PharmaShots

FEBRUARY 22, 2023

In 2021, the revenue of Trulicity increased by 28% in the U.S., Some of its FDA-approved competitors include: Patents7 Eli Lilly carries big expectations from Trulicity to boost its revenue. In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026). mL, 3 mg/0.5

Insurance 64

Insurance Compounding Dosage Communication 64

European Pharmaceutical Review

DECEMBER 21, 2022

Although some psychedelics have a long history in traditional medicine, regulatory agencies must evaluate psychedelic compounds the same way they assess any other drug. Psychedelic compounds are assessed by regulators the same way as any other drug. This US pathway offers early-phase benefits, including greater FDA collaboration.

Compounding 119

Compounding Controlled Substances FDA Patient Care 119

The FDA Law Blog

AUGUST 8, 2023

Nitrosamines are hardly ever good, Now FDA has issued policy. All of these deviations discussed in FDA inspectional observations and Warning Letters have caused serious issues for manufacturers of APIs or finished drug products. An earlier FDA guidance, revised in 2021. An earlier FDA guidance, revised in 2021.

FDA 74

FDA Compounding 74

The Checkup by Singlecare

MARCH 25, 2024

Wegovy (semaglutide) is an injectable medication approved in 2021 for people with obesity or who are overweight and have a weight-related medical condition. Others have just waited or turned to a compounded version of the drug,” Dr. Jordan says. It’s injected weekly to help lose weight and maintain weight loss.

Compounding 98

Compounding FDA Insurance Compounding Pharmacies 98

pharmaphorum

JANUARY 11, 2023

Anima uses its mRNA Lightning platform to discover small molecules and determine their mechanisms of action for diseases previously deemed undruggable, with scientists searching for compounds that target proteins with roles in regulating mRNA, so as to affect disease states through post-transcriptional regulation (i.e.

Compounding 105

Compounding FDA 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database. AbbVie reported a 22.7%

Vaccines 108

Vaccines Documentation Compounding FDA 108

pharmaphorum

MARCH 2, 2022

The term ‘psychedelic treatments’ incorporates a broad spectrum of different compounds, from LSD, psilocybin and DMT, to MDMA, ibogaine and ketamine. The latter compound has already been approved for treatment-resistance depression as the product Spravato (esketamine), after being developed by Janssen. Paving the way to patients.

Compounding 105

Compounding FDA 105

pharmaphorum

OCTOBER 2, 2020

Phase 1 first-in-man pharmacokinetic studies are expected to start in Q4 2021. Including an $80 million series B round in April, Compass had already raised more than $100 million to fund research into the compound, which is being developed for treatment resistant depression, a subset of patients with major depressive disorder.

Compounding 122

Compounding FDA 122

pharmaphorum

JUNE 12, 2025

Skip to main content Thursday 12 June 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Health and Personal Care Stores 59

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Insurance Coverage 59

The Checkup by Singlecare

MARCH 7, 2024

Yet the Food and Drug Administration (FDA) hasn’t approved this GLP-1 agonist injection for weight loss. Instead, it’s FDA approved to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of adverse cardiovascular events in adults with Type 2 diabetes and known heart disease.

Compounding Pharmacies 93

Compounding Pharmacies Insurance Insurance Coverage Compounding 93

Omnicell

JANUARY 10, 2023

Sterile compounding is also one of the costliest functions in pharmacy operations. Still, many hospital pharmacies continue to struggle to improve safety and efficiency in their sterile compounding operations. Insourcing IV compounding services at Moses H. Register today at Omnicell Illuminate 2021. 5 at 2 p.m.

Sterile Compounds 52

Sterile Compounds Omnicell Compounding Hospitals 52

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

Compounding 98

Compounding Documentation Insurance Immunization 98

pharmaphorum

OCTOBER 28, 2020

Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert Bourla believes hasn’t been given the credit it is due by Wall Street analysts. The post FDA sets April verdict for Pfizer’s “underestimated” atopic dermatitis drug appeared first on.

FDA 52

FDA Compounding 52

European Pharmaceutical Review

OCTOBER 19, 2023

With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use. This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

Chemotherapy 105

Chemotherapy Compounding Immunization FDA 105

pharmaphorum

FEBRUARY 2, 2022

ViiV claimed the latter compound infringes its patents for dolutegravir and other compounds based on the drug’s chemical scaffold. billion in the last three months of 2021 – ahead of analyst forecasts – but Biktarvy was once again the star of the show with a 22% rise to $2.5 Veklury sales decline 30% to $1.4

Compounding 72

Compounding FDA 72

The Checkup by Singlecare

OCTOBER 11, 2023

Phenylephrine In September 2023, the FDA announced that a common decongestant found on shelves, phenylephrine, is not actually effective to decrease congestion. Some studies suggest curcumin, the active compound in turmeric, may even have antiviral properties. Here’s what to skip. or make an anti-inflammatory chicken soup.

Mayo Clinic 106

Mayo Clinic Immunization FDA Compounding 106

The FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. For each of these facilities, FDA did not conduct an on-site inspection of the facility prior to issuing the warning letter. By McKenzie E.

FDA 52

FDA Compounding 52

European Pharmaceutical Review

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. FDA assigned a provisional AI of 26.5 10 It is not clear whether FDA will adopt a similar t-AI. 2021; 110(6): 2311-2328. References 1.

FDA 98

FDA Compounding 98

The FDA Law Blog

JULY 2, 2025

Food and Drug Administration (FDA) launched the Over-the-Counter Monograph User Fee Program (OMUFA) in 2020, the Agency has been pushing for modernization and self-funding of its regulatory oversight for over-the-counter (OTC) products. By Charles D. Snow — Since the U.S. FDCA § 502(ff).

FDA 52

FDA Compounding Labelling 52

Pharmaceutical Technology

MARCH 23, 2023

Among other late-stage trials, Padcev is being evaluated in combination with Keytruda (pembrolizumab) in the frontline setting, with the trial granted priority review by the FDA. Tivdak, a tissue-factor targeting ADC that was developed in collaboration with Genmab, was approved in 2021.

Chemotherapy 59

Chemotherapy Compounding FDA 59

The Checkup by Singlecare

SEPTEMBER 28, 2023

Supplement with turmeric Curcumin is the main compound of the herb turmeric, and according to Dr. Garcia-Ibáñez, it works as a powerful antioxidant and anti-inflammatory. Garlic Garlic does contain anti-inflammatory compounds that, in theory, might reduce congestion. National Library of Medicine (2021) What is a HEPA filter?

Compounding 105

Compounding Immunization Mayo Clinic Dosage 105

European Pharmaceutical Review

SEPTEMBER 25, 2023

NMR relaxation methods distinguish between components (phases or compounds) that have different molecular mobilities For monoclonal antibodies, identification methodologies can employ chromatography, spectroscopy, isoelectric focusing, capillary electrophoresis and peptide mapping techniques. 2021; 110(7): 2765–70. Cited 2023Feb].

Compounding 98

Compounding Pharmaceutical Companies Pharmaceutical Companies FDA 98

pharmaphorum

JANUARY 23, 2023

” It was modified again in the middle of 2021. Janssen opted not to continue with the first two integrin targets at the end of 2021, due to “a lack of target validation in the specific disease of Janssen’s interest,” and has now dropped the third, bringing the partnership to an early end.

Compounding 52

Compounding FDA 52

BuzzRx

OCTOBER 31, 2022

In July 2021, the pharmaceutical company Pfizer issued a voluntary nationwide recall of Chantix (varenicline) tablets as a precautionary measure; this is due to the evidence of higher levels of nitrosamines in Chantix than what’s considered acceptable by the U.S. FDA guidelines. Why was the smoking cessation drug Chantix recalled?

Adverse Reactions 52

Adverse Reactions FDA Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JUNE 29, 2023

This challenge is further compounded by increasingly complex drug formulations and global ingredient supply chains that stretch manufacturers’ capabilities in testing and control of impurities. But with the spate of recalls, the FDA developed a Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs. Internet] 2023.

FDA 98

FDA Compounding 98

pharmaphorum

JUNE 23, 2022

The suit – filed in a Massachusetts district court – claims that Paxlovid (nirmatrelvir and ritonavir) infringes its 11,358,953 patent which covers “compounds and pharmaceutically acceptable salts which inhibit coronavirus replication activity, and methods of treating a coronavirus infection” and was awarded earlier this month.

Compounding 52

Compounding Documentation FDA 52

pharmaphorum

AUGUST 31, 2021

His departure comes after a tricky period for Galapagos, which van de Stolpe alludes to in his retirement announcement, saying: “despite recent setbacks, we continue to progress a deep pipeline of novel target-based compounds, while the commercial roll-out of our first approved product is underway.” GLPG rocks!!

Compounding 52

Compounding FDA 52

The Checkup by Singlecare

MAY 28, 2024

While L-theanine itself doesn’t contain caffeine, the two psychoactive compounds sometimes occur naturally together and are marketed as a combination in supplement form. Combining the two compounds can enhance cognition, increase alertness and focus, and reduce adverse caffeine side effects. Does L-theanine have caffeine in it?

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Compounding Documentation FDA 78

Drug Topics

JUNE 25, 2025

The study found that from 2019 to 2024, GLP-1 prescriptions among this patient population increased from 12.3% Of the prescriptions, semaglutide accounted for 23.7% Although dulaglutide had the highest amount of prescriptions at 70.4% in 2019, that number fell to 7.8% However, dulaglutide prescriptions increased in 2024 to 65.4%.

Compounding 363

Compounding Specialty Pharmacies Independent Pharmacies Insurance 363

The Checkup by Singlecare

NOVEMBER 21, 2023

Food and Drug Administration (FDA), to encourage manufacturers to fortify food products like bread, flour, cereals, pasta, rice, corn masa, and cornmeal with up to 100 micrograms of folic acid per 100 grams. 2021) Calcium Intake in Bone Health: A Focus on Calcium-Rich Mineral Waters. For example, 1.5

Compounding 126

Compounding FDA 126

pharmaphorum

APRIL 10, 2022

10,808,039) covering ADCs that include auristatin compounds coupled to an antibody via a linker molecule. Seagen has a long history in ADC development, claiming FDA approval for Adcetris (brentuximab vedotin) as a treatment for classical Hodgkin lymphoma and anaplastic large cell lymphoma (ALCL) in 2011.

Compounding 52

Compounding FDA 52

The Checkup by Singlecare

JANUARY 10, 2024

Berberine is a yellow alkaloid compound extracted from several plants such as goldenseal, Oregon grape, and tree turmeric. Beyond that, berberine isn’t as effective for weight loss as methods approved by the Food & Drug Administration (FDA). Does berberine help with weight loss? appeared first on The Checkup.

Dosage 105

Dosage Compounding Insurance FDA 105

Drug Topics

JUNE 27, 2025

Image Credit: REDPIXEL - stock.adobe.com Thimerosal is a mercury-containing compound that has been widely used as a preservative in some biological and drug products, such as promoting the safe use of multidose vials and packaging of vaccines. It is often thought to be used in some seasonal and pandemic influenza vaccines.

Vaccines 405

Vaccines Independent Pharmacies Immunization Compounding 405

European Pharmaceutical Review

JUNE 24, 2022

The US Food and Drug Administration (FDA) requires that manufacturers establish whether nitrosamines, including NDSRIs, could be present in active pharmaceutical ingredients (APIs) and drug products, using the “three-step mitigation strategy described in the agency’s guidance”. Updated 24 February 2021. 18 November 2021.

FDA 52

FDA Documentation Compounding 52

The Checkup by Singlecare

JULY 10, 2024

This allows more of its beneficial compounds to reach the gut, where it can correct gut bacteria imbalances. Costa says a 2021 study suggests that zinc might support hormone levels and sexual function in postmenopausal women. Other studies suggest that the compounds found in seaweed could have anti-aging properties.

Immunization 85

Immunization Compounding Packaging Communication 85

pharmaphorum

JUNE 4, 2021

This article appears in our free digital magazine Deep Dive: Market Access 2021. Compounding this problem is the fact that the healthcare sector is often glacial in its pace of change, while digital innovations are evolving rapidly every year.

Compounding 45

Compounding FDA 45

The Checkup by Singlecare

FEBRUARY 19, 2024

In 2021 alone, 21 million adults —or 8.3% Turmeric Turmeric coupons “Turmeric contains an active compound called curcumin, which has potential benefits, including depression,” Dr. Mandel explains. It’s also important to remember that the FDA doesn’t regulate or approve supplements before they are marketed to consumers.

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Dosage Compounding Labelling FDA 105