Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

European Pharmaceutical Review

OCTOBER 14, 2022

Amgen’s 2022 market report has detailed how competition has driven savings across healthcare, estimating that a considerable number of biologics will be in competition with biosimilars in five to 10 years. In Q2, savings in drug spend due to biosimilar availability is estimated to be a substantial $3.2

Competition 77

Competition Healthcare Healthcare Food and Drug Administration 77

World of DTC Marketing

NOVEMBER 24, 2021

needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S. SUMMARY: The U.S.

Food and Drug Administration 266

Food and Drug Administration Insurance Prescription FDA 266

Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

Healthcare 40

Healthcare Healthcare Marketing Pharma 40

Pharmaceutical Technology

JUNE 20, 2023

Santhera Pharmaceuticals and Catalyst Pharmaceuticals have signed an exclusive licence and collaboration deal for Santhera’s vamorolone in the US, Canada and Mexico. Catalyst Pharmaceuticals will gain exclusive rights to commercialise vamorolone across the region.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Medicine 98

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. This authorisation of BEQVEZ is based on results from the pivotal Phase III BENEGENE-2 study.

Food and Drug Administration 72

Food and Drug Administration Medicine FDA Food 72

European Pharmaceutical Review

AUGUST 29, 2023

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes.

Food and Drug Administration 82

Food and Drug Administration Safety Medicine Food 82

Pharmaceutical Technology

FEBRUARY 2, 2023

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. We also explore how AI is being used to design digital twins for clinical trials.

Food and Drug Administration 98

Food and Drug Administration Food Pharma Pharmaceutical 98

European Pharmaceutical Review

MARCH 27, 2024

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). Merck/MSD stated that WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

Food and Drug Administration 80

Food and Drug Administration FDA Healthcare Provider Food 80

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

Food and Drug Administration 87

Food and Drug Administration Transportation FDA Medical 87

World of DTC Marketing

SEPTEMBER 7, 2022

Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it.

Pharma 210

Pharma Food and Drug Administration Marketing Prescription 210

Pharmaceutical Technology

JULY 21, 2022

Listed below are the key technology trends impacting the ESG performance in the healthcare sector, as identified by GlobalData. AI also speeds up the drug development process, which could translate into cheaper drugs for patients. 3D bioprinting offers an alternative to animal testing in drug development. 3D printing.

Food and Drug Administration 98

Food and Drug Administration Government Pharma Healthcare 98

World of DTC Marketing

NOVEMBER 12, 2020

The median premarket clinical development period (investigational new drug submission to FDA approval) was 8.1 President Elect Biden has the challenge of choosing a healthcare people in his Administration who can restore public trust and not see a conspiracy in everything. Of these, 4 (19.0%) received Accelerated Approval.

Food and Drug Administration 187

Food and Drug Administration FDA Distribution Government 187

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

Food and Drug Administration 78

Food and Drug Administration Manufacturing Management Safety 78

World of DTC Marketing

AUGUST 25, 2020

Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals. For the first time, I am now in fear of FDA drug approvals. scientists. Dr. Stephen Hahn, the F.D.A.’s

Food and Drug Administration 188

Food and Drug Administration FDA Ethics Prescription 188

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

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. “If

Food and Drug Administration 119

Food and Drug Administration FDA Healthcare Provider Prospecting 119

World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

European Pharmaceutical Review

MARCH 31, 2023

Only seven months after the first regulatory approval of cabotegravir LA for PrEP by the US Food and Drug Administration (FDA), ViiV Healthcare and MPP signed a voluntary licence agreement in July 2022.

Medicine 102

Medicine Manufacturing Food and Drug Administration Food 102

Penrod

JUNE 6, 2024

Health Cloud was a version of Salesforce CRM tailored to healthcare providers, insurance companies, and other organizations’ unique needs with patient-focused business models. Like many healthcare providers, life science companies aren’t reaching their goals for digital transformation.

CRM 52

CRM Food and Drug Administration Healthcare Provider Management 52

European Pharmaceutical Review

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. 1 It defined LBPs as drug products containing live microorganism(s) to be used to prevent, treat or cure a disease or condition in human beings. Download and read more now… .

Food and Drug Administration 99

Food and Drug Administration FDA Medicine Government 99

Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Covid-19 vaccines stay in the spotlight.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Pharma 52

Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ 505(b)(2) new drug application (NDA) for a ready-to-use oncology injectable, PEMRYDI RTU. Amneal Pharmaceuticals claimed that PEMRYDI RTU is the first and only ready-to-use presentation of pemetrexed for injection.

Food and Drug Administration 52

Food and Drug Administration FDA Food Pharmaceutical 52

European Pharmaceutical Review

APRIL 17, 2024

These results demonstrate the potential of subcutaneous OCREVUS as a treatment option that can be matched to the individual needs of people with MS and healthcare professionals,” Newsome added. The post Encouraging data for Roche multiple sclerosis injection appeared first on European Pharmaceutical Review.

Food and Drug Administration 66

Food and Drug Administration Safety Medicine Food 66

Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. The drug works by blocking an enzyme known as BACE1, which is responsible for producing beta-amyloid.

Food and Drug Administration 52

Food and Drug Administration FDA Consulting Food 52

Pharmaceutical Technology

APRIL 17, 2023

Australian pharmaceutical company Incannex has appointed Quest Pharmaceutical Services (QPS) to advance CannQuit-N (Nicotine), CannQuit-O (Opioid) and Renecann Products in the USA and the European Union (EU). In 2022, the company acquired CannQuit and ReneCann products as part of the acquisition of APIRx Pharmaceuticals.

Food and Drug Administration 52

Food and Drug Administration Management Food Pharmaceutical 52

European Pharmaceutical Review

DECEMBER 15, 2023

The positive European opinion, follows a world first approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in November. Casgevy was also approved by the US Food and Drug Administration (FDA) for use in patients with sickle cell disease earlier in December.

Medicine 87

Medicine Food and Drug Administration Food Patients 87

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Management 74

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 74

European Pharmaceutical Review

AUGUST 11, 2023

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. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA).

Marketing 82

Marketing Food and Drug Administration Medicine FDA 82

Pharmaceutical Technology

APRIL 25, 2023

Rhythm Pharmaceuticals has launched Imcivree (setmelanotide) in Germany to treat obesity and control of hunger associated with Bardet-Biedl syndrome (BBS). A melanocortin-4 receptor (MC4R) agonist, Imcivree has been designed for the treatment of hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases.

Food and Drug Administration 52

Food and Drug Administration Insurance Food Pharmaceutical 52

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades. .

Food and Drug Administration 106

Food and Drug Administration Medicine Food Government 106

Pharmaceutical Technology

SEPTEMBER 29, 2022

Indian company Torrent Pharmaceuticals has signed a definitive agreement for the complete acquisition of Curatio Healthcare for $245.16m (Rs20bn). Torrent Pharmaceuticals director Aman Mehta said: “We are delighted to enter into this deal with Curatio. Torrent R&D infrastructure employs over 800 scientists.

Food and Drug Administration 59

Food and Drug Administration Pharma Specialization Food 59

Pharma Marketing Network

MARCH 25, 2023

Pharmaceutical advertising is a crucial aspect of promoting and marketing drugs to the public. With the increase in competition, it has become essential for pharmaceutical companies to find the most effective methods of advertisement to reach their target audience.

Pharma 52

Pharma Food and Drug Administration Prescription Pharmaceutical 52

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. The post MHRA authorises alopecia treatment appeared first on European Pharmaceutical Review.

Food and Drug Administration 83

Food and Drug Administration Side effects Medicine Food 83

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals.

Food and Drug Administration 52

Food and Drug Administration FDA Biopharma Food 52

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. In addition, Ayvakit is the only treatment approved across the spectrum of indolent and advanced systemic mastocytosis.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare Provider 98