Apr. 22, 2014, 4:24 PM
Apr. 22, 2014, 4:04 PM
Apr. 22, 2014, 12:10 AM
Apr. 21, 2014, 5:35 PM
Apr. 17, 2014, 5:20 PM
- EVP and Chief Operating Officer Ken Keller resigns to take a CEO job with another firm.
- Joseph Turgeon replaces him as President and COO reporting to Chairman Dr. Rajesh C. Shrotriya.
- Prior to joining Spectrum Pharmaceuticals (SPPI -2%) Mr. Turgeon was VP, Sales at Amgen (AMGN -0.1%).
- VP, Corporate Accounts Tom Riga promoted to EVP and Chief Commercial Officer reporting to Mr. Turgeon.
Apr. 10, 2014, 9:32 AM
- In its recent healthcare budget, French lawmakers introduced a measure that will allow pharmacists to substitute generics for prescribed brand-name biotech drugs. This has rattled the industry since France is Europe's #2 pharmaceutical market behind Germany.
- A decree must be passed before it becomes effective.
- France is the first European country to pursue biologic substitution. Big Pharma fears a domino effect if it is successful despite the heretofore slow uptake of biosimilars.
- The initiative applies only to patients starting a new course of treatment. Doctors will still retain the ability to demand the branded product.
- Unsurprisingly, Big Pharma is upset at not being consulted prior to the law's passage.
- Some analysts believe France could save up to $1.4B by 2020 by using generics.
- Substitutions only apply to retail pharmacies. 40% of biotech prescriptions are filled in hospitals.
- (RHHBY) (AMGN) (NVS) (SNY) (LLY) (PFE) (BMY) (MRK) (GSK) (JNJ) (HSP) (ABBV) (AZN) (BAYRY)
Apr. 7, 2014, 3:56 AM
- Pfizer's (PFE) Palbociclib treatment doubled progression-free survival to 20.2 months in a Phase 2 trial of 165 patients with advanced breast cancer.
- Palbociclib also helped patients live four months longer, although the result isn't statistically significant.
- Palbociclib is part of a new class of drug called CDK 4/6 inhibitors, which limit the activity of two enzymes involved in cell division — cyclin-dependent kinases 4 and 6.
- Palbociclib is considered a potential blockbuster that could be used with other cancers, and it is forecast to sell $3.11B by 2020. Amgen (AMGN) would receive an 8% royalty on any sales. (PR)
Apr. 4, 2014, 10:19 AM
- Amgen's (AMGN -0.3%) melanoma drug meets its primary endpoint in a Phase 3 clinical trial but misses its secondary.
- The study evaluated the safety and efficacy of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor ((GM-CSF)).
- The primary endpoint of durable response rate was met but the secondary endpoint of overall survival was not.
- EVP of R&D Sean Harper, M.D. says the company will conduct further research on the product's efficacy in melanoma.
Apr. 3, 2014, 10:19 AM
- Amgen (AMGN -1.3%) ends its collaboration with Glaxo Group (GSK -0.9%) regarding the commercialization of denosumab for osteoporosis indications in certain geographies. The partnership began on July 27, 2009.
- All commercial activities assigned to GSK other than those in Australia will transition back to AMGN by the end of the year.
- In exchange for the early termination, AMGN will pay GSK $275M plus $15M in reimbursements for transition-related costs.
Mar. 30, 2014, 1:51 AM
- Amgen's (AMGN) Evolocumab cut "bad" LDL cholesterol by 55-66% vs a placebo in three Phase III trials. The drug also didn't show any serious safety problems.
- Amgen presented the data yesterday, fleshing out an earlier disclosure that the drug had achieved its main targets in five late-stage trials of 4,000 patients. Amgen is set to present data from the other two studies today.
- Evolocumab is part of a new class of drugs called PCSK9 inhibitors, which block a protein that inhibits the ability of the liver to remove LDL from the blood.
- Analysts have forecast that annual sales of each such drug could hit $3B or more. (PR)
Mar. 26, 2014, 8:33 AM
- Large cap pharma and biotech firms have regenerative therapy R&D programs underway according to a recent survey.
- 69% of respondents are focused on developing cellular-based therapies.
- Wound healing and burns have the greatest near-term potential.
- Long term areas of interest are cardiovascular disease, oncology, neurodegenerative disease, monogenic disorders and ocular disease.
- (AGN) (AMGN) (BAX) (BIIB) (CELG) (LLY) (GSK) (JNJ) (NVS) (NVO) (PFE) (RHHBY) (SNY) (MRK) (SHPG)
Mar. 17, 2014, 9:39 AM
- Amgen's (AMGN) evolocumab hits its primary endpoint in its TESLA phase III trial of the percent reduction from baseline at week 12 in LDL-C. The results are statistically significant.
- Evolocumab is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.
- TESLA was a two-part phase 2/3 evaluating evolocumab in patients with homozygous familial hypecholesterolemia.
Mar. 11, 2014, 9:14 AM
Mar. 7, 2014, 4:24 PM
- The FDA requests that Regeneron (REGN) and Sanofi (SNY) assess potential neurocognitive side effects of their late stage cholesterol drug alirocumab, a PCSK9 inhibitor.
- Memory loss, impaired concentration and paranoia, though rare, have been associated with the use of statins for lowering LDL cholesterol.
- Both firms disclosed in their regulatory filings that the appearance of these side effects could delay or stop the product's development.
- Pfizer (PFE) and Amgen (AMGN) are also working on PCSK9 inhibitors.
Mar. 5, 2014, 5:38 PM
Mar. 5, 2014, 4:57 PM
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