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 133

pharmaphorum

SEPTEMBER 13, 2022

The FDA has started a priority review of Chiesi ‘s velmanase alfa, an enzyme replacement therapy for lysosomal storage disease (LSD) alpha-mannosidosis, with a decision expected in the first half of 2023. The post FDA starts review of first drug for alpha-mannosidosis, from Chiesi appeared first on.

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FDA 105

STAT

APRIL 23, 2024

So judging the FDA’s accelerated approval program without assessing its full impact on overall survival presents a very slanted story. Overall survival is usually considered the gold standard in oncology because people with cancer generally want to take medications that can help them live longer.

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FDA 104

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 97

STAT

NOVEMBER 7, 2023

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

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FDA 88

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 97

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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FDA Documentation 52

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 97

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

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

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

European Pharmaceutical Review

SEPTEMBER 22, 2022

The application of Bayesian methodology has been recognised by the US Food and Drug Administration (FDA) as useful in early phase clinical trials involving paediatric populations. 2013 Oct; 48(10): 943–953. Published online 2013 Jul 2. FDA presentation. Regulatory and payer guidance. Pediatr Pulmonol. doi: 1002/ppul.22693.

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Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 122

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

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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FDA Packaging 52

The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 ( here and here ).

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Documentation FDA Labelling 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

The FDA Law Blog

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. While no office at FDA truly works in a vacuum, we can safely call OPQ the tip of FDA’s quality spear. In FY2021 and FY2022 combined, FDA added 77 companies.

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FDA 59

The Checkup by Singlecare

NOVEMBER 4, 2024

Trintellix (vortioxetine) is a brand-name prescription medication that was approved by the Food and Drug Administration (FDA) in 2013 to treat major depressive disorder (MDD) in adults. It belongs to a class of drugs known as serotonin modulators and stimulators (SMS) that balance serotonin, a substance in the brain that affects mood.

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Insurance Hospitals FDA 52

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

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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FDA Immunization 114

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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Insurance Prescription Filling FDA Dosage 105

pharmaphorum

AUGUST 20, 2020

billion in annual earnings as a result of unmanaged mental illness, and depression alone cost the global market $1 trillion in lost productivity in 2013. This year, Akili received FDA clearance for their digital therapeutic for children with ADHD by forcing the brain to adapt with a cleverly designed video game that forces focus.

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Communication FDA 122

pharmaphorum

OCTOBER 31, 2022

It is the first FDA-approved treatment for Zaire ebolavirus. Yancopoulos continued: “Our scientists realised that the science demanded they adapt these technologies to deliver the first FDA-approved recombinant monoclonal antibody treatment for any viral disease, and they picked one of the most challenging ones in Ebola.”.

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FDA Immunization 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

European Pharmaceutical Review

OCTOBER 19, 2023

we must prove the effectiveness of radiopharmaceuticals through clinical trials… This has been demonstrated recently with PLUVICTO… the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer” At this moment, there is no single treatment for cancer today.

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Chemotherapy Compounding Immunization FDA 105

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

Pharmaceutical Technology

JULY 29, 2022

In 2013, the US Food and Drug Administration (FDA) approved Ravicti (glycerol phenylbutyrate), manufactured by Hyperion Therapeutics, which has since then been acquired by Horizon Pharma. Drugs for dialysis, amino acid supplements, and drugs which convert blood ammonia are marketed right now as the go-to urea cycle disorder treatments.

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FDA 98

The FDA Law Blog

MARCH 27, 2023

FDA has been implementing the UDI system with different compliance dates for different types of medical devices to ensure a smooth implementation. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. See 21 CFR 801.40(d).

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Packaging Labelling FDA Documentation 45

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

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 Mayo Clinic Adverse Reactions 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

pharmaphorum

SEPTEMBER 29, 2022

In the United States, the Food and Drug Administrator (FDA) has so far published three draft guidance documents on patient-focused drug development, with a fourth expected in the coming months. EMA and FDA backing represents a huge step forward for patient centricity as a force for good in pharmaceutical development.

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Documentation FDA 98

pharmaphorum

SEPTEMBER 28, 2020

for the period from 2007-2013. That study, conducted in partnership with the FDA, concluded that digital CME and targeted short form messages reduced prescription of the drug, positively impacting clinical behaviour and public health. Data from the US cited during the webinar showed a five-year survival rate of 34.2%

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FDA Hospitals 105

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

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

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

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