PM360

JANUARY 7, 2025

Acquisition highlights companies shared commitment to clients, workplace culture, and attracting the industrys best people TORONTO, ON/SARATOGA SPRINGS, NY January 7, 2025 Klick Health today announced it has acquired Peregrine Market Access, a leading market access strategy and value communications specialist in life sciences.

Marketing 52

Marketing Leads Medical Consulting 52

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. Of course, they should, but in the end, it’s going to come down to trust in their doctor and the FDA. Do patients care?

Patients 200

Patients FDA Doctors Physicians 200

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

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 RMAT designation will provide the benefits of added intensive FDA guidance and expedited review through the programme’s development.

Food and Drug Administration 105

Food and Drug Administration FDA Medicine Food 105

World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post , says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.”

FDA 187

FDA Side effects Patients Doctors 187

World of DTC Marketing

NOVEMBER 18, 2021

group that reviews the value of medicines said on Tuesday. leading to an almost $1.4 According to Fierce Pharma “AbbVie has filed for 165 patents on Imbruvica, and officials have granted 88 of them, the Initiative for Medicines, Access & Knowledge reports. According to Reuters “drugmakers hiked U.S.

Pharma 202

Pharma Medicine Prescription Manufacturing 202

European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. It is located on the company’s existing Devens site, which has been developing, producing, and testing clinical and commercial medicines for over a decade.

Manufacturing 105

Manufacturing Food and Drug Administration FDA Engineering 105

Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Pharmaceutical 98

pharmaphorum

SEPTEMBER 13, 2022

The FDA has started a priority review of Chiesi ‘s velmanase alfa, an enzyme replacement therapy for lysosomal storage disease (LSD) alpha-mannosidosis, with a decision expected in the first half of 2023. The post FDA starts review of first drug for alpha-mannosidosis, from Chiesi appeared first on.

FDA 105

FDA Distribution Prospecting Patients 105

Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. at six months and 24 months, respectively, following infusion.

Food and Drug Administration 105

Food and Drug Administration FDA Side effects Food 105

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

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. A marketing authorisation application (MAA) is under review by the European Medicines Agency (EMA) with a regulatory decision expected in early 2024.

FDA 98

FDA Food and Drug Administration Food Leads 98

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. The mutation leads to disordered thyroid hormone transport, which causes patients to experience intellectual and motor disabilities. The company plans to submit an MAA to the EMA in H1 this year.

FDA 126

FDA Safety Pharmaceutical Patients 126

European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). This can lead to extremely fragile skin that blisters and tears with minor friction or trauma. The “landmark approval” declared Krish S.

Food and Drug Administration 105

Food and Drug Administration Medicine FDA Food 105

European Pharmaceutical Review

FEBRUARY 28, 2025

1 Figure 3 : Documents by country or territory (Credit: Elsevier BV – Scopus) The rare disease therapy landscape in the UK In the UK however, challenges remain when it comes to providing rare disease patients with the medicines they need. substantial amendments, nearly 65 percent more than the average for non-rare diseases.

Education 88

Education Patients Medicine Pharma 88

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

Pharmaceutical Technology

JULY 1, 2022

Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults. The collaboration with Sixth Street has three parts.

Medicine 59

Medicine Food and Drug Administration Prospecting Sales 59

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

European Pharmaceutical Review

MAY 12, 2023

Innovative therapies for rare diseases The acquisition will help to drive the growth of CTI’s lead product, kinase inhibitor VONJO ® (pacritinib) “in treating myeloproliferative disease,” stated Dr Adam Craig, President, Chief Executive Officer and Interim Chief Medical Officer of CTI BioPharma.

Food and Drug Administration 105

Food and Drug Administration Biopharma Medicine Food 105

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

FDA 115

FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

Food and Drug Administration 119

Food and Drug Administration FDA Healthcare Provider Prospecting 119

PM360

AUGUST 26, 2024

Now, precision medicine needs an overhaul. Traditionally, precision medicine was defined as a targeted approach using DNA, molecular signatures, epigenetics, lifestyle, comorbidities, and other factors. During the period from 2008 through 2020, the number of precision medicines in the US increased from 5 to 285. What happened?

Medicine 52

Medicine Food and Drug Administration Government Insurance 52

European Pharmaceutical Review

APRIL 4, 2025

One of the most significant challenges is keeping up with the changing regulatory requirements set by agencies such as the US FDA, EMA and International Council for Harmonisation (ICH). The human element plays a significant role in analytical testing for pharmaceuticals, as variability between analysts can lead to inconsistencies.

Pharmaceutical products 64

Pharmaceutical products Manufacturing Pharmaceutical Safety 64

European Pharmaceutical Review

AUGUST 11, 2023

The European Commission has revoked the conditional marketing authorisation (MA) for Novartis’ sickle cell medicine crizanlizumab in the European Union (EU) and EEA. The decision follows a May recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

Marketing 98

Marketing Food and Drug Administration Medicine FDA 98

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 Cedars-Sinai Board of Governors Regenerative Medicine Institute and the Smidt Heart Institute will lead the project.

Food and Drug Administration 98

Food and Drug Administration Medicine Training Electronics 98

Pharmaceutical Technology

APRIL 3, 2023

Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa. Its reference medicine, Humira, initially received approval with an adalimumab 50 mg/mL concentration.

Marketing 105

Marketing Food and Drug Administration Medicine Food 105

European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. The FDA’s approval of Ogsiveo is based on results from the Phase III DeFi clinical trial , which were published this year in the New England Journal of Medicine.

Food and Drug Administration 104

Food and Drug Administration Medicine FDA Food 104

pharmaphorum

NOVEMBER 14, 2022

The EMA’s human medicines committee (CHMP) has recommended IL-4 and IL-13 inhibitor Dupixent (dupilumab) to treat adults with moderate to severe PN, a disease which causes hard lumps to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain.

Sales 118

Sales Medicine Patients Leads 118

Pharmaceutical Technology

OCTOBER 11, 2022

Swiss biotech company Stalicla has signed a licensing deal with Evgen Pharma for the latter’s lead asset, SFX-01, in neurodevelopmental disorders and schizophrenia. in milestone payments that include $5m upon receipt of the investigational new drug (IND) from the US Food and Drug Administration (FDA), which is expected late next year.

Leads 59

Leads Food and Drug Administration Food Medicine 59

European Pharmaceutical Review

AUGUST 18, 2023

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat geographic atrophy (GA). FDA approves first treatment for geographic atrophy Avacincaptad Pegol Avacincaptad pegol (ACP) is a complement C5 protein inhibitor.

Food and Drug Administration 97

Food and Drug Administration Medicine FDA Food 97

European Pharmaceutical Review

MARCH 8, 2023

Ekaterina received her medical degree from St Petersburg Medical Academy in St Petersburg, Russia, and then moved to the US where she completed her Internal Medicine residency training. She worked in private practice, academic medicine and public health for more than 15 years in the greater New York area.

Leads 52

Leads Pharma Food and Drug Administration Medicine 52

pharmaphorum

JANUARY 30, 2023

One of the reasons is the most evident: the winter months often lead to greater need for antibiotics, and that can lead to shortages. For its part, the US Food and Drug Administration (FDA) posted its drug shortage list , which contains various formulations of amoxicillin that are limited in supply.

Food and Drug Administration 104

Food and Drug Administration Medicine Manufacturing Pharmaceutical 104

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Chief, Hip and Knee Division of Sports Medicine Institute, Hospital for Special Surgery in New York. TKA is a phenomenal operation, but it has its limitations. Are you hiring?

Marketing 96

Marketing FDA Food and Drug Administration Recruitment 96

pharmaphorum

DECEMBER 16, 2022

CSL’s gene therapy for haemophilia B has been recommended for approval by the EMA’s human medicine committee, setting up a decision by the European Commission early next year. million – making it the most expensive medicine in the world – which was above the $2.9 CSL launched the therapy in the US with a list price of $3.5

Medicine 126

Medicine Prospecting Networking Marketing 126

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. BEQVEZ is currently being reviewed by the European Medicines Agency (EMA), Pfizer confirmed.

Food and Drug Administration 96

Food and Drug Administration Medicine FDA Food 96

World of DTC Marketing

DECEMBER 10, 2020

In November 2017, a study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before. years to win FDA approval, at a median cost of $648 million.

Insurance 181

Insurance Pharma Manufacturing Retail 181

European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose.

Food and Drug Administration 104

Food and Drug Administration Side effects Medicine Food 104