Exelixis collaborator, Daiichi Sankyo, Receives Regulatory Approval for MINNEBRO™ (Esaxerenone) Tablets for Hypertension in Japan Exelixis (EXEL) and Daiichi Sankyo announced that the the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Minnebro™ (esaxerenone) tablets of ,1.25 mg, 2.5 mg, and 5 mg, for hypertension. Minnebro was identified during a prior research collaboration between Exelixis and Daiichi Sankyo, which was entered into in March 2006. The product has been subsequently developed …

Earlier this month the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for CTX001 for sickle cell disease (SCD). CTX001 is in clinical trials conducted by CRISPR Therapeutics (CRSP) and Vertex Pharmaceuticals (VRTX). It is an investigational, autologous, gene-edited hematopoietic stem cell therapy for patients suffering from severe hemoglobinopathies. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs to …

Rhythm Pharmaceuticals, Inc. (RYTM) is a biopharmaceutical company focused on the development and commercialization of therapeutics for rare genetic disorders of obesity. It is currently evaluating the efficacy and safety of setmelanotide, the company’s first-in-class MC4R agonist in Phase 3 studies, in patients who suffer from POMC deficiency obesity, LEPR deficiency obesity, BBS and Alström Syndrome. It is obvious that this firm has taken advantage of …

Gilead Sciences (GILD) and Scholar Rock Holding Corporation (SRRK) announced entering into a strategic collaboration to discover and develop highly specific inhibitors of transforming growth factor beta (TGFβ) activation for the treatment of fibrotic diseases. Under the terms of the agreement Gilead has exclusive options to license worldwide rights to product candidates that emerge from the following three Scholar Rock TGFβ programs:  – Inhibitors that target activation of latent …

Agenus (AGEN) announced recently that it entered into an immuno-oncology (I-O) partnership with Gilead Sciences (GILD). The partnership is focused on developing and commercializing up to five novel I-O therapies. The terms of the agreement Agenus is entitled to receive a $120 million upfront cash payment and a $30 million equity investment.   The agreement also includes approximately $1.7 billion in potential future fees and milestones. …

In the NEWS AstraZeneca (AZN) announced a collaboration with Cancer Research UK to launch a center of excellence in genetic screening, cancer modelling and big data processing aimed at accelerating the discovery of new cancer medicines. During the announcement of the news, Mene Pangalos, the firm’s Executive Vice President, Innovative Medicines & Early Development, said, the best science doesn’t happen in isolation, which is why AstraZeneca …

The Chinese National Medical Products Administration (NMPA) has approved Gilead’s (GILD) HIV combination product Descovy®.  In China, Descovy is to be indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged 12 years and older with a body weight of at least 35 kg). TAF, which is part of the combination treatment, is a novel, targeted prodrug of …

Exelixis (EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) announced the initiation of COSMIC-312. A phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) versus sorafenib, in previously untreated advanced hepatocellular carcinoma (HCC). The co-primary endpoints of the trial are: progression-free survival and overall survival. An exploratory arm will also evaluate cabozantinib monotherapy in this first-line setting. COSMIC-312 is a multicenter, randomized, controlled phase 3 pivotal trial that …

At the 60th American Society of Hematology (ASH) Annual Meeting   CAR T is Still a Star With all the pessimistic views critics have sprayed around in the past few years about the cell therapy for cancer, the CAR T approach remained a star of prominent cancer gatherings. This phenomenon confirms the value of the FDA decision of approving the CAR T products, in spite of their …

Vertex Pharmaceuticals’ triple combination, which added the corrector VX-659 to the tezacaftor and ivacaftor combination, resulted in statistically significant improvements in lung function (percent predicted forced expiratory volume in one second, or ppFEV1) in two Phase 3 studies in people with cystic fibrosis (CF). Data from Vertex’s (VRTX) Phase 3 study in people with one F508del mutation and one minimal function mutation resulted in a mean absolute …

As we expected in our posting yesterday under Today’s Highlights, the U.S. Food and Drug Administration (FDA) approved Loxo Oncology’s (LOXO) Vitrakvi® (larotrectinib), the first oral TRK inhibitor for adult and pediatric patients with solid tumors having a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. The approval is for the cancers that have no known acquired resistance mutation, are metastatic or where surgical resection is likely to result …

Aimmune Therapeutics (AIMT) has news. A lot of it is from a successful phase 3 trial for its peanut allergy drug as well as other news that boosts our conviction that this product is, indeed, important and has a good chance for approval in the U.S. and overseas.   Aimmune is a biopharmaceutical company developing treatments for potentially life-threatening food allergies. The firm’s Characterized Oral …

In today’s news Jazz Pharmaceuticals (JAZZ) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for the approval of solriamfetol.  Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment of excessive daytime sleepiness in adult patients with narcolepsy, obstructive sleep apnea, and Parkinson’s disease. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma. The aim of the …

RegenxBio (RGNX) has granted Abeona Therapeutics (ABEO) an exclusive worldwide license to its NAV AAV9 viral vector (subject to certain non-exclusive rights previously granted for MPS IIIA) for the treatment of four diseases: Sanfilippo syndrome type A (MPS IIIA) and type B (MPS IIIB), Infantile Batten Disease, also known as neuronal ceroid lipofuscinosis type 1 (CLN1 Disease) and Juvenile Batten Disease, also known as neuronal ceroid lipofuscinosis type 3 …

Illumina (ILMN) and Pacific Biosciences (PACB) announced they have signed an agreement for Illumina to acquire Pacific Biosciences at a price of $8.00 per Pacific Biosciences share, in an all-cash transaction. The agreement has already been approved by the board of directors of both firms. The acquisition complements Illumina’s sequencing solutions with accurate long-read sequencing capabilities to answer complex genomic questions. Why the acquisition? While Illumina’s accurate and economic short-read sequencing platforms address the …

A number of biotech or biopharmaceutical companies have succeeded in the past couple of years in changing their statuses from clinical stage to revenues-generating firms. A number of these firms reside in the Prohost Portfolio, picked up before they generated revenues from their newly approved products’ sales. We are following up on these firms’ news as they come out of their new journeys towards marketing …

Tanezumab, an investigational humanized monoclonal antibody developed by Pfizer (PFE) and Eli Lilly (LLY), met all three co-primary endpoints in patients with osteoarthritis (OA). The 16-week Phase 3 study, which evaluated subcutaneous administration of tanezumab in patients with OA, demonstrated that the patients who received two doses of tanezumab, separated by eight weeks, experienced a statistically significant improvement in pain, physical function and patients’ overall assessment …

Amgen (AMGN) announced that AmgevitaTM, a biosimilar to adalimumab, will launch in markets across Europe beginning on October 16, 2018. According to Amgen’s press release, AmgevitaTM is the first adalimumab biosimilar to be approved by the European Commission (EC). The EC approval is based on analytical, pharmacokinetic and clinical data, including results from two Phase 3 confirmatory studies of the product for moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The …

Exelixis (EXEL) announced its initiation of a phase 3 pivotal trial (COSMIC-311) of Cabometyx (cabozantinib) in patients with radioiodine-refractory differentiated thyroid cancer (DTC) who have progressed after two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies. The co-primary endpoints for the trial are progression-free (PFS) survival and objective response rate (ORR). Why conducting trial on patients with radioiodine-refractory differentiated thyroid cancer.    Differentiated thyroid tumors make up …

The U.S. Food and Drug Administration (FDA) has approved Paratek Pharmaceuticals’ (PRTK) product Seysara™ (sarecycline) for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Paratek has exclusively licensed U.S. development and commercialization rights of Seysara for acne to Allergan PLC, who has assigned such rights to Almirall SA. Paratek retains development and commercialization rights in the rest of the world. Seysara (sarecycline) …