AMGEN AND OSTEOPOROSIS Amgen And UCB Announce Positive Top-Line Results From The Phase 3 Study of Romosozumab In Postmenopausal Women With Osteoporosis The FRAME Study Met All Primary Endpoints by Reducing the Incidence of New Vertebral Fracture Through 12 and 24 Months Amgen (AMGN)and UCB (Euronext Brussels: UCB): Top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME). The results  showed …

Incyte: A Good Company Facing Irrelevant Investors’ Reaction  Incyte decided to stop an early ongoing trial of a combination treatment ruxolitinib (Incyte) plus regorafenib (Bayer) for colon cancer after observing the combination wasn’t working. Both drugs are approved for different indications and both are doing well in the market. At this moment in the market chaos, this news looked as if a terrible thing that must cause an unwarranted …

Halozyme Therapeutics (HALO) seems to have closed the previously announced $150 million royalty-backed debt transaction with investment funds managed by Pharmakon Advisors and Athyrium Capital Management.  The debt is said to be secured by future royalties of ENHANZE™ products, received from Halozyme's collaborations Roche and Baxalta only. Halo declared delight with the conclusion of this deal as it is a non-dilutive financing and because it finds …

Theravance Biopharma (TBPH) announced the commercial launch of VIBATIV® (telavancin) in Canada. VIBATIV is a once-daily antibiotic with a dual mechanism of action against Gram-positive bacteria, including difficult-to-treat methicillin-resistant Staphylococcus aureus (MRSA). The drug is approved in Canada for adult patients with hospital-acquired bacterial pneumonia (HAP) and ventilator-associated bacterial pneumonia (VAP) known or suspected to be caused by susceptible isolates of Staphylococcus aureus including methicillin-susceptible S. aureus (MSSA) and MRSA. VIBATIV is …

The Market is Surely Ignoring the Historical Summit Biotech achievements are standing on Right Now     The latest biotech sector’s breakthroughs we presented was the novel powerful gene editing techniques CRISPR/cas9 and TALEN. Our article in the Prohost Letter #390 meant to enable the reader to understand that the evolution in biological sciences, especially in sequencing and analyzing the genome of the sick and healthy cells, has reached a stage …

Escaping the slaughter, or taking advantage of it, or  accumulating the stocks we love, or turning from positive to negative investors are all choices on the table. The problem is that the prophets stop prophesizing at times when prophesies are badly needed. The prophets themselves are asking questions, rather than providing answers. The experts and officials who know better and were just claiming that the …

Of the Biotech Sector’s Selloff Testing the lows in biotech firms’ stock prices is nothing but testing the biotech investors’ degree of vulnerability to fear. Fear leads many biotech investors to hysterically sell their stocks just by hearing negative stories about the sector. The stock selloff continues even when the frightening fabricated stories happen not to make sense that convince mature people to believe them. …

Improving the management of inflammatory and autoimmune diseases has been a dream that seems to be happening slowly but surely in the past years. The improvement has gained energy and speed in 2015. The advancement in treatments has been demonstrated on several inflammatory and autoimmune diseases, including psoriatic arthritis, rheumatoid arthritis (RA), Crohn’s disease, systemic lupus erythematosus (SLE) and many other autoimmune diseases. Psoriasis   …

Exelixis Announces Positive Results from Subgroup Analyses of the METEOR Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma - The results will be Presented at ASCO 2016 Genitourinary Cancers Symposium this month. - Data further highlight clinical benefit of cabozantinib across subgroups of patients with advanced renal cell carcinoma   - METEOR data are the foundation for the U.S. NDA filing submitted …

On Oct. 28, 2015, Gilead Sciences (GILD) announced that it has submitted a New Drug Application (NDA) to the FDA for an investigational, once-daily fixed-dose combination of the approved nucleotide analog polymerase inhibitor sofosbuvir (Sovaldi®) abbreviated as (SOF) and the investigational pan-genotypic NS5A inhibitor velpatasvir, abbreviated as (VEL) for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA was supported by …