Tue.May 09, 2023

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Breast cancer screening should begin at 40, not 50, federal health panel recommends

STAT

The United States Preventive Services Task Force on Tuesday created new draft guidelines recommending all women begin screening mammography at age 40, a decade earlier than previous guidelines, and continue screenings every other year until age 74. The change is bound to be controversial, adding fresh fuel to a long-standing debate around when people should begin breast cancer screening, how often they should do it, and if specific groups, such as Black women , ought to be screened differently.

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This ‘hot-blooded’ CEO is aiming to transform the way burn victims heal

PharmaVoice

Cutiss CEO Daniela Marino is funneling her bold personality and expertise in regenerative medicine into a startup developing bioengineered skin grafts.

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Trending Sources

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Opinion: Health care coaches are the next big thing. They’re also completely unregulated

STAT

John, a hypothetical middle-aged man, is told at his job about a new workplace wellness initiative that, among other things, offers two free sessions with a health coach. John immediately jumps at the chance — his primary care doctor had even suggested he consider working with a health coach. The health coach recommends a litany of lifestyle changes including diet, exercise, and supplements, which John conscientiously implements.

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Led by the Pfizer-Seagen deal, ADCs are starting to ‘take center stage’

PharmaVoice

Antibody-drug conjugates got a major boost with the megamerger of Pfizer and Seagen, and experts believe they will continue to be an important catalyst in biopharma.

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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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STAT+: What to know about a pivotal FDA hearing on Sarepta’s gene therapy for Duchenne

STAT

On Friday, a committee of advisers to the Food and Drug Administration will meet to discuss Sarepta Therapeutics’ closely watched experimental gene therapy for Duchenne muscular dystrophy. It will be the first FDA advisory panel hearing for a Duchenne drug from Sarepta since 2016, when hundreds of patients and family members traveled to the FDA campus in Maryland to plead with experts to authorize an earlier therapy from the company despite limited evidence.

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Diversity and Representation in Pharmacy

Pharmacy Is Right For Me

Pharmacy is an ever-evolving field that offers great career opportunities for people of all backgrounds. However, for people of color, there are some unique benefits to consider. Diversity in pharmacy is important for increasing representation in the field. Diversity is essential in any industry, and the pharmacy field is no exception. As a pharmacist, you’re a vital member of the healthcare team and your role in patient care is critical.

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GaBI Journal publishes Whitepaper on Canadian Ophthalmologist Survey

Safe Biologics

On May 9th, GaBI Journal published a whitepaper titled “Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars”, based on the recent survey of 41 Canadian ophthalmologists by ASBM and the International Federation on Ageing (IFA). The paper is authored by IFA Secretary-General Jane Barratt and ASBM Executive Director Michael Reilly.

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Opinion: The IRA’s nonsensical distinction between small- and large-molecule drugs

STAT

Thanks to advances in science, notably the completion of the Human Genome Project 20 years ago, we are able to treat diseases more effectively than ever before. Researchers have more sophisticated tools not only to identify new drug targets, but also to make drugs to hit those targets. A wide variety of therapeutic agents help make these drugs, including chemically synthesized small molecules; larger molecules made of amino acids like peptides, proteins, and antibodies; and nucleic acids like RN

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GaBI Journal publishes Whitepaper on Canadian Ophthalmologist Survey

Safe Biologics

On May 9th, GaBI Journal published a whitepaper titled “Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars”, based on the recent survey of 41 Canadian ophthalmologists by ASBM and the International Federation on Ageing (IFA). The paper is authored by IFA Secretary-General Jane Barratt and ASBM Executive Director Michael Reilly.

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Why health care needs to shift its thinking on AI, FDA’s health tech progress, & the latest on Carbon’s insurance dust-up

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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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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The emergence of tranq amidst the fentanyl crisis

Pharmaceutical Technology

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the f

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An artist uses the canvas to make sense of her partner’s illness, and her own

STAT

For Lauryn Welch, a 32-year-old artist with roots in New Hampshire, painting and chronic illness were synchronized revelations. Learning her longtime partner, Samuel Geiger, had a connective tissue disorder called hypermobile Ehlers-Danlos syndrome, led her to the canvas. She needed an outlet, a way of making sense of what her partner was feeling, and the brushes helped.

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Gilead acquires San Diego startup for early-stage cancer, immune drugs

BioPharma Dive

The buyout of privately held XinThera continues a string of recent acquisitions of smaller biotechs by Gilead and hands it a group of drug prospects that could begin clinical testing later this year.

Immunity 106
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STAT+: ‘Hard to catch up’: FDA commissioner on regulating new digital health tools

STAT

WASHINGTON — Digital health tools are developing faster than the Food and Drug Administration is able to regulate them, FDA Commissioner Robert Califf acknowledged this week.  “I think we’re behind, and it’s going to be really hard to catch up,” Califf said in a speech Monday at the National Health Council’s patient engagement symposium.

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Should Pharmacy School Admissions Hold Off on the PCAT Retirement Party?

Pulses

By: Esther L. Albuquerque, Pharm D Candidate and W. Renee’ Acosta, R.Ph., M.S. The Pharmacy College Admissions Test (PCAT) has been a mainstay of the pharmacy school admissions process since 1974. The exam was designed to measure a prospective student’s academic preparedness for the rigors of the professional pharmacy curriculum. With the COVID-19 pandemic in 2020 being a barrier to pharmacy school application numbers, the PCAT was one of the first requirements that moved to optional status.

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STAT+: Gilead defeats federal government in closely watched battle over patents for HIV prevention pills

STAT

A federal jury handed a major win to Gilead Sciences on Tuesday in a closely watched battle with the U.S. government over the rights to groundbreaking HIV prevention pills. The jury decided Gilead did not infringe on patents held by the Centers for Disease Control and Prevention and, in fact, that the agency’s patents were invalid. The CDC helped fund academic research into HIV prevention that later formed the basis for the pills.

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Where will the new pharmacy funding be allocated?

The Pharmacist

The new £645m investment in community pharmacy will be split between funding the existing NHS Pharmacy Contraception and Hypertension Case-Finding services, a new national Pharmacy First scheme and investment in IT services to give pharmacies greater access to patient notes. The Pharmaceutical Services Negotiating Committee (PSNC) said that it was not yet known how the […] The post Where will the new pharmacy funding be allocated?

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STAT+: What FDA mandate? Sun Pharma halts shipments from a plant with a troubled history

STAT

In a fresh sign of quality-control problems in the Indian pharmaceutical industry, the Food and Drug Administration decided that a Sun Pharmaceuticals facility failed to comply with a legal mandate to correct serious shortcomings. As a result, the company has halted exports from the plant to the United States. At issue is a facility Sun bought eight years ago from Ranbaxy Laboratories, which was a poster child for lax manufacturing standards in India.

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Ginkgo and Boehringer partner to develop hard-to-treat disease therapies

Pharmaceutical Technology

Ginkgo Bioworks and Boehringer Ingelheim have collaborated to develop breakthrough therapies for hard-to-treat diseases. The companies will use the natural product discovery capabilities of Ginkgo Bioworks to expedite the discovery and development of new therapeutic molecules to address diseases with high unmet patient needs. They will also use the metagenomic sequence database of Ginkgo Bioworks which comprises more than three terabases of sequence data and over two billion protein sequences fr

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Can GLP-1 obesity therapy restore NK cell function?

European Pharmaceutical Review

NK cell functionality was restored in participants following gold-standard pharmacological obesity GLP-1 analogue treatment, according to a study published in Obesity. This may contribute to the benefits reported with these medications in people with obesity, the data showed. Reducing the risk of cancer in obese individuals Boosting function of NK cells Previous research has found that people with obesity are at higher risk for developing cancer.

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Life Bio, Forge to develop gene therapies for aging-linked diseases

Pharmaceutical Business Review

This partnership aims to help advance the company’s partial epigenetic reprogramming platform for aging-related diseases, such as its lead programme that targets the ophthalmic indications. Through the alliance, Forge Biologics will provide cGMP manufacturing, toxicology, adeno-associated virus (AAV) process development, and analytical services to Life Biosciences.

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Emerade pens recalled due to risk of device failure if dropped

The Pharmacist

The government has issued an urgent recall of all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors from patients, due to a risk of device failure if the pen has been dropped. Patients should be told to obtain a prescription for and be supplied with an alternative brand, and should then […] The post Emerade pens recalled due to risk of device failure if dropped appeared first on The Pharmacist.

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FibroGen grabs an option to buy cancer drug startup Fortis

BioPharma Dive

The deal, which gives FibroGen four years to acquire Fortis at a pre-negotiated price, allows the startup to earn returns for its investors without relying on an IPO in a tough market.

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Pharmacy First to launch before the end of 2023

The Pharmacist

A nationally funded Pharmacy First service will be launched in England before the end of 2023, subject to consultation, NHS England has announced today. The service, backed by a £645m investment in community pharmacy, will allow pharmacists to supply prescription-only medicines including antibiotics and antivirals where clinically appropriate, to treat seven common health conditions without […] The post Pharmacy First to launch before the end of 2023 appeared first on The Pharmacist.

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Baxter to sell BPS business to Advent and Warburg Pincus for $4.25bn

Pharmaceutical Technology

Baxter International has signed a definitive agreement to sell its BioPharma Solutions (BPS) business to private equity investor Advent International and growth investor Warburg Pincus, in a deal valued at $4.25bn in cash. BPS offers parenteral delivery systems, sterile contract manufacturing solutions and customised support services to the pharma and biotech industries.

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4 key facts on medicine prices and spending

PhRMA

This week, policymakers on Capitol Hill will continue to discuss the cost of lifesaving medicines and how to make them more affordable for Americans. It’s an important discussion that the biopharmaceutical industry believes we need to have. A new treatment or cure can’t improve a patient’s life if they can’t get it. As the conversation continues in Congress, IQVIA is out with a new and timely report on medicine prices and spending.

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Alembic Pharma gets EIR from USFDA for its solid oral formulation facility at Jarod

Express Pharma

Alembic Pharmaceuticals has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out at the company’s solid oral formulation facility (F-4) at Jarod, Vadodara during the period from December 8 -16, 2022. This was pre-approval inspection to cover Alembic’s solid oral drug products for which ANDAs were filed with USFDA.

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The State of the Specialty Market 2023: Reflections, Trends, and Photos from #Asembia23

Drug Channels

Last week, Paula and I had the pleasure of attending Asembia’s 2023 Specialty Pharmacy Summit at the wonderful Wynn Las Vegas. As I do every year, I will violate Vegas code and tell you what happened there. I offer reflections on my keynote session with Seema Verma, share my experiences during the featured session, and highlight some crucial specialty industry trends.

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At Agilent, we believe that sustainability, productivity and efficiency can co-exist in a lab without compromising on ROI

Express Pharma

What are the top three to five sustainability challenges in today’s pharma labs? Several sustainability challenges must be addressed in today’s pharma laboratories to minimise environmental impacts and support a more sustainable future. One of the most difficult challenges in pharma labs today is that they generate a significant amount of waste, which includes both hazardous and non-hazardous materials, which can have serious environmental consequences.

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First patient dosed in pivotal CureVac flu vaccine study

Pharma Times

Modified influenza vaccine candidates have been developed in collaboration with GSK

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Who’s saying what? Cybersecurity mentions in company filings of pharmaceutical industry increased by 113% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 113% rise in company filings mentions of cybersecurity in Q1 2023 compared with the previous quarter, with the highest share accounted for by Alnylam Pharmaceuticals with 114% year-on-year increase, according to GlobalData’s analysis of over 667 pharmaceutical company filings. GlobalData’s Cybersecurity in Healthcare – Thematic Research market report helps get a detailed understanding on how Cybersecurity impacts the value chain in the

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Positive opinion for Gilead’s Hepcludex

Pharma Times

The therapy treats adults with chronic hepatitis delta virus and compensated liver disease

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Concerns £645m cash injection ‘not enough’ to address pharmacy funding shortfall

The Pharmacist

The government and NHS England has today announced a £645m investment in community pharmacy, to go towards the existing NHS Pharmacy Contraception and Hypertension Case-Finding services as well as a brand new Pharmacy First common conditions scheme. But while the pharmacy sector has largely welcomed the additional investment and the opportunity to provide more patient […] The post Concerns £645m cash injection ‘not enough’ to address pharmacy funding shortfall appeared first on The Pharmac

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Who’s saying what? Cybersecurity mentions in company filings of pharmaceutical industry increased by 113% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 113% rise in company filings mentions of cybersecurity in Q1 2023 compared with the previous quarter, with the highest share accounted for by Alnylam Pharmaceuticals with 114% year-on-year increase, according to GlobalData’s analysis of over 667 pharmaceutical company filings. GlobalData’s Cybersecurity in Healthcare – Thematic Research market report helps get a detailed understanding on how Cybersecurity impacts the value chain in the

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‘Her pain has come back’: sick child left without medicine by courier used by NHS

The Guardian - Pharmaceutical Industry

The mother of Autumn Powell, 8, says her daughter got more unwell after Sciensus failed to deliver Seriously ill children put at risk by firm’s failure to deliver NHS medication A Guardian investigation has found that children with serious health conditions are getting sicker owing to persistent failings by Sciensus, a private company paid millions by the NHS to deliver vital medicines.

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