STAT

JANUARY 8, 2024

The two men worked together from 2013 until 2022, when Jonas left to start a biotech incubator with funding from investment giant CBC Group. The VC firm has hired Jeff Jonas, Sage’s former chief executive, and Al Robichaud, Sage’s former chief scientific officer, as partners, the team told STAT exclusively.

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Labelling FDA 124

STAT

MAY 19, 2023

Founded in 2013, Pear was the most prominent company developing prescription digital therapeutics, or Food and Drug Administration-cleared software applications ordered by doctors to treat health conditions. A hearing to approve the sale will be held on May 22.

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FDA 145

pharmaphorum

JANUARY 25, 2023

The 501(c)3 non-profit Tidepool, which seeks to empower the next generation of innovations in diabetes management, has announced that the US Food and Drug Administration (FDA) has cleared Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in those six years old and above.

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FDA 59

STAT

MAY 15, 2023

Hospitals ran short of essential treatment medications and were unable to source those drugs from manufacturers or from the outsourcing facilities that had been authorized by Congress in 2013 to “fill the gap” in such situations. Read the rest…

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Compounding Pharmacies Compounding Hospitals FDA 98

STAT

NOVEMBER 7, 2023

In August 2013, the FDA made news when it issued cybersecurity guidance for medical devices.

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FDA 105

The FDA Law Blog

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” Note that FDA is currently soliciting applications to staff this committee. Tobolowsky & James E. Raver & Frank J.

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FDA 59

The FDA Law Blog

AUGUST 27, 2023

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. By Karla L. the ability to associate the saleable return product with the transaction information/statement with the particular product).

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The FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.

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pharmaphorum

JUNE 20, 2022

New Zealand medical tech startup Alimetry has claimed an FDA approval for a wearable device that can be used to diagnose gastric disorders non-invasively. Functional dyspepsia alone was estimated to cost the US upwards of $18 billion in healthcare expenses, according to figures published in 2013.

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FDA 52

European Pharmaceutical Review

MARCH 11, 2024

elaborated, noting that based on recall data collected by the US Food and Drug Administration (FDA) in over 100 products between 2000–2010, “fungi existed in 21 percent of products.” The authors also shared: “in the last three years [since 2023], the US FDA has recalled several drugs due to fungal contamination.” Ahmed et al.

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Sterile Compounds Compounding Packaging Pharmaceutical Companies 83

pharmaphorum

JULY 16, 2021

Safety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca’s roxadustat for anaemia associated with chronic kidney disease (CKD) in the US, after FDA advisors voted comprehensively against the drug yesterday.

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Pharmaceutical Technology

MARCH 27, 2023

In 2022, the US FDA disappointingly approved almost a third fewer of the most innovative drugs than it did in 2021. During 2013–2022, NME approvals were lower only in 2013 and 2016. Faced with such a disappointing approval number last year, manufacturers hope for more NMEs to enter the market in 2023.

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FDA 52

pharmaphorum

OCTOBER 27, 2022

GSK licensed otilimab from German biotech MorphoSys in 2013 in a deal valued at up to €423 million, including around €23 million upfront. Daprodustat backed. There has been somewhat better news for GSK for another of its top pipeline prospects – renal anaemia drug daprodustat – although that also came with disappointment.

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FDA 97

European Pharmaceutical Review

AUGUST 30, 2022

The report, Clinical Trials – The Importance of Diversity in Clinical Trials , examined data from clinical trials initiated between 1 January 2013 and 16 June 2022. Earlier this year the US Food and Drug Administration (FDA) published draft guidance to support companies in enrolling more ethnically diverse trial populations.

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FDA 77

pharmaphorum

MARCH 23, 2022

” Baynes joined Merck in 2013, a year before the company launched its cancer blockbuster Keytruda (pembrolizumab) which has since grown into a $17 billion-a-year product and racked up FDA approvals across more than 15 cancer types.

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Vaccines FDA 98

The FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). By Kalie E. Richardson & Karla L. See 21 U.S.C. Section II at 2.

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Compounding FDA Hospitals Labelling 52

The Checkup by Singlecare

DECEMBER 1, 2023

Food and Drug Administration (FDA) certifies the Red Dye 40 as safe for human consumption. Apart from Red Dye 40, there are eight other certified color additives approved for use in food by the FDA: Blue No. The FDA has denied any link between the two for years. The controversy surrounding Red Dye 40 The U.S. 1, Blue No.

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Labelling FDA Documentation 52

Roots Analysis

MARCH 26, 2024

The field has also witnessed various expansion initiatives undertaken by industry players during the period 2013-2020 (till January). As a result, many success stories have come into the light which involves continuous manufacturing of a drug.

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Pharmaceutical Companies Pharmaceutical Companies FDA 52

pharmaphorum

NOVEMBER 11, 2022

18% of study participants were Black/African American in 2013, but that contracted to 14% in 2020 and then plunged to just 9% in 2021. For Hispanics, participation in trials increased from 7% in 2012 to a high of just under 10% in 2017 but fell back to levels of around 8% to 9% in the past two years.

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FDA 97

pharmaphorum

FEBRUARY 23, 2022

AbbVie has filed with the FDA to extend the uses of its bipolar disorder therapy Vraylar to include adjunctive therapy for major depressive disorder, part of a plan to build sales of the drug to peak sales of $4 billion or more. Analysts at GlobalData are predicting peak sales of $383 million for the drug in 2029.

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Labelling FDA 52

The Checkup by Singlecare

DECEMBER 5, 2023

Food and Drug Administration (FDA) recently approved Zepbound , a new version of Mounjaro, for weight loss. It can help trigger a feeling of fullness after a meal and slow the digestion process. Tirzepatide is manufactured under the brand name Mounjaro for Type 2 diabetes treatment.

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pharmaphorum

NOVEMBER 15, 2021

Invokana was the first SGLT2 inhibitor to reach the market for diabetes after it was cleared by the FDA in 2013, and sales accelerated to a peak of nearly $1.4 billion in 2016 before the product was linked to an increased risk of lower limb amputation.

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Labelling FDA 105

Pharmaceutical Technology

JANUARY 19, 2023

However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000. The first clinical attempt at managing AML with CAR-T cells was reported in 2013 with a small Phase I study that did not demonstrate activity.

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FDA 52

pharmaphorum

DECEMBER 29, 2022

The FDA granted full approval to Par’s generic on 28 March, 2013. Plaintiffs – in this case direct purchasers, indirect purchasers and retailers including CVS Health, Kroger, Rite Aid and Walgreens Boots Alliance according to Reuters – filed suit against Novartis and Par in 2018 alleging violation of federal antitrust laws.

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Specialty Pharmacies Documentation FDA 52

The Checkup by Singlecare

NOVEMBER 30, 2023

Food and Drug Administration (FDA) used to rely heavily on a letter-based rating system for drug safety during pregnancy , with category A drugs being the safest to take, category X drugs being contraindicated because the risks outweigh the benefits, and category B, C, and D drugs varying in safety and adverse effects.

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pharmaphorum

JULY 15, 2022

.” KW-6356 is a follow-up to Kyowa Kirin’s first-generation adenosine A2 antagonist Nourianz/Nouriast (istradefylline), which finally claimed FDA approval in 2019 as an add-on to levodopa in Parkinson’s after more than two decades of R&D and has been available in Japan since 2013.

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FDA 59

The Checkup by Singlecare

FEBRUARY 1, 2024

Food and Drug Administration (FDA). Functions and action mechanisms of flavonoids genistein and icariin in regulating bone remodeling , Journal of Cellular Physiology (2013). Consumption of flaxseed, a rich source of lignans, is associated with reduced breast cancer risk , Cancer Causes & Control (2013). Molecules (2019).

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Mayo Clinic Compounding FDA 95

ISPE

MAY 22, 2023

Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the World Health Organization (WHO); and Joyce Cirunay, Director IV of the Center for Drug Regulation and Research at the Philippines FDA. Hustead Executive Director, Regulatory Affairs Merck & Co.,

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Communication FDA 98

The Checkup by Singlecare

FEBRUARY 8, 2024

In fact, in late 2023, its manufacturer, Eli Lilly, released another brand form of tirzepatide, Zepbound , with Food and Drug Administration (FDA) approval for weight loss. Still, according to the FDA’s boxed warning , anyone with a history of MTC or a personal or family history of MEN2 should avoid it.

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Labelling Adverse Reactions Mayo Clinic FDA 98

European Pharmaceutical Review

OCTOBER 19, 2022

The US Food and Drug Administration (FDA) has recently expressed concern to the US PTO about some types of innovator patent strategies that potentially delay generic entry into the market. FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs. 23 April 2013.

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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.

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FDA Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

SEPTEMBER 28, 2022

The GRADE study began in 2013 and key results of the FDA-approved medicine’s performance were published in The New England Journal of Medicine (NEMJ). The large-scale trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH).

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Hospitals FDA 52

Druggist

DECEMBER 31, 2020

Vibegron (brand name: Gemtesa) is the latest drug used to treat overactive bladder that has been approved by the FDA in the USA. Mirabegron is reserved as an optional treatment in the symptoms of overactive bladder in patients whom (NICE, 2013): . NICE, (2013). In this post, I will summarise: . Propiverine hydrochloride.

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FDA 59

Impact Pharmaceutical Services

AUGUST 9, 2022

In 2013, the IMPACT (now part of Syner-G BioPharma Group) management team decided that the company needed to build a Regulatory Operations department to support their existing and future client base. During the last year, IMPACT has submitted several FDA meeting packages for this consultant as well.

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FDA Packaging Documentation 40

The Checkup by Singlecare

JANUARY 18, 2024

Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor Ozempic (semaglutide) has been the talk of the nation, more so for its use for weight loss rather than its actual Food and Drug Administration (FDA) indication, type 2 diabetes mellitus.

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Mayo Clinic Labelling FDA Hospitals 52

Pharmaceutical Technology

SEPTEMBER 22, 2022

In 2013, the FDA first approved Vazkepa solely for the reduction of triglyceride levels for hypertriglyceridemia. Following this, in 2019, the FDA approved Vazkepa for the reduction of cardiovascular risk. GlobalData is the parent company of Pharmaceutical Technology.

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Pharmaceutical Companies Pharmaceutical Companies FDA Dosage 52

DiversifyRx

NOVEMBER 24, 2023

Exploring the Drug Supply Chain Security Act (DSCSA) The DSCSA, signed into law in 2013, aims to heighten the security of the pharmaceutical supply chain by creating a framework for traceability and accountability. Its main goals are: 1. These records include information on the receipt, storage, handling, and dispensing of prescription drugs.

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Independent Pharmacies Packaging Documentation FDA 52