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How stricter EtO regs could shape the medtech industry

The Environmental Protection Agency recently implemented new regulations to limit emissions of a common but cancer-causing medical device sterilant, after years of health meetings, lawsuits and debate about how to handle the issue. Medical device companies will need to comply with new requirements governing ethylene oxide (EtO) emissions, and some device sterilizers are searching for suitable alternatives. In April, the EPA published a final rule that sets new limits for medical device sterilizers that use EtO. Now, companies will have three years to comply with the new standards. The agency is also working on a separate set of requirements to reduce EtO exposure for workers in sterilization plants. Long-term exposure to the chemical can increase a person’s lifetime cancer risk. In the meantime, the Food and Drug Administration has been evaluating other ways of sterilizing medical devices and changes companies can make to reduce EtO emissions. It has also launched ...
- Source: drugdu
- 104
- May 14, 2024
Answering the Call

From Big Pharma to biotech—and a globe-spanning journey along the way—Yvonne Greenstreet, this year’s Healthcare Businesswomen’s Association Woman of the Year, is right where she wants to be: leading efforts to advance “bold ideas” in RNAi therapeutics into life-changing gains for patients. Yvonne Greenstreet, CEO, Alnylam It’s no surprise that Yvonne Greenstreet is winning awards. On Jan. 9, the Healthcare Businesswomen’s Association (HBA) announced the Alnylam CEO as its 2024 Woman of the Year. In the release, the HBA said that Greenstreet had earned the honor through her “notable and remarkable commitment and valuable contributions to women in the healthcare ecosystem.” It went on to describe Greenstreet as a trailblazer, advocate, and a true leader. Specifically, Greenstreet’s leadership at Alnylam, an RNA interference (RNAi) therapeutics company, was recognized. Since being appointed CEO in October 2021, she has helped steer Alnylam to being named one of Fortune’s Best Workplaces for Women. ...
- Source: drugdu
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- May 14, 2024
Avoiding the Digital Age is Hurting Research Efforts

Mike Hollan Pharmaceutical ExecutivePharmaceutical Executive: May 2024 Mike Hollan, Assistant Managing Editor, Pharmaceutical Executive When it comes to developing new drugs and therapies, there is obviously nothing more important than data. Countless bits of data are collected for each medication before it hits the market, and researchers continue to collect data after that. Even before the modern technology boom, data was a key component of the life sciences industry. In the modern world, data is more valuable than ever. New technologies, such as AI and machine learning algorithms, are capable or collecting, sorting, and analyzing bits of data at a faster rate than ever before. Researchers across almost every industry are seeing the benefits and discovering new ways to innovate based on these discoveries. In the life sciences industry, this data is being used for everything from drug development, market analysis, and even scheduling sales reps calls. It’s undeniable that ...
- Source: drugdu
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- May 14, 2024
RAPT terminates Phase II trials for lead candidate following clinical hold

RAPT Therapeutics has announced plans to terminate two Phase II trials for its lead candidate, zelnecirnon (RPT193), three months after the US Food and Drug Administration (FDA) placed a clinical hold on them. In February, the US regulatory agency placed a clinical hold on the Phase IIa (NCT05935332) and Phase IIb trials (NCT05399368) that evaluated zelnecirnon in atopic dermatitis and moderate to severe asthma, respectively. The hold was placed after a patient in the atopic dermatitis trial suffered liver failure possibly caused by zelnecirnon. Following the trial termination news, RAPT’s stock was down by 41.7% at market close on 9 May, compared to market close on the previous day. Since the clinical hold was announced on 20 February, the company’s stock has dropped by over 82% compared to its peak before the news. RAPT ended Q1 with $141.6m in cash reserves and a net loss of $30.5m. Rapt’s market cap ...
- Source: drugdu
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- May 14, 2024
Hengrui Pharmaceuticals’ HRS5580 for Injection for Prevention of Postoperative Nausea and Vomiting Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals’ subsidiary Fujian Shengdi Pharmaceutical Co., Ltd. received the Approval Notice of Drug Clinical Trial issued by the State Drug Administration, which approved the company’s HRS5580 for injection to carry out clinical trials for the prevention of postoperative nausea and vomiting. Postoperative nausea and vomiting (PONV) mainly occurs within 24 hours after surgery, but can also be as long as 3~5 days, is one of the common complications of surgery. The incidence of PONV is estimated to be 20% to 37%, with a probability of up to 80% in high-risk patients. Nausea and vomiting can be a distressing experience for patients when combined with postoperative pain. The effectiveness of the current main clinical agents for the prevention of PONV for the prevention of vomiting after surgery needs to be improved, and the development of new therapeutic agents is urgently needed. HRS5580 for injection is an injectable agent independently ...
- Source: drugdu
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- May 14, 2024
Sanofi signs $1.2bn licensing agreement for Novavax’s Covid-19 vaccine

Sanofi has signed a $1.2bn licensing agreement with Novavax to co-commercialise its stand-alone adjuvanted Covid-19 vaccine. Starting in 2025, the drugmaker will co-commercialise the vaccine worldwide, except for in countries such as India, South Korea, and Japan where Novavax already has existing partnerships in place. As per the “co-exclusive” agreement, Sanofi will also support certain R&D, regulatory, and commercial expenses. The American vaccine company has faced tough times in the post-Covid-19 landscape, going as far as to issue a “going concern” warning in 2023 about its ability to continue operating. At the time, Novavax said it was subject to “significant uncertainty” concerning future sales and funding from the US Government. Following the deal with Sanofi, the removal of this warning was noted in Novavax’s first quarter 2024 financial results and operational highlights released today. Novavax CEO John Jacobs told CNBC that the agreement with Sanofi would allow it to lift ...
- Source: drugdu
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- May 14, 2024
BIO-THERA BAT1308 (PD-1) in combination with BAT8006 (ADC- FRα) approved for clinical trials in advanced solid tumors

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, which approves the clinical trial application of the Company’s investigational drug BAT1308 in combination with BAT8006 for the treatment of advanced solid tumors. BAT1308 injection is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA. Its active ingredient is an antibody targeting human programmed cell death protein 1 (PD-1) expressed by Chinese hamster ovary cells, which belongs to the immunoglobulin IgG4κ subtype, and is capable of binding specifically to human PD-1 with high affinity, thus blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2. BAT1308 is able to bind to PD-1 on the surface of T-cells and release the inhibitory effect of ...
- Source: drugdu
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- May 14, 2024
The Impact of Micropayments in Clinical Trials

Micropayments provide an additional incentive for patients to complete required tests, procedures, and diary entries, ensuring that sites, sponsors, and CROs are able to collect the required data needed to complete a clinical trial on time and on budget. By Tanya Kogan on May 10, 2024 Clinical trials today require more patient involvement than ever before. Yet longer, more frequent site visits or participation that requires extensive travel can impact a patient’s willingness to participate in and remain in a clinical trial over the long term. As a result, patient recruitment and retention can be a challenge for sites and pharmaceutical companies, especially when the target patient population is small or geographically dispersed. Sadly, the average dropout rate across clinical trials is 30 percent. With the increasing need for consistent and accurate patient data, sponsors and sites are investing in electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessment (eCOA) ...
- Source: drugdu
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- May 13, 2024
Biotech’s Road to Recovery Takes a Wobbly Turn

Barbara Ryan Now-unclear timing on rate cuts puts onus back on fundamentals. Barbara Ryan, Founder, Barbara Ryan Advisors As of the writing of this column (May 1), the XBI stood at $88.30, well off of its recent recovery high of $102+ on Feb. 27, but still more significantly above the Oct. 27, 2023, low of $64. For context, the index hit an all-time high of $140 in October of 2020 (the COVID-19 “sugar high”), which was followed by a painful three-year decline of 54% from peak to trough, a bloody run for biotech specialists to be sure. The least fortunate early-stage companies who went public with limited capital and no proof-of-concept data fared far worse; some falling 90+%, others are no longer in business, and those who have survived have done so by making difficult decisions, including reprioritizing programs, restructuring to extend cash runways, or pursuing reverse mergers or shut-downs/liquidations. ...
- Source: drugdu
- 117
- May 13, 2024
FDA posts final guidance on remanufacturing medical devices

Dive Brief The Food and Drug Administration published final guidance on the remanufacturing of medical devices on Thursday. Acting on feedback from groups including Advamed, the FDA has changed the title of the text and added a section on the regulatory requirements for remanufacturers. The new section, which applies to original equipment manufacturers and service providers, is intended to help entities that are less familiar with the medical device regulatory requirements. Dive Insight The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing. The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products. After assessing feedback on the draft, the FDA has retained its definition of remanufacturing ...
- Source: drugdu
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- May 13, 2024

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