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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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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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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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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Insurance Transportation Medical Medicine 273

pharmaphorum

JUNE 10, 2024

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri.

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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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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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FDA Food and Drug Administration Pharma Pharmaceutical manufacturing 105

World of DTC Marketing

DECEMBER 23, 2020

During the first quarter of 2020, the number of telehealth visits increased by 50%, compared with the same period in 2019, with a 154% increase in visits noted in surveillance week 13 in 2020, compared with the same period in 2019. The FDA can be myopic when researching how consumers view and react to DTC.

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Prescription Doctors Side effects Marketing 249

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. Covis Pharma added the drug to its portfolio through the acquisition of AMAG Pharmaceuticals in November 2020.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. Covis Pharma added the drug to its portfolio through the acquisition of AMAG Pharmaceuticals in November 2020.

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Food and Drug Administration FDA Food Pharma 95

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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Food and Drug Administration FDA Food Patients 105

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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Food and Drug Administration Pharma Marketing Food 213

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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Food and Drug Administration FDA Pharmaceutical Food 234

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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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

JUNE 6, 2021

The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware. Meanwhile, a 2020 study found Medicaid beneficiaries were 27% more likely to have obesity than those who had commercial insurance. .

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World of DTC Marketing

JANUARY 8, 2021

Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. Can the FDA really control the quality of vaccine orders this big? So far the winners are Pfizer and Moderna. Supply Issues?

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Government Safety FDA Pharma 266

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 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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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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Food and Drug Administration FDA Safety Food 105

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

SEPTEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) for bivalent formulations of Moderna and Pfizer -BioNTech’s Covid-19 vaccines as boosters. The EUA amendments by the FDA are based on the totality of available data. In August, Moderna sought FDA EUA for the BA.4/BA.5

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FDA Food and Drug Administration Safety Food 104

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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World of DTC Marketing

NOVEMBER 9, 2020

million Americans age 65 and older are living with Alzheimer’s dementia in 2020. Evidently the FDA panel did not find Biogen’s recut data a reason to believe that this drug should be approved. The FDA could still grant approval but they would be doing patients’ and caregivers’a huge disservice.

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FDA Food Patients Pharma 186

World of DTC Marketing

MARCH 10, 2022

AbbVie, Humira’s manufacturer, kicked off 2020 with a price increase in excess of 7 percent on its mega-blockbuster brand-name treatment. AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said”. Sales of Humira earned AbbVie $20.7 So how do people who work for AbbVie feel?

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Prescription Pharmaceutical products Pharmaceutical Marketing 205

World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). The FDA’s stamp of approval for the Fitbit sensor is a big deal. Generic drugs versus branded is also a considerable expense.

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Healthcare Healthcare Food and Drug Administration FDA 227

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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Insurance Doctors Healthcare Healthcare 139

World of DTC Marketing

JANUARY 24, 2022

VCs invest money in biotech because they see a potential windfall via a profitable acquisition or sale, but when the FDA weighs in with delays, VCs can be ruthless. 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 billion. .

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World of DTC Marketing

MARCH 6, 2022

Global consumers will spend $49 billion by 2020 on digital health solutions. This is why the FDA is going to need to establish a division to monitor digital health products. Maybe, however, they should check with patients first. A 2016 study reported that 259,000 digital health apps were available for consumers.

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Patients Doctors Leads FDA 244

World of DTC Marketing

FEBRUARY 25, 2022

31, 2020, deadline. According to the lawsuit Bristol Myers withheld or belatedly submitted critical information to the FDA for Breyanzi’s approval, and did not prepare its manufacturing plants for required inspections. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec.

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pharmaphorum

OCTOBER 24, 2022

Tremelimumab has been approved by the FDA in the US for use in tandem with AZ’s PD-L1 inhibitor Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC), the most common tumour type affecting the liver. The post AstraZeneca gets first FDA okay for CTLA4 drug tremelimumab appeared first on.

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FDA Side effects Patients Leads 85

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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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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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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Medical FDA Safety Recruitment 95

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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Safety FDA Medicine Patients 98

World of DTC Marketing

DECEMBER 22, 2020

In 2020, there should be over 592 million daily app downloads, and a survey by Gallup revealed that nearly half (45%) of Americans have at least tried digital health products such as fitness trackers or mobile health apps.Indeed, 1 in 5 (20%) have tried or are using both fitness trackers and apps. 33% would be somewhat likely.

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Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. In 2020, OxfordVR secured a $12.5m

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