Jun. 12, 2014, 4:16 PM
- Privately-held biosimilar developer Epirus Biopharmaceuticals acquires Zalicus (ZLCS +38.9%) in an all-stock deal. The post-merger firm will be named Epirus Biopharmaceuticals. Current ZLCS shareholders will own ~19% of the combined enterprise. Their proportion could go down as low as 14% if Zalicus' cash position falls below $9M at closing.
- Epirus's pipeline includes biosimilars for Janssen's (JNJ -0.8%) Remicade, AbbVie's (ABBV -1.1%) Humira and Genentech's (RHHBY -0.6%) Avastin.
Jun. 10, 2014, 4:47 PM
- Health Canada approves Roche's (RHHBY +1.2%) cobas 4800 HPV assay as a first-line screening test for cervical cancer in women at least 25 years old. The test provides pooled high-risk HPV DNA results as well as individual detection of HPV 16 & 18, the types responsible for 70% of cervical cancer.
- The company also launches the fully automated CINtec PLUS assay to improve the detection and early intervention of pre-cancerous cervical disease.
Jun. 4, 2014, 11:29 AM| Comment!
Jun. 2, 2014, 12:35 PM
- Roche's (RHHBY +1.5%) BTD-designated PD-1 inhibitor MPDL3280A shrinks tumors in 43% of bladder cancer patients that are positive for PD-L1 in a 68-patient Phase 1 trial. Of the 30 patients were PD-L1 positive, 13 experienced an objective response as defined by RECIST (43%) at six weeks. The response rate increased to 52% at 12 weeks but this was due to n falling to 25 (13/25). The mean time to response for all subjects was 42 days.
- MPDL3280A is an investigational mAb designed to interfere with PD-L1 thus preventing tumor cells from binding to PD-1 and B7-1 on the surface of T cells. This helps activate the T-cells and restores their ability to target and attack cancer cells.
Jun. 2, 2014, 8:01 AM
- At this week's American Society of Clinical Oncology meeting in Chicago, cancer immunotherapies are all the rage. Using the body's immune system to battle cancer is significantly extending survival times for a variety of cancers and has created the next frontier for blockbusters. Bristol-Myers Squibb (BMY), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are all racing to bring their offerings to market.
- Some caution is warranted, however. The drugs work for only a minority of patients and they frequently have significant side effects, especially when a combination of therapies is used. For example, in a trial of BMY's Yervoy for advanced lung cancer, half of the 46 patients in the trial suffered serious side effects and three died from the drugs themselves.
Jun. 2, 2014, 7:00 AM
- Roche (RHHBY) acquires privately-held U.S. gene sequencing company Genia Technologies for as much as $350M. The deal involves $125M up front and as much as $225M in contingent payments depending on certain milestones.
- Genia's value proposition is low cost sequencing. It uses cheap electronic semiconductors in its platform instead of optical sensors. Roche expects the technology to increase speed and sensitivity in addition to lowing costs.
May 27, 2014, 11:38 AM
- Demonstrating its continued commitment to the development of leading edge automated laboratory instrumentation, Roche (RHHBY -0.8%) Diagnostics renews its 10-year contract with partner Hitachi High-Tech. The two firms have a 36-year history that has produced over 55K instrument placements in laboratories worldwide in immunodiagnostics and clinical chemistry.
May 27, 2014, 7:54 AM
- The EU Committee for Medicinal Products for Human Use recommends that the EC approve Roche's (RHHBY) Gazyvaro (obinutuzumab) in combination with chlorambucil for the treatment of adults with chronic lymphocytic leukemia (CLL) who have comorbidities making them unsuitable for full-dose fludarabine.
- In a Phase 3 trial Gazyvaro plus chlorambucil reduced the risk of disease worsening or death by 86% and increased survival time in untreated CLL patients who received chlorambucil alone.
- The EC's full decision should occur in the next several months. The product is already approved in the U.S. and rest of the world.
May 22, 2014, 7:44 AM
- Roman Abramovich's investment company, Millhouse LLC and OAO Pharmstandard buy a majority share of Russian biosimilar manufacturer Biocad. Millhouse will own 50%, Pharmstandard 20% and Biocad founder and CEO Dmitry Morozov will own 30%. The purchase price is undisclosed but the firm is valued at ~$1B according to a source close to the matter.
- Pfizer (PFE) and Amgen (AMGN) reportedly had interest in the firm.
- Biocad is currently recruiting patients for clinical studies of copies of Roche's (RHHBY) Rituxan, Herceptin and Avastin. The firm also cancer chemotherapies, a drug for genital infections and three drugs for viral infections.
May 22, 2014, 7:27 AM
- The FDA approves the Immucor Precise Type Human Erythrocyte Antigen (HEA) Molecular BeadChip Test. It is the first molecular assay used in transfusion medicine to assist in determining blood compatibility, specifically donor and patient non-ABO/non-RhD (non-ABO) red blood cell types.
- The test works by detecting genes the govern the exprssion of 36 antigens that can appear on the surface of red blood cells. It uses thousands of coded beads that bind with the genes coding for non-ABO red blood cell antigens present in the sample. A light signal is generated from each bead that captures a specific gene. System software decodes the light signals to report which antigens are predicted to be present.
- Related tickers: (ABT) (RHHBY)
May 19, 2014, 4:44 AM
- Swiss voters have overwhelmingly rejected a proposal to institute a minimum wage of 22 Swiss francs ($25) an hour, which would have been the highest in the world. Over 76% of voters cast a "no" ballot.
- "It's a strong sign to Switzerland as a center of employment," Economy Minister Johann Schneider-Ammann said. "Accepting the initiative would have led to job cuts in economically weak, rural areas."
- Major corporations that could have been affected by a "Yes" vote include UBS (UBS), Credit Suisse (CS), Roche (RHHBY), Novartis (NVS), ABB (ABB), Glencore Xstrata (GLCNF) and Nestle (NSRGY).
- Switzerland's SMI index is -0.8%, while the USD-CHF is -0.1% at 0.8914 francs.
- ETFs: FXF, EWL, FSZ
May 18, 2014, 2:29 AM
- The Swiss are going to the polls today to vote on whether to approve a minimum wage of 22 francs ($25) an hour, which would be the highest in the world.
- The measure would affect the one-in-ten workers who earn below the 4,000 francs that the initiative stipulates.
- Businesses are against the union-backed proposal, saying it would force more people into part-time jobs and increase Switzerland's 3.2% unemployment rate. Polls show 64% of voters are against the initiative.
- Still, major corporations that could be affected include UBS (UBS), Credit Suisse (CS), Roche (RHHBY), Novartis (NVS), ABB (ABB), Glencore Xstrata (GLCNF) and Nestle (NSRGY).
- The referendum is the latest nationwide ballot relating to business. In March last year, voters authorized giving shareholders more say over executive pay but rejected a measure in November to cap management salaries.
- The Swiss are also voting today over whether to spend 3.1B francs on 22 new Saab (SAABF) fighter jets.
- ETFs: FXF, EWL, FSZ
May 15, 2014, 9:10 AM
May 12, 2014, 9:02 AM
- Inovio (INO) revenues: $1.4M vs $14.3K; net loss: ($108M) (-21.3%); loss/share: ($0.05) (+16.7%); quick assets (ex-A/R): $116.8M (+122.1%).
- Capital position should be sufficient to fund the firm's operations through 2017.
- Management expects to report data on the Phase 2 trial for VGX-3100, SynCon immunotherapy against HPV-caused cancers and pre-cancers delivered with the Cellectra electroporation device by mid-year.
- INO-5150 cancer immunotherapy Phase 1 trial to be launched in Q3. This will trigger a milestone payment from partner Roche (RHHBY).
Apr. 28, 2014, 9:41 AM
- The European Commission approves Roche's (RHHBY) rheumatoid arthritis drug RoACTEMRA (tocilizumab) for subcutaneous administration.
- It is the first anti IL-6 receptor biologic available in both subcutaneous and intravenous formulations for both monotherapy and combination therapy with methotrexate.
- Japan and the U.S. approved the formulation last year.
Apr. 24, 2014, 4:04 PM
- The FDA approves Roche's (RHHBY -0.2%) cobas HPV molecular diagnostic assay for use as a stand-alone screening test for HPV. Previously, the product was cleared only for use in conjunction with or as a follow-on diagnostic to a PAP test for women at least 30 years old.
- The test detects HPV types 16 and 18 which are responsible for 70% of cervical cancer. It detects 12 other high risk types in a pooled result.
- The clinical trial also showed that utilizing the automated cobas HPV test as a first-line diagnostic and then reflexing to a cervical cytology (PAP) test would enable clinicians to detect more disease and eliminate unnecessary follow-up procedures.
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