pharmaphorum

NOVEMBER 2, 2022

Citeline and Norstella have completed a merger, first announced in June, to create one of the largest players in the pharmaceutical intelligence category. As a result, it can “quickly answer key questions related to the patient journey, payer reimbursement, and the safety and efficacy of therapeutics,” said Norstella.

Drug Development 101

Drug Development Communication 101

pharmaphorum

OCTOBER 7, 2022

As we enter October and the Frontiers Health 2022 conference in Milan, we’re shining a spotlight on some of the Steering Committee members who have helped make the event what it is. Here we talk to Fredrik Debong, who cofounded MySugr in 2012 and sold it to Roche Diabetes Care five years later in an eight- to nine-figure deal.

Documentation 98

Documentation Diabetes 98

Drug Channels

JUNE 13, 2022

Cannot be combined with special category rates or other offers. Don’t miss the IDN & Bio/Pharma Partnering Summit coming up this summer in Philadelphia, where you'll be part of the important discussions on how to best optimize strategic partnerships to improve patient access and outcomes. Other restrictions may apply.

Specialty Pharmacies 71

Specialty Pharmacies 71

ID Stewardship

APRIL 14, 2024

In this article a comparison of Rebyota versus Vowst is provided, to help learners differentiate these two fecal microbiota therapies. Authored by: Natalie Boyer, Pharm.D. Candidate 2025 Mentored by: Christina G. O’Connor, Pharm.D., While it is normal for C. Most cases of C. diff can then grow unchecked. diff (oral vancomycin or fidaxomicin).

Hospitals 129

Hospitals Communication 129

pharmaphorum

JULY 5, 2021

The handover comes four years after Pamplona Capital Management bought the company for around $5 billion, and just a few weeks after lab tech company Thermo Fisher Scientific agreed to acquire another CRO – PPD – in a deal valued at $17.4 billion to claim ownership of the contract research organisation.

Vaccines 63

Vaccines Drug Development 63

pharmaphorum

APRIL 12, 2021

Exscientia is entering a category with some heavyweight competition, including Novartis, Johnson & Johnson/AdoRx and AstraZeneca as well as smaller players like Arcus, Corvus and iTeos Therapeutics. Tumour cells produce high levels of adenosine, which binds to the A2A receptor on T-cells and helps them escape immune system detection.

Immunity 126

Immunity Immunization Compounding 126

Express Pharma

AUGUST 7, 2023

Aspirin, the most notable chemically modified drug, came into being in 1897 and the penicillin was also a chance event in Alexander Fleming’s lab in 1928. This is true for the whole world whether it is America, Japan, China, Europe, India, the Amazon or wilds of Africa. Their utility and justification to be used took a long time.

Drug Pricing 95

Drug Pricing Hospitals 95

pharmaphorum

JULY 4, 2022

Schultz promptly launched a big restructuring drive that delivered $3 billion in savings, but also a dramatic reduction in headcount and the shutdown of dozens of offices, labs and manufacturing sites. Eric A Hughes. He will be based out of Teva’s US headquarters in Parsippany, New Jersey.

Generic Medicine 52

Generic Medicine Biosimilars 52

European Pharmaceutical Review

FEBRUARY 21, 2023

Then of course, it is a huge amount of work to set up a new quality management system (QMS) and lab from scratch. The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. Short discussed the heavy workload involved in navigating the regulations associated with a controlled drug.

Pharmaceutical Companies 131

Pharmaceutical Companies Pharmaceutical Companies Compounding Drug Development 131

pharmaphorum

NOVEMBER 22, 2022

Founded by prolific biotech entrepreneur and Harvard professor Gregory Verdine (pictured above) – along with WeiQing Zhou, John McGee, Professor Sir David Lane – FogPharma’s approach draws on research carried at Verdine’s Harvard lab on cell-penetrating miniproteins (CPMPs), of which Helicons are one class.

Packaging 52

Packaging Compounding Drug Development 52

pharmaphorum

OCTOBER 20, 2021

An artificial intelligence-based tool for identifying hard-to-detect spinal fractures, developed by Belgian drugmaker UCB, has been licensed out to ImageBiopsy Lab for further development. Catching these fractures more quickly could allow diagnosis and treatment earlier, and potentially reduce complications associated with osteoporosis.

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FDA Law Blog: Biosimilars

DECEMBER 6, 2023

Javitt — On Monday, Hyman, Phelps & McNamara, P.C. filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation.

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pharmaphorum

APRIL 7, 2022

During the initial stage of the collaboration, Ares developed a an AI-powered anti-infectives platform using microbiological lab techniques and bioinformatics that can be used to identify effective antimicrobial compounds or combinations against specific pathogens, which Sandoz can use to inform its “portfolio and commercial decisions.”

Compounding 52

Compounding 52

pharmaphorum

FEBRUARY 19, 2021

In lab studies involving animal models, R552 has been shown to reduce inflammation and tissue damage. In lab studies involving animal models, R552 has been shown to reduce inflammation and tissue damage. Denali also had to terminate another candidate a few years ago because of safety issues.

Compounding 52

Compounding Immunity Immunization Drug Development 52

pharmaphorum

JUNE 16, 2021

billion agreement with Bristol-Myers Squibb last month with a $50 million upfront fee – means that Exscientia is now one of the most well-funded biotechs in the AI category. A string of other partnerships – including a $1.2 A string of other partnerships – including a $1.2

Compounding 58

Compounding 58

Pharmacy Joe

SEPTEMBER 6, 2021

It seems, whether consciously or unconsciously, physicians place non-physicians they interact with into one of two categories: 1. Other physicians make it into the first category automatically. Nurses automatically get placed into the first category. We need to work hard to avoid being placed in the second category.

Hospitals 52

Hospitals Documentation Medical Records Inpatient 52

Putting Patients First Blog

AUGUST 28, 2023

Scope of the Proposal New technologies generally fall into three categories. Scope of the Proposal New technologies generally fall into three categories. CMS currently defers coverage decision-making on items and services in this latter category to its local Medicare Administrative Contractors (MACs).

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FDA Law Blog: Biosimilars

JUNE 22, 2023

Though there has been a large number of OTC IVD clearances and decades of experience reviewing OTC IVDs, the bulk of OTC IVD clearances fall in just a few categories, such as pregnancy tests, drugs of abuse tests, and glucose monitoring devices. In the intervening decades, FDA has cleared approximately 1,200 OTC IVDs.

Labelling 59

Labelling Hospitals 59

pharmaphorum

JANUARY 26, 2021

From telehealth to digital trials, customer engagement to healthcare data, Healthware Group outlines the key trends that are expected to shake up digital health this year. Well, it goes without saying, COVID-19 has resulted in a rapid adoption of digital technologies across all industries, most notably in healthcare.

Health and Personal Care Stores 141

Health and Personal Care Stores Medication Guidelines Communication 141

Syner-G

MAY 4, 2022

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager. In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions.

Documentation 52

Documentation Drug Development Communication 52

Pulses

MAY 25, 2023

Assignment categories are outlined in Table 1. When compared to assigning grades, descriptive feedback is more helpful in improving student learning. 2 As a result, experts have suggested moving away from traditional grading systems and towards alternative grading strategies such as competency-based assessment and pass/fail grading.

Documentation 98

Documentation 98

GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. Every laboratory facility has unique functions, equipment and facility layout.

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Documentation Method Validation Compounding Data Entry 52

Community Pharmacy

SEPTEMBER 30, 2022

Since 2004, October has been highlighted as American Pharmacist Month , a time to recognize and celebrate the profession of pharmacy. Combining the cutting edge of medical science and chemistry, pharmacists for centuries have played a key role in local communities. As a profession on the rise, there’s never been a better time to become a pharmacist.

Community Pharmacies 52

Community Pharmacies Doctor of Pharmacy Dosage Communication 52

GMPSOP

MARCH 25, 2024

What is computer system validation (CSV) in GMP Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST NEXT POST Next Computer system validation or CSV is also called software validation. Validation of those computerized systems provides evidence that the process outcomes are fit for purpose at all times.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

The Happy PharmD

FEBRUARY 1, 2023

Thus, even when these decisions didn’t fit into the fair and consistent category, the staff was more understanding and accepting of these decisions. I was talking to my friend the other night. He recently became the Director of a long-term care facility. He was discussing his decision-making capabilities. Why is this an either/or?

Long-Term Care Facilities 52

Long-Term Care Facilities Hospitals 52

The Thyroid Pharmacist

APRIL 28, 2023

I also had other seemingly odd symptoms for someone my age, like frequent muscle cramps, stiffness, carpal tunnel in both arms, and pain. I’ve shared articles on pain and will be sharing one on carpal tunnel soon as well.) Most common are acute (or acquired) myopathies, such as stiffness, spasms, or cramping.

Immunity 94

Immunity Immunization Diabetes Dosage 94

pharmaphorum

JUNE 1, 2021

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. To implement on-dose authentication, microtaggants are incorporated into coatings or inks used on each tablet or capsule; these can then be verified using desk-top readers or handheld devices, such as smartphones.

Online Pharmacies 52

Online Pharmacies Dosage Packaging Pharmaceutical Companies 52

pharmaphorum

NOVEMBER 5, 2021

Google parent Alphabet has drawn on its DeepMind artificial intelligence division to form a drug discovery unit that it calls Isomorphic Labs. That raised the hope that it could be used accelerate research into how diseases affect the body, and develop new medicines that can latch onto troublesome proteins effectively. Demis Hassabis.

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pharmaphorum

SEPTEMBER 24, 2022

Apps related to healthcare are a broad, growing category. is not new, with hundreds of apps now populating the category. Instead of swiping a co-pay card and filling out a paper form by hand, the receptionist says, “Please bring your phone closer. We take Apple Health here.” Your co-pay is then deducted from a Health Savings Account.

Medical Records 105

Medical Records Diabetes Pharmaceutical Companies Pharmaceutical Companies 105

GMPSOP

MARCH 8, 2024

04 Steps to Investigate Out of Specification (OOS) Result Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST What is out of specification (OOS) result? An Out of specification (OOS) result is simply the result that lies outside the specifications to which it is required to conform.

Documentation 52

Documentation Dosage Pharmaceutical Manufacturing Packaging 52

The Thyroid Pharmacist

JULY 14, 2023

Here’s an excerpt from my book, Hashimoto’s Protocol : Most physicians and endocrinologists will say that in Hashimoto’s, hypothyroidism is irreversible and ends with complete thyroid cell damage, leading to a lifelong requirement of thyroid hormone medications. However, this isn’t always true!

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Dosage Immunity Immunization Documentation 95

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered. Change to the IVD definition First, the mechanics of the change. direct-to-consumer tests, tests for use in a public health emergency).

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Labelling 64

The Physician Pharmacist

OCTOBER 27, 2023

️ Prepare for an enlightening Episode 7 of The Physician Pharmacist Podcast Miniseries, where we sit down with Dr. Steven Berk, a seasoned Internal Medicine Physician with over 25 years of experience. A Glimpse into Pharmacy Academia : Discover the world of pharmacy academia and the contributions that pharmacists make to education and research.

Medical Schools 52

Medical Schools Medical Records Hospitals Clinical Pharmacology 52

The Thyroid Pharmacist

JULY 1, 2022

Through my years of experience working with people with thyroid disease, I’ve found that food sensitivities are often a huge trigger for people with Hashimoto’s. I too have had major sensitivities to dairy and gluten, and getting off of both of these foods helped me get rid of the acid reflux I had been battling for over three years.

Compounding 52

Compounding Labelling Immunity Immunization 52

pharmaphorum

MAY 25, 2022

Angle’s entry into the market is somewhat in a category of its own, with the device making it possible for repeat, non-invasive monitoring of people with cancer from intact living cells rather than from circulating tumour DNA from fragments of dead cells.

Hospitals 110

Hospitals 110

European Pharmaceutical Review

AUGUST 24, 2023

Subin Baral, EY Global Deals Leader for Life Sciences at Ernst & Young LLP told EPR that companies in the sector need strategies to help adapt and secure future growth beyond the wave of biopharmaceutical patent expiries that will continue to roll over the industry until the end of the decade.

Pharmaceutical Companies 87

Pharmaceutical Companies Pharmaceutical Companies Drug Pricing 87

Pharmaceutical Technology

APRIL 28, 2023

The company has been ranked in the Business Expansion and Research and Development categories in the Pharmaceutical Technology Excellence Rankings. The company has been ranked in the Business Expansion and Research and Development categories in the Pharmaceutical Technology Excellence Rankings. until 2026.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52