Biotech News and Comments
26 Jul 2010
In October 2009, Onyx (ONXX) paid $276 million up front to acquire the privately held Proteolix to get to its multiple myeloma drug carfilzomib. It promised $535 million in future payments largely contingent on carfilzomib's approval. As usual, investors did not like Onyx paying money, because investors do not like any company to pay money to develop or acquire state-of-the- art products. When somebody hates something he sees everything in…
The Biotechnology Revolution: A New State-Of-The-Art Diagnostic TestGenomics are changing the way medicine is being practiced, bringing to the labs state-of-the-art diagnostic tests that do much more than ruling in, or out diseases. The new laboratory tests enable physicians to determine the most effective treatment options for their patients’ diseases, to monitor the disease progression and install the treatment at the right time. This is no dream any longer, but…
14 Jul 2010
When people began to develop acute immune deficiency syndrome and die, horror was the feeling of humans allover the world. Nobody had yet known the cause of the catastrophe and no science could deliver any explanation. When the explanation emerged, the horror became a double horror for those who found out that the culprit is a new virus that has the ability to destroy the immune system and its presence…
07 Jul 2010
The First Conjugated Monoclonal Antibody From ImmunoGen’s (IMGN) Technology To Reach That StageIn Today’s news, Genentech, a member of the Roche Group, announced that the company has, indeed, submitted a Biologics License Application (BLA) to the FDA for trastuzumab-DM1 (T-DM1). The drug’s technology is licensed from ImmunoGen (IMGN). The BLA is for approval of T-DM1 in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and…
Following Exelixis (EXEL) press release, which announced that it has regained full rights from Bristol-Myers Squibb (BMS) to its cancer drug XL184, the firm’s stock plummeted. In the press release, Exelixis stated that BMS’ priorities made it difficult for BMS to align on the scope, breadth and pace of the ongoing clinical development of XL184 as agreed upon in the original agreement. Those who instigated the sell-off did not buy…
Regeneron’s (REGN) Phase 3 study in gout patients initiating allopurinol therapy to lower their uric acid levels showed that the company’s drug Arcalyst (rilonacept), known as IL-1 Trap, prevented gout attacks, as measured by the primary endpoint of the number of gout flares per patient over the 16 week treatment period. Is this s good, or bad news?Judging from investors’ reaction to the news, one would believe the clinical trial…
In June 2009, Illumina announced the launch of its individual genome sequencing service. The service is built around physician-patient consultation, with a physician’s order required to initiate the process. Sequencing is performed in Illumina’s CLIA-certified, CAP-accredited laboratory, following a rigorous process that focuses on physician involvement, patient privacy and data quality. The news was big, but what makes such milestones in the medical fields achievable is individuals’ serious consideration, which…
In a surprising move, the FDA approved Amgen’s (AMGN) osteoporosis drug Prolia (denosumab) two months earlier than the scheduled date, after it had caused several months delay in the drug’s marketing. The question is, why scientists label Prolia a breakthrough and why most analysts expect it to become a blockbuster, generating billions of dollars in revenues? Assessment of breakthrough drugs entails many intellectual practices that require knowledge of history that…
June 1, 2010 - Postmenopausal women at increased risk of bone fractures from osteoporosis, and men with prostate cancer who suffer bone loss associated with hormone ablation treatment will finally get Amgen’s (AMGN) drug Prolia (denosumab) in Europe. The good news for these patients and for Amgen (AMGN) has come as the European Medicines Agency’s (EMEA) Commission has granted approval for the use of Prolia in both conditions. Suddenly, Prolia…
Better than expected results are announced from phase 3 randomized, double-blind, placebo-controlled ADVANCE study with Vertex’ hepatitis C drug telaprevir. Around 1,095 patients suffering from the genotype 1 chronic hepatitis C virus took telaprevir, which has tremendously increased the cure rate at record treatment duration. Many liver experts considered this news a historical advancement in the management of progressive disabling, life-threatening and sometimes deadly chronic hepatitis C viral infection. First,…
