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EVIO Inc (OTCMKTS:EVIO) Reports The Appointment of New President

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EVIO Inc (OTCMKTS:EVIO) reported the appointment of Mr. Al Lustig as President of company, reporting to CEO William Waldrop. Lustig’s major responsibility will be to lead company’s growth in both existing and new markets by executing and developing national and international operational strategies and sales.

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Lustig joins EVIO post completing a successful career at Pfizer Inc (NYSE:PFE). Lustig joined Pfizer as a Professional Sales Representative in in 1986 and later quickly ascended to roles of increased responsibility, becoming a State Director. During his role at Pfizer, Lustig led, helped and built manage several regional, national and district sales firms that consistently surpassed all performance outlooks.

Lustig redefined conventional business models that led in the successful launches of innovative and new pharmaceuticals, generating billions in sales and enhancing the lives of many patients. While at Pfizer, he even led several cross functional teams and associated with senior leadership to support integrate Sales, Operations, Strategy & Analytics, Government, Marketing and Medical Relations across business operations.

Waldrop, the CEO of EVIO, reported that as they embark upon their next phase of fast growth, Al’s history of known success in sales leadership and corporate growth at Pfizer, one of the largest bio-pharmaceutical firms across the world, makes him an ideal fit to help direct EVIO into 2018 and beyond. They look forward to using Al’s expertise and leadership from the pharmaceutical segment. Current EVIO Chief Operating Officer and President Lori Glauser has resigned from her role as President to pave way for Lustig in the Senior Leadership team. Glauser will remain with the firm as Chief Operating Officer, heading both company’s laboratory expansion and advisory services division.

In the last trading session, the stock price of EVIO jumped more than 10% to close the day at $2.16. The gains came at a share volume of 176,030 compared to average share volume of 141,794.

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PharmaCyte Biotech Inc. (OTCMKTS:PMCB) Files Pre-EUA Application For SARS-CoV-2 Test Kit And Finalization LAPC product

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PharmaCyte Biotech Inc. (OTCMKTS:PMCB) has announced that the FDA’s Centre for Devices and Radiology Health has issued it with Medical Devices Establishment Registration. The registration is vital to companies planning the importation of medical devices from abroad.

PharmaCyte gets Medical Devices Registration For COVID-19 tests and files Pre-EUA

The biotechnology company has established itself as the main Hai Kang Life Corporation Limited agent in the US to import coronavirus in vitro test kits. Equally, PharmaCyte is planning to sell its PCR diagnostic test kits to laboratories across the US that are certified by Clinical Laboratory Improvement Amendments.

Also, the company has announced that it is in discussion with the FDA regarding a Pre-Emergency Use Authorization application to the FDA. With the submission, it means the FDA can accelerate the approval of new medical devices and drugs during a national emergency. The FDA has recommended that for the SARS-CoV-2 devices, suppliers and manufacturers can submit a Pre-EUA to work interactively towards EUA approval. According to the FDA, companies should file a draft earlier so that the FDA examiner can give them feedback to do away with unwanted delays when reviewing the final EUA.

PharmaCyte’s consultant carrying a final audit on its LAPC clinical trial product  

The company has also announced that its GMP consultant, cGMP Validation, is carrying a final audit of its Thailand manufacturing facility, where company’s its Austrianova Singapore manufactured clinical study product. Once the audit is finalized, cGMP Validation will approve the importation of the product by PharmaCyte to its US supply chain dealers for storage at -80C until the time it will be required.

Interestingly cGMP Validation and Austrianova have now finalized their work. They have achieved what has been considered as compliant batch records for cGMP in two successful production runs from Austrianova. The companies collaborated to review the batch records produced during the two successful production runs that resulted in PharmaCyte’s clinical study product for the expected Phase 2b clinical study in inoperable locally advanced pancreatic cancer (LAPC).

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Meridian Bioscience, Inc. (NASDAQ:VIVO) Reports Revenues Of $57.3 Million In Q2 2020

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Meridian Bioscience, Inc. (NASDAQ:VIVO) has posted revenues of $57.3 million in Q2 2020. It is an increase of 14% year-on-year. The life sciences segment has contributed $22.4 million (up 33%) to the revenues by responding early to the COVID-19 pandemic. Meridian’s diagnostic segment contributed revenues of more than $34.9 million (up 4%).

CEO of Meridian, Jack Kenny, said the company has performed very well in Q2. He said its Life Sciences segment has offered extraordinary performance by responding to the coronavirus crisis early. The company’s raw materials are widely used in molecular tests worldwide to find a coronavirus vaccine.

FDA clears HpSA and Curian Analyser

Meridian has received the FDA nod for its HpSA and Curian Analyzer in Q2 2020. HpSA and Curian analyzer expect to contribute revenues soon to the Diagnostic segment, which has delivered outstanding performance during the quarter.

Unprecedented response for Life Science products

Chief Financial Officer of Meridian, Bryan Baldasare said the company has exhibited strong growth despite the ongoing coronavirus crisis. It has received an unprecedented response for its Life Science products. Meridian expects to post better results going forward in 2020.

Collaborates with QuantuMDx

Meridian collaborates with QuantuMDx for its newly introduced SARS-CoV-2 assay for use in laboratories. QuantuMDx benefits from the Lyo-Ready 1-Step RT-qPCR master mix of Meridian for a quick and reproducible assay, stable at ambient temperature. Meridian facilitated the production of several COVID-19 assays since the coronavirus outbreak by establishing partnerships with more than 35 diagnostic companies across the world. The company has expanded its manufacturing facilities to satisfy the burgeoning demand of various customers that comprise QuantuMDx.

Vice President (Global Sales of Life Sciences) of Meridian, Todd Howren said the association with QuantuMDx shows how its master mixes help to expedite the development of assay and improve efficacy and quality of the molecular test. The company is pleased to partner with QuantuMDx in meeting the testing requirements at this difficult juncture.

Vice President (R&D) of QuantuMDx, Colin Toombs said the Lyo-Ready Mix of Meridian is vital for improving sensitivity, performance, and run time needed for the assay. The company expects to continue its association with Meridian for current and future needs.

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Insys Therapeutics Inc (NASDAQ:INSY) Issues An Update on CBD Pharmaceuticals and Spray Technology Products

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Insys Therapeutics Inc (NASDAQ:INSY) has issued an update on the naloxone nasal and epinephrine sprays and CBD oral solutions. CEO and President of Insys Therapeutics, Saeed Motahari said the company is focusing on novel drug delivery systems and pharmaceutical grade cannabinoids to drive the growth going forward. It is moving away from opioids. The company is transforming its business strategy to include patient-centric formulations over the past one year. Going forward,  Insys Therapeutics is preparing to submit 6 innovative drug applications in the next 3 years. The company is scheduling two of them in 2019.

An update on the Opioid Related Assets

As per the announced plans,  Insys Therapeutics is scheduling the alternative review of the opioid related assets. As of now, nine firms have entered into a pact with  Insys Therapeutics and are reviewing the confidential information. The company will release an update on this aspect in early 2019.

An Update on the Lifesaving Products

Insys Therapeutics is in the advanced stages of developing the lifesaving investigational products that are based on spray technologies. Its lifesaving products in development include epinephrine nasal spray for anaphylaxis and naloxone nasal spray for the opioid overdose.

The company is also focusing on cannabinoids like CBD oral solution targeting the child absence epilepsy treatment (phase 2), Prader Willi Syndrome (phase 2), infantile spasms (phase 3), and dronabinol inhalation to treat a variety of conditions such as anorexia in patients suffering from cancer.

Insys Therapeutics is conducting a non-clinical toxicity study on naloxone nasal spray and expects to announce the results in March 2019. The company has set the timeframe for the NDA submission in Q1 2019.

Epinephrine nasal spray, which is intended for needle-free delivery, is a substitute to the intramuscular injection. According to the study, it is readily absorbed via the nasal mucosa. The company has obtained FDA nod for fast track designation for the drug in August 2018. It has also provided specific guidelines for filing requirement and clinical development. Insys Therapeutics is optimistic to complete the filing requirements for epinephrine NDA in Q4, 2019. It is subject to successful completion of PK study.

The company has successfully completed a proof of concept study on dronabinol inhalation in September 2018. Insys Therapeutics will arrange a meeting with clinical experts in Q1 2019 to discuss further development for this investigational formulation.

Insys Therapeutics Signs a Pact with Lunatus for Commercializing SUBSYS

Insys Therapeutics has signed a definitive accord with Lunatus for commercializing Subsys in 8 nations in the Middle East. Following the deal, Lunatus will act as an authorized agent and licensee in the UAE, Lebanon, Kuwait, Jordan, Saudi Arabia, Qatar, Oman, and Bahrain.

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