Roche ($RHHBY) and Genentech won a landmark approval for the cancer drug vismodegib today. After gaining significant efficacy data from a Phase II study on basal cell carcinoma, the drug giant not only went straight to the regulators for a decision, they won the approval well ahead of the agency’s decision deadline. And top regulators signaled that they would look kindly on other developers who take the same approach to targeted therapeutics.
SAN DIEGO and DUBLIN, Ireland — January 27, 2012 /PRNewswire/ — Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON™ (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes. BYDUREON is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. BYDUREON will be available in pharmacies nationwide in February.
It proved to be third time lucky for Amylin Pharmaceuticals, Inc. (AMLN) and Alkermes plc (ALKS) with the companies finally gaining US Food and Drug Administration (FDA) approval for their once-weekly type II diabetes treatment, Bydureon (exenatide extended-release for injectable suspension).
Carlsbad-based Isis Pharmaceuticals Inc. has launched Phase 1 clinical studies for a drug that aims to help severely obese people lose weight without interacting with the brain or heart, the company said on Dec. 20.
Curis Inc. has $6 million more in its coffers from a milestone payment after its collaborator Roche submitted its small molecule cancer drug candidate, vismodegib, to the European Medicines Agency for approval in treating advanced basal cell carcinoma.
We’ve identified twelve small to mid-cap biotechnology companies to watch in 2012, broken down into six categories based on valuation, fundamentals, their pipeline, potential M&A, potential turnarounds, and potential make or break data.
A molecular signature found in serum samples may predict future development of Alzheimer’s disease (AD), even before the first symptoms of the disease occur in patients, new research suggests.
There is no cure for Alzheimer’s disease, and as far as treatment goes, the best doctors can do (for now) is try to slow its progression. Identifying people in the earliest stages of the disease — even before any symptoms appear — would thus be very useful.
Takeda has expanded its capabilities in the oncology field with the purchase of small molecule drugs specialist Intellikine
Via its subsidiary Takeda American Holdings, the company will acquire Intellikine for an initial cost of $190 million (120.47 million pounds), with an additional $120 million dependent on clinical development milestones.
The pros and cons of patenting in the biosimilars scheme recently enacted as part of the Patient Protection and Affordable Care Act have been discussed, here and elsewhere (see “Will Patents Become Irrelevant in a Biosimilars Future?”). Whether envisioned by the bill’s drafters or not, the provisions of the Biologics Price Competition and Innovation Act of 2009 (particularly the litigation provisions) contain incentives for biologic drug innovators not to rely on patents to protect these drugs and the return on investment (or at least the reasonable prospect thereof) needed to support the capital-intensive effort that must be exerted to bring such drugs to market. Limitations on claim scope, possibilities of successful “design arounds” and the limited scope available for infringement by equivalents, as well as the uncertainties associated with amino acid sequence and other variants, make biologic drugs different from conventional small molecule drugs, which have been protected by patents under the Hatch-Waxman regime.