As the tension around reproductive health grows, one company is expanding its reproductive and sexual health offerings to provide more support for patients. New York City-based Hey Jane, a virtual abortion provider, announced last week that it is now offering vaginal infections treatment. This includes treatment for urinary tract infections, bacterial vaginosis and herpes. It is also offering birth control and emergency contraception. Patients complete an intake form, are connected with a provider on Hey Jane and then are able to discuss their needs with the provider via text, phone or video. The company chose to expand beyond abortion services after hearing a need from its current patients, said Alyssa Wagner, DNP, RN, APRN, WHNP-BC, head of medical at Hey Jane. She added that it was a natural step for the company. “All abortion is is reproductive health, just like yeast, just like herpes, just like birth control,” Wagner said ...
By Tristan Manalac Pictured: U.S. Supreme Court building in Washington, DC/ iStock, SeanPavonePhoto A U.S. federal appeals court on Wednesday imposed restrictions on access to the abortion pill mifepristone, though this ruling will not take effect immediately as its effectivity is pending the Supreme Court’s review. While it did not rule that mifepristone had to be taken off the market completely, the U.S. 5th Circuit Court of Appeals in its 93-page decision upheld a lower court’s ruling that disallowed telemedicine prescriptions for the drug and its delivery by mail. “In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote for the court, adding that the regulator also did not consider the “cumulative effect” of lifting several safeguards simultaneously. “And it failed to gather evidence that affirmatively showed that mifepristone could ...
Pfizer is shelling out $43 billion to acquire Seagen primarily for the Seattle biotech’s antibody-drug conjugate (ADC) capabilities. But a trial win for a small-molecule cancer drug makes the deal more attractive. Seagen on Wednesday said a phase 3 trial testing a combination of its Tukysa and Roche’s Kadcyla has hit its main goal in patients with previously treated HER2-positive breast cancer. Compared with Kadcyla and placebo, the combo significantly reduced the risk of tumor progression or death, Seagen said. Data on patient survival remain immature. Seagen plans to share the detailed results from the HER2CLIMB-02 trial at a medical meeting and will discuss them with the FDA, the company’s R&D chief, Roger Dansey, said in a statement. The positive results further de-risk the Seagen acquisition by Pfizer, Leerink Partners analysts said in a Wednesday note. Since securing FDA approval in 2020, Tukysa has been used alongside trastuzumab (Herceptin) and ...
Pharmaceutical businesses face a unique challenge: they must navigate a maze of strict industry standards when marketing their products, ensuring every step aligns with industry regulations and legal requirements. While these constraints can seem daunting, digital marketing holds vast potential for these enterprises, offering myriad channels and methods to craft compelling strategies that not only resonate with potential audiences but also remain compliant. Drugdu.com has summarized five digital marketing strategies specifically for the industry: 1.Gain Attention on Search Engines Using SEO Search Engine Optimization (SEO) is the cornerstone of any online digital marketing. It ensures your website or page appears in the search engine results, leading customers to you. As SEO can drive traffic to your website, it plays an indispensable role in pharmaceutical digital marketing. To stand out amongst numerous websites, optimization is key. How to achieve a good ranking in search engines? ① Optimize titles and tags ② Eye-catching ...
Dr. Heather Sandison, a leading expert in Alzheimer’s Disease and Related Dementia (ADRD) care, has recently published a groundbreaking study in the Journal of Alzheimer’s Disease, highlighting significant improvements in cognitive function among individuals with cognitive decline. The study is the second to employ a multimodal, individualized care plan and offers further hope for managing and potentially reversing cognitive impairment. The study, “Improved Cognition in People with Cognitive Decline: A Multimodal Intervention Approach,” is published in the Journal of Alzheimer’s Disease Volume (94) Issue (3) and focused on individuals with objective cognitive impairment (OCI), a precursor to Alzheimer’s disease. Dr. Sandison and her team recruited 34 participants from the San Diego, CA area to receive a comprehensive intervention based on potential contributors to cognitive decline, such as lifestyle changes, nutraceutical support, and medications. Over the course of six months, the participants underwent regular clinical visits and received ongoing nutrition support ...
By Connor Lynch Pictured: Cancer patient in bed looking out window/iStock, Ridofranz Biotech Seagen announced promising Phase III results Wednesday for its tyrosine kinase inhibitor Tukysa (tucatinib), in combination with Genentech’s antibody-drug conjugate Kadcyla (ado-trastuzumab emtansine), which met its primary endpoint of progression-free survival in HER-2 breast cancer patients. The HER2CLIMB-02 trial was investigating the efficacy of Tukysa in combination with Genentech’s Kadcyla to treat locally advanced or metastatic HER-2 breast cancer that had received previous treatment with taxane and trastuzumab. While the trial met the primary endpoint of PFS, the study’s data on its secondary endpoint of overall survival “were not yet mature,” Seagen Chief Medical Officer Roger Dansey said in a statement. The combination arm of the trial also resulted in more discontinuation “due to adverse events,” but also noted that “no new safety signals emerged for the combination.” Serious adverse reactions occurred in the study in 26% ...
The stockholders of Diffusion Pharmaceuticals have approved a merger with EIP Pharma, which is on track to close on 16 August. Diffusion’s stockholders approved all proposals as part of a special meeting, including the issuance of Diffusion Common Stock and a reverse stock split of outstanding Diffusion Common Stock, based on the 15 August press release. Specifically, 71% of stockholders voted in favour of the transaction, while 73% voiced their support for the Reverse Split. The combined company is expected to have cash runway through the trial until the end of 2024, based on a 30 March press release. If all goes ahead, the soon-to-be merged companies will begin trading as CervoMed under the trading symbol CRVO when NASDAQ opens on 17 August. The merger’s approval marks a further development in Diffusion’s strategic review process. In October 2022, Diffusion authorised the evaluation of additional strategic opportunities, which included joint ventures, ...
Novo Nordisk’s blockbuster weight loss injection Wegovy could prevent up to 1.5 million heart attacks, strokes and other cardiovascular events in the U.S. over 10 years, according to a study released this week. Researchers from the University of California, Irvine, also found that Wegovy could result in 43 million fewer Americans with obesity over a decade. Notably, the study was partly funded by Novo Nordisk. The study results complement the initial data the Danish company released last week from a large clinical trial, which found that Wegovy slashed the risk of serious heart problems and heart-related death by 20%. Novo Nordisk’s trial studied overweight or obese patients with established cardiovascular disease, while UC Irvine’s study examined similar patients, albeit without the disease. Together, the results suggest that Wegovy and, likely, similar obesity drugs have significant health benefits beyond shedding unwanted pounds. Physicians and Wall Street analysts hope that could eventually ...
For three years, Teva has been defending against claims from the U.S. government that it paid illegal kickbacks to boost sales of its multiple sclerosis drug Copaxone. Now, with a trial just weeks away, Teva has scored a delay to pursue a unique appeal strategy. The trial was previously scheduled for September but has been postponed because of “substantial ground for difference of opinion” in one important aspect of the case, U.S. District Judge Nathaniel Gorton wrote in a Monday order (PDF) published by Reuters. The case centers on allegations from the government that Teva paid two patient foundations hundreds of millions of dollars to cover Medicare co-pays for patients on Copaxone for many years. The company made payments to the foundations even as it repeteadly raised prices, according to the government. The U.S. also alleges violations of the Anti-Kickback Statute, which prohibits drugmakers from directly funding Medicare co-pays. The ...
Drugdu.com expert’s response: To export pharmaceuticals to the United States, in addition to obtaining FDA certification, one must also comply with other U.S. import regulations. After receiving FDA approval, the drug also needs to adhere to the import regulations set by the U.S. Customs and Border Protection (CBP). Sometimes, this may involve obtaining additional import permits or certificates, but the specific requirements can vary based on the type of product and specific circumstances. Before shipping the drug to the U.S., ensure that you are familiar with and compliant with all relevant regulations. Collaborating with local import/export agents might be helpful as they are typically knowledgeable about these regulations and can provide specific guidance.
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