Iovance Biotherapeutics, Inc a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology,announced that the first patient was dosed in its C-145-04 Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma.
Applied Genetic Technologies Corporation a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, announced that it has filed an Investigational New Drug application (IND) with the U.S. Food and Drug Administration to conduct a Phase 1/2 clinical trial of the company's gene therapy product candidate for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene.
Manufacturers of the Medical Devices are required to obtain manufacturing license under the provisions of Drugs and Cosmetic (D&C) Act & Rules which is notified by Directorate General of Health Services, Ministry of Health & Family Welfare.
Sun Pharma to aquire US based Krystal Biotech in 7 million USD. Krystal Biotech is a biopharmaceutical company using gene therapy to develop treatments for patients suffering from rare debilitating disorders.
AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is an investigational, highly selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.
Zydus Cadila has received the final approval from the USFDA to market Temozolomide Capsules in strengths of 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg.
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Acyclovir Ointment USP, 5%, the generic version of Zovirax® Ointment, 5%, of Valeant International Bermuda.
RedHill Biopharma Ltd a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported, following a second pre-planned meeting to assess the safety and efficacy data from its ongoing first Phase III study with RHB-104 for Crohn’s disease (the MAP US study) by an independent Data and Safety Monitoring Board (DSMB), that it has received a unanimous positive recommendation from the DSMB to continue the study as planned.
AXIM Biotechnologies, Inc a world leader in cannabinoid research and development, today announced that it has entered into a Clinical Study Agreement (CSA) with the University of British Columbia in Canada to begin a clinical trial with its CanChew Plus® cannabidiol (CBD) chewing gum product to treat drug-induced psychosis in adult patients.
Titan Pharmaceuticals, Inc. a specialty pharmaceutical company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura™ long-term, continuous drug delivery technology, announced today that it has entered into a venture loan and security agreement with Horizon Technology Finance Corporation, which provides Titan with up to USD10 million of available borrowing capacity.
A first tranche of USD7 million was funded upon execution of the loan agreement. A second tranche of USD3 million will be available to Titan, at its option, through March 31, 2018, subject to the satisfaction of certain revenue and product development milestones, and other borrowing conditions.
The loan agreement has a term of 46 months, with interest only payments through December 31, 2018, followed by equal monthly installments of principal and accrued interest for 30 months thereafter. The initial interest rate is 9.63%, which is based on a floating rate equal to the sum of the one month LIBOR (floor of 1.10%) plus 8.4%. Each loan tranche is also subject to a 5.0% final payment when the principal is paid in full. The loan is senior debt and is secured by all of Titan's assets, with the exception of its intellectual property.
"We believe this transaction balances our capital needs and opportunity to grow the company, and our commitment to minimizing dilution for shareholders to the extent possible," commented Titan President and CEO Sunil Bhonsle. "We were impressed with Horizon's ability to tailor a financing structure that matched Titan's objectives. We expect that our existing cash on hand, combined with the net proceeds from the first tranche of this loan, will be sufficient to fund planned operations into early 2019."
Gerald A. Michaud, President of Horizon, stated, "We are pleased to provide this debt financing to Titan. The company's proprietary long-term drug delivery platform, ProNeura, represents a new standard of chronic disease management utilizing subdermal implants. We look forward to working with Titan as its lead product, Probuphine®, advances in the marketplace and the company continues to develop a growing pipeline of new treatments for select therapeutic markets."
In connection with this transaction, Titan issued to Horizon warrants to purchase an aggregate of 280,612 shares of Titan's common stock. The per share exercise price of these warrants is the lower of USD1.96 or the price per share of any securities that may be issued by the company in an equity financing during the next 18 months. The company also issued the lender a warrant that will only become exercisable upon the funding of the second tranche of the loan, with number of shares and exercise price to be calculated at such time. The company has agreed to file a registration statement with the Securities and Exchange Commission (SEC) within the next 90 days covering the resale of the shares underlying the lender warrants.
CLICK HERE TO SUBSCRIBE,
PHARMATUTOR's DAILY EMAILS
Do Not Forget to Verify
(Click on Subscription link in your inbox)
--------
