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Federal Appeals Court Rules for Tighter Restrictions on Abortion Pill

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 ...
- Source: drugdu
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- August 19, 2023
With trial win, Seagen’s breast cancer drug Tukysa boosts Roche’s Kadcyla—and Pfizer’s $43B buyout

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 ...
- Source: drugdu
- 152
- August 19, 2023
A Comprehensive Guide

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 ...
- Source: drugdu
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- August 18, 2023
B2B Platforms Content Marketing Digital Marketing Pharmaceutical Companies Reputation Management SEO Social Media
Medtronic’s dialysis device recall assigned to Class I by the FDA

Dive Brief Medtronic’s recall of hemodialysis catheters was categorized by the U.S. Food and Drug Administration as a Class I event, according to a Friday entry in the FDA’s database. The company contacted customers in June after routine manufacturing testing identified a blockage that could obstruct the catheter, potentially delaying treatment and leading to outcomes such as blood clots and the destruction of red blood cells. Healthcare providers with devices covered by the recall should immediately quarantine and stop use of the catheters. Medtronic has received no confirmed complaints related to the problem, and no reports of adverse events or deaths. Dive Insight The Medtronic recall affects specific lots of Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple Lumen Catheters. Medtronic’s Mahurkar Elite Catheters are unaffected by the recall. “Medtronic initiated a voluntary recall related to Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple ...
- Source: drugdu
- 148
- August 18, 2023
Multimodal intervention approach shows promise in managing and reversing cognitive impairment

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 ...
- Source: drugdu
- 205
- August 18, 2023
Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection

By Tristan Manalac Pictured: Cancer cells growing on the liver/iStock, Rasi Bhadramani The FDA on Monday approved Delcath Systems’ Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma, capping a nearly decade-long effort to secure regulatory approval. Hepzato’s label covers metastatic uveal melanoma (mUM) patients with unresectable hepatic metastases that afflicts less than 50% of their liver and who do not show signs of extra-hepatic disease. Hepzato can also be used in cases of extra-hepatic spread, provided it is limited to the bone, lymph nodes, subcutaneous tissues or lungs. Monday’s approval makes Hepzato “the only liver-directed therapy that can treat the whole liver,” Delcath Chief Medical Officer Vojislav Vukovic said in a statement. The approved product comes with a boxed warning for severe peri-procedural complications, such as hemorrhage and hepatocellular injury, as well as myelosuppression. To manage these risks, the company will implement a Risk Evaluation ...
- Source: drugdu
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- August 18, 2023
Seagen Touts Phase III Data for Breast Cancer Combo Therapy

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% ...
- Source: drugdu
- 205
- August 18, 2023
Diffusion Pharma’s stockholders support merger with EIP Pharma

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, ...
- Source: drugdu
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- August 18, 2023
Wegovy could prevent up to 1.5 million heart attacks, strokes over 10 years, study says

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 ...
- Source: drugdu
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- August 18, 2023
Legend exec

Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option. Carvykti generated $117 million in the second-quarter sales, up from $72 million in the first three months of the year. The increase suggests the two companies’ efforts to ramp up supply are working. Manufacturing capacity has been a limiting factor for Carvykti’s performance since its launch last Spring, and expansion is key as the partners angle for earlier lines of treatment. Under a regular review timeline, the FDA has set April 5, 2024, as the target decision date for Carvykti’s application as a second- to fourth-line myeloma treatment, Legend said Tuesday. The standard review is somewhat disappointing given that industry watchers were expecting a priority review, which might’ve enabled a launch in December. But the longer timeline shouldn’t be much of a problem because J&J and Legend don’t have ...
- Source: drugdu
- 121
- August 18, 2023

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