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.

Healthcare 227

Healthcare Healthcare Food and Drug Administration FDA 227

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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FDA Side effects Biopharma Marketing 98

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.

FDA 105

FDA Patients Pharmacology Pharmaceutical 105

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.

FDA 85

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.,

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Medical 98

World of DTC Marketing

SEPTEMBER 7, 2022

COVID-19 has not impacted the number of launches in the oncology space, as 2020 and 2021 have seen similar rates of drug launches as in 2019. This leads to a question; “where does it end?” While that sounds encouraging, most cancer drugs launched between 2009 and 2014 cost more than USD 100,000 annually. .

Pharma 210

Pharma Food and Drug Administration Marketing Prescription 210

pharmaphorum

SEPTEMBER 15, 2022

Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt. That, in turn, allows toxins such as creatinine to build up in the body, causing damage to the liver and in 40% to 70% of cases leads to death within four weeks.

FDA 98

FDA Manufacturing Physicians Leads 98

pharmaphorum

OCTOBER 4, 2022

This week has seen two readouts for rivals from Clovis Oncology and Pfizer in prostate cancer – one of several indications on the Lynparza (olaparib) label – that could lead to a challenge to the $3 billion blockbuster. The post PARP rivals close in on AZ and Merck’s market leading Lynparza appeared first on.

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Leads Marketing FDA Patients 52

pharmaphorum

JUNE 22, 2022

The pharmaceutical industry is no different, with India and China becoming two of the leading manufacturers and exporters of generic medicine, as well as medical supplies, antibiotics and ingredients required to manufacture treatments. By its own figures, the agency managed 61% of the planned inspections it had scheduled for 2020.

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Pharma Manufacturing Government FDA 114

pharmaphorum

SEPTEMBER 27, 2022

It comes after Johnson & Johnson’s Janssen Biotech division signed up to access the bispecific antibody technology in 2020, without revealing any financial details. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022. 2 T cells, which have potent tumour-killing activity.

Safety 111

Safety Sales FDA Leads 111

European Pharmaceutical Review

AUGUST 11, 2023

Adakveo (crizanlizumab) received conditional authorisation by the EC in October 2020. This review started after results of a Phase III study (STAND) did not show a statistically significant difference between crizanlizumab and placebo in rates of pain crises leading to a healthcare visit over the first-year.

Marketing 98

Marketing Food and Drug Administration Medicine FDA 98

pharmaphorum

DECEMBER 16, 2022

The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

Medicine 126

Medicine Prospecting Networking Marketing 126

European Pharmaceutical Review

AUGUST 11, 2022

The study compared outcomes for 110 patients treated with remdesivir and dexamethasone and 81 treated with both those medications plus baricitinib at Saint Peter’s University Hospital in New Jersey, USA, between June 2020 and June 2021. .

Food and Drug Administration 96

Food and Drug Administration Patients Medical Food 96

pharmaphorum

JANUARY 27, 2023

It refiled in the US, but got a complete response from the FDA in December with a request for more clinical information that has delayed the programme even further, and the CHMP’s decision will further undermine confidence in the drug’s prospects.

FDA 98

FDA Marketing Medicine Prospecting 98

pharmaphorum

JANUARY 4, 2023

In 2020 in Europe, over 50,900 people were diagnosed with multiple myeloma and more than 32,400 died from it. The MAA to the EMA also follows a Biologics License Application (BLA) to the FDA, made in December 2022. In multiple myeloma, malignant plasma cells change and grow out of control.

Marketing 98

Marketing Medicine FDA Patients 98

pharmaphorum

JULY 15, 2022

The PureTech group company – which scored the first FDA and EMA approvals for a DTx for attention-deficit hyperactivity disorder (ADHD) – is developing AKL-T01 to tackle cognitive impairments that can affect people with SLE. The post Akili digital therapeutic shows promise in lupus patients appeared first on.

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Patients Engineering Marketing Medical 129

European Pharmaceutical Review

MAY 4, 2023

Adjuvanted vaccine Arexvy has been approved by the US Food and Drug Administration (FDA). The agency’s approval is important, because according to the US Centers for Disease Control and Prevention, RSV leads to around 60,000-120,000 hospitalisations and 6,000-10,000 deaths in adults 65 years of age and older every year in the US.

Food and Drug Administration 98

Food and Drug Administration Safety FDA Food 98

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. In addition, the median time between regulatory approval and the first patient receiving a first dose was 247 days in 2020 – an increase of 25 days since 2018.

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Government Recruitment Medicine Patients 98

Pharmaceutical Technology

JUNE 30, 2022

In 2020, there was an increase in foreign aid funding , which was attributed to Covid-19 related efforts in developing countries. In July 2021, the FDA approved the use of Fexinidazole, a once-daily oral treatment for sleeping sickness. Fraisse considers the product a flagship for DNDi’s efforts.

Leads 64

Leads Pharma Medicine FDA 64

pharmaphorum

OCTOBER 17, 2022

While a smaller patient group than menopausal women, carving out a niche in breast cancer could give Bayer an advantage over Astellas, which is currently in the lead with fezolinetant as it is due to hear from the FDA on a filing for the drug in menopausal VMS next February. There are around 2.3

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Patients Medical FDA Leads 111

pharmaphorum

DECEMBER 12, 2022

The San Antonio Breast Cancer Symposium (SABCS) has highlighted some of the most promising clinical research being undertaken by drugmakers in the category, with AstraZeneca leading the charge with a trio of major trial readouts. The FDA is already reviewing a marketing application based on the data, with a verdict due in February.

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Pharma Patients Physicians Leads 105

Clarivate

AUGUST 2, 2022

Four major trends came to light from CIRS’ most recent analysis of new active substance (NAS) approvals for the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

European Pharmaceutical Review

AUGUST 1, 2022

Therefore, it is essential that we broaden the scope of medical trials and research,” commented Tinamarie Duff, DAWN Global People & Business Resource Group Lead. The US Food and Drug Administration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations. .

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Food and Drug Administration Medical Medicine Engineering 122

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.

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Sales Competition Pharmaceutical Pharmaceutical research 108

Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019. It received an Orphan Medicinal Product designation from the EMA and Breakthrough Therapy designation from the NMPA in 2020.

Medicine 119

Medicine Food and Drug Administration Food Medical 119

pharmaphorum

SEPTEMBER 16, 2022

The companies hope that in the year to come those data targets will be entered for validation, hit generation, and lead selection. Next, they need experiential evidence that will support progressing these revealed prioritised targets into the discovery of lead molecules. Technological breakthroughs in molecular biology.

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Leads Patients Medicine FDA 135

European Pharmaceutical Review

JANUARY 29, 2024

During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. 3 Differences include that potency category 1 in FDA’s CPCA approach is 26.5 FDA has also published the AIs of some 265 NDSRIs. ng/day, compared to EMA which is 18 ng/day.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

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.

Food and Drug Administration 52

Food and Drug Administration FDA Food Patients 52

pharmaphorum

NOVEMBER 2, 2022

This leads to psychological harm becoming a significant factor in chronic pain, alongside the physical symptoms. At the beginning of this year , the US Food and Drug Administration (FDA) issued draft guidance to provide recommendations to companies developing non-addictive alternatives to opioids. The potential for a digital solution.

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Food and Drug Administration Food Patients FDA 135

Pharmaceutical Technology

SEPTEMBER 5, 2022

On 23 August, at a Reuters Newsmakers online forum, Soriot announced his interest in increasing AstraZeneca’s portfolio of bolt-on acquisitions leading up to 2025. In 2020, AstraZeneca acquired Dogma Therapeutics’ preclinical oral PCSK9 inhibitor program. These have been major steps in the company’s plan to expand its portfolio.

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FDA Pharmaceutical Biopharma Pharma 114

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

pharmaphorum

AUGUST 5, 2022

The structure of the agreement on this drug is a little different, with Innovent developing the drug but Sanofi taking the lead on commercialisation, with the Chinese biotech standing to receive up to €60 million in milestones plus royalties. The post Sanofi looks east with €300m Innovent cancer alliance appeared first on.

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Side effects Marketing Pharma Medicine 104

pharmaphorum

SEPTEMBER 28, 2022

. “What we’re really trying to do is drive discoveries that can lead to more tailored prevention, diagnosis, and treatment for all individuals. This dual approach will lead to better medical research that will benefit all populations.” In March 2020, when the pandemic hit, we had to pause in-person recruitment.

Medicine 98

Medicine Food and Drug Administration Medical FDA 98

Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. About MicroPort NaviBot MicroPort NaviBot International LLC was incorporated in 2020 and is headquartered in Foxborough, MA.

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Food 98

European Pharmaceutical Review

JUNE 29, 2023

A reduced global inspections rate in a post-pandemic world further augment the challenge; in 2022 the US Food and Drug Administration (FDA) inspected only six percent of approximately 2,800 overseas manufacturers. But with the spate of recalls, the FDA developed a Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Food Medicine 98

Legacy MEDSearch

AUGUST 25, 2022

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical. Are you hiring?

Medical 52

Medical FDA Recruitment Pharmacology 52

pharmaphorum

JANUARY 9, 2023

China still hasn’t approved western mRNA vaccines, despite submission, and the US FDA rejects Chinese-only trial data for cancer medicines. Some of the more resilient launches since 2020 have had these benefits to health systems. Pharma’s starting to wake up to this. In fact, first six months sales are almost 20% lower.

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Medicine Healthcare Healthcare Manufacturing 98