On August 3, 2020 ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (Nasdaq: ANIP) reported that Nikhil Lalwani has been named the Company’s President and Chief Executive Officer, effective September 8, 2020 (Press release, ANI Pharmaceuticals, AUG 3, 2020, View Source [SID1234562713])
. Mr. Lalwani will also be elected to the Company’s Board of Directors, effective upon his start date. Mr. Lalwani will succeed Patrick D. Walsh, who will continue to serve as Interim President and CEO until Mr. Lalwani joins the Company and who will remain as Chairman of the Board.

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"We are delighted to welcome Nikhil to ANI Pharmaceuticals. With his proven ability to create high-growth cultures and deliver financial results, together with his operational experience in both generics and specialty pharmaceuticals, Nikhil is an ideal choice to lead our next phase of growth and to achieve our corporate objectives," stated Patrick Walsh, Interim President and Chief Executive Officer of ANI Pharmaceuticals.

"Nikhil’s track record of building strong performance-based environments and his experience in strategic planning and acquisitions, marketing, P&L optimization, and product development and commercialization, will complement our senior team as we advance our lead product candidate, Cortrophin Gel, and pursue additional strategic expansion opportunities," concluded Walsh.

"I am delighted to join ANI Pharmaceuticals at an exciting time for the business. ANI has an attractive product mix, a robust pipeline of commercial opportunities, including the Cortrophin Gel opportunity, and expansion potential in North American-based contract manufacturing. I look forward to working with the Board of Directors and all of the dedicated employees of ANI to realize the full potential of the Company’s diverse products and services, and to ensure access to our cost effective therapeutics for the patients, physicians and payors we serve," said Nikhil Lalwani.

Mr. Lalwani is a proven executive who brings over 20 years of pharmaceutical and healthcare industry experience to ANI. Mr. Lalwani recently served as CEO of Cipla USA, a top 10 pharmaceutical company, and the U.S. subsidiary of Cipla Ltd (NSE: CIPLA), a global pharmaceutical company with a focus on respiratory, anti-retroviral, oncology, urology, cardiology, anti-infective and CNS segments. Mr. Lalwani held positions of increasing responsibility while at Cipla, including CEO of InvaGen, Head of US Strategy, M&A & Integration, and Head of Cipla’s Global Respiratory business. In these roles, Mr. Lalwani developed and executed multi-year strategic growth plans for key products and facilitated successful acquisitions as Cipla entered the specialty pharmaceutical space. Prior to Cipla, Mr. Lalwani was an Associate Partner with McKinsey & Company serving pharmaceutical and healthcare companies across the world, and an engineer with Medtronic.

Mr. Lalwani earned an MBA from the Wharton School at the University of Pennsylvania and graduated Summa Cum Laude with a B.S. in Electrical Engineering from the Georgia Institute of Technology in Atlanta.

On August 3, 2020 PharmaCyte Biotech (OTCQB: PMCB) reported that it has reached what can only be described as a momentous milestone in its history and what should be considered a remarkable moment for any small biotech—the submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, AUG 3, 2020, View Source [SID1234562712]). This upcoming interaction with the FDA to request a planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) is the product of years of meticulous work and dedication to the development of a treatment for the third leading cause of cancer-related deaths in the United States.

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Pancreatic cancer is a hard-to-treat disease with only a 9% five-year survival rate, so the recent announcement that PharmaCyte’s partner, Austrianova, has submitted a Drug Master File (DMF) to the FDA is welcomed news because it symbolizes the IND package that we expect will be submitted to the FDA early this month (August) is very near completion.

PharmaCyte’s Chief Executive Officer (CEO), Kenneth L. Waggoner, said "We’ve reached an exciting milestone at PharmaCyte that has us on the precipice of reaching our long-awaited goal of submitting an IND. We’re elated to announce that our partner, Austrianova, submitted a DMF with the FDA for the production of our Cell-in-a-Box encapsulated cell product CypCaps. This DMF is an important and significant event since it is the last prerequisite for the formal FDA application process. It will support and now facilitate the submission of our IND."

Dr. Brian Salmons, the CEO and President at Austrianova, said, "The DMF provides all of the confidential and detailed, comprehensive, information covering the production of Cell-in-a-Box encapsulated cell products, including PharmaCyte’s CypCaps product.

"As you well know, the DMF is an important milestone event that represents a culmination of many years of work on the GMP-production process, the studies that led to the parameters chosen, the materials used in the manufacturing and their specs, processing, packaging, and storing of the Cell-in-a-Box encapsulated cell products, including CypCaps. It also provides detailed information on Austrianova’s production facilities in Thailand where the CypCaps product is produced under GMP."

Of note, a DMF is a prerequisite to securing approval and commercialization and "ensures confidentiality of proprietary information" related to the Active Pharmaceutical Ingredient (API). It is this confidentiality that is sacred to both Austrianova and PharmaCyte and exactly why it’s one of the very last items to be crossed off the lengthy checklist before the IND can be submitted.

Dr. Salmons agrees, "Information on the drug product must be included in the IND and detailed information on, among other things, the manufacture and testing of the drug product, is contained in the DMF. So, in a way, it can be considered the final piece of the puzzle."

In reality, just 2 items remain before PharmaCyte can submit its IND and both will likely be accomplished in the coming days. In a June 23rd press release, PharmaCyte announced a list of tasks that needed to be completed before it could submit its IND to the U.S. FDA. Most of that work was performed by PharmaCyte’s consultants and has been completed.

PharmaCyte’s CEO, commenting on the status of the IND, said, "Virtually all of the IND has been completed. During the last few months, we have completed the Trial Protocol, the Investigator’s Brochure, the Environmental Analysis, the General Investigation Plan, the Introduction Summary, the Nonclinical Overview, the Clinical Overview, the Nonclinical Written and Tabulated Summaries, the Pharmacy Manual, the Study Reports and related information of the prior clinical studies pertinent to the treatment for LAPC, the Regulatory Publishing of the IND and supporting documents, and the Drug Master File. Some of these documents are being updated with new data.

"So, we’re now left with completing the Informed Consent, which is being prepared by our Principal Investigator, Dr. Manuel Hidalgo and his staff, and we need to hire a Chief Medical Officer (CMO) in oncology to represent the company’s interest in the planned clinical trial. Two well-qualified candidates have been interviewed and the selection process is nearly complete. We expect that both the Informed Consent and the hiring of a CMO should be completed over the next week. When this is complete, we plan to file the long-awaited IND."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On August 3, 2020 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that Charles Theuer, M.D., Ph.D., President and CEO, will present a corporate overview at the 2020 BTIG Virtual Biotechnology Conference on Monday, August 10th, at 11:30 am EDT (Press release, Tracon Pharmaceuticals, AUG 3, 2020, View Source [SID1234562711]).

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To access a live webcast of the presentation, please visit the "Events and Presentations" page within the "Investors" section of the TRACON Pharmaceuticals website at www.traconpharma.com.

On August 3, 2020 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that it will report second quarter 2020 financial results on Thursday, August 6, 2020 after the U.S. financial markets close (Press release, Celldex Therapeutics, AUG 3, 2020, View Source [SID1234562710]). Celldex executives will host a conference call at 4:30 p.m. EDT on the same day to review the second quarter financial results and to provide an update on key research and development and business objectives for the remainder of 2020.

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The conference call and presentation will be webcast live over the Internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (800) 446-2782 (within the United States) or (847) 413-3235 (outside the United States). The passcode is 49870841.

A replay of the call will be archived on the Company’s website.

On August 3, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported plans to report its financial results for the second quarter ended June 30, 2020 on Monday, August 10, 2020 (Press release, Akebia, AUG 3, 2020, View Source [SID1234562709]). In lieu of a second quarter financial results and business update call, Akebia management plans to host a conference call and webcast in early September to report top-line data from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs. The two PRO2TECT studies, which have progressed through database lock, evaluated the efficacy and safety of vadadustat, Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in 3,513 adult patients not on dialysis.

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"The Akebia team, together with all the clinical site staff, did an extraordinary job completing the last patient visits and other work to lock the PRO2TECT database, despite the logistical challenges of operating under the present COVID-19 environment. Locking the database marks an important step toward the completion of our global Phase 3 program for vadadustat, and we look forward to reporting top-line results from the PRO2TECT program in early September," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics.