The FDA advisory committee members’ inability to rule for or against the approval of Valeant (VRX) anti plaque psoriasis drug brodalumab was not unexpected. However, more outside observers were expecting the committee to flatly reject the skin disease drug that would subject people to commit suicide or to cardiovascular side effects, including death. Indeed, the discussions were mostly about the drug’s side effects specifically the …

Important news is the news that informs about successful achievements that make a difference in treating life-threatening diseases, chronic diseases and diseases with no available treatments. Sometime you might not have a personal interest in one, or another or even all the mentioned firms in the news. For investors in the biotech sector, however, it is good to know the successful treatments that might be …

News about approvals or insinuations about almost guaranteed future approvals of products that promise improving the management of chronic and life-threatening diseases are always welcomed with enthusiasm. Of course some approvals are more rewarding than others, which has to be assessed by investors. For the patients, however, any improvement, small or phenomenal is always considered good news. Let’s have a look at one of the …

The FDA approved INSIGHTEC firm’s Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication. Using focused ultrasound waves Exablate Neuro precisely targets and ablates tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement …

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 …

AMGEN Repatha is the human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR). The binding  prevents PCSK9-mediated LDLR degradation, permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs …

Juno Therapeutics (JUNO) announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known as the “ROCKET” trial. The clinical hold was initiated after patients’ death last week, which followed a recent addition of fludarabine to the pre-conditioning regimen. …

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 …

PsiOxus Therapeutics’ adenovirus product in combination with Opdivo (nivo-lumab) for late-stage cancers.     Bristol-Myers Squibb (BMY) and PsiOxus Therapeutics (PsiOxus) announced an agreement to evaluate PsiOxus’ drug enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with Bristol-Myers Squibb’s checkpoint inhibitor opdivo (nivolumab) for a range of tumor types in late-stage cancer patients. Enadenotucirev is designed to have immune stimulating effects while Opdivo is designed …

- Tesaro's (TSRO) drug niraparib significantly improved progression-free survival for patients with ovarian cancer in both cohorts of the phase 3 NOVA trial - The NOVA trial successfully achieved its primary endpoint of PFS in the germline BRCA mutant cohort   - The NOVA trial successfully achieved its primary endpoint of PFS in the germline and non-germline BRCA mutant cohort. PFS endpoint is also achieved in …