Puma’s controversial cancer drug secures FDA approval

Puma | July 17, 2017

The U.S. Food and Drug Administration was forced to draw a line in the sand on Monday, with its approval of neratinib (Nerlynx), an adjuvant treatment for patients with early stage HER2-positive breast cancer. Manufactured by Los Angeles, California-based Puma Biotechnology, neratinib polarized experts with its Phase 3 data showing marginal efficacy and high rates of side effects. Many have questioned whether the benefits really outweigh the risks. On Monday, FDA settled that debate by granting it marketing approval.

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HEALTH TECHNOLOGY

CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema

Pulmonx Corporation | September 05, 2022

Pulmonx Corporation a global leader in minimally invasive treatments for severe lung disease, announces the presentation of interim results from the CONVERT Study at the 2022 European Respiratory Society International Conference. Data on the first 40 patients in the study demonstrated that treatment with the AeriSeal System successfully converted the collateral ventilation status in 78% of patients who were subsequently treated with Zephyr Valves. The AeriSeal System is used to close collateral air channels in a target lung lobe of a patient with severe COPD/emphysema, making the patient eligible to then undergo Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Valves. Patients whose lungs have untreated collateral ventilation are currently ineligible for treatment with Zephyr Valves and have limited options once medical management alone does not control symptoms. Once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr Valves, which has been shown to improve lung function, quality of life, and exercise capacity for patients with severe COPD/emphysema. The CONVERT study uses the AeriSeal System to close collateral air flow. Once the treated lobe tests negative for collateral ventilation Zephyr Valves are implanted to address hyperinflation of that target lobe to ease emphysema symptoms without major surgery. Successfully converted patients who received Zephyr Valves had clinically meaningful Target Lobe Volume Reduction with a mean reduction of greater than one (1) liter. The CONVERT trial is ongoing and full clinical outcomes of BLVR with Zephyr Valves were not reported at this time. However, results recently published from a single-center feasibility study at Macquarie University Hospital in Australia showed that the AeriSeal System successfully closed collateral air channels and allowed for successful clinical outcomes after treatment with Zephyr Valves.2 At 6 months, AeriSeal and Zephyr Valve treated CV+ patients experienced clinically meaningful improvements similar to improvements in CV- patients treated with Zephyr Valves alone.2 Improvements included Lung function (FEV1 increase of 19.7%, Residual Volume decrease of 16.2%) Quality of life (SGRQ score decrease of 15.1 points) Exercise capacity (Six-Minute Walk Distance increase of 77.2 meters) There were no serious adverse reactions experienced by patients in the Australian feasibility study; 20% of patients in the CONVERT Study experienced an inflammatory response following AeriSeal treatment - all were transient, medically managed, and resolved. The available data suggest that patients with collateral ventilation can undergo successful BLVR with Zephyr Valves following closure of the fissure gap with the AeriSeal System. “This is very promising news for patients with advanced COPD. We know that treatment with Zephyr Valves can provide long-term improvements in lung function, breathing, and quality of life, but for patients with collateral ventilation, this minimally invasive treatment has not been available as an option,” explains Dr. Michela Bezzi, Department Head and Director Interventional Pulmonology - ASST Spedali Civili, University Hospital, Brescia, Italy. “Having a technology like the AeriSeal System to convert collateral ventilation positive patients to negative status means we can provide a treatment to patients who currently have very few options.” “This work reflects our continued commitment to developing and testing new medical technologies to help patients with severe lung disease breathe easier and have better quality of life. These early study results are encouraging and move us closer to the goal of helping severe emphysema patients who have collateral ventilation benefit from our proven Zephyr Valve treatment.” Glen French, President and Chief Executive Officer of Pulmonx About the CONVERT Study CONVERT is a prospective, open-label, multi-center, single-arm study being conducted at up to 20 investigational sites. The study plans to enroll 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System, which uses a synthetic polymer foam to occlude collateral air channels in a target lung lobe and convert the target lung lobe to having little to no collateral ventilation. Patients will then undergo Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves. Zephyr Valves are not effective if collateral ventilation (CV+) is present but once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr Valves which has been shown to improve lung function, quality of life, and exercise capacity for patients with severe COPD/emphysema. About Zephyr Valves The Zephyr Valve is a minimally invasive treatment option for severe COPD/emphysema. Zephyr Valves are placed via bronchoscopy to block off a diseased portion of the lung to prevent air from getting trapped and reduce hyperinflation, which allows the healthier lung tissue to expand and take in more air. This results in patients being able to breathe easier, be less short of breath, and have an improvement in their quality of life.1 National and global treatment guidelines for COPD include Endobronchial Valves like Zephyr Valves with the Global Initiative for Chronic Obstructive Lung Disease giving valves an ‘Evidence A’ rating. More than 25,000 patients have been treated with the Zephyr Valve worldwide. About Pulmonx Corporation Pulmonx Corporation is a global leader in minimally invasive treatments for severe lung disease. Pulmonx’s Zephyr® Endobronchial Valve, Chartis® Pulmonary Assessment System and StratX® Lung Analysis Platform are designed to assess and treat patients with severe emphysema/COPD who, despite medical management, are still profoundly symptomatic. Pulmonx received FDA premarket approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially available in more than 25 countries, with over 100,000 valves used to treat more than 25,000 patients.

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HEALTH TECHNOLOGY

IMPLANET Signs an Exclusive Distribution Contract for SMTP Technology Co.’s Ultrasonic Surgical Scalpel in France

IMPLANET | November 23, 2022

IMPLANET a medical technology company specializing in vertebral implants, announces the signing of an agreement with SMTP Technology Co., a high-tech medical device company specialized in the manufacturing and marketing of ultrasonic medical equipment, for the exclusive distribution of its latest generation ultrasonic surgical scalpel in France. Adam Li, GMA & International Business Manager at SMTP Technology Co., stated: “We are delighted with the signing of this contract tying us to IMPLANET, which will henceforth ensure the distribution of our latest generation ultrasonic surgical scalpel. This innovative solution will increase surgical efficiency while ensuring greater patient safety. Thanks to this collaboration with IMPLANET, a company recognized for its expertise in the field of spine surgery and its foothold in French medical centers, we are strengthening the credibility of our solutions for their international deployment”. “This latest contract, which comes close on the heels of the commercial and technological partnership signed with Sanyou Medical, further emphasizes the pertinence of our repositioning on the spine market. The surgical scalpel developed by SMTP, through its innovation and ease of use, should meet the needs of surgeons and patients alike. IMPLANET is proud to be able to work with one of the only players in the world capable of developing this type of product based on ultrasound”. Ludovic Lastennet, IMPLANET’s Chief Executive Officer The ultrasonic surgical scalpel developed by SMTP Technology Co. can support both open surgery, minimally invasive surgery and endoscopic intervertebral spine surgery. This product, which has been granted marketing clearance in China, the European Union and the United States, stands out through its innovative design, guaranteeing enhanced surgical safety. Thanks to the smaller amplitude of its cutting tip, the scalpel cuts bone tissue by the acceleration of hundreds of thousands of mechanical vibrations per second while sparing soft tissue. The agreement signed today between IMPLANET and SMTP Technology Co. follows the signing of the distribution contract and technological partnership with Sanyou Medical, of which SMTP Technology Co. is a subsidiary. This new agreement gives IMPLANET exclusive rights to distribute the scalpel on the French market. SMTP Technology Co., founded in 2010, is a high-tech medical device company focusing on the innovative research and development, manufacturing and marketing of ultrasonic surgical equipment. The ultrasonic osteotomy surgical system manufactured by SMTP Technology, which supports both open surgery and minimally invasive surgery under the channel and intervertebral endoscope, has been granted marketing approval in China, the European Union and the United States. Based in the Zhangjiagang free trade zone in Jiangsu province, SMTP is a subsidiary of the Sanyou group with 100 employees and revenue of 14 million euro. About IMPLANET Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its activity revolves around a comprehensive innovative solution for improving the treatment of spinal pathologies complemented by the product range offered by Orthopaedic & Spine Development (OSD), acquired in May 2022. Implanet’s tried-and-tested orthopedic platform is based on the traceability of its products. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration in the United States, the CE mark in Europe and ANVISA approval in Brazil. IMPLANET employs 39 staff and recorded a consolidated revenue of €6.1 million in 2021. Based near Bordeaux in France, IMPLANET opened a US subsidiary in Boston in 2013. IMPLANET is listed on the Euronext Growth market in Paris.

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HEALTHTECH SECURITY

Tivic Health to Acquire Assets of Reliefband

Tivic Health | October 18, 2022

Tivic Health® Systems, Inc. a commercial-phase health technology company focused on bioelectronic medicine, announced it has entered into a definitive agreement to acquire the Reliefband product line for nausea treatment and all related assets from Reliefband Technologies, LLC. Reliefband has been an innovator in wearable, FDA-cleared electronic therapeutics for treatment of nausea and vomiting. Reliefband has multiple products available both over-the-counter and by prescription. “We are incredibly excited to add the full suite of Reliefband products to our commercial portfolio. The Reliefband team successfully pioneered a direct-to-consumer business model for medical products. This acquisition, when combined with our growing direct-to-consumer sales of ClearUP, will significantly accelerate Tivic’s revenue opportunities.” Jennifer Ernst, CEO of Tivic Health Recurring nausea impacts approximately 1 in 6 US adults. According to QY Research, nausea treatment is a $2.4B market in the US and $5.5B globally, growing at 6.5% CAGR. Reliefband’s wrist-worn electronic nerve stimulators have been FDA-cleared for treatment of nausea associated with seven independent clinical indications, including nausea from motion sickness, pregnancy, migraines, anxiety, chemotherapy, various medications and hangovers. The patented products are backed by 40 peer-reviewed clinical studies and have generated over 3500 Amazon reviews averaging 4+ stars. Both Reliefband and ClearUP products offer consumers ways to manage health-related conditions without the issues and side effects often associated with medication use. Both are FDA-cleared, highly effective, fast-acting, convenient, and drug-free. Both currently are sold primarily online, and both have received CE Marks allowing international expansion. In addition to the Reliefband direct-to-consumer branded products, Tivic will also acquire Reliefband’s Reletex-branded prescription nausea treatments. Reletex products are currently distributed by hospitals and medical professionals and are reimbursed under HCPCS code E0765 for certain conditions. “We look forward to growing Tivic with the addition of clinically proven, revenue-producing bioelectronic products that have seen strong customer adoption and growth,” continued Ernst. Consideration to be provided by Tivic consists of up to $33.5 million, of which up to $1.5 million can be paid, at the election of Tivic, in restricted common stock of Tivic. Consideration is subject to working capital adjustments, less Reliefband transaction expenses and any indebtedness of Reliefband at closing. The transaction is expected to be consummated in the fourth quarter of 2022 or first quarter of 2023 after the satisfaction of certain customary closing conditions, including but not limited to securing the financing necessary to pay the purchase price. Additional information on the transaction can be found in a Current Report on Form 8-K filed by Tivic with the Securities and Exchange Commission (SEC).

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HEALTH TECHNOLOGY

Annuo Med Tech Solutions Enters Partnership Agreement with WeKo GP

Annuo Medical Technology Solutions Pty Ltd | October 17, 2022

New health networking platform, Annuo™, has entered a working agreement with WeKo GP to assist with the identification and treatment of patients with chronic disease in Australia. This key partnership will facilitate the management of people living with chronic disease by General Practice teams using WeKo and Annuo™. WeKo’s Clinical System solution launched in 2019 and provides proactive chronic disease screening and detection based on patient medical data. “We believe our solutions are highly complementary and have the ability to offer an amazing patient and clinician experience,” commented WeKo Founder, Ross Hadfield. “We are excited to announce a trial partnership between Annuo and WeKo GP which will open up more possibilities for Annuo™ to help the 10.8M Australians currently living with chronic disease,” Dr Jeni Wellington, Founder and CEO of Annuo Med Tech Solutions At a high-level, the partnership will facilitate the identification and treatment of patients at high risk of chronic disease, using the Annuo platform and WeKo’s Clinical System. It will ensure patients are engaged in the creation of an agreed care plan and that the clinical teams involved are fully supported. About Annuo Med Tech Annuo Med Tech Solutions is a new Australian digital health technology company developing Annuo - a healthcare networking platform for doctors, patients and allied health professionals. Annuo™, is the first medical networking platform in Australia designed by specialists. More than that, Annuo™ is advocating for collaborative care for patients living with chronic disease in Australia. With 47% of Australians today living with one or more chronic diseases, there has never been a better time to help improve the lives of everyday people trying to navigate their treatment. Annuo™ encourages people living with chronic disease to engage with their treatment in an holistic way. Annuo promotes collaborative care for patients and is inclusive of those seeking to make diet, exercise and alternate therapies as part of their treatment planning. Annuo™ will engage with healthcare providers and enable them to better connect with their patients through the digital health space. The platform comes fully customised for each medical specialty at a competitive price.

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