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

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.

Food and Drug Administration 76

Food and Drug Administration Medicine FDA Food 76

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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FDA Doctors Patients Prescription 75

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 88

World of DTC Marketing

JANUARY 4, 2022

In 2014, cancer patients paid $4 billion out-of-pocket for cancer treatment. The FDA says it has used innovative research shortcuts to speed up the availability of medicines for desperately ill patients. Cancer patients may struggle to pay out-of-pocket expenses due to the high expenses incurred, the medical debt, or loss of work.

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Insurance Transportation Medical Prescription 273

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.

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Food and Drug Administration Pharma Marketing Food 213

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?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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.

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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

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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Food and Drug Administration Medicine Training Electronics 86

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

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

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 Medicine Patients FDA 90

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.

Competition 85

Competition FDA Pharmaceutical Marketing 85

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 Management 74

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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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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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 Pharmacology Side effects 98

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. 25 Sun et al.

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Pharmaceutical Food and Drug Administration Medicine FDA 98

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

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

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

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 57

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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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.

Safety 59

Safety Sales Marketing Patients 59

European Pharmaceutical Review

DECEMBER 21, 2022

This US pathway offers early-phase benefits, including greater FDA collaboration. This US pathway is usually leveraged at later stages in drug development and permits sponsors to use surrogate endpoints to get faster FDA approval. Thus they, too, are taking an evolutionary approach to encourage psychedelic research. Priority review.

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Food and Drug Administration Medicine Food Government 109

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

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.

Sales 52

Sales Pharma Patients Medicine 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.

Government 59

Government Specialization Physicians Education 59

Legacy MEDSearch

JUNE 27, 2022

IOPS® is FDA 510(k) cleared and currently launching in the US at select sites. Founded in 2014, Centerline Biomedical is headquartered in Cleveland, Ohio. The company’s FDA-cleared technology platform enables dramatically improved visualization and guidance in endovascular procedures.

Recruitment 52

Recruitment Healthcare Healthcare Safety 52

Legacy MEDSearch

OCTOBER 6, 2022

” Founded in 2014 with the vision of saving lives through the democratization of innovative medical technologies, Body Vision Medical’s first commercial product, LungVision , uses artificial intelligence (AI) to transform X-ray images from any C-arm into real-time, intraoperative CT scans. About Body Vision Medical.

Consulting 52

Consulting Medical Recruitment Marketing 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 FDA Sales 104

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 100

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.

Medicine 92

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 92

pharmaphorum

DECEMBER 14, 2022

Amgen’s Blincyto (blinatumomab) was the first bispecific T cell engager to be approved for marketing way back in 2014, but has been a slow burner product for Amgen, with sales rising slowly to $472 million last year in its main indication in B-cell acute lymphoblastic leukaemia (B-ALL).

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Side effects Patients Sales Safety 52

European Pharmaceutical Review

OCTOBER 20, 2022

The US Food and Drug Administration (FDA) defines eight different types of water: non-potable, potable (drinkable), purified, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection and sterile water for irrigation. References. US Food and Drug Administration. European Council.

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Food and Drug Administration Pharma Manufacturing Food 90

Rep-Lite

FEBRUARY 26, 2021

Excluding Siemens Healthineers, which saw a huge jump in medtech sales per employee after being spun out of its parent conglomerate in 2017, the winner is Philips, which has increased this figure 77% from 2014 to reach $190,000 last year. Even here, though, a storm is gathering on the horizon.

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Sales Retail Government Medical 52