The Checkup by Singlecare

DECEMBER 7, 2023

Here are the 5 top health and wellness posts of 2023, based on what pharmacy professionals read most. But because they’re dietary supplements, they’re not regulated by the FDA. In case you missed them, here are eight blockbuster drugs from 2023, plus their indications and benefits. Read more here. Read more here. Read more here.

Controlled Substances 52

Controlled Substances Pharmaceutical Companies Pharmaceutical Companies FDA 52

Birth Control Pharmacist

APRIL 18, 2023

Over 100 countries worldwide have approved OTC birth control options, but as of April 2023 the United States is not one of them. In June 2022, the AMA urged the FDA to approve an OTC contraceptive method with no age restriction. In order for a drug to be approved for OTC use by the FDA, certain criteria must first be met.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

APRIL 17, 2024

Food and Drug Administration (FDA) approved Wegovy for adults and children 12 years and older who have a body mass index (BMI) of 30 or higher or who have a BMI of 27 or higher with a related medical condition, such as high blood pressure, Type 2 diabetes, or high cholesterol. Medicare prohibits Part D plans from covering certain medications.

Insurance 98

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98

European Pharmaceutical Review

MARCH 11, 2024

For example, rising ambient temperatures and ingress of mould from items entering cleanrooms, has resulted in some vaccine and pharmaceutical companies in Europe experiencing increased contamination. The authors also shared: “in the last three years [since 2023], the US FDA has recalled several drugs due to fungal contamination.”

Sterile Compounds 98

Sterile Compounds Compounding Packaging Pharmaceutical Companies 98

Pharmaceutical Technology

APRIL 3, 2023

HUTCHMED (China) has completed the new drug application (NDA) rolling submission to the US Food and Drug Administration (FDA) for fruquintinib to treat refractory metastatic colorectal cancer (CRC).

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

NOVEMBER 16, 2022

Pharmaceutical company Indivior has announced it will acquire Opiant Pharmaceuticals , Inc. It received US Food and Drug Administration (FDA) Fast Track Designation in 2021 and is expected to complete its New Drug Application (NDA) submission in late 2022, with launch in the US expected in the following months.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies FDA 98

PharmaShots

MARCH 29, 2023

Shots: Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versions Like every other utility patent, pharmaceuticals also get market exclusivity of 20 years. Currently, the drug is not accessible in generic form.

FDA 49

FDA Chemotherapy Immunization Dosage 49

Pharmaceutical Technology

FEBRUARY 8, 2023

Pfizer is likely to continue maintaining its position by breaking into the race for a respiratory syncytial virus (RSV) vaccine; it is currently awaiting FDA marketing approval for its RSV vaccine, which was awarded priority review with a PDUFA date decision in May 2023.

Vaccines 78

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 78

The Checkup by Singlecare

NOVEMBER 14, 2022

Food and Drug Administration (FDA) has assigned “currently in shortage” status to oral powder for suspension amoxicillin. 28, the FDA listed 23 amoxicillin products on its current drug shortages page due to increased demand for the drug. . The FDA has not stated when they expect the shortage to conclude. . In fact, as of Oct.

FDA 105

FDA Pharmaceutical Companies Pharmaceutical Companies 105

The Checkup by Singlecare

FEBRUARY 14, 2024

One such medication is Mounjaro (tirzepatide), a GLP-1 receptor agonist manufactured by the pharmaceutical company Eli Lilly. That’s why even though the medication is only approved by the Food and Drug Administration (FDA) for Type 2 diabetes, it’s also used off-label as a weight-loss medication. of their body weight.

Dosage 115

Dosage Labelling FDA Pharmaceutical Companies 115

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies Immunization Process Improvement 115

Pharmaceutical Technology

MARCH 22, 2023

The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format. In the US Drug Quality and Security Act (DSCSA), the FDA mandates that manufacturers and trading partners should have full interoperable electronic track and trace systems in place by November 2023.

Labelling 105

Labelling Data Entry Communication FDA 105

Pharmaceutical Technology

APRIL 12, 2023

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir).

Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies Vaccines FDA 59

The Checkup by Singlecare

DECEMBER 2, 2024

However, the Food and Drug Administration (FDA) has approved a generic mixture of ipratropium and albuterol —Combivent Respimat’s active ingredients—for use by COPD patients. Generic drugs are often more affordable than their brand-name references, but unfortunately, there are no current generics for Combivent Respimat. Many times, yes.

Insurance 52

Insurance Insurance Coverage Dosage FDA 52

pharmaphorum

APRIL 1, 2022

And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko. In September of 2021, the FDA approved Byooviz , which references Roche and Novartis’ blockbuster eye drug Lucentis. Humira Biosimilars launching in 2023. market is just beginning to heat up. billion over the next 5 years.

FDA 59

FDA Pharmaceutical Companies Pharmaceutical Companies Insurance 59

The Checkup by Singlecare

JULY 20, 2023

As pharmaceutical scientists innovate, blockbuster drugs in your pharmacy also evolve. Even if you’re familiar with the term, you may be curious about what exactly makes a medication a “blockbuster drug” and what the potential blockbuster drugs of 2023 could be. Read on to learn more about potential blockbuster drugs of 2023.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

DECEMBER 28, 2022

So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness? Any purchasing company would ideally like to integrate their acquisitions into their company seamlessly.

Documentation 119

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 119

European Pharmaceutical Review

APRIL 10, 2024

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications. Internet] Pharmaceutical Technology. 2023; 62:102111.

Immunization 95

Immunization Chemotherapy FDA Pharmaceutical Companies 95

The Checkup by Singlecare

SEPTEMBER 10, 2024

It is approved by the Food and Drug Administration (FDA) to treat plaque psoriasis , psoriatic arthritis , Crohn’s disease , and ulcerative colitis. According to the FDA , biological products are complex medicines made from living cells, like those from plants or animals. Wezlana (ustekinumab-auub) was FDA approved on Oct.

FDA 52

FDA Vaccines Specialty Pharmacies Pharmaceutical Companies 52

ISPE

NOVEMBER 1, 2022

All of this energy has been channeled by the International Board into a rewriting of the ISPE Strategic Plan for 2023–25 with a “more confident position: Shaping the Future of Pharma.”. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. iSpeak Blog.

FDA 98

FDA Insurance Chemotherapy Documentation 98

The Checkup by Singlecare

APRIL 5, 2024

Health condition Insurance companies are much more likely to cover Ozempic when it’s prescribed for diabetes than for weight loss. That’s because the Food and Drug Administration (FDA) has approved it for Type 2 diabetes , while weight management is technically an off-label treatment.

Insurance 78

Insurance Documentation Insurance Coverage Pharmaceutical Companies 78

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

Vaccines 64

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 64

European Pharmaceutical Review

NOVEMBER 8, 2022

There are also several pending bills that seek to lower drug costs by means other than price regulations, including: 1) deterring the delay in FDA approval of drug applications caused by sham ‘Citizen Petitions’. Citizen Petitions before the FDA. 562 would permit the FDA to deny the petition if either of these factors were satisfied.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

The People's Pharmacy

JUNE 12, 2023

The parties that benefit are the pharmaceutical companies and the pharmacies. The losers are patients, insurance companies and the country as a whole for wasting money on unneeded things. If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. The FDA does virtually no testing.

Labelling 62

Labelling Mail-Order Pharmacies Adverse Reactions FDA 62

Pharmaceutical Technology

DECEMBER 27, 2022

This year, volatility resulting from the Russian war on Ukraine, residual uncertainty from the Covid-19 pandemic, and more led to fluctuating dynamics in the pharmaceutical space. However, despite external pressures, major pharma deals still came to pass, which some experts say could be a harbinger for things to come in 2023.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies Vaccines 52

Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans.

Packaging 59

Packaging Vaccines Pharmaceutical Companies Pharmaceutical Companies 59

Roots Analysis

DECEMBER 18, 2023

In 2018, the French-based Advanced Accelerator Applications, a subsidiary of Novartis, achieved a significant milestone by obtaining the FDA approval for its product Lutathera®, a next-generation drug conjugate designed for GEP-NET (Gastroenteropancreatic Neuroendocrine Tumors).

FDA 40

FDA Pharmaceutical Companies Pharmaceutical Companies 40

European Pharmaceutical Review

MARCH 7, 2024

radioligand therapeutics are expected to grow by 30 percent per year over the next 10 years” Dodet expanded on this prediction, highlighting that based on the 2023 MEDraysintell report, radioligand therapeutics are expected to grow by 30 percent per year over the next 10 years.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Immunization FDA 52

The People's Pharmacy

MAY 4, 2023

The drug lecanemab ( Leqembi ) was recently approved by the FDA to treat early Alzheimer’s disease. Pharmaceutical companies do not know what to make of this unexpected complication. The news from Eli Lilly about its experimental Alzheimer’s drug donanemab was upbeat. Put another way, the lower the score the better.

Nursing Homes 65

Nursing Homes Pharmaceutical Companies Pharmaceutical Companies FDA 65

Roots Analysis

APRIL 20, 2022

On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. Further, studies indicate that more than 100,000 tons of pharmaceutical products are consumed globally per year. trillion in 2023. 3] Some of the advantages offered by pharmaceutical secondary packaging have been depicted below.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Labelling 52

The Checkup by Singlecare

JUNE 7, 2024

Humira is a brand-name medication made by the pharmaceutical company AbbVie, Inc. Cyltezo is an interchangeable biosimilar (similar to a generic, but for biologic drugs like Humira) made by Boehringer Ingelheim Pharmaceuticals, Inc. Humira is a biologic drug and a monoclonal antibody that the FDA approved in 2002.

Vaccines 52

Vaccines Insurance FDA Insurance Coverage 52

Pharmaceutical Technology

APRIL 28, 2023

At its Biocon Park campus in Bengaluru the company set up and commissioned a new microbial cGMP facility and expanded its mammalian cell manufacturing facility Meanwhile, Bristol Myers Squibb (BMS), one of the world’s largest pharmaceutical companies, celebrated 25 years of collaboration with Syngene in March 2023.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA 52

The Checkup by Singlecare

JUNE 7, 2024

Made by the pharmaceutical company Janssen Biotech, Inc., Wezlana In October 2023 , the Food and Drug Administration (FDA) approved Wezlana , which is an interchangeable biosimilar to Stelara. It works on proteins that affect the immune system, which helps improve symptoms such as inflammation.

Immunization 52

Immunization Dosage Vaccines FDA 52

ISPE

NOVEMBER 28, 2022

Process Performance and Product Quality Monitoring System : ICH Q10 establishes an expectation for pharmaceutical companies to “plan and execute a system for the monitoring of process performance and product quality to ensure a state of control is maintained.”. Valid 18 November 2022 – 31 January 2023. Member Price: $750.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

JANUARY 30, 2024

Repatha is made by the pharmaceutical company Amgen Inc. Sources Understanding homozygous familial hypercholesterolemia , American Heart Association (2023) Repatha , DailyMed (2023) Repatha , PDR Evolocumab injection , MedlinePlus (2018) Paying for Repatha , Amgen The post How much is Repatha without insurance?

Insurance 52

Insurance Insurance Coverage Dosage Pharmaceutical Companies 52

pharmaphorum

APRIL 19, 2022

RudaCure hopes to launch phase 1 and 2 trials for RCI002 in 2023. Further on the horizon, the company is investigating treatments for wet age-related macular degeneration, metastatic cancer and complex regional pain syndrome, a rare disease.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication FDA 52

ISPE

JULY 6, 2023

ICH Q13 and What Is Next for Continuous Manufacturing Trudy Patterson Thu, 07/06/2023 - 06:51 Features July / August 2023 ICH Q13 and What Is Next for Continuous Manufacturing Gabriella Dahlgren, PhD Douglas B. 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation FDA Dosage Pharmaceutical Companies 52