JUNO   Juno Therapeutics (JUNO), the CAR T developing firm that aims at revolutionizing cancer treatment has gotten the news we anticipated, but significantly faster than we expected. Indeed, the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Phase 2 of the ROCKET clinical trial of its CAR T product JCAR015. The trial was conducted in adult patients with relapsed …

Good news is not always great news that makes a difference. In the drug industry, clinical trial results that demonstrate a drug has fulfilled the requirements of the trials, including the primary and secondary endpoints does not always guarantee that the drug will be successful if and when it hits the market. Experience and follow up on certain firms enables us to see the real …

The Royal Divorce On Sunday, the next day after the announcement of the British referendum’s results, a turbulence in the stock markets was in the making by professionals who cited all kind of pessimistic likelihoods and negative projections that England divorce will cause havoc, devastating the stock markets for months, and maybe for years to come. On Monday, the markets were, indeed, devastated and the …

Innoviva (INVA) and GlaxoSmithKline plc (GSK) announced positive results from the pivotal Phase 3 FULFIL study of the Closed Triple combination of fluticasone furoate, umeclidinium, and vilanterol) for patients with chronic obstructive pulmonary disease (COPD). The advancement in the treatment of COPD is obvious as the data demonstratedsuperiority for the Closed Triple combination as compared to the currently marketedSymbicort® Turbohaler® in improving lung function and …

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 …

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, …

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 …

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 …

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 …

EXELIXIS AGAIN They said: Sell EXEL, as no partner is interested in the firm’s FDA approved cabozantinib to date. What really happened: It did not take long for IPSEN to come forward and take the responsibility of marketing cabozantinib abroad and pay $200 million upfront payment to Exelixis. They said: Although the FDA approved Cabometyx (cabozantinib) for advanced renal cell carcinoma (RCC), the drug will …

GILEAD SCIENCES The people who cause the selloff of Gilead’s (GILD) stock because it missed 5 cents are the same who continue to complain about the high price of its HCV drug. This is intriguing because those who advocated selling the stock said that the reason for the miss is the huge discounts the firm is making on the drug price. Gilead is the undisputed …

Congratulations.   The FDA approved Exelixis’ (EXEL) drug Cabometyx™ (cabozantinib) tablets for advanced renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. Cabometrix is the first drug to demonstrate robust and clinically meaningful improvements in a phase 3 trial in patients with advanced RCC. The drug satisfied all key efficacy parameters — …

Meaningful Presentations at the Annual Meeting of the American Association for Cancer Research (AACR) NEKTAR THERAPEUTICS NKTR-214 Drug Improves Survival and Extends Immunity in cancer Immunotherapy Nektar Therapeutics (NKTR) investigational immune-stimulatory cytokine therapy NKTR-214 is in Phase 1/2 trial. At the Annual Meeting of the American Association for Cancer Research (AACR) meeting, Nektar announced new preclinical data for NKTR-214, which demonstrate both its activity as a single-agent and its synergistic activity with checkpoint blockade. …

Juno Therapeutics (JUNO) is due to receive a fee payment of $50 million from Celgene. The reason for this compensation is that Celgene has exercised its option to develop and commercialize Juno CD19 program outside North America and China. From now on, Juno will share with Celgene the global development expenses for products in the CD19 program outside the U.S. and china and Celgene will have pay …

Dealing With Bacterial Resistance To Antibiotics    In the NEWS THERAVANCE BIOPHARMA At the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Theravance Biopharma (TBPH) demonstrated that its drug Vibativ® (televancin) possesses a potent in vitro activity against broad range of Staphylococcus aureus (S. aureus) clinical isolates. These isolates included Methicillin-resistant S. aureus (MRSA). The antibiotic activity for VIBATIV was seen in 100% of the evaluated S. aureus clinical isolates regardless of their type or resistance …

Years ago, a friend who is a highly regarded Immunologist lectured us during one of our visits to his home city Milano in Italy about the important role well written press releases play in highlighting the prominence of unknown, yet, capable biotech firms. “If not for its announced news, millions of interested people around the world, including myself, wouldn’t have heard on time about Genentech …

Many in Wall Street have been anxious, sitting on fire while waiting to learn, which biotech company Gilead Sciences (GILD) would decide upon acquiring that would deepen and enhance its pipeline. In Today’s news, a firm called Nimbus Therapeutics, LLC today announced that it has signed a definitive agreement under which terms Gilead will acquire Nimbus Apollo, Inc., a Nimbus Therapeutics wholly-owned subsidiary. Important is that the acquisition …