Tribeca Knowledge

NOVEMBER 17, 2020

A ny fears that COVID-19 might stem the flow of new drug approvals in 2020, depleting or diverting resources at regulatory agencies and their pharmaceutical clients, appear largely premature.

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Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

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Pharmaceutical Technology

APRIL 4, 2023

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. Between 2020 and 2021, the number of designations increased by 600%, with seven designations being awarded by the FDA in 2021.

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European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018. Edge Biologicals Inc.,

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Pharmacy Times

FEBRUARY 2, 2024

Daratumumab and hyaluronidase-fihj in combination with other therapies was previously approved by the FDA in May 2020 for 8 indications in multiple myeloma.

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Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. The post US FDA approves GSK’s Jesduvroq to treat anaemia of CKD appeared first on Pharmaceutical Technology.

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European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. This draft guidance builds on recommendations published by the agency in 2020.

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Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. AML makes up 23.1% of total leukaemia cases globally.

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World of DTC Marketing

JULY 9, 2021

SUMMARY: Pfizer asks for accelerated approval for a COVID booster shot even though the FDA says it’s unnecessary. From 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period.”

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pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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pharmaphorum

AUGUST 16, 2022

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. Rubraca was approved in 2020 for BRCA1/2 mutated mCRPC, and is in two phase 3 trials to extend its label.

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pharmaphorum

AUGUST 17, 2022

The clock is now ticking on the FDA’s review of GSK’s momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 The post GSK gets June 2023 FDA decision date for momelotinib appeared first on. billion acquisition of Sierra Oncology which completed last month.

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MedCity News

JANUARY 26, 2023

commercial rollout of the company’s implantable device, which received FDA de novo clearance in 2020. Miach Orthopaedics — a medical device company focused on restoring torn ACLs instead of reconstructing them — recently received $40 million in funding. The capital will be used to expand the U.S.

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Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

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World of DTC Marketing

JANUARY 4, 2022

billion in 2020 (2020 U.S. The FDA says it has used innovative research shortcuts to speed up the availability of medicines for desperately ill patients. The real question is how much is three of four months of life worth, and will insurers and the FDA say the drugs that only provide mild efficacy are not worth the money?

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Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc.,

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Food and Drug Administration FDA Recruitment Food 98

Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. The post US FDA accepts Regeneron’s pozelimab BLA for priority review appeared first on Pharmaceutical Technology.

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pharmaphorum

JANUARY 25, 2023

An FDA advisory committee has recommended approval of Cidara Therapeutics’ once-weekly antifungal therapy rezafungin, setting it up to become the first new option for severe infections caused by Candida species in a decade. Melinta is privately-owned, after emerging from bankruptcy protection in 2020.

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MedCity News

JULY 24, 2023

In 2020, 46.9% of all novel drugs approved by the FDA were for rare diseases, as compared to 23.5% Investment is expected to continue trending upward, with estimates suggesting that global spending on rare disease therapies will reach $260 billion by the end of 2025.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals. HLX02 is intended for adjuvant treatment of HER2-overexpressing breast cancer.

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Food and Drug Administration FDA Biopharma Food 52

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. 85% of accelerated approvals from 2010 to 2020 were for oncology indications. The FDA has also been revisiting cancer therapy approvals made through the program.

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Legacy MEDSearch

NOVEMBER 7, 2022

a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. Allotrope Medical Inc., For the past year, StimSite has been used by surgeons to help locate and identify ureters through electrical stimulation.

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Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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Pharmaceutical Technology

MAY 10, 2023

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Farxiga (dapagliflozin) to reduce the risks of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) emergency care visits in HF adult patients.

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Food and Drug Administration FDA Food Patients 52

pharmaphorum

DECEMBER 14, 2022

An FDA advisory committee has voted against approval of Cytokinetics’ cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough. The post FDA adcomm votes down Cytokinetics heart failure drug appeared first on. There was also no impact on quality-of-life measures.

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Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). InTandem, which is designed to be used independently by a patient in a home setting, received Breakthrough Device Designation from the FDA in 2020. Earlier this year, MedRhythms announced successful completion of a pivotal clinical trial for InTandem. Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

OCTOBER 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. With this FDA 510(k) clearance, Pleural Dynamics will begin real-world clinical use of the ACES System with select hospitals and health systems. Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

APRIL 12, 2024

Of note, between 2020 to 2022, there was a “remarkable surge” in deal worth. billion in 2020 to $15.8 In other recent gene therapy news, last month the US Food and Drug Administration (FDA) authorised Lenmeldy (atidarsagene autotemcel) for children with early-onset metachromatic leukodystrophy (MLD). billion, the research found.

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World of DTC Marketing

JANUARY 10, 2022

A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 According to the study in JAMA “the FDA approved 355 new drugs and biologics over the study period. 2020 was a massive year for biotech venture financing – and 2021 has already eclipsed it.

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World of DTC Marketing

NOVEMBER 12, 2020

That, however, didn’t stop a conspiracy loving imbecile from blaming the FDA and Pfizer. According to JAMA , “between January 2010 and June 2020, the FDA approved 21 vaccines, most commonly for influenza (5 [23.8%]) and meningococcus (5 [23.8%]). Of these, 4 (19.0%) received Accelerated Approval.

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World of DTC Marketing

NOVEMBER 18, 2021

prices on seven of the 10 costliest prescription drugs in 2020 without justification, increasing drug spending by $1.67 Using pricing data from 2019 and 2020, ICER pegged Humira’s net price increase at 9.6% According to Reuters “drugmakers hiked U.S. billion, a U.S. group that reviews the value of medicines said on Tuesday.

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World of DTC Marketing

FEBRUARY 2, 2021

Among their findings: Downloads of apps supporting consumers with mental health needs increased by nearly 200% from summer 2019 to summer 2020 Downloads of those supporting consumers with diets and weight loss rose by a massive 1294% from mid-2019 to mid-2020. Some may see this as a good sign but we need to proceed with caution.

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pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? A new cross-sectional study has found that the FDA green lit 95% of the 89 new oncology therapies approved between 2010 and 2019 before the EMA, with the Europeans trailing the Americans by a median of 241 days. An abundance of caution?

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Legacy MEDSearch

MAY 10, 2023

Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape Town, South Africa. . The vast majority of medical devices used in pediatrics are not FDA-cleared or designed for children.

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Legacy MEDSearch

AUGUST 14, 2023

Kerecis had previously donated its burn products for victims of both the California wildfires in 2020 and the volcanic eruption on White Island in New Zealand in 2019. The post Kerecis to Donate FDA-Approved Fish Skin for Burn Victims of Maui Wildfires appeared first on Legacy MedSearch | Medical Device Recruiters. Are you hiring?

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World of DTC Marketing

FEBRUARY 1, 2022

According to EY, there were 69 deals worth $128 billion in 2020 and 90 deals worth $108 billion in 2021. 1ne: More scrutinization by the FDA on new drug applications. The days of approving almost all cancer drugs, for example, maybe over as the FDA takes a closer look at data. What’s scaring investors?

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