Paratek Pharmaceuticals (PRTK) announced positive results from Phase 3 registration study comparing its once-daily, broad spectrum antibiotic, omadacycline, to linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI). The firm’s press release stated that its antibiotic drug met the FDA-specified primary efficacy endpoint of early clinical response. The study has also met the European Medicines Agency (EMA)-specified co-primary efficacy endpoints for …

ARIAD Pharmaceuticals (ARIA) announced the initiation of a New Drug Application (NDA) submission for brigatinib, the firm’s investigational anaplastic lymphoma kinase (ALK) inhibitor to the FDA. Earlier than expected, ARIAD is seeking U.S. marketing approval of brigatinib for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib, which has received Breakthrough Therapy designation from the FDA for for this NSCLC condition …

CELATOR PHARMACEUTICALS Good News That Might Go to JAZZ Pharmaceuticals Celator Pharmaceuticals (CPXX): At the European Hematology Association (EHA) 21st Annual Congress, Celator  presented positive response rate results in acute myeloid leukemia (AML) patients with the FLT3 (FMS-like tyrosine kinase-3) mutation.   The results came from Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection in patients with high-risk (secondary) acute myeloid leukemia (AML). Data, …

SPARK Spark (NASDAQ: ONCE) is on its way to get an FDA approval of its first gene therapy for a rare genetic condition that causes blindness in children. The firm’s gene therapy product,SPK-RPE65 for inherited retinal dystrophies is designed to be given only once to produce the expected cure. In recent news, Spark is financing through a secondary public offering. The firm plans to use …

Le CompaGnon Part 1 TUESDAY June 14, 2016 The Eternal Market Games Unfortunately, the fabrication and misrepresentation of reality in media articles about member firms of the biotech sector succeeded in devastating promising companies having exceptional technologies and products. The damages went far beyond investors unwarranted losses. The damages were grave as to ruin of many firms. Indeed, many promising firms were forced to declare …

Agenus (AGEN) announced that a lead product candidate is selected under its license and research collaboration with Merck, which is known as MSD outside the United States and Canada. Merck has selected a lead antibody candidate and several backup antibodies, discovered by Agenus, to an undisclosed Merck checkpoint target. Agenus received a $2 million milestone payment from Merck. According to the terms of the agreement, …

Prohost Letter #396 CELEBRATING MEMORIAL DAY - Wish you celebrated the Memorial Day. Memorial Day’s purpose was remembering the people who died while serving in the country’s armed forces. The Memorial Day was initiated as Decoration Day after the Civil War in the year 1868 when the Grand Army of the Republic - an organization of Union Veterans in Illinois established it to decorate the graves …

Additional data from pivotal METEOR trial underscore clinically meaningful benefit of Exelixis’ (EXEL) drug Cabometyx™ for patients with Advanced RCC AT the ASCO Meeting: ABSTRACT #4557, #4558 Cabometyx’™ benefit was robust and consistent regardless of prior treatment, location and extent of tumor metastases Positive data will be presented at the 2016 American Society of Clinical Oncology (ASCO) from subgroup analyses of the pivotal METEOR trial. …

Enrollment has been completed in all the three ongoing clinical trials comprising the firm’s Phase 3 program for Theravance Biopharma’s (TBPH) revefenacin (TD-4208). The drug is an investigational long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD). The three revefenacin Phase 3 program are meant to support the registration of the product in the U.S. More than 2,300 patients have been enrolled and Top-line …

Biomarin Pharmaceutical’s (BMRN) decision to withdraw its DMD drug Kyndrisa™ (drisapersen) Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) means more than pressuring the FDA to approve Sarepta’s DMD product eteplirsen. As we see from Biomarin press release, its decision was based on several reasons, including the discussions at the May 2016 Committee for Medicinal Products for Human Use (CHMP) meeting, which clearly …

Ionis Pharmaceuticals (IONS) stock plummeted when GlaxoSmithKline (GSK) stopped pursuing a late stage trial of Ionis-TTR the TTR amyloidosis called familial amyloid polyneuropathy (FAP). This product represents one wagon in Ionis train, which has several wagons representing the firm’s pipeline products. GSK is still occupying one of these wagons known as the familial amyloid cardiomyopathy (FAC). All the other BIG names riding Ionis’ train are still there, no …

GlaxoSmithKline and Innoviva: The COPD inhaler Relvar® Ellipta® (known as Brio Ellipta in the United States) Demonsterates Superiority Over Usual Care. According to GlaxoSmithKline plc (GSK) and Innoviva (INVA), the results came fromSalford lung study, which demonstrated that Relvar® Ellipta® 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved a superior reduction in exacerbations versususual care   in patients with chronic obstructive pulmonary disease COPD, in an everyday …

Yes, indeed, the good news has come from the randomized CABOSUN phase 2 trial with Exelixis’ (EXEL) drug cabozantinib. The news is indirectly telling us that Cabozantinib may soon become the first-line treatment for previously untreated advanced renal cell carcinoma (RCC). We say that because the randomized CABOSUN trial that was conducted on advanced renal cell carcinoma patients who have not been treated before has shown a …

CANCER Everyday something new is discovered that explains cancer behavior, including proliferation, response to treatment, resistance to treatment, metastasis, recurrence, etc. Today we have several news, including one that might have cleared a puzzle regarding a continuous growth of colon cancer after oncologists block a well known signaling molecule recognized as playing a major role in making, not breaking the cancer. We also have news …

Notwithstanding the unrelenting improvements being constantly made in managing blood coagulation’s problems, conventional anticoagulants still have thrombotic incidents (clots) in patients taking anticoagulants (blood thinners) and bleeding remained the most feared side effect of these indispensable life-saving drugs. In recent years, several novel anticoagulants demonstrating obvious advantages over conventional anticoagulants have been created, developed and marketed. Their advantages over conventional anticoagulants have been validated through …

COLLABORATIONS Preparing for the Future, Biogen Signs a Lucrative Collaborative Agreements While Highlighting the Small Firm REGENXBIO Pursuing gene therapy, Biogen (BIIB) announced collaborations with two gene therapy experts from the University of Pennsylvania as well as a gene therapy technology licensing deal with THE small gene therapy firm RegenxBio (RGNX). The deal will allow Biogen to license RegenxBio proprietary NAV Technology Platform for the …

Underestimating the Value of Drugs that Disrupt the DNA Repair Mechanisms in Cancer Cells. AstraZeneca’s (AZN) Chief Executive Pascal Soriot said that while DNA damage response was under-recognized by investors, oncologists were already “very excited” by its potential of the drugs targeting DNA repair mechanisms inside cancer cells. According to AstraZeneca, drugs that disrupt the DNA repair mechanisms inside cancer cells are showing tangible promise for …

Seres Therapeutics (MCRB), is microbiome therapeutics platform company. It focuses on developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ programs comprise: SER-109: This product has completed a Phase 1b/2 study with results showing a clinical benefit in patients with recurring …

GILEAD After years of controversial refraining, official India reversed course and granted Gilead Sciences its patent rights to Sovaldi hepatitis C treatment. More than a victory for Gilead, it was the prevalence of fairness after years of underestimating the power to fairness to keep resurfacing until reinstated. The Indian Patent Office had rejected Gilead’s patent application based on a notion that it did not demonstrate …

By June, which is next month, Incyte (INCY) will be the owner of the European operations of Ariad (ARIA). That’s what both firms have announced yesterday. Among other details, the firms decided on signing a licensing agreement for exclusive development and commercialization rights to Ariad’s Iclusig (ponatinib) in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia. Iclusig is approved …