Today - Sunday, May 3, 2015
- Chinese regulator SAIC accused Siemens' (OTCPK:SIEGY) healthcare unit last year of committing "commercial bribery," sources told Reuters.
- The company allegedly donated medical devices in return for agreements to exclusively buy from it the expensive reagants needed to run them,
- The investigation (which involved as many as 1,000 hospitals) also follows a wide-reaching probe into the Chinese pharmaceutical industry that last year saw GlaxoSmithKline fined nearly $500M for bribing officials to push its medicine sales.
Friday, May 1, 2015
- Tucson, AZ-based HTG Molecular Diagnostics (Pending:HTGM) is set for its IPO of 3.57M shares of common stock at $13 - 15.
- The commercial stage firm markets a novel technology platform, called HTG Edge, that facilitates the routine use of complex molecular profiling. According to the company, it can simultaneously profile thousands of molecular targets from samples a fraction of the size required by other methods. The HTG Edge system, consisting of instrumentation, consumables and software analytics, is ideally suited for tumor profiling, molecular diagnostic testing and biomarker development.
- 2014 Financials ($M): Revenues: 3.3 (+48.4%); Operating Expenses: 13.0 (+8.9%); Net Loss: (14.0) (-18.6%); Cash Burn: (13.0) (-10.2%).
- San Diego-CA-based aTyr Pharma (Pending:LIFE) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage firm develops medicines for rare diseases. Its technology is based on Physiocrine biology, a newly discovered class of naturally occurring physiological modulators. The company has identified ~300 to date. The company believes they promote homeostasis, a fundamental process of restoring stressed or diseased tissue to a healthier state.
- Its lead product candidate is the Phase 1b/2-stage Resolaris, for the potential treatment of adult patients with facioscapulohumeral muscular dystrophy (FSHD), a severe and rare genetic disorder characterized by muscle weakness and wasting. The muscles most affected are those on the face (facio), around the shoulder blades (scapulo-) and in the upper arms (humeral). The FDA designated Resolaris an Orphan Drug for FSHD in February.
- 2014 Financials ($M): Operating Expenses: 23.6 (+21.0%); Net Loss: (24.8) (-14.3%); Cash Burn: (22.8) (-31.8%).
- Chembio Diagnostics (CEMI +1.3%) announces that its SURE CHECK HIV 1/2 self-testing device has been launched in the UK and France under private label. In the UK, BioSure Ltd. will market the product as BioSURE HIV Self Test while in France, AAZ will market it as autotest VIH.
- People living with HIV infection in the UK and France total 110K and 160K, respectively. The number of people unaware of their positive HIV status is about 26K and 29K, respectively, in the UK and France.
- SURE CHECK HIV 1/2 is marketing in the U.S. as Clearview Complete.
- Oxfordshire, UK-based Adaptimmune Therapeutics (Pending:ADAP) is set for its IPO of 9.375M American Depositary Shares at $15 - 17.
- The clinical stage biopharmaceutical firm develops cancer immunotherapies based on its T-cell receptor platform, which identifies cancer targets (peptides), genetically engineers T-cell receptors (TCR) and then produces the therapeutic candidates for administration to patients. According to the company, the breadth of targets for TCR therapies is greater than those based on chimeric antigen receptor T cells (CAR-Ts) because the TCRs target both intracellular and extracellular cancer antigens. CAR-Ts, which genetically engineer T cells to produce chimeric antigen receptors on their surface, are extracellular only.
- Its lead program is the Phase 1/2-stage NY-ESO, a TCR therapy for the potential treatment of solid tumors, blood cancers, ovarian cancer and esophageal cancer. In a synovial cancer study, six of 10 patients who received NY-ESO-TCR responded, one complete (before relapsing nine months later) and five partial. In a study of multiple myeloma following autologous stem cell transplant, 13 of 22 patients with active disease at time of transplant experienced complete or near-complete responses at 100 days post administration. Additional data will be reported later this year.
- Financials (six-month period ending Dec. 31 2014) ($M): Revenues: 3.8 (+55.8%); Net Loss: (4.8) (-55.8%); Cash Burn: (15.2) (-55.8%).
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11:00 AM| Comment!
- According to Reuters, Pfizer (PFE +0.2%) is negotiating a takeover of Swedish Orphan Biovitrum, known as Sobi. The potential price is unknown but the Stockholm-based firm's market cap is 35.8B Swedish crowns (US$4.3B).
- Sobi develops medicines for orphan diseases in hemophilia, inflammation, inherited metabolic disorders and oncology. Its top sellers are Kineret (anakinra), an interleukin-1 (IL-1) antagonist for the treatment of rheumatoid arthritis and neonatal-onset multisystem inflammatory disease (NOMID), and Orfadin (nitisinone) for the treatment of hereditary tyrosinemia type 1, a genetic disorder characterized by excess levels of tyrosine in the blood.
- Pfizer has a relationship with Sobi via its marketing of the hemophilia treatment ReFactor AF, which Sobi manufactures.
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- Momenta Pharmaceuticals (MNTA +6.5%) Q1 results: Revenues: $8.6M (-20.4%); R&D Expense: $22.7M (-15.0%); SG&A: $7.9M (-32.5%); Operating Loss: ($22.1M) (+19.9%); Net Loss: ($21.9M) (+20.1%); Loss Per Share: ($0.40) (+24.5%); Quick Assets: $198.7M (+3.8%).
- Q2 2015 Guidance: Net Cash Usage: ~$28M - $32M.
10:13 AM| Comment!
- U.S. drug wholesaler McKesson (MCK +0.2%) settles investigations from several federal agencies, including the Department of Justice, over suspicious order reporting practices for controlled substances.
- The settlement requires the firm to pay a $150M fine and suspend the registrations of at least three distribution centers for two years. The suspensions will not affect product supply to any customer.
- The company's Landover, MD distribution center is still being investigated for its activities regarding controlled substances.
- McKesson accounted for the settlement in its fiscal year ended March 31.
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