STAT

MAY 6, 2024

WASHINGTON – Two New York University professors collaborated directly with executives of the vaping company Juul without disclosing those relationships to academic journals or Congress, a STAT investigation reveals. At the height of the youth vaping crisis, when many public health experts were calling for sweeping action that could upend the entire industry, David Abrams and Ray Niaura emerged as two authoritative voices willing to defend vaping — despite its growing popularity amo

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Documentation 359

PharmaVoice

MAY 6, 2024

With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies.

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STAT

MAY 6, 2024

For more than 30 years, Alzheimer’s researchers have thought of APOE4 as a major genetic risk factor for most cases of the devastating neurologic disease. But a new study published on Monday argues that this gene variant plays an even more important role than scientists had realized and causes a distinct form of Alzheimer’s. Researchers analyzed data from more than 13,000 people, including nearly 800 APOE4 homozygotes, people who carry two copies of the gene variant.

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ALiEM - Pharm Pearls

MAY 6, 2024

It has been 3 years since the 8-week, self-guided Bridge to Emergency Medicine (EM) curriculum was launched to help graduating medical students prepare for EM residency. The curriculum has been viewed over 43,000 times and we have awarded over 5,000 ALiEMU course certificates. It is now a part of many residency programs’ intern boot camp. Launching the 2nd edition of Bridge to EM (2024) We are thrilled to announce that we launching the second edition of the curriculum.

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Communication 189

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

MAY 6, 2024

A new study looking at the distribution of receptors that flu viruses can attach to in different cow tissues may help to explain the pattern of illness being seen in the outbreak of H5N1 bird flu in U.S. dairy cattle — and also is sparking debate about the implications of the cow outbreak for human disease. The study, a preprint that hasn’t yet been through peer review by a scientific journal, found that tissue from the mammary gland contains abundant receptors of the kind to which

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PharmaVoice

MAY 6, 2024

Tests frequently used in clinical trials will soon be regulated like medical devices — with some exceptions.

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Pharmaceutical Commerce

MAY 6, 2024

Radio frequency identification (RFID) not only helps hospitals boost their medication safety standards, as it also allows clinicians to continue to provide quality patient care.

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Hospitals 111

STAT

MAY 6, 2024

What happens when you catapult cancer into space? Or shoot stem cells toward the stars? Catriona Jamieson, a hematologist and director of the Sanford Stem Cell Institute at the University of California, San Diego, has done both. Through collaborations with organizations like NASA, her lab has sent tumors and stem cells aboard private spaceflights like SpaceX CRS-24 and the recent Axiom-3 mission to be studied in the International Space Station.

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Express Pharma

MAY 6, 2024

API Holdings secured the biggest deal ($216 million), followed by La Renon ( $70 million) and Biodeal Pharmaceuticals ($13.2 million). Funding was raised by 291 per cent for the sector in April 2024, 1045 per cent higher than the same month last year ($29 million) , accounting for $332 million, over 15 rounds in total. As per the data presented by Tracxn.com, API Holdings secured the biggest deal by raising $216 million in healthcare, healthtech and life sciences.

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STAT

MAY 6, 2024

Children and adolescents diagnosed with high blood pressure have double the risk of major cardiovascular problems as adults, a new study that followed them into their 20s and 30s reports.  It’s another example of a serious disease striking people at younger ages than in previous generations and should serve as a call to action for routine blood pressure screening in primary care, Rahul Chanchlani, the senior author of the new study, told STAT.

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Pharmacy Management

FDA Law Blog: Biosimilars

MAY 6, 2024

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C).

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Documentation 105

STAT

MAY 6, 2024

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine. Sign up to get it in your inbox every Monday. About that 90,000 number UnitedHealth Group CEO Andrew Witty faced Congress last week, where lawmakers pressed him on the Change Healthcare cyberattack (my colleague Brittany Trang  watched the hearings closely  and tried to break down  what it all means ).

Hospitals 236

Hospitals 236

BioPharma Dive

MAY 6, 2024

A 12-year-old boy in the Washington, D.C., area is set become the first patient treated with Lyfgenia since its U.S. approval last December.

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STAT

MAY 6, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning! Today, we learn more about studying tumors at the International Space Station, study the buzzy Amgen weight loss drug MariTide, and find a lawsuit in which a former Spark Therapeutics executive is accusing ex-colleagues of sexism.

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Drug Pricing Drug Development 203

pharmaphorum

MAY 6, 2024

The Novo Nordisk Foundation, the Bill & Melinda Gates Foundation, and Wellcome have joined forces to tackle some of the most pressing threats to human health and wellbeing. The new initiative gets underway with $300 million in funding over three years earmarked for handling infectious diseases and antimicrobial resistance (AMR), addressing climate change, and raising our understanding of how nutrition can impact immunity, disease, and the development of children.

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Immunity Immunization 100

STAT

MAY 6, 2024

Steward Health Care, which once trumpeted its community hospital system as a low-cost alternative to Boston’s medical goliaths before expanding nationally and falling into a deep financial crisis, filed for bankruptcy protection early Monday morning. Under Chapter 11 of the US bankruptcy code, Steward will become a “debtor in possession,” continuing to operate its 32 hospitals in eight states while it seeks to restructure its debt under court supervision.

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Hospitals 200

Express Pharma

MAY 6, 2024

The event brought together over 330 professionals from across the industry’s value chain Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. According to its statement, PHARMAP 2024 brought together over 330 professionals from across the industry’s value chain. Among the attendees, contract manufacturing organisations, service providers and experts were present.

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Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 99

STAT

MAY 6, 2024

In the spring of 2020, as Covid-19 took hold around the world, Centers of Disease Control and Prevention director Mandy Cohen was the head of North Carolina’s Department of Health and Human Services. Among the challenges she and her team had to face was the antiquated state of data pervasive in public health and medicine. “One of our first things that we had to do was stop receiving lab data by fax machine ,” Cohen shared at the Milken Institute 2024 Global Conference , wher

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European Pharmaceutical Review

MAY 6, 2024

New results from a Phase I/II clinical trial of a CRISPR/Cas9 gene editing therapy show that around 79 percent of patients with a rare form of inherited blindness experienced “measurable improvement”. The BRILLIANCE trial included 14 participants (12 adults and two children) who received an injection of EDIT-101 in one eye. These individuals had a form of Leber Congenital Amaurosis (LCA) caused by mutations in the centrosomal protein 290 (CEP290) gene.

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Hospitals 94

Express Pharma

MAY 6, 2024

The new nano carrier could help people with diabetes avoid side-effects linked to insulin injections such as hypoglycemia, inform the researchers Research led by the University of Sydney and Sydney Local Health District has developed a system using nanotechnology that could allow people with diabetes to take oral insulin in the future. Offering 75 million people worldwide, who use insulin for diabetes, a more effective and needle-free alternative.

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Diabetes 94

pharmaphorum

MAY 6, 2024

Boehringer drug shows promise in diabetic macular ischaemia (DMI), a common and irreversible complication of the eye in people with diabetes with no approved therapies

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Diabetes 93

Express Pharma

MAY 6, 2024

China, India, and South Korea among the top three countries The Asia-Pacific (APAC) region is leading in clinical trials in Asthma, with China, India, and South Korea among the top countries in this space, according to GlobalData. According to GlobalData’s Clinical Trials Database, during 2019-23, 51.8 per cent of asthma trials were initiated in the APAC region.

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European Pharmaceutical Review

MAY 6, 2024

Following a review on the suitability of different technologies, researchers have determined that “[nucleic acid amplification techniques] NATs combined with an efficient extraction method” is the fitting alternative for compendial mycobacterial testing in biological products. The current challenge in mycobacterial testing information on using mycobacterial testing for the quality control of biologicals is limited, the paper noted.

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pharmaphorum

MAY 6, 2024

Pfizer has named Citi analyst Andrew Baum as its chief strategy and innovation officer, taking point on portfolio management and capital deployment

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BioPharma Dive

MAY 6, 2024

With many chemotherapy and ADHD drugs stuck in stubbornly short supply, several agencies are looking for new solutions.

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Chemotherapy 102

pharmaphorum

MAY 6, 2024

Shah Capital has stepped up its campaign for change at vaccine producer Novavax, lobbying against the re-election of three directors and executive pay packages in a letter to fellow stockholders. The hedge fund says it wants to send a “strong and clear message” to the board at Novavax, reiterating the claim – first made a few weeks ago – that the company is “being hindered by an overly conservative board and management that clings to failed strategies.

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Packaging Vaccines 89

Pharmaceutical Technology

MAY 6, 2024

The UK MHRA approved two formulations of ViiV Healthcare’s cabotegravir, offering a new prevention option for HIV-1 infection.

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World Pharma News

MAY 6, 2024

About 79% of clinical trial participants experienced measurable improvement after receiving experimental, CRISPR-based gene editing that is designed to fix a rare form of blindness, according to a paper published today in the New England Journal of Medicine. "This trial shows CRISPR gene editing has exciting potential to treat inherited retinal degeneration," said Mark Pennesi, M.D., Ph.D., a corresponding author on the paper, an ophthalmologist and Oregon Health & Science University's lead

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Express Pharma

MAY 6, 2024

A significant level of increase is seen in Chinese companies within the Antibody-drug conjugates market. According to GlobalData, a significant level of increase is seen in Chinese companies within the Antibody-drug conjugates market. Half of the top 10 developers seek to capitalise on potential returns. ADCs combine the specificity of monoclonal antibodies with the potency of cytotoxic drugs, via a linker, to selectively target and eliminate cancerous cells.

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Chemotherapy 64

BioPharma Dive

MAY 6, 2024

One analyst thinks the collaboration “bodes well” for Gossamer, which has had trouble convincing investors its drug seralutinib can compete on the market.

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Drug Patent Watch

MAY 6, 2024

Annual Drug Patent Expirations for SYMDEKO+%28COPACKAGED%29 Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier.

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BioPharma Dive

MAY 6, 2024

The British drugmaker, which has made genetic medicine a larger priority of late, added $140 million to a deal to develop up to 10 gene and cell therapies.

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Pharmaceutical Commerce

MAY 6, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Martin Hawes, Global Head of Product Development, Tower Cold Chain offers insights on the future of cell & gene therapies when it comes to cold chain storage.

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Pharmaceutical Business Review

MAY 6, 2024

The BLA seeks approval for the use of subcutaneous nivolumab as a monotherapy, as maintenance therapy after treatment with Opdivo plus Yervoy (ipilimumab) combination regimen, or along with chemotherapy or cabozantinib in adult patients. A regulatory decision on the approval under the Prescription Drug User Fee Act (PDUFA) is expected on 28 February next year.

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Chemotherapy Labelling 59

Pharmaceutical Commerce

MAY 6, 2024

The latest news for pharma industry insiders.

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