PM360

SEPTEMBER 21, 2023

Attention deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) , manufactured by Takeda, also is facing generic competition. In the respiratory area with inhalers, it’s tough to get drugs approved, so the competition comes slowly,” he said. In 2024, ARPA removes the 100% AMP cap.

Management 105

Management Manufacturing Sales Competition 105

pharmaphorum

JULY 11, 2022

One issue dogging the programmes has been cases of blood clots in late-stage trials, which prompted the FDA to place the drug under a clinical hold a few years ago. Sanofi acquired the drug when it bought Bioverativ in 2018 for $11.6 The post Sanofi trumpets data with haemophilia treatment duo at ISTH appeared first on.

Engineering 52

Engineering Side effects Competition Sales 52

pharmaphorum

NOVEMBER 25, 2022

The Parma site, as yet only nine months into construction, is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. In brief, the European plan for Chiesi is in-house drug development of biologicals and rare disease targeting. The situation was reversed only 25 years ago.

Pharmaceutical 98

Pharmaceutical Manufacturing Medicine Competition 98

Nixon Gwilt Law

JANUARY 16, 2024

What can digital health innovators and investors anticipate for the industry in 2024? What can digital health innovators and investors anticipate for the industry in 2024? Read on to find out what else is on our Legal Vision Board for 2024! The field is already saturated, so we will see companies exit as leaders emerge.

Healthcare 52

Healthcare Healthcare Management Insurance 52

Pharmaceutical Technology

JANUARY 10, 2023

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

Marketing 52

Marketing Physicians Leads Sales 52

Zymewire

FEBRUARY 8, 2024

Over t his period , Axonis has brought together and become world leaders in KCC2 biology , which has further separated us from our competition. In this climate you have to evaluate which assets have the maturity to reach FDA approval as quickly as possible, then we redirect most of our capital towards that effort.

Competition 52

Competition Leads Patients Marketing 52

PM360

JULY 26, 2023

I believe that the real innovation in this space, both in terms of advancing AI capabilities and in making it easier and safer to deploy, will come from a competitive marketplace that includes the startup community building solutions to challenge the large incumbents. That is really driving a lot of action on the part of our policymakers.

Government 95

Government Marketing Management Education 95

Evolve Your Success

APRIL 11, 2023

We have launched into the US marketplace and got the product design through FDA. I’ve got an FDA issue.” It’s a competitive field but if you’re in sales, don’t be afraid of competition. It’s very competitive. We are launching it here in the US. It is crowded.

Sales 52

Sales Medical Medical sales Media 52

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.

FDA 115

FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The company aims to then increase supplies in 2024.

Manufacturing 98

Manufacturing FDA Food and Drug Administration Pharmaceutical 98

Pharmaceutical Technology

JANUARY 6, 2023

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

Pharmaceutical 97

Pharmaceutical Doctors Healthcare Provider Prescription 97

Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Others are made by big pharma giants like Boehringer Ingelheim , Novartis , or Pfizer , which has raised the expectations for a competitive market. . Biosimilar uptake could be more gradual.

Marketing 104

Marketing Physicians Competition Patients 104

Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995. GlobalData is the parent company of Pharmaceutical Technology.

Medicine 59

Medicine Pharmaceutical FDA Sales 59

Pharmaceutical Technology

MARCH 29, 2023

In June 2020, the FDA gave ATX01 an orphan drug designation in erythromelalgia. The company expects to have data from both trials ready in mid-2024, says Thiroloix. Talks for this fundraise will likely start at the beginning of 2024, and the aim is to raise a significantly higher sum than in the previous rounds, confirms Thiroloix.

Recruitment 52

Recruitment Patients Prospecting Competition 52

Clarivate

DECEMBER 14, 2023

Pharmaceutical benefit managers, M&A activity among integrated delivery networks, disruption by nontraditional healthcare entities, enrollment, and the 2024 presidential election are five areas to pay attention to moving into 2024. Clarivate experts explain why these topics are ones to watch in 2024.

Marketing 52

Marketing Healthcare Healthcare Insurance 52