Progenics Pharmaceuticals (PGNX) has good news today. The U.S. Food and Drug Administration (FDA) has accepted for review the firm’s New Drug Application (NDA) for its product Azedra® for recurrent and/or unresectable pheochromocytoma and paraganglioma — rare neuroendocrine tumors. The FDA has also granted Progenics’ request for Priority Review and has set an action date of April 30, 2018, under the Prescription Drug User Fee Act (PDUFA). The NDA is supported by data from a pivotal phase …

The FDA Grants Fast Track Status to DelMar Pharmaceuticals’ Product VAL-083 Dec.26, 2017 – DelMar Pharmaceuticals (DMPI) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s lead product candidate, VAL-083, in recurrent glioblastoma (rGBM). This Fast Track status applies to two ongoing clinical trials sponsored by DelMar Pharmaceuticals to evaluate VAL-083 as a potential treatment for rGBM.  These trials include: …

Two months ahead of the PDUFA date scheduled for February 28, 2018, the Food and Drug Administration (FDA) approved Aerie Pharmaceuticals’ (AERI) ophthalmic solution) 0.02% Rhopressa® (netarsudil for the lowering of elevated intraocular pressure (IOP) in open-angle glaucoma. Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie said that the firm will hire a sales force of 100 sales representatives early in the first quarter of …

After years of spending efforts in creating and developing its pipeline products, Portola (PTLA) has just been granted a U.S. Food and Drug Administration’s (FDA) approval of its Prior Approval Supplement (PAS) for the anticoagulant product Bevyxxa® (betrixaban). The product is approved ahead of its scheduled January 30th action date, which enables the release and distribution of its product inventory. Bevyxxa® is a factor Xa inhibitor approved on June 23, 2017 as a single-drug regimen for …

UCART19 UCART19 is one of the Cellectis’ (CLLS) lead allogeneic anti-CD19 CAR T-cell products. The word allogeneic is important as it makes the difference between Cellectis’ CAR T products and the two approved chimeric antigen receptor (CAR T) products and some of the investigational CAR T immuno-oncology products. Except for Cellectis’ and a few other  biotechs including  Celyad’s (CYAD)  products all other CAR T treatments are non-allogeneic (autologous) treatments. Being allogeneic, Cellectis’ products …

All the necessities, including future plans, are being taken care of by institutions, academia and biotech companies that are increasingly offering the medical community what they need to treat diseases based on their genetic mutations, if any. In recent news, a publicly-traded biotech firm called Foundation Medicine (FMI) has offered the medical community what could bring hope for change in the the treatment of diseases, …

The Treatment is Not A New Way as Being Stated, It is Only the Target, Which Has Been Changed   Outstanding news announced that leukemia patients who relapsed after being treated with the chimeric receptor antigen T cell (CAR T) targeting CD-19 were saved from imminent death by a CAR T targeting CD-22. The new treatment, which is being presented in some articles as a …

Important news has come from the FDA, which issued new guidelines to speed the introduction of treatments with human cells and tissues, including gene therapy. Cracking down on rogue clinics offering dangerous or unproven versions of gene therapy or stem cell therapy is also included in the report. Scott Gottlieb, the commissioner of the FDA stated that regenerative medicine and other important gene therapy treatments …

Nektar Therapeutics (NKTR) stock rallied, reaching all-time high with positive results in every aspect of the firm’s fundamentals from reported finances, to reported products’ results, etc.,  Cash and investments in marketable securities at September 30, 2017, were $412.2 million as compared to $389.1 million at December 31, 2016. The cash includes the $150.0 million upfront payment by Eli Lilly & Company for the development and commercialization of NKTR-358. As Howard W. Robin, President and CEO of …

Amgen (AMGN) and Kirin Holdings (Kirin) announced an agreement upon, which Kirin-Amgen, a joint venture between the two companies, will redeem Kirin’s shares in the joint venture and as a result, Kirin-Amgen will become a wholly-owned subsidiary of Amgen. The Kirin-Amgen joint venture was established in 1984 as a 50-50 joint venture between Amgen and Kirin to fund the global development of Epogen® (epoetin alfa). The scope of …

As expected by those who welcome good news from publicly-traded firms, the Food and Drug Administration (FDA) has given the green light to a second CART immuno-oncology product with the trade name Yescarta.  This drug, which has been developed by Kite Pharma is now belonging to Gilead Sciences (GILD) together with the rest of Kite’s CAR T wealthy pipeline after Gilead acquired Kite less than …

Two game changing news has come together on October 16, 2017, both indicating that  Exelixis (EXEL) is on its way to reach its goal becoming the leader in the current oncology discovery and development field.  THE FIRST GOOD NEWS announced that the U.S. Food and Drug Administration (FDA) determined that Exelixis’ supplemental New Drug Application (sNDA) for the approval of Cabometyx® in patients with previously …

–The Agreement Covers the Development of Investigational Plasma Kallikrein Inhibitors for Diabetic Macular Edema (DME) – Upfront Fee ($37 Million).  Potential Milestone Payments. Royalties On Sales. The deal could be worth $750 million – Merck Acquires 9.9% Stake in KalVista in Private Placement.    -Phase 2 Clinical Trial for the Investigational Intravitreal DME Candidate KVD001 Still Planned to Initiate in 2017. Surprise? Indeed, it is. KalVista Pharmaceuticals …

On November 2, 2017 Mannkind (MNKD) announced that the FDA has approved an update to its inhaled insulin product Afrezza prescribing information to include new clinical data that were presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016. Afrezza (human insulin) inhaled powder is approved by the FDA to improve glycemic control in adult patients with type 1 and type 2 diabetes …

Realizing the dream of approval of a small biotech’s lead drug would usually lead a small development-stage firm to either walking on the road to more achievements and growth, or walking in place doing nothing but spending its revenues while no dream materializes. We have seen both possibilities occur time and time again.     Seattle Genetics (SGEN) is now a revenue generating biotech. The firm, which …

Exelixis (EXEL) announced that Daiichi Sankyo (“Daiichi Sankyo”) reported positive top-line results from a phase 3 pivotal trial of esaxerenone for essential hypertension in Japan. The product is the fruit of the collaboration agreement signed by both firms back in 2006. The Story More than ten years ago, in March 2006, Daiichi Sankyo and Exelixis signed a research collaboration agreement to discover, develop and commercialize …

Agenus (AGEN) announced that the U.S. Food and Drug Administration (FDA) Advisory Committee voted unanimously, recommending the approval of GlaxoSmithKline’s (GSK) shingles vaccine candidate, Shingrix, containing Agenus’ proprietary immune adjuvant, QS-21 Stimulon®. This is good news for Agenus. As Garo Armen, Ph.D., Agenus CEO and Chairman of the Board said, “The Advisory Committee’s recommendation for the approval of Shingrix marks the first for a product …

Mirati Therapeutics (MRTX) announced positive preliminary data from two ongoing clinical trials of its product sitravatinib in non-small cell lung cancer (NSCLC). Combination of sitravatinib and Bristol Myers Squibb (BMS) checkpoint inhibitor Obdivo (nivolumab) might have broken the resistance against the immunotherapy checkpoint inhibitor drug in NSCLC patients with documented progression following prior checkpoint therapy. The results of the combination sitravatinib/nivolumab demonstrated 3 confirmed Partial …

Amicus (FOLD) announced the failure of its topical wound-healing product SD-101 for patients with epidermolysis bullosa (EB). The drug failure was revealed when top-line results from the randomized, double-blind, placebo-controlled Phase 3 clinical ESSENCE study SD-101 were announced. The results showed that the drug did not demonstrate a statistically significant difference from placebo in the intent to treat (ITT) population. The first primary endpoint results …

Indeed, updated data from the ongoing Phase 2 NLG2103 study of NewLink Genetics (NLNK) IDO inhibitor immunotherapy product indoximod in combination with the PD-1 pathway inhibitor, KEYTRUDA (pembrolizumab) demonstrate positive results in advanced melanoma. The news rallied the stock that has been cremated following news that the same drug Indoximoll has failed to meet the endpoint in mid-phase trials on breast cancer in combination with …