STAT

MAY 18, 2023

This legislative session, Gov. Bill Lee made history by signing a bill that makes Tennessee the first state in the country to remove redundant medical-residency requirements for top international doctors. By opening a new pathway for doctors trained outside the United States, HB1312 and SB1451 , introduced by state Rep. Sabi Kumar and state Sen. Kerry Roberts, will help Tennessee address its growing physician shortage.

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PharmaVoice

MAY 18, 2023

Pending Senate confirmation, NCI head Monica Bertagnolli will take the helm of the collection of research organizations as it faces increasing bipartisan scrutiny.

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STAT

MAY 18, 2023

Terry Horgan, the 27-year-old patient who died eight days after receiving a CRISPR therapy custom-built for him, likely suffered a fatal innate immune response to the virus used to deliver the treatment, investigators concluded.  The findings, posted late Thursday to the preprint server Medrxiv , confirmed that CRISPR, the Nobel-Prize winning genome editing tool now being used to develop treatments for a wide range of diseases, played no role in Terry’s death.

Immunity 246

Immunity Immunization 246

PharmaVoice

MAY 18, 2023

Global product teams are common in pharma but have yet to gain traction in biotech. Here's why this model can work.

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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 18, 2023

The largest organ in the body is a wonder. Skin is soft, flexible, and sensitive to every imaginable stimuli, and seamlessly plugs into the nervous system. This makes it extremely difficult to replicate — but that hasn’t stopped a team of Stanford researchers from trying. “We hope in the future, prosthetic devices can not only give the functionality but also the appearance of our natural body,” said Weichen Wang, an engineering Ph.D. and first author on a paper on ele

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BioPharma Dive

MAY 18, 2023

At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth prospects.

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Pulses

MAY 18, 2023

By: Tayana Cuffee, Pharm D Candidate and Krista Donohoe,Pharm.D., BCPS, BCGP Some pharmacy students have responsibilities caring for others, what can pharmacy schools learn from their experiences? Pharmacy school is a very rigorous program that requires a lot of time and effort both in and outside of the classroom. Pharmacy students regularly experience stressors such as high work demands, numerous assessments, Advanced Practice Pharmacy Experiences (APPEs), and finding the right career path. 1

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STAT

MAY 18, 2023

A recent study by the Association of American Medical Colleges projects  a shortage of between 17,800 and 48,000 primary care physicians by 2034. A December 2021  survey  found that one in three physicians and advanced practice registered nurses intends to reduce their work hours, and one in five physicians plans to retire. By sheer number, the shortage is projected to be the  worst  in California, Texas, and Florida.

Medical Schools 240

Medical Schools 240

Pharma Times

MAY 18, 2023

The therapy is a brain-penetrant used in various combinations in patients with progressive glioblastoma

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STAT

MAY 18, 2023

A committee of vaccine experts voted to recommend the Food and Drug Administration approve Pfizer’s maternal RSV vaccine on Thursday, though the panel expressed some safety concerns. The Vaccines and Related Biological Products Advisory Committee voted 14-0 that Pfizer’s data showed the vaccine was effective in preventing severe disease in infants born to people who were vaccinated during pregnancy.

Vaccines 239

Vaccines Immunity Immunization 239

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Pharmacy Management

Pharmaceutical Technology

MAY 18, 2023

The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. Within the 14-page document , published by an EMA special task force, are 10 recommendations of best practices that “marketing authorisation holders, wholesalers, distributors, and manufacturers can consider adopting to ensure continuity of medicinal product supply and reduce the impact of shortages”.

Online Pharmacies 99

Online Pharmacies Communication Documentation 99

STAT

MAY 18, 2023

Federal health officials warned Thursday that there was a significant risk the mpox virus will resurge this summer and reiterated calls for people at high risk to get vaccinated if they have not already done so. The warnings came after a cluster of 21 mpox cases were identified in Chicago this month, one of the first major clusters since the outbreak in the U.S. died down last fall, and as three different estimates of the mpox vaccine’s effectiveness were published Thursday afternoon.

Vaccines 238

Vaccines 238

Orsini Pharmacy

MAY 18, 2023

Whether it's open, limited, or exclusive, the main goal of all healthcare distribution network systems should be to provide patients access to the needed medications in the most efficient and affordable way possible. One of the initial steps in the RFP process is payor credentialing to see which specialty pharmacy can meet this goal. Many pharmacy benefit managers (PBMs) have some type of comprehensive credentialing process in place because rare diseases are complex with many drug nuances to man

Specialty Pharmacies 95

Specialty Pharmacies 95

STAT

MAY 18, 2023

As the deans of the two public medical schools in Nevada, we are watching with pride as our recent graduates prepare to start their internships. But that pride is tempered by concern about a looming threat to the delivery of medical care in our state.

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Medical Schools Hospitals 233

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA. Shortages can lead to medicine rationing, delay in critical treatments and can mean patients may need to use less-effective alternatives and face an increased risk of me

Documentation 91

Documentation Communication 91

STAT

MAY 18, 2023

There is, according to Wall Street, no worse investment in biotech than Galapagos NV. The Belgian company trades at an enterprise value approaching negative $2 billion. That means its liquid assets, mostly cash, are worth more than the company itself. It means, according to the market, that every dollar Galapagos puts toward inventing new drugs would be better spent doing pretty much anything else.

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Pharma Times

MAY 18, 2023

The approved drug has been developed to treat patients with moderate to severe Crohn’s disease

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STAT

MAY 18, 2023

In a case that had the pharmaceutical industry on edge, the U.S. Supreme Court upheld a lower court ruling that Amgen failed to disclose sufficient information about patent claims for a best-selling drug. The court ruled unanimously that Amgen failed to provide what amounts to a roadmap for others to recreate the claims made in two patents for Repatha, a cholesterol medication.

Drug Pricing 198

Drug Pricing Biosimilars 198

European Pharmaceutical Review

MAY 18, 2023

Hepcludex ® (bulevirtide) is the first medicine to be conditionally licensed for chronic hepatitis delta virus (HDV) infection in Great Britain” The National Institute for Health and Care Excellence (NICE) has recommended NHS use of Hepcludex ® (bulevirtide). It is the first medicine to be conditionally licensed for chronic hepatitis delta virus (HDV) infection in Great Britain.

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STAT

MAY 18, 2023

Does the FTC have it out for pharma? What does it take to make an RSV vaccine? And how do you say “setting cash on fire” in Dutch? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Jared Holz, biotech strategist at Mizuho Securities, joins us to explain why federal regulators are suing to block Amgen’s $28 billion merger with Horizon Therapeutics and what it means for the drug industry.

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Vaccines 175

assurecare

MAY 18, 2023

The current community pharmacy dispensing model has become increasingly difficult to sustain in recent years. As reimbursement for prescription medications continue, pharmacies have been forced to explore alternate sources of revenue beyond traditional prescription reimbursement. Medication Therapy Management (MTM) , cash-based prescriptions and clinical services, medical billing for vaccines, point of care tests, and many other acute and chronic conditions are some of the common routes being ex

Medication Therapy Management (MTM) 84

Medication Therapy Management (MTM) Community Pharmacies Vaccines 84

STAT

MAY 18, 2023

Top of the morning to you, and a fine one it is. Once again, crystal clear blue skies and soothingly cool breezes are enveloping the Pharmalot campus, where the official mascot and his stay-over playmate are bounding about the grounds. As for us, we are engaged in the usual rituals at this hour of the day. We are brewing a few cups of stimulation — our choice is chocolate raspberry — and foraging for items of interest to pass along.

Drug Pricing 162

Drug Pricing Documentation 162

European Pharmaceutical Review

MAY 18, 2023

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AbbVie’s upadacitinib (Rinvoq ® ) as an option for treating moderately to severely active Crohn’s disease in adults. The therapy is the first janus kinase (JAK) inhibitor that will be available for treatment of Crohn’s disease in England and Wales, AbbVie said.

Immunity 83

Immunity Immunization Hospitals 83

Outsourcing Pharma

MAY 18, 2023

A small molecule drug has been recommended by Englandâs National Institute for Health Care and Excellence (NICE) for the treatment of adults with moderate to severe chronic kidney disease (CKD)-associated pruritus in adult patients on haemodialysis.

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Big Molecule Watch

MAY 18, 2023

The USPTO has proposed several fee changes for implementation in 2025. If implemented, these changes will increase filing fees for Inter Partes Reviews (IPRs) and Post Grant Reviews (PGRs) by 25% “to improve cost recovery.” Additionally, the PTO is proposing to allow IPR and PGR petitions to exceed the current word limits (14,000 and 18,700, respectively) via a new fee structure.

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Biosimilars 78

World Pharma News

MAY 18, 2023

Pfizer and Thermo Fisher Scientific Inc. (NYSE: TMO) announced they have entered into a collaboration agreement to help increase local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East and Asia where advanced genomic testing has previously been limited or unavailable.

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Drug Channels

MAY 18, 2023

Today’s guest post comes from Patrick Leary, Chief Commercial Officer at Phil, Inc. Patrick describes how barriers to medication access affect manufacturers and patients. He offers four tactics that can help field teams unlock coverage for patients. To learn more about Phil’s access and commercialization solutions, download their free whitepaper, Modernize the Patient Access Experience: Transform Your Pharmaceutical Brand.

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The Pharmacist

MAY 18, 2023

Over 29,000 primary care staff have been recruited into general practices under the Additional Roles Reimbursement Scheme (ARRS) since 2019, meeting the government’s recruitment target one year ahead of schedule. In its election manifesto, the Conservative government committed to recruit 26,000 additional primary care professionals – such as practice-based pharmacists, general practice nurses and mental […] The post ARRS recruitment progressing quicker than planned appeared first on The Ph

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BioPharma Dive

MAY 18, 2023

The court's rejection of Amgen's arguments is a win for Regeneron in a long-running case over the companies' competing cholesterol drugs, and could have broad implications for the industry.

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The Pharmacist

MAY 18, 2023

Multi-year funding – rather than the pressure to deliver a balanced budget year-on-year – could provide a solution to primary care’s funding crisis, pharmacist and president of the National Association of Primary Care (NAPC) Ash Soni has told The Pharmacist. He said that spending more on primary care would deliver savings for the health system […] The post Spending on primary care now will ‘reap benefits’ down the line appeared first on The Pharmacist.

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PharmaTech

MAY 18, 2023

The UK and Switzerland are negotiating a modern free trade agreement.

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Pharmaceutical Technology

MAY 18, 2023

HLB subsidiary Elevar Therapeutics has submitted a new drug application to the US Food and Drug Administration for its rivoceranib drug candidate plus camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC), which is the most common type of liver cancer. The application is supported by positive results from the Phase III CARES 310 randomised, open-label, international trial.

Labelling 59

Labelling 59

PharmaShots

MAY 18, 2023

Shots: The business combination will deliver gross proceeds to enGene of ~$135M incl. Forbion Growth’s existing investment in FEAC Class A shares of $20M plus investment commitments of $115M, anchored by Forbion Growth with the participation of new institutional investors & existing enGene investors. The transaction is expected to be close in H2’23 Net proceeds will be used to finance enGene’s operations through multiple potential value inflection milestones towards a BLA s

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pharmaphorum

MAY 18, 2023

Servier doubles up on ‘digital twin’ alliance with Aitia Phil.

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Pharmaceutical Technology

MAY 18, 2023

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AstraZeneca ’s dapagliflozin (Forxiga) to treat chronic heart failure. Dapagliflozin is recommended to treat symptomatic chronic heart failure in adult patients with preserved or mildly reduced ejection fraction, which occurs when the heart’s left side doesn’t properly fill with blood during the diastolic (filling) phase.

Hospitals 52

Hospitals 52