STAT
JULY 2, 2024
As the H5N1 bird flu outbreak in dairy cows enters its fourth month, the Centers for Disease Control and Prevention is taking steps to ramp up the nation’s capacity to test for the virus in people. In a call with reporters Tuesday, Nirav Shah, the CDC’s principal deputy director, emphasized that the risk to the general public remains low at this time.
Drug Topics
JULY 2, 2024
Three posters presented at the American Diabetes Association 84th Scientific Sessions examined GLP-1 use and cardiovascular disease risk in several different patient populations.
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STAT
JULY 2, 2024
Why do Americans pay so much more for common medications than people in other countries? Why does an inhaler that costs $7 in France cost almost $500 in the United States? These are just a few of the questions the Senate Judiciary Committee looked to answer in a recent hearing. The common answer? Dominant corporations use a variety of patent-related strategies to protect their power, maximize their profits, and squash their competition.
Fierce Pharma
JULY 2, 2024
After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.
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
JULY 2, 2024
The unilateral decision by Peter Marks, a top official at the Food and Drug Administration, to approve the gene therapy Elevidys , a treatment for Duchenne muscular dystrophy, despite the misgivings of his staff, looks even more surprising on a close examination. Marks’ decision to overrule three different review teams appears unprecedented in recent FDA history.
Pharmacy Times
JULY 2, 2024
Donanemab-azbt is the first and only amyloid plaque targeting therapy that supports stopping therapy when the plaque is removed.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
Drug Topics
JULY 2, 2024
Donanemab-azbt was approved under the FDA's Fast Track Review, Priority Review, and Breakthrough Therapy designations.
STAT
JULY 2, 2024
Moderna has been awarded $176 million by the Biomedical Advanced Research and Development Authority to accelerate development of messenger RNA-based pandemic influenza vaccines, the company announced in a statement Tuesday. BARDA, a strategic preparedness arm of the Department of Health and Human Services, has said for weeks that it has been in talks with mRNA vaccine manufacturers with an aim to diversify the government’s pandemic flu vaccine response capacity.
Fierce Healthcare
JULY 2, 2024
It didn’t take long for hospitals to bring the Supreme Court’s dismantling of the Chevron deference into their crusade against the formula for disproportionate share hospital (DSH) payments. | The complaint questioning CMS' formula for enhanced rates was filed the same day the Supreme Court gutted federal agencies' ability to interpret ambiguous statute.
STAT
JULY 2, 2024
The Food and Drug Administration’s rare pediatric disease priority review voucher program , which has been providing incentives for lifesaving innovations since 2012, is doomed to disappear unless Congress reauthorizes it before the end of September. Some lawmakers have downplayed its impressive track record based on unfounded allegations. I have data showing it works.
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.
Pharmacy Times
JULY 2, 2024
By taking a research-based approach, clinical trials can become more diverse and better serve the needs of all individuals.
STAT
JULY 2, 2024
A looming anti-China biotechnology bill has spooked U.S. life sciences companies, according to a new report. The report by the China-based L.E.K. Consulting quantifies what until now has been mostly a vibe check. At this year’s Biotechnology Innovation Organization’s international conference, multiple biotech companies told STAT they plan to switch from striking deals with Chinese companies to U.S.
Pharmacy Times
JULY 2, 2024
Artificial intelligence (AI) may optimize cash pricing strategies in community pharmacies.
Fierce Healthcare
JULY 2, 2024
The House Ways and Means Committee advanced bipartisan legislation on Thursday that would grant Medicare coverage to novel medical technologies for four years while the Centers for Medicare & M | The House Ways and Means Committee advanced updated legislation to expedite Medicare coverage of breakthrough medical devices. The new version of the bill reduces its cost by 75%, according to co-sponsor Rep.
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Pharmacy Times
JULY 2, 2024
The committee, after being presented evidence by the working group, recommended the vaccine for adults aged 65 and older and those 19 or older who have current recommendations to receive a pneumococcal vaccine.
Fierce Healthcare
JULY 2, 2024
The Biden administration has awarded $206.3 million of funding to clinician training programs to bolster the nation’s geriatrics care workforce. | Forty-two programs training physicians, nurses and other clinicians will integrate geriatric care training into their primary care programs.
The Checkup by Singlecare
JULY 2, 2024
If you’ve been diagnosed with hypertension (high blood pressure), your healthcare provider may prescribe Zestril ( lisinopril )—a widely-used ACE inhibitor—to help manage your condition. On top of lowering blood pressure, it can treat heart failure and help improve survival after a heart attack. For high blood pressure, this medication is taken daily, on a long-term basis.
pharmaphorum
JULY 2, 2024
Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it down for a second time.The CHMP said at its late June meeting that it was issuing a negative opinion for Syfovre (pegcetacoplan) for the treatment of GA secondary to age-related macular degeneration (AMD), a progressive disease leading to sight loss.
STAT
JULY 2, 2024
The U.S. has slid backward on control of high blood pressure, despite ready access to medicines and other tools to moderate its risks. Dan Jones, former president of the American Heart Association, thinks the nation can learn from China. Researchers there recently detailed the success of community health workers — well trained people but not M.D.s — helping thousands of people living with high blood pressure in rural regions.
Pharmacy Times
JULY 2, 2024
Chimeric antigen receptor (CAR) T-cell therapy can engineer T cells to target malignant cells in multiple myeloma.
STAT
JULY 2, 2024
WASHINGTON — The Supreme Court took up an e-cigarette case Tuesday, weighing Food and Drug Administration decisions blocking the marketing of sweet flavored products amid a surge in vaping by young people. The FDA is appealing a lower court ruling siding with vape companies who argue the FDA unfairly denied more than a million applications to market fruit or candy flavored versions of nicotine-laced liquid that’s heated by the e-cigarette to create an inhalable aerosol.
Pharmacy Times
JULY 2, 2024
Pennsylvania, California, and New York were within the top 3 states, according to the findings.
STAT
JULY 2, 2024
Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the third quarter: Late last month, Alnylam Pharmaceuticals reported positive, top-line results from its HELIOS-B clinical trial testing vutrisiran in an increasingly common heart disease called ATTR-CM. Detailed study results are being presented at the annual meeting of the European Society of Cardiology in late August.
Drug Topics
JULY 2, 2024
A pilot study presented at the American Diabetes Association 84th Scientific Sessions showed that CGM technology could produce reliable results without complications in children with leukemia/lymphoma at risk for hyperglycemia.
Fierce Pharma
JULY 2, 2024
With four contract modifications totaling more than $250 million, the government is leveling up its agreements with long-time medical countermeasures supplier Emergent BioSolutions. | The drugmaker will supply its anthrax vaccine Cyfendus, its smallpox vaccine and two other drugs to help bolster the U.S. government's medical countermeasures stockpile.
Pharmaceutical Technology
JULY 2, 2024
The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.
STAT
JULY 2, 2024
Peter Slavin, who ran Massachusetts General Hospital in Boston for nearly two decades before stepping down in 2021 , has taken a new job heading up Cedars-Sinai Medical Center in Los Angeles. Slavin, 66, starts Oct. 1 as president and chief executive of Cedars-Sinai, an institution dubbed the “hospital for Hollywood stars.” He’ll also lead parent Cedars-Sinai Health System, which includes several other owned and affiliated hospitals and a network of outpatient clinics.
Fierce Pharma
JULY 2, 2024
Even as the BIOSECURE Act charts an uncertain path through the legislative process, the draft bill has already seriously harmed the U.S. | Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found.
STAT
JULY 2, 2024
Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of maple bourbon for the occasion. Spring has sprung, after all.
pharmaphorum
JULY 2, 2024
Explore the latest hires in pharma and biotech, including executive moves at Seaport Therapeutics, Anthos Therapeutics, Pfizer, and Novartis, from April 2024. Stay updated with the industry's top talent movements.
Outsourcing Pharma
JULY 2, 2024
The Spanish company Esteve Pharmaceuticals is building a manufacturing unit in its Girona plant with the aim to expand its production of active pharmaceutical ingredients (APIs).
pharmaphorum
JULY 2, 2024
The FTC is reported to have opened an investigation into Teva focusing on improperly listed patents in the FDA’s Orange Book
Fierce Pharma
JULY 2, 2024
In recent months, frequent pharma critic Sen. | As the November U.S. elections near, it's clear that drug pricing will remain an important topic for voters and politicians. In a Tuesday op-ed, President Joe Biden and Sen. Bernie Sanders placed a spotlight on Novo Nordisk and Eli Lilly's drug pricing.
pharmaphorum
JULY 2, 2024
Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.
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