Regulatory

Clinical trials offer clinicians a unique opportunity to lead advances in medicine, granting access to cutting-edge therapies that address unmet patient needs. They are a cornerstone of clinical practice that enhance patient outcomes, particularly for those with complex or refractory cases who have exhausted standard treatment options. Clinicians understandably prioritize the well-being and interests of…

Facility design challenges for small biopharma startups For small biopharma startups, the leap from groundbreaking discoveries in the lab to full-scale drug production is both exhilarating and daunting. While scientific innovation drives initial success, translating laboratory methods into manufacturing processes presents challenges beyond technical expertise.  For all of the hurdles both compliance and technical rigor…

Merck recently won FDA approval for its sotatercept-csrk Winrevair for treating adults with pulmonary arterial hypertension. The drug was approved to increase exercise capacity and reduce the risk of clinical worsening events, according to the Rahway, N.J.-based company. It previously received FDA breakthrough designation and is the first FDA-approved action signaling inhibitor therapy for pulmonary…

Japanese health authorities searched a Kobayashi Pharmaceutical factory in Japan following reports of five deaths related to dietary supplements, Reuters reports. The plant inspection in western Japan is the second in recent days as health authorities inspected the company’s Osaka facility. In addition to the five reported deaths, there have been more than 100 hospitalizations…

Imagine scaling a mountain only to later lose digits or an entire hand to the unforgiving ravages of frostbite. For climbers, explorers, adventurous backcountry skiers, and even those caught in unexpected winter storms, severe cold exposure carries a devastating risk — amputation. Today,  thanks to a potentially landmark FDA approval, the prospect of losing one’s…

AbbVie (NYSE: ABBV) recently announced the launch of its Parkinson’s disease drug Produodopa (foslevodopa/foscarbidopa) in the European Union. Produodopa is for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement). It’s indicated for use when combinations of Parkinson’s medicinal products have not given satisfactory results. North…

Social media has become the new wild west for questionable prescription drug marketing. According to an investigation by Bloomberg Law, TikTok has emerged as a hotbed for inappropriate and potentially dangerous promotion of medications from self-dubbed influencers without any medical expertise. Drugs featured prominently include Novo Nordisk’s bestselling GLP-1 drug Ozempic and Pfizer’s migraine medication…

In the latest move targeting Big Pharma, the Biden Administration has signaled its intent to target the pricing of dozens of prescription drugs. In a recently announced Fact Sheet, the Administration announced a strategy under the Inflation Reduction Act to focus on 48 Medicare Part B drugs that have raised prices faster than inflation. This…

The ever-evolving landscape of pharmaceutical regulations has long been challenging to navigate, but now pharma companies face additional complexities with the introduction of the Inflation Reduction Act (IRA) and the ongoing implementation of the 340B drug pricing program. In recent years, the IRA has made waves for its impact on the pharmaceutical industry, including proposals…

In recent years, interest in the use of oral ketamine has surged for mood disorders, thanks to the marketing efforts of companies like Mindbloom, Better U, Nue Life and Joyous. FDA released a statement describing the risks involved in taking compounded oral ketamine, noting that the dissociative anesthetic is not FDA approved for any psychiatric…