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, …

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 …

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 …

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 …

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 …

Medivation is a Target for Acquisition The Question is: Who Will Acquire Medivation? Sanofi has made a bid to acquire Medivation for $9.3 billion (£6.37B). Sanofi is expected to pay $52.50 per share in cash for Medivation. Why Medivation? Sanofi's chief executive Olivier Brandicourt said, "Thanks to Medivation's excellent prostate cancer treatments, we believe that a merger with Medivation would benefit patients and, at the same time, create value …

Biotech NEWS   AGENUS Agenus’ First Checkpoint Inhibitor to reach Clinical Trial The first patient has been dosed in Agenus (AGEN) Phase 1 clinical trial of its checkpoint inhibitor product AGEN1884. The open-label, multicenter trial in patients with advanced or refractory cancer is designed to evaluate the safety of AGEN1884 and determine the estimated maximum tolerated dose. AGEN1884 is an anti-CTLA-4 (cytotoxic T-lymphocyte antigen-4) checkpoint …

The AACR 2016 meeting presentations differed substantially from previous meetings. The  2016 meeting has brought near certainty that, indeed, defeating cancer is a reachable objective. The road is lengthy, but the speed in analyzing the data and acting upon them towards improvement is unprecedented. You will find the most important information about the AACR cancer meeting in the upcoming Prohost Letter. In the NEWS TAPIMMUNE …

Illumina Showing 6% revenue increase over the same quarter last year, Q1 2016, was not enough as Illumina (ILMN) missed analysts’ expectations and its own projections regarding its revenues. Prior to the announcement of its Q1 results, the giant gene sequencing firm offered investors a comprehensive explanation of the origin of the miss and the actions it has already begun to take to avoid future misses. Illumina pinpointed …

In the biotech sector, daily stories (news) are not just announced, but mostly edited in ways that project the narrators’ tendencies and wishes rather than the original news. Last week’s headlines comprised positive news from a firm’s drug aimed at treating a chronic progressive disease, muscular dystrophy, which disables children’s by weakening their voluntary and involuntary muscles, while threatening their hearts and lungs and lives. Other headlines …

Pursuing its goal in treating hepatitis, Gilead Sciences (GILD) is at the finish line of clinical trials on another virus, this time the Hepatitis B virus. HBV not HCV. Two large Phase 3 trials evaluating once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection met the primary endpoints of non-inferiority to Gilead’s Viread® (tenofovir disoproxil fumarate (TDF) 300 mg.  …

Regeneron and Intellia to Discover and Develop CRISPR/Cas Therapeutics Moving forward is Regeneron Pharmaceuticals’ (REGN) strategy based on strong scientific and technological capability that needs no validation by external validators. The quality, i.e., safety and efficacy, of Regeneron’s approved products and the clinical trial outcomes of the firm’s drugs in late phase trials speak for themselves. Good news from the firm is flooding the media. The most recent …

Another day, another badly needed treatment for a dangerous disease is on its way to be FDA approved. The day was yesterday, Thursday, April 7, 2016. The company is Intercept (ICPT), the disease is primary biliary cirrhosis renamed primary biliary cholangitis (PBC), the drug is called Ocaliva™ (obeticholic acid). The good news came from the FDA's Gastrointestinal Drugs Advisory Committee, which voted 17 to 0to recommend accelerated approval of Ocaliva™.    Now …

Pfizer (PF) terminated its acquisition agreement with Allergan Plc (AGN) The new set of rules released by the U.S. Treasury Department to make it difficult for U.S. companies to conduct tax inversions contributed Pfizer’s decision. Analysts noted that the new regulations seem almost directly aimed at Pfizer-Allergan. In one of two major parts of the new rules, the U.S. government would not consider the assets acquired …

PFIZER Pfizer (PF) announced that its oral drug tofacitinib in doses of 5 mg and 10 mg twice daily  met Phase 3 endpoints on psoriatic arthritis. The trial was conducted on adult patients with active psoriatic arthritis (PsA). The recruited patients had an inadequate response to at least one conventional anti-rheumatic drug (csDMARD) and were tumor necrosis factor inhibitor (TNFi)-naïve. Patients enrolled in the study were …

Incyte (INCY) and Eli Lilly (LLY): The New England Journal of Medicine published detailed results of RA-BEACON — a pivotal phase 3 global study of baricitinib, a once-daily oral treatment for moderate-to-severe rheumatoid arthritis (RA). The study met its primary endpoint of ACR 20 response for baricitinib compared with placebo at week 12. ACR 20 response rates were (P≤0.001 for each baricitinib dose versus placebo): 55 percent for baricitinib 4 mg; 49 percent …