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. The post FDA grants swift review to Lynparza in first-line prostate cancer appeared first on.

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FDA Patients Sales Marketing 99

European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. Pfizer stated that the gene therapy enabled sustained bleed protection, “potentially avoiding years of treatment burden with prophylaxis for many patients”.

Food and Drug Administration 75

Food and Drug Administration Medicine FDA Food 75

Pharma Leaders

JUNE 27, 2023

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec. Pfizer obtained the licence for gene therapy from Spark Therapeutics in December 2014.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Engineering 52

Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

Patients 98

Patients Recruitment Pharmacology Side effects 98

World of DTC Marketing

JANUARY 10, 2022

Data were mainly accessible for smaller firms, effects in some therapeutic regions, orphan drugs, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between 2014 and 2018. According to the study in JAMA “the FDA approved 355 new drugs and biologics over the study period.

Food and Drug Administration 213

Food and Drug Administration Pharma Marketing Food 213

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

Patients 79

Patients Pharma Consulting Transportation 79

World of DTC Marketing

SEPTEMBER 17, 2020

Not only has the FDA become a political pawn but almost half the population is now obese. In 2019, 12 states had obesity rates in the highest category for this survey (35 percent or greater), a jump from three states in 2014, and nine in 2018. IN SUMMARY: American healthcare is failing. We need to do to obesity what we did for smoking.

Healthcare 242

Healthcare Healthcare Insurance Healthcare Provider 242

World of DTC Marketing

SEPTEMBER 7, 2022

While that sounds encouraging, most cancer drugs launched between 2009 and 2014 cost more than USD 100,000 annually. For DTC, the model will become one of collaboration with patients as they help them navigate the complex system of American healthcare. Their future model includes helping HCPs rather than trying to sell to them.

Pharma 210

Pharma Food and Drug Administration Marketing Prescription 210

Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. The trial reported a statistically significant reduction of clinical decline in the patients.

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Food and Drug Administration Side effects Prospecting FDA 52

Pharmaceutical Technology

MAY 16, 2023

Silverthorn said to Pharmaceutical Technology , the consortium aims to overcome the current patient participation in clinical trial barriers, associated with rare diseases , by working with patient advocacy groups and contact registries. The BGTC was launched in October 2021, as the first AMP initiative.

Manufacturing 90

Manufacturing Medicine Patients FDA 90

European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. The organisation considers collaboration will advance scientific discovery, clinical advances and training. Scientific and operational teams.

Food and Drug Administration 85

Food and Drug Administration Medicine Training Electronics 85

pharmaphorum

OCTOBER 26, 2022

The first patient has already been enrolled into its FIBRONEER phase 3 programme for BI 1015550, which already has a breakthrough designation from the FDA after a positive phase 2 trial showed improved lung function in patients with IPF over a 12-week period.

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Recruitment Prospecting Marketing Patients 95

pharmaphorum

DECEMBER 14, 2022

When patients experience intense emotion, either positive or negative, they are rendered unconscious. Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002.

Competition 94

Competition FDA Pharmaceutical Marketing 94

pharmaphorum

OCTOBER 3, 2022

After review of all data, including RWE, feedback from patients and clinicians and caregivers, as well as that collected from the MAA – NICE released its draft guidance based on “limited and highly uncertain” evidence of improved later stages of the disease or improved survival with Translarna.

Patients 85

Patients Medicine FDA Management 85

Pharmaceutical Technology

JANUARY 23, 2023

However, this progress is not reflected with respect to approved treatments for paediatric IBD patients. Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients.

Medical 59

Medical Ethics Specialization Physicians 59

pharmaphorum

SEPTEMBER 11, 2022

The US FDA has cleared the first-in-class tyrosine kinase 2 (Tyk2) inhibitor as Sotyktu , and BMS says it now plans to launch the new drug later this month, aiming to mount a challenge to Amgen’s $2.3 It had been approved since 2014 for moderate to severe cases only. billion oral psoriasis therapy Otezla (apremilast).

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FDA Marketing Sales Patients 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

The FDA has granted the drug an orphan drug designation, and Phase III trials with eplontersen were completed In June. Prior to this, the FDA had granted Enhertu regulatory approval for breast cancer treatment. Between 1 May 2016 and 31 May 2021, the FDA approved 207 drugs for cancer and malignant haematology.

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Pharmaceutical Technology

JULY 8, 2022

In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. months vs. 4.0

Safety 59

Safety Sales Marketing Patients 59

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. 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. ng/day, compared to EMA which is 18 ng/day.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Medicine FDA 98

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. What are the most promising microbiome therapeutics in clinical development?

Food and Drug Administration 99

Food and Drug Administration Manufacturing Medicine Pharma 99

pharmaphorum

AUGUST 19, 2022

The study met its primary and secondary efficacy objectives, according to CSL’s head of R&D Dr Bill Mezzanotte, who said the “underscore our belief that garadacimab has the potential to become a transformative first-in-class therapy for people living with HAE, a patient group that CSL has been serving for many years.”

Sales 52

Sales Pharma Patients Medicine 52

European Pharmaceutical Review

DECEMBER 21, 2022

For example, the MHRA launched its Innovative Licensing and Access Pathway (ILAP) in January 2021 with the goal “…to accelerate the time to market, facilitating patient access to medicines. This US pathway offers early-phase benefits, including greater FDA collaboration. Breakthrough therapy designation. Fast track designation.

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Food and Drug Administration Medicine Food Government 109

Legacy MEDSearch

JUNE 27, 2022

Centerline Biomedical’s system improves visualization and guidance in endovascular procedures while reducing dependence on radiation and contrast agents with the goal of improving patient outcomes, as well as overall efficiency for clinicians. IOPS® is FDA 510(k) cleared and currently launching in the US at select sites.

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Recruitment Healthcare Healthcare Safety 52

pharmaphorum

DECEMBER 14, 2022

. “These results suggest iptacopan […] could essentially allow patients to live a normal life with just one pill each morning and night,” he added. Almost all patients treated with Novartis’ drug had no need for blood transfusions over the course of the study. g/dL, compared with an average decrease of 0.04

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Side effects Patients Sales Safety 52

pharmaphorum

SEPTEMBER 27, 2022

The suit claimed that Biogen paid millions of dollars to doctors in the form of speaker honoraria, training fees, consulting fees, and meals to induce them to prescribe the MS drugs Avonex (interferon-beta-1a), Tysabri (natalizumab), and Tecfidera (dimethyl fumarate) between 2009 and 2014.

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Government Doctors Consulting Training 44

European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

Medical 86

Medical Food and Drug Administration Pharmacology Medicine 86

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. Available from: [link]. Leem JW, Jeon HJ, Ji Y, et al.

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Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 92

Pharmaceutical Technology

OCTOBER 5, 2022

Between 2009 and 2014, the time period of Biogen’s alleged misconduct, the standard of care for MS involved the use of Biogen’s immunomodulatory drugs such as Avonex (Interferon beta-1a), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab). The company currently has three MS drugs in its pipeline.

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Government Specialization Physicians Education 59

Rep-Lite

FEBRUARY 26, 2021

As hospitals prioritize the urgent care of Covid-19 patients they are shifting away from buying expensive equipment – many of the da Vinci models sell for more than a million dollars. Covid-19 will not help: the group has suspended sales to new patients in its retail treatment centers owing to the pandemic.

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Sales Retail Government Medical 52

pharmaphorum

NOVEMBER 16, 2022

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. RxDx Assay – Roche’s immunohistochemistry (IHC) companion diagnostic for identifying ovarian patients eligible for ELAHERE – has been contemporaneously approved by the FDA.

FDA 67

FDA Patients Safety Medicine 67

pharmaphorum

NOVEMBER 29, 2022

At NeoImmuneTech, a Biotech company founded in Maryland, US, in 2014, the answer to this question looks straightforward: “We believe in incremental progress”, says Dr Se Hwan Yang, president and chief executive officer of the company. It is worth noting that patients with r/r PaC or r/r MSS-CRC have very limited treatment options.

Safety 104

Safety Patients Engineering Recruitment 104

Legacy MEDSearch

FEBRUARY 10, 2023

Food and Drug Administration (FDA) to market its fully convertible stemmed total shoulder arthroplasty system with an ellipsoid anatomic head. Regardless of surgeon or patient need, Catalyst offers an innovative and differentiated clinical solution, creating implants that are purposefully designed to be better.” Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 52

Evolve Your Success

JUNE 28, 2022

Despite the very incredible data showing, endoscopic was better for the patient. This was from 2008 to 2014. By 2014, we were on our way with Providence. In 2014, it was clear that Thayer was going to be hard. We got a couple of our products FDA cleared and we raised our first venture financing. It was a lesson.

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Sales Pharma Medical sales reps Medical sales 52

Pharmaceutical Technology

MARCH 30, 2023

On the same day, researchers presented new interim data from the Phase III RUBY trial of GSK’s PD-1 antibody Jemperli (dostarlimab) in patients with primary advanced or recurrent endometrial cancer. Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market.

Food and Drug Administration 52

Food and Drug Administration FDA Sales Food 52

Pharmaceutical Technology

MAY 19, 2023

Rituxan received its first FDA approval in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma (B-NHL) and reached peak global sales of $7.5bn in 2014. As of 2022, over 20% of US patients, over 10% of EU patients, and over 70% of Japanese patients are estimated to have switched to biosimilar rituximab.

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Sales Competition Marketing Patients 59

Pharmaceutical Technology

NOVEMBER 22, 2022

The company began formulating ERVEBO™ in 2014 while the Ebola Virus Disease (EVD) epidemic raged in West Africa. The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.

Manufacturing 52

Manufacturing Government FDA Safety 52

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. We can see a future where millions of patients no longer carry the burden of regular injections.”

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Food and Drug Administration Manufacturing Safety Pharmaceutical 90