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 …

Based on statistically significant results from the randomized phase 2 CABOSUN trial in patients with previously untreated renal cell carcinoma (RCC), the U.S. Food and Drug Administration (FDA) approved Exelixis’ (EXEL)drug Cabometyx® (cabozantinib) for the expanded indication of patients with RCC. The results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus sunitinib, a current standard of care. Today’s label expansion follows the initial FDA approval …

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 …

Juno Therapeutics (JUNO) is one of the casualties that occurred during the 59th American Society of Hematology (ASH) Annual Meeting. The stock experienced undeserved selloff except for the fact that it had a deserved rally that we believe will remain as long as the firm is spending effort towards improving its cancer treatment. This cancer treatment is the  living genetically engineered chimeric antigen receptor (CAR) T cell expected …

The Week in Review #13 From the Prohost Portfolio - 1. Betting on the technology - HALOZYME - As expected, the pulse of fat agreements with HALO is accelerating . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Gilead Sciences (GILD) has unsurprisingly agreed to acquire Cell Design Labs in a structured buy out valued for up to $567 million, including the shares of Cell Design Labs held by Kite, the CAR T firm that Gilead has recently acquired. Brian Atwood, President and CEO of Cell Design Labs, Inc., said, “Bringing our robust technology platforms under the Gilead umbrella, with its outstanding research …

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, …

Prohost Letter #415 New Promising Technologies PROTAC - A Technology That Offers a Superior Class of Drugs PROTAC is an approach that created a new class of drugs described as superior and far less toxic than targeted drugs known to block disease-­causing proteins. The technology belongs to a private Company called Arvinas . . . This content is for paid subscribers. Please click here to subscribe …

The Week in Review #12 Answering You - Many questions still need answers in the biotech’s fast moving universe and we are doing our best to answer them.  We found out that we should start answering questions even though we are in a middle of a reasonably short vacation that we dared to take after over 5 years of constant working . . . This …

On Nov. 21, 2017, Portola Pharmaceuticals (PTLA) announced that the U.S. Food and Drug Administration (FDA) has informed it that it will respond to the Prior Approval Supplement (PAS) request to change the current manufacturing release specification within the standard 60-day extension period. No additional information was requested at this time. The new action date is January 30, 2018. Bill Lis, chief executive officer of Portola said, “As …

DelMar Pharmaceuticals (DMPI) -- A biopharmaceutical company focused on the development of cancer therapies provided an overview of three scientific posters presented at the 22nd Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) held on November 16-19, 2017 in San Francisco, CA. DelMar might have surprised the financial community reporting that 93% of patients with Glioblastoma multiforme (GBM) were alive and 40% of …

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 …

The Week in Review #11 A New Era - Faster than the speed of light, the management of diseases is shifting from fast improvement to a total gigantic unprecedented change. Some of the conquering approaches towards providing long-­lasting cures look as if the outcome of magic rather than mere science . . . This content is for paid subscribers. Please click here to subscribe or here to log …

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 …

Yes, it is Sangamo’s (SGMO) zinc finger nuclease (ZFN) gene-editing technology, which for the first time in history enabled a patient to receive a treatment to edit the DNA of his cells directly inside the body. That was the news coming today from Sangamo. The Story Sangamo’s gene editing product known as SB-913 -- an investigational in vivo genome editing therapy was introduced for the first time …

Halozyme Therapeutics (HALO) announced that it will present nonclinical data at the 32nd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) which demonstrate the potential for PEGPH20, Halozyme's pegylated recombinant human hyaluronidase, to increase the infiltration of immune cells into the tumor microenvironment and enhance the efficacy of immuno-oncology drugs in an HA-accumulating murine colon tumor model. The study shows that degradation of hyaluronan (HA) …

A couple of days ago, Cellectis (CLLS), which uses its own proprietary gene editing technology known as “transcription activator-like effector nuclease (TALEN®)” in developing immunotherapies, received the following good news: The FDA has lifted the clinical hold, which the Agency has put on Phase 1 trials of Cellectis’ UCART123 product candidate.       The Story In February 2017, Cellectis received an Investigational New Drug (IND) approval …