European Pharmaceutical Review

NOVEMBER 28, 2024

This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria.

Government 105

Government Medical Safety Management 105

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. Starting in 2026, the provision will affect 10 Part D drugs.

Management 105

Management Manufacturing Sales Competition 105

Medico Reach

OCTOBER 17, 2022

million by 2028. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. The potential increase in industry competition could also spell trouble for some. Now, the demand for such equipment is on track to grow exponentially.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

Pharmaceutical Technology

FEBRUARY 13, 2023

By this same virtue, PROTACs are able to degrade previously undruggable targets, which provides a major competitive advantage for this modality if shown to be true. GlobalData’s analyst consensus forecast database estimates peak annual sales for ARV-110 of $325 million in 2028. with Calquence, 16% with Imbruvica, NCT02477696).

Competition 59

Competition Safety Patients Pharmaceutical 59

European Pharmaceutical Review

FEBRUARY 7, 2023

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. However, a delicate balance will need to be struck between the need for affordable and accessible medicinal products and the desire to foster innovation and competitiveness in the EU.

Medical 117

Medical Government Marketing Medicine 117

Clarivate

OCTOBER 25, 2023

The dearth of cancer drugs (only blood cancer drug Imbruvica made this first list) stems from CMS only pursuing negotiations for Part D drugs in 2026 and 2027, then expanding to Part B drugs in 2028. exclusions exist for orphan drug designation and biosimilar competition ).

Prescription 52

Prescription Physicians Manufacturing Healthcare 52

Clarivate

AUGUST 27, 2024

In our September 2023 report on the electrophysiology market, Clarivate projected that by 2028, PFA would represent 50% of the U.S. In addition, the improved safety profile of PFA is making the cost-benefit of ablation an easier calculation for many patients. ablation market and would have a total global market value of $3 billion.

Marketing 52

Marketing Competition FDA Electronics 52