CiRA, Takeda & T-CiRA Less than five years ago the Center for iPS Cell Research and Application (CiRA)1 at Kyoto University and Takeda Pharmaceutical (TAK)2 established a research program. Today, Takeda and CiRA announced that induced pluripotent stem cell-derived chimeric antigen receptor (CAR) T-cell therapy (iCART . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Gilead and Galapagos Global Research Collaboration Gilead Sciences (GILD) and Galapagos NV (GLPG) entered into a 10-year global research and development collaboration. Gilead will gain access to innovative compounds, including six molecules currently in clinical trials, more than 20 preclinical programs and a proven drug discovery platform. Galapagos will receive a $3.95 billion upfront payment and a $1.1 billion equity investment from Gilead. Galapagos will use the …

Exelixis is Expanding Cohorts for COSMIC-021, the Phase 1b Trial for Cabozantinib  From Exelixis (EXEL) we learned about its decision to expand the two original cohorts, and the addition of four new cohorts, to the protocol for COSMIC-021; the phase 1b trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with locally advanced or . . . This content is for paid subscribers. …

Illumina Stock Dropped Following Their Preliminary Revenue Announcement Illumina (ILMN) stock dropped 16% following the firm's announcement of preliminary revenue for the second quarter of the fiscal year 2019 and updated its 2019 revenue guidance. According to the firm’s press release its second quarter results were impacted by an approximately $30 million lower revenue than expected; associated with population genomics initiatives, including a sizeable sequencing . …

The EC Granted Conditional Approval for Regeneron and Sanofi Product Libtayo for CSCC The European Commission (EC) conditional approval for Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) product Libtayo® (cemiplimab) is a historical event and a game changer in the prognosis of metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC).   Before the approval of Libtayo patients with advanced CSCC , who are not candidates for curative surgery or curative radiation, had …

Sangamo and Pfizer Gene Therapy SB-525 Resulted in a Sustained Increase in Factor VIII Levels in Hemophilia Patients Sangamo Therapeutics (SGMO) and Pfizer (

Gilead to File NDA for Filgotinib for Rheumatoid Arthritis Meeting with the U.S. Food and Drug Administration (FDA) Gilead (GILD) announced it discussed with the agency the Phase 3 FINCH studies; as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with its filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease. As a result of this discussion a path forward has …

Small Biotech Firms That Can Become Top-Tier Biotech Giants We Start With... Abeona Therapeutics Abeona Therapeutics (ABEO) is a clinical-stage biopharmaceutical gene and cell therapy company. In September 2016 Abeona acquired an exclusive worldwide license of a next-generation gene therapy AAV capsid portfolio from University of North Carolina at Chapel Hill.  The AIM™ vector system . . . This content is for paid subscribers. Please click here to subscribe …

ImmunoGen’s Big Internal Changes ImmunoGen (IMGN) announced a radical impacting decision following the completion of an in-depth operational review aimed at extending the Company’s cash runway; delivering on its promises to continue developing a promising antibody drug conjugate (ADC) product and moving into the clinic what it believes will be next-generation ADCs.   Based on the outcomes of its review, ImmunoGen prioritized continuing the development of mirvetuximab and …

Atossa Genetics Promising News for Endoxifen Atossa Genetics (ATOS) has promising news from a Phase 2 trial of its topical Endoxifen for mammographic breast density (MBD) reduction.     Preliminary analysis from a recently completed Phase 2 study of Atossa’s proprietary 20mg daily topical Endoxifen has caused a significant and a rapid reduction . . . This content is for paid subscribers. Please click here to subscribe or here to …

Krystal Biotech Krystal Biotech (KRYS) is a gene therapy firm focused on developing topical intradermal therapeutics for rare dermatological diseases. It developed its a gene therapy product KB103 for the treatment of the broad Dystrophic epidermolysis bullosa (DEB) population, including both recessive and dominant forms of the disease. The vector that introduces the genes into dermal cells is an HSV . . . This content is for …

AMAG Pharmaceuticals’ Vyleesi™ was Approved The U.S. Food and Drug Administration (FDA) approved AMAG Pharmaceuticals’ (AMAG) product Vyleesi (bremelanotide injection); a melanocortin receptor agonist for premenopausal women having acquired, generalized hypoactive sexual desire disorder (HSDD)   To be a candidate for Vyleesi a woman’s low sexual desire must not be the outcome of a co-existing medical or psychiatric condition, problems within the relationship or the side …

AstraZeneca and Merck PARP Inhibitor Lynparza The AstraZeneca (AZN) and Merck (MRK) PARP inhibitor Lynparza (olaparib) has been granted approval in Europe for first-line maintenance monotherapy . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Pfizer to Acquire Array Pfizer (PFE) announced that it has agreed to acquire Array Biopharma (ARRY) in a deal valued at $11.4 billion.  The Terms of the Agreement Under the terms of the agreement, Pfizer will pay $48 in cash for each Array share. That is around 62% above the $29.59 stock price as it closed on Friday. The price paid represents around $10.64 billion …

Why has bluebird bio Been Hammered in the Market Recently? Investors should be asking why bluebird bio (BLUE) has been hammered in the market recently before asking why the stock gained $6.37 in trading yesterday. Why was it subjected to a selloff a few days ago? Why? When you consider the announcement of conditional marketing authorization, granted from the European Commission (EC), for the firm’s …

Nektar Announced Results for NKTR-358  During an oral session at the Annual European Congress of Rheumatology (EULAR) 2019, in Madrid, Nektar Therapeutics (NKTR) announced results of the first-in-human Phase 1a study evaluating single-ascending doses of NKTR-358 for the treatment of autoimmune and other chronic inflammatory conditions.  The . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Good News about Novartis’ Cosentyx® for Psoriatic Arthritis Novartis (NVS) has good news for Cosentyx®. Data emerging out 0f the FUTURE 5 clinical trial on patients with psoriatic arthritis (PsA) showed that there was no radiographic progression in around 90% of PsA patients who were treated with Cosentyx® (secukinumab) 300 mg, over 2 years. These data are being presented at the Annual European Congress of Rheumatology (EULAR) on 12-15, June, in …

Vertex and CRISPR Therapeutics While some groups are doubting the gene editing capability of CRISPR gene editing Vertex’s (VRTX) scientists enjoyed what they experienced during their clinical collaboration with CRISPR Therapeutics (

AT ASCO Gilead Sciences and Yescarta® By Acquiring Kite Pharma Gilead Sciences(GILD) gained Kite’s CAR T technology and its FDA approved therapy Yescarta.  At the ASCO 2019 two new analyses were presented from the ZUMA-1 clinical trial of Yescarta®  in adult patients with relapsed or . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Zynteglo™ from bluebird bio Gets European Conditional Approval European marketing authorization for Zynteglo follows the fastest assessment of an advanced therapy medicinal product (ATMP) as part of the European Medicines Agency’s Priority Medicines (PRIME) program. Zynteglo is bluebird bio’s first gene therapy to gain regulatory approval. Gene therapy is, indeed, moving towards the clinic to provide cures; to save people from an early death from …