EU regulators to fast-track Janssen’s multiple myeloma CAR-T

Janssen | April 04, 2019

European regulators are to hasten development of Janssen’s CAR-T therapy for patients with multiple myeloma, after promising early-stage trial results. Janssen, the pharma arm of Johnson & Johnson, said the European Medicines Agency has granted a PRIME (PRIority MEdicines) designation for the investigational B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, JNJ-4528. Janssen has been developing the CAR-T previously known as LCAR-B38M with China’s Legend Biotech following a deal signed in December 2017. US biotech bluebird bio and partner Celgene are competitors and have two BCMA CAR-T therapies in early stage development for multiple myeloma, while Amgen’s AMG 420 has also emerged as a potential contender with some spectacular remission rates in a small trial announced last September.

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EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

EyePoint Pharmaceuticals, Inc. | April 19, 2022

EyePoint Pharmaceuticals, Inc. a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company’s 2016 Long-Term Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4). The Company granted stock options to purchase up to an aggregate of 56,500 shares of EyePoint Pharmaceuticals common stock to four new employees. The stock options were granted on April 14, 2022. The grants were approved by the Compensation Committee and made as an inducement material to each employee entering into employment with EyePoint Pharmaceuticals in accordance with NASDAQ Listing Rule 5635(c)(4). The option awards have an exercise price of $12.69 per share, the closing price of EyePoint Pharmaceuticals’ common stock on April 14, 2022. The options have a ten-year term and vest over four years, with 25% of the original number of shares vesting on the first anniversary of the applicable employee’s date of grant and the remainder vesting in equal monthly installments over the following three years. Vesting of the options is subject to the employee’s continued service with EyePoint Pharmaceuticals through the applicable vesting dates. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential six-month intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. Durasert’s proven intravitreal drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ® for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

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TendoNova wins FDA Clearance for Its New Microinvasive Ocelot Surgical Tool

TendoNova | March 24, 2022

TendoNova, an emerging leader in microinvasive sports medicine procedures, is pleased to announce the FDA 510 clearance of its new Ocelot surgical tool, which uses an innovative technology for fragmentation or debridement of soft tissue. The FDA found the Ocelot TDS 1000 substantially equivalent to the Tenex TX1 which is routinely used for percutaneous tenotomy in orthopedics, sports medicine, pain management, and podiatry. The Ocelot System's form factor and price point make it an exciting alternative to existing tools. Using technology licensed from Georgia Institute of Technology and Emory University School of Medicine, the Ocelot facilitates procedures that require fragmentation and debridement of soft tissue under external image guidance in a simple hand-held format. TendoNova was able to achieve this success through grants and investor backing of groups such as the Georgia Research Alliance and the NFL Players' Association. "According to studies cited by the Centers for Disease Control and Prevention, more than 30 million people in the U.S. suffer from chronic tendon pain, and half of those have little or no relief from physical therapy or medication. The Ocelot is the company's first product and was conceived in response to a request by Atlanta Hawks head team physician Dr. Ken Mautner for an improved tool." TendoNova CEO, Mark A Samuels Dr. Mautner, who practices at Emory, commented that, "After 15 years of treating elite and recreational athletes for tendinopathy, I have been frustrated by the tools we have had to help heal these injuries. The TendoNova device could be a game changer in getting our athletes back to the healthiest level possible." The Ocelot System performs mechanical fragmentation or debridement of a targeted area. The use of fragmentation and debridement is part of a common treatment for encouraging the growth of healthy tendon to supplant painful pathologic tendon tissue. Chronic tendon pain disorders, or tendinopathies, include tennis elbow, plantar fasciitis, and jumper's knee. Tendinopathy is prevalent in athletes and anyone else who engages in repetitive tasks. If left untreated, can lead to months or years of pain and even career-ending injuries. TendoNova plans to manufacture the Ocelot in Georgia and is presently working to validate the Ocelot disposable component production. The Ocelot is expected to be available to physicians in the second half of 2022. About TendoNova Founded in 2017, TendoNova is a medical device company that is an emerging leader in microinvasive sports medicine procedures. The company's initial product is the Ocelot™ TSD 1000, a patented, FDA cleared medical device for fragmentation or debridement of soft tissue. TendoNova is also working on a digital health solution projected to provide device operating feedback during a procedure to reduce training times and improve outcomes. Dedicated to helping people live healthier lives with less pain and fewer injuries, the company plans a series of instrumented microinvasive tools designed to help physicians better heal patients suffering from advanced tendon and other pathologies.

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Acorda Therapeutics and Biopas Laboratories Announce Agreement to Commercialize INBRIJA® in Latin America

Acorda Therapeutics, Inc. | May 12, 2022

Acorda Therapeutics, Inc. and Biopas Laboratorie announced that they have entered into distribution and supply agreements to commercialize INBRIJA® in Latin America. INBRIJA is indicated in the United States for the intermittent treatment of episodic motor fluctuations in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. Under the terms of the agreements, Acorda will receive a significant, double-digit, tiered percentage of the selling price of INBRIJA in Latin America in exchange for supply of the product. Acorda will also receive sales-based milestones. Biopas will have the exclusive distribution rights to INBRIJA in nine countries within Latin America, including Brazil and Mexico. According to current population estimates, there are at least 400,000 people living with Parkinson's disease in Latin America1. Biopas plans on seeking marketing authorization in all countries to make Inbrija available for patients as quickly as possible. “BIOPAS is the leader in commercializing CNS therapies in Latin America and we are delighted to announce these agreements to make INBRIJA available there to people with Parkinson’s disease who suffer from OFF periods. We are also in active discussions with other companies for the rights to commercialize INBRIJA in additional countries.” Ron Cohen, M.D., President and CEO of Acorda Therapeutics “We are excited to be collaborating with Acorda to make INBRIJA available to people with Parkinson’s disease in Latin America. This important partnership supports Biopas’ mission to cover unmet medical needs of patients from Argentina to Mexico. Inbrija further strengthens Biopas’ complete and innovative CNS portfolio now consisting of nine original treatments: for Parkinson’s disease, epilepsy, movement disorders, sialorrea, multiple sclerosis, anxiety, and sleep disorders,” said Pascal Forget, CEO of Biopas. About Acorda Therapeutics Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® Extended Release Tablets, 10 mg. About Biopas Laboratories Biopas is a leading and differentiated Latin American Pharmaceutical company, focused on in-licensing, marketing and selling cutting-edge specialty pharmaceutical products. Biopas offers the best-in-class capabilities in sales, marketing, medical, support functions and provides integral services to support the launch and development of products. All its functions operate in compliance with international standards and regulations. Biopas covers 20+ countries in LatAm through fully owned subsidiaries and is a trusted partner of reputable multinational pharmaceutical companies, and has products in leading positions in CNS, Immunology, Rare Disease, Oncology, and Dermatology.

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Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Multiple European Countries

Ascletis Pharma Inc. | February 14, 2022

Ascletis Pharma Inc.announces that it has submitted marketing authorization applications for ritonavir in Germany, France, Ireland and United Kingdom through its agent in Europe. It is expected that more marketing authorization applications for ritonavir in certain other countries, including the ones in Europe, North America and Asian Pacific will soon be submitted. Ascletis has been in discussion with both domestic and international companies, including major multi-national pharmaceutical companies, for the commercial supplies of ritonavir in China and globally. Oral ritonavir tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases and a component of oral antiviral drug Paxlovid. Ascletis aims to be one of the global commercial suppliers of oral ritonavir tablets. Ascletis owns the only authorized oral ritonavir tablet in China, which passed bioequivalence study. Ascletis' oral ritonavir tablet was approved in September 2021 by China National Medical Products Administration. Ascletis has been applying sophisticated formulation technology to significantly increase human bioavailability of ritonavir which has a very poor solubility and successfully achieved human bioequivalence with the oral ritonavir tablets produced by the originator, AbbVie. On January 3, 2022, Ascletis announced that oral ritonavir tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange, a global platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC, and cancer to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis targets those therapeutic areas with unmet medical needs from a global perspective, and efficiently advances the developments of pipelines with an aim of leading in global competition. To date, Ascletis has three marketed products and 20 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.

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