From a purely scientific standpoint, the news about the Ebola outbreak has been encouraging. New genomic technologies enable unprecedented surveillance of the virus. There are drugs and vaccines in clinical trials. And in response to the urgency of the crisis, both drugmakers and regulatory agencies are making efforts to expedite the process of getting weapons against Ebola through the regulatory process and into the field, where they are needed. (See BioWorld Today, Oct. 22, 2014.) (more…)
Amgen Inc.’s moves into the biosimilar space drew attention during the company’s business review meeting, which followed the release of investor-pleasing third quarter financial results that showed the company beating estimates and included higher guidance for the full year’s earnings.
Piper Jaffray analyst Joshua Schimmer called Thousand Oaks, Calif.-based Amgen “hands down, the best large cap pipeline around. While no new data were presented, the company highlighted its late-stage product portfolio which we believe is unrivaled in its incremental revenue-generating potential.” (more…)
Compared with the relatively non-specific cytotoxic drugs currently used in most cancer treatments, a new era of cancer therapy is expected to be dominated by targeted treatments and cancer immunotherapies. Targeted and immunotherapies targeting specific pathways or receptors provide an advantage over traditional chemotherapies that act on all rapidly dividing cells, be they normal or cancerous. The side effects of chemotherapy are much greater due to their effects on normal cells, whereas targeted therapies cause little or no collateral damage to normal cells, which improves the quality of life of the cancer patient. The use of targeted therapy has also markedly changed the outcomes for some cancers. (more…)
Personalized medicine. Big data. Wellness. The growing impact of diagnostics on pharmaceuticals. The med-tech buzzwords and ideas of yesterday are actually the innovations of today. Those once abstract ideas were more tangible and were present during this year’s Cleveland Clinic Medical Innovation Summit, which was held last month. (more…)
Friedhelm Blobel, CEO, Sciclone Pharmaceutical Inc. spoke with BioWorld about the ongoing investigation related to possible violations of the U.S. Foreign Corrupt Practices Act (FCPA) in China. He also discussed the company’s resulting compliance program and confirmed that, despite these challenges, being in China outweighs all of the expenses and risks. (more…)
Amgen Inc. put the biopharma world on notice by disclosing positive findings from the first phase III study evaluating efficacy and safety of its lead biosimilar candidate. The randomized, double-blind, active-controlled study of ABP 501, whose reference drug is Humira (adalimumab, Abbvie Inc.), met its primary endpoint: improving the Psoriasis Area and Severity Index (PASI) within a prespecified equivalence margin, compared to adalimumab, from baseline to week 16 in patients with moderate to severe plaque psoriasis. (more…)
The M&A activity in the Life Sciences sector in Q3 2014, as expected, experienced a slowdown for tax inversion deals, looking at the regulatory uncertainty and scrutiny from the US agencies.
The quarter-over-quarter total disclosed deal value dropped by 45% from $90 billion in Q2 to $50 billion in Q3, as per Thomson Reuters Recap. However, the sector registered highest deal activity with 112 deals in Q3 as compared to 88 and 93 deals in Q1 and Q2, respectively. (more…)
Bladder cancer is one of the ten most prevalent solid tumors worldwide, particularly in Westernized countries. With a median age of diagnosis of 73 years and a 4:1 predominance of male patients, the malignancy is closely linked to risk factors such as tobacco smoking, the effects of which may be amplified in the presence of genetic risk factors. (more…)