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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Pharmacy Times

MAY 20, 2024

In 2014, the cobas human papillomavirus test was approved by the FDA for first-line, primary screening in women aged 25 years and older.

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FDA 52

Pharmacy Times

JANUARY 16, 2024

Previously, IgG-hyaluronidase recombinant was approved by the FDA in 2014 for the treatment of primary immunodeficiency in adult patients and has expanded to include some pediatric patients.

FDA 58

FDA Patients 58

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. 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. ” Why are the costs so high?

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Pharma Food and Drug Administration Marketing Prescription 210

PharmExec

JANUARY 15, 2024

The FDA issued the 39th overall approval for Keytruda (pembrolizumab), with the latest in combination with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer.

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FDA Patients 52

Pharmacy Times

JANUARY 15, 2024

The approval was based on the results of a phase 3 trial that found an improvement in progression-free survival among individuals treated with pembrolizumab.

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FDA 49

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. ImmunoGen, Inc.

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FDA Patients Safety Medicine 69

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 licensed BEQVEZ from Spark Therapeutics in December 2014.

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Food and Drug Administration Medicine FDA Food 96

pharmaphorum

DECEMBER 14, 2022

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. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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Competition FDA Pharmaceutical Marketing 116

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.

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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. Dr Se Hwan Yang, PhD, President and Chief Executive Officer, founded NeoImmuneTech in January 2014.

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Safety Patients Engineering Recruitment 105

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.

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Food and Drug Administration FDA Safety Engineering 52

pharmaphorum

OCTOBER 3, 2022

Translarna has had European approval for usage since 2014 and has also been available under terms similar to the MAA to DMD patients in Scotland since 2021. Last week, Sarepta Therapeutics filed for accelerated FDA approval of its DMD gene therapy developed with Roche, SRP-9001 (delandistrogene moxeparvovec).

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Patients Medicine FDA Leads 98

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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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. There are more than 200 lung disorders that can lead to pulmonary fibrosis.

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Recruitment Prospecting Marketing Patients 98

Pharmaceutical Technology

MAY 16, 2023

The AMP was launched in 2014 as a partnership between the FDA , the National Institutes for Health, and several public and private organisations. BGTC will likely simultaneously work towards multiple IND applications for different diseases, she added. The BGTC was launched in October 2021, as the first AMP initiative.

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Manufacturing Patients Medicine FDA 90

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. Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D., Catalyst OrthoScience Inc. About Catalyst OrthoScience Inc. Headquartered in Naples, Fla., Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 52

Medical Device Success

JANUARY 29, 2014

What will you be doing to increase your marketing acumen and ROI in 2014? In the medical device world, the FDA and other regulatory bodies limit how we can promote many of our products. Reading time: 4 – 6 minutes. For example, today I watched a webinar on video marketing. It was an hour well spent.

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pharmaphorum

JANUARY 3, 2023

SPK-9001 was licensed by Pfizer from Spark Therapeutics pursuant to a December 2014 agreement, under which Spark was responsible for conducting all phase 1 and 2 studies for the gene therapy.

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Medicine Engineering Safety FDA 98

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.

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Patients Recruitment Management Pharmacology 98

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. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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Food and Drug Administration Side effects Prospecting FDA 52

European Pharmaceutical Review

JULY 26, 2024

DURVEQTIX was approved by the US Food and Drug Administration (FDA) for haemophilia B as BEQVEZ TM in April this year. The pharmaceutical company licensed the gene therapy DURVEQTIX from Spark ® Therapeutics in December 2014.

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Food and Drug Administration Engineering Food Patients 52

pharmaphorum

NOVEMBER 11, 2022

Viehbacher led Sanofi between 2008 and 2014 and has decades of experience with both large pharmaceutical companies and small biotechs. However, in 2014 Sanofi fired Viehbacher over a boardroom fight regarding his management. — Bloomberg (@business) November 10, 2022. Biogen’s shares rose 2.4% to $289.01

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Insurance Doctors FDA Pharma 40

Pharmaceutical Technology

MARCH 30, 2023

Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market. Earlier in March, the FDA shared a draft guidance on how to run clinical trials for the accelerated approval of cancer drugs.

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Food and Drug Administration FDA Sales Food 52

Pharmaceutical Technology

FEBRUARY 22, 2023

Developed by Sanofi and Regeneron, Praluent was approved by the FDA in July 2015. Amgen sued the two companies in 2014 over supposed patent infringement. The legal dispute is centered around rival cholesterol-lowering drugs produced by the two companies, which were approved in the summer of 2015. Both drugs come with a high price tag.

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Pharma Government Sales FDA 104

European Pharmaceutical Review

AUGUST 23, 2022

The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. Counterfeit drugs: fighting illegal supply chains: Subcommittee on oversight and investigations of the committee on energy and commerce house of representatives; 2014. Available from: [link]. ACS Central Science.

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Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

Pharmaceutical Technology

JANUARY 23, 2023

Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014.

Medical 59

Medical Ethics Specialization Physicians 59

pharmaphorum

NOVEMBER 22, 2022

He was head of Sandoz – Novartis’ soon to be spun off generics business – between 2014 and 2019, and previously spent 12 years at Biogen, ending up as president and head of Biogen US, where he oversaw the launch of multiple sclerosis blockbuster Tecfidera (dimethyl glutamate).

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Sales Medicine FDA Pharma 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

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.

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Safety Sales Marketing Patients 59

European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

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Food and Drug Administration Manufacturing Medicine Pharma 105

pharmaphorum

DECEMBER 29, 2022

The case revolves around allegations that Novartis made an agreement in 2011 with Par Pharmaceutical when Exforge (valsartan/amlodipine) was nearing the end of its patent life that was designed to keep Par’s generic version of the drug off the market until 30 September, 2014.

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Retail Marketing Doctors Government 52

pharmaphorum

JANUARY 23, 2023

If it shows its worth in the clinical, it could offer an oral approach to targeting alpha 4 beta 7, which is currently the target of Takeda’s $4 billion blockbuster Entyvio (vedolizumab), approved by the FDA for IBD back in 2014. The post Morphic loses second partner as J&J exits integrin alliance appeared first on.

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Safety FDA Pharma 52

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). 4 integrins, which play a key role in MS pathology.

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Government Specialization Physicians Marketing 59

Evolve Your Success

JUNE 28, 2022

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 had a term sheet and it was going to be great. It’s around the same time as Providence is going.

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Sales Pharma Medical sales reps Medical sales 130

pharmaphorum

AUGUST 19, 2022

Pharming attempted to extend the use of its C1 esterase inhibitor product Ruconest (conestat alfa) into the prevention setting, having won FDA approval for acute treatment of attacks in 2014, but was knocked back by the regulator. It is administered as an intravenous injection.

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Sales Pharma Patients Medicine 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 45