Platelets are always in low supply with an additional problem with these sticky cell pieces being that platelets usually need to be utilized within five days, unlike whole blood, which may be stored for up to 35 days following donation. Ashley Brown, a biomedical engineer at North Carolina State University (NCSU), stated that platelets cannot be stored. He further added that it is not customary to transport platelets or other blood products to distant locations, like rural hospitals or combat zones, or to have them in an ambulance. Platelet retrieval is extremely challenging in these regions ..read more

The FDA has placed Neumora’s schizophrenia medication on hold due to reports of convulsions in rabbits. Neumora Therapeutics’ phase 1 study aimed at treating schizophrenia has been halted by the FDA following preclinical findings indicating convulsions in rabbits administered the medication. Thirty healthy adult individuals received doses of NMRA-266, a positive allosteric modulator of the M4 muscarinic receptor, as part of the single and multiple-ascending-dose phase 1 trial. Neumora stressed that none of these individuals displayed any signs of seizures. The biotech company stated that it is ..read more

Microbiome biotech MaaT Pharma says it will market its pooled fecal treatment medicine for acute graft-versus-host disease (aGvHD) in two years based on data collected 18 months after the treatment’s long-running trial hold was removed. A total of 140 patients with steroid-refractory or steroid-dependent gastrointestinal aGvHD who participated in the Pharma Early Access Program run by the French biotech were included in the 18-month data set. With a total survival rate of 54% at six months, 47% at a year, and 42% at 18 months, the findings clearly demonstrated a distinct survival edge among th ..read more

First, due to the burden on its patients and healthcare infrastructure, and now with the Food and Drug Administration’s (FDA) demand that they submit an additional 3 months of data for the subcutaneous version of their currently infused Alzheimer’s disease drug Leqembi, it is no longer feasible for Eisai and Biogen to make good on their promise of ensuring that their drug be brought to the reach of 10,000 patients by the end of March this year. Analysts have long thought of Leqembi as the turning or inflection point of Eisai and Biogen’s company trajectory and have been eagerly awaiting an inj ..read more

The successful sale of ZimVie’s spine division to investment firm H.I.G. Capital has triggered many noteworthy developments in the medical space that have resulted in the formation of spinouts. It was anticipated that this $375 million acquisition, which was revealed in December, would establish Highridge Medical as a distinct business with its main office situated in Colorado. Highridge’s main focus will be on producing fixation systems, screw and plate implants, bone-healing technology, among numerous other products related to the spine. Glen Kashuba, the CEO of Highridge, indicated belief i ..read more

As a therapy for two uncommon illnesses, ulcerative colitis (UC) and multiple sclerosis (MS), Bristol Myers Squibb’s Zeposia (ozanimod) has garnered interest. However, the sphingosine 1-phosphate (S1P) receptor modulator’s approval era may be coming to an end. The New Jersey-based business reported that its trial evaluating Zeposia in Crohn’s disease had not shown positive results. The medication did not achieve its primary aim of clinical remission at Week 12, according to the company’s preliminary analysis of data from a 12-week induction trial. In the indication, BMS did not disclose its st ..read more

With Regeneron’s desire to move its blood cancer medicine odronextamab from fifth line to first in some instances as treatment, the Food and Drug Administration (FDA) has now issued a complete response letter (CRL) to the company demanding that the current enrollment status of the confirmatory trials needs to be worked on. Unless the aforementioned issues are fixed the agency has refused to approve the drug under the accelerated review pathway. When a submission was initially made to the agency it was supplemented by the phase 1 ELM-1 study and the phase 2 ELM-2 study. In order to support the ..read more

Despite a setback when the FDA denied its first effort at clearance for Vafseo, an oral therapy for chronic kidney disease (CKD) anemia, two years ago, Akebia remained unwavering in its trust in the product. But the business just achieved a big milestone when it got the FDA’s long-awaited clearance for Vafseo. With this clearance, patients with CKD-associated anemia who have received dialysis for at least three months can take Vafseo. This creates a competitive market environment as Akebia and GSK compete head-to-head. After Akebia provided further safety data from Japanese patients—where Vafs ..read more

Olympus has joined forces with the American Lung Association (ALA) to raise awareness about the detection and staging of lung nodules, supporting educational materials that describe the procedure for patients. As detailed on the website and in the corresponding video, both chest X-rays and CT scans have the capacity to identify lung nodules that necessitate monitoring or further examination to diagnose their malignant or benign nature. In cases where the likelihood of cancer is deemed low, taking into account the attributes of the nodule and the patient’s lifestyle, the physician may recommend ..read more

As anticipated this week, the FDA is poised to authorize Merck’s pioneering treatment for pulmonary arterial hypertension (PAH). However, Johnson & Johnson has already secured approval from the U.S. regulator for its latest PAH therapy, effectively beating its New Jersey counterpart to the milestone. The FDA has granted approval for Opsynvi, a tablet formulation that blends J&J’s Opsumit (macitentan) with United Therapeutics’ Adcirca (tadalafil). These medications are commonly prescribed in combination to manage PAH, a rare and swiftly progressing ailment characterized by the narrowing ..read more