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California Man Tells Jury of Getting Cancer After Using J&J Baby Powder
A California man suing Johnson & Johnson (JNJ.N) told jurors on Monday how his life was upended by a cancer diagnosis that he blames on using the company’s baby powder since childhood, as the first trial over the product in nearly two years neared its end.
“I just turned into a scared little kid,” Emory Hernandez, fighting back tears, said of his 2022 mesothelioma diagnosis while testifying in Alameda County Superior Court, according to an online broadcast of the trial by Courtroom View Network. He said he would have avoided J&J’s talc if he had been warned it contained asbestos, as his lawsuit alleges.
J&J has denied that its baby powder contained asbestos or causes cancer. J&J has argued in the case that Hernandez’s illness, which affects the tissue around his heart rather than the more common form affecting the lungs, is extremely rare and has not been linked to asbestos exposure.
Hernandez’s trial, expected to conclude later this week, comes as J&J seeks to resolve thousands of similar talc lawsuits through a settlement.
J&J subsidiary LTL Management in April filed for bankruptcy in Trenton, New Jersey, proposing to pay $8.9 billion to settle more than 38,000 lawsuits and prevent new cases from coming forward in the future. It is the company’s second attempt to resolve talc claims in bankruptcy after a federal appeals court rejected an earlier bid.
GSK’s Gonorrhea Vaccine Receives FDA’s ‘Fast-Track’ Designation
GSK‘s (GSK.L) vaccine candidate to treat sexually transmitted infection gonorrhea has been granted a fast-track designation by the U.S. Food and Drug Administration (FDA), the British drugmaker said on Tuesday.
The Neisseria gonorrhoeae investigational vaccine is currently at a mid-stage trial and aims to demonstrate the efficacy of the vaccine in healthy adults who are at high risk of the infection, the company said in a statement.
The FDA’s “Fast Track” designation is intended to facilitate the development and expedite the review of potentially important new drugs and vaccines to treat or prevent serious conditions with unmet medical needs.
Gardasil Vaccine Lawsuits Selected for Initial Bellwether Pool and ‘Workup’ for Trial
The U.S. District Judge presiding over all federal Gardasil vaccine lawsuits will meet this week with lawyers involved in the litigation, as initial “workup” gets underway in a group of 16 cases selected for early bellwether trials to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the growing number of claims brought by individuals who experienced complications after receiving the HPV vaccine.
Gardasil is a widely used vaccine that is typically administered to teens and young adults before they are sexually active, to protect against HPV infections, which can lead to the development of cervical cancer later in life. However, despite being marketed as safe and effective, lawsuits allege that the Merck & Co. HPV vaccine caused debilitating autoimmune complications, including postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure and other side effects.
There are currently nearly 90 complaints pending in the federal court system, which have been centralized before U.S. District Judge Robert J. Conrad in the Western District of North Carolina since they each involve common questions of fact and law. However, over the coming months and years, it is widely expected that the litigation will continue to expand, and hundreds of individual cases will ultimately be filed in the HPV vaccine MDL (multidistrict litigation).
Eli Lilly Experimental Obesity Drug Could Beat Rivals in Total Weight Loss for Patients
Eli Lilly’s experimental drug helped patients lose up to 24% of their weight after almost a year, the highest reduction seen in the obesity treatment space to date, according to new mid-stage clinical trial results released Monday.
The phase two trial followed 338 adults who were obese or overweight and either received the pharmaceutical company’s injection, retatrutide, or a placebo each week.
The trial’s researchers said average weight loss did not appear to plateau after 48 weeks, suggesting a longer study could show even more. Eli Lilly is currently recruiting patients for a phase three trial. That data suggests Eli Lilly’s retatrutide is the “most effective anti-obesity med to date,” Michael Weintraub, an endocrinologist at NYU Langone Health, said in a Twitter post.
Like Wegovy and Mounjaro, Eli Lilly’s retatrutide is a weekly injection that changes the way patients eat and leads to decreased appetite by mimicking certain hormones in the gut. But Wegovy only mimics one hunger-regulating hormone called GLP-1, while Mounjaro mimics GLP-1 and another hormone called GIP.
Pfizer Shares Drop After It Halts Development of Obesity Drug Due to Safety Concerns
Pfizer Inc. shares fell after it halted the early development of an oral drug for weight loss on safety concerns, raising investor anxiety about an alternative therapy the company is still developing.
The drugmaker will stop work on lotiglipron based on data from phase 1 clinical trials and lab measurements showing elevated levels of enzymes called transaminases from an ongoing mid-stage study, according to a statement Monday. The enzymes play a key role in liver function. None of the patients reported liver side effects or symptoms, Pfizer said.
The shares fell as much as 5.6% at 10:51 a.m. in New York, their biggest intraday drop since February 2022. Struggling to recover from waning COVID vaccine demand, Pfizer is racing to catch up with Novo Nordisk A/S and Eli Lilly & Co. in an obesity-treatment market estimated to grow to more than $100 billion in size in the coming years. Pfizer is pinning its hopes on danuglipron, another treatment still in development, to compete with the likes of Novo’s Wegovy and Lilly’s Mounjaro, both seen as blockbuster market leaders.
Merck, Ridgeback Withdraw COVID Drug Application in EU
Merck and Co (MRK.N) and partner Ridgeback Biotherapeutics said on Tuesday they had withdrawn their COVID-19 pill application in the European Union, months after the region’s regulator did not back the drug citing insufficient data.
Merck had requested the regulator’s Committee for Medicinal Products for Human Use (CHMP) to re-examine the application for molnupiravir, which is sold under the brand Lagevrio in several countries after CHMP advised against its market authorization in February. The agency had said the drug could not demonstrate benefits in treating COVID patients who did not need oxygen support and were at risk of their disease worsening.
The DEA Relaxed Online Prescribing Rules During COVID. Now It Wants to Rein Them in.
Federal regulators want most patients to see a healthcare provider in person before receiving prescriptions for potentially addictive medicines through telehealth — something that hasn’t been required in more than three years.
During the COVID-19 public health emergency, the Drug Enforcement Administration allowed doctors and other healthcare providers to prescribe controlled medicine during telehealth appointments without examining the patient in person. The emergency declaration ended on May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.
Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.
Regulators said they decided to extend the current regulations — which don’t require an in-person appointment — until November 11 after receiving more than 38,000 comments on the proposed changes, a record amount of feedback. They also said patients who receive controlled medications from prescribers they’ve never met in person will have until November 11, 2024, to come into compliance with the agency’s future rules.
