharmD candidate If students hate it so much, why do we keep doing it? While hearing the phrase “get into your assigned groups” may cause anxiety and distress among many students, there are good reasons collaborative learning (CL) is beneficial. 1 Let’s dig into why students cringe when they hear “group work.” From an early age, schools often emphasize individual achievement and personal growth over teamwork and group achievement.

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17th Edition Project Portfolio and Resource Management Excellence for Pharma

Drug Patent Watch

17th Edition Project Portfolio and Resource Management Excellence for Pharma July 11-13, 2023 | Sheraton Philadelphia University City Hotel | Philadelphia, PA Mastering Resource and Project Prioritization, Operational Excellence, and People Development… The post 17th Edition Project Portfolio and Resource Management Excellence for Pharma appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: Drug companies and pharmacies reach $17.3 billion settlement over opioid crisis

STAT

Two large drugmakers and two of the biggest pharmacy chains finalized a $17.3 billion deal to settle accusations by state governments that they contributed to the opioid crisis that swept across the U.S. for more than a decade and contributed to thousands of overdose deaths. The agreement  —which involves Teva Pharmaceuticals; Allergan, a unit of AbbVie; CVS; and Walgreens — is the latest involving several major players blamed for the crisis.

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Deal of the week: Strive Health raises $166m to aid kidney health services

Pharmaceutical Technology

Each week, Pharmaceutical Technology’s editors select a deal that illustrates the themes driving change in our sector. The deal may not always be the largest in value, or the highest profile. But it will tell us where the leading companies are focusing their efforts, and why. This new, thematic deal coverage is driven by our underlying Disruptor data which tracks all major deals, patents, company filings, hiring patterns and social media buzz across our sectors.

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FDA sets advisory meeting date for Brainstorm’s ALS cell therapy

BioPharma Dive

Having taken the rare step of filing for approval over protest, Brainstorm will get another chance to make a case for its drug NurOwn during a Sept. 27 meeting of cell, tissue and gene therapy experts.

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DrugChatter Featured Questions

Drug Patent Watch

DrugChatter recently launched as an experimental AI chat-based business intelligence tool. Here’s some of the more interesting questions it’s been asked: Cost savings for bulk lipitor Who Invented Advil? What… The post DrugChatter Featured Questions appeared first on DrugPatentWatch - Make Better Decisions.

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Opinion: Your health insurance may not be as good your state requires — and it’s perfectly legal

STAT

In 2017, the Massachusetts state Legislature passed a law to ensure ease of access to birth control. It says there should be no copay for hormonal birth control prescriptions. It also allows women to fill a 12-month prescription at once. Infertility care has similar protections. The state mandates that plans cover “ medically necessary expenses of diagnosis and treatment of infertility ” if the insurance provides other pregnancy-related benefits.

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Element to increases lab equipment presence

Pharma Times

New division aims to provide laboratories with the equipment and support to uphold analytical data - News - PharmaTimes

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Medicare sets next tranche of drugs to face price hike penalties

BioPharma Dive

CMS named 43 Part B drugs for which prices rose more than inflation, and which will have lower coinsurance rates next quarter as a result.

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FDA grants orphan drug designation to DTx Pharma’s CMT1A therapeutic

Pharmaceutical Technology

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). DTx-1252 is a fatty acid ligand conjugated oligonucleotides (FALCON) small interfering RNA (siRNA) therapeutic which represses the PMP22 gene in Schwann cells. It induces remyelination of axons to normal levels, increases muscle coordination, agility, mass, grip and strength, and improves electrophysiological measurem

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STAT+: Immunogen drug prolongs survival of women with advanced ovarian cancer

STAT

CHICAGO — An antibody that delivers chemotherapy directly to tumor cells extended the lives of women with a form of advanced ovarian cancer in a large study, researchers reported Sunday. The drug, called Elahere, is made by the biotech company Immunogen. It was granted conditional approval in the U.S. last November based on preliminary evidence showing it shrank tumors.