Sat, Feb. 7, 11:53 AM
- The FDA approves Genentech's (OTCQX:RHHBY) Breakthrough Therapy-tagged Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy in patients with diabetic macular edema. It is administered by a physician as a once-monthly injection into the eye.
- Previously: Decision today for FDA review of Lucentis expanded label (Feb. 6)
Fri, Feb. 6, 10:30 AM
- Today is the PDUFA date for the FDA's review of Genentech's (OTCQX:RHHBY) supplemental Biologics License Application (sBLA) submitted on August 7 for the use of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy, an eye disease affecting nearly 8M Americans.
- Lucentis is currently cleared for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
- Previously: FDA accepts sBLA for Lucentis label expansion (Oct. 8, 2014)
Wed, Feb. 4, 7:23 AM
- On the basis of an pre-planned interim analysis by an independent data monitoring committee, a Phase 3 clinical trial assessing Roche's (OTCQX:RHHBY) Gazyva (obinutuzumab) in patients with refractory indolent non-Hodgkin's lymphoma was ended early after it was determined that it met its primary endpoint. The results showed that patients treated with Gazyva plus bendamustine followed by Gazyva alone lived significantly longer without disease worsening or death (progression-free survival or PFS) that those treated with bendamustine alone. The study was stopped because the benefit was profound with no unexpected adverse events.
- The data will be presented at a future medical conference and will be used in regulatory applications in the U.S. and E.U.
- Gazyva/Gazyvaro is a monoclonal antibody designed to attach to a B-cell surface protein called CD20. Along with the body's immune system, it attacks and kills targeted cells. It is approved in more than 40 countries, in combination with chlorambucil, for the treatment of treatment-naive chronic lymphocytic leukemia.
Mon, Feb. 2, 7:05 AM
- The FDA designates Roche's (OTCQX:RHHBY) investigational cancer immunotherapy, MPDL3280A, a Breakthrough Therapy for the treatment of patients with PD-L1-positive non-small cell lung cancer (NSCLC) whose disease has progressed or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor).
- This is the second BTD tag for the product candidate. The first, for metastatic bladder cancer, was granted in 2014.
- Breakthrough Therapy status allows a more rapid review of the New Drug Application (NDA) or Biologics License Application (BLA), including allowing the submission after a Phase 2 trial, in certain cases.
- Roche intends to initiate new Phase 3 studies this year evaluating MPDL3280A in additional tumor types.
Thu, Jan. 29, 9:12 AM
- Roche (OTCQX:RHHBY) and Qualcomm subsidiary Qualcomm Life enter into a strategic collaboration to improve remote monitoring and management of chronic disease patients. Roche will use Qualcomm Life's wireless 2net platform to seamlessly and securely capture data from a patient's medical devices and transmit it to Roche's cloud-based back-end services. The initiative will start with anticoagulation meters.
- Roche Point of Care SVP Jeremy Moss says, "This collaboration marks a significant milestone for Roche as we launch a new generation of point-of-care solutions that enable healthcare professionals to better keep in touch remotely with patients, whenever and wherever they are. By combining Qualcomm Life's leadership in powering connected health solutions with our point-of-care expertise, we are taking an important step forward to realize our connected care strategy, ultimately enabling physicians to improve the overall quality of life for patients."
- Financial aspects of the partnership are undisclosed.
Wed, Jan. 28, 7:31 AM
- Roche (OTCQX:RHHBY) Q4 results (CHFm): Total Revenues: 12,705 (+6.6%); Pharmaceuticals: 9,731 (+6.8%), Diagnostics: 2,974 (+6.3%).
- Pharmaceuticals: U.S.: 4,294 (+17.1%), Europe: 2,352 (+2.2%); Japan: 895 (-2.0%); International: 2,190 (-1.8%).
- Sales By Product: MabThera/Rituxan: 1,776 (+1.8%), Avastin: 1,668 (+8.0%), Herceptin: 1,596 (+7.5%), Lucentis: 441 (+0.7%), Tarceva: 321 (0.0%), Actemra/RoActemra: 327 (+19.3%), Pegasys: 204 (-28.4%), Xolair: 507 (+153.5%), Perjeta: 285 (103.6%), Xeloda: 153 (-55.7%).
Wed, Jan. 28, 3:23 AM
- Missing analysts’ forecasts, Roche (OTCQX:RHHBY) said net income attributable to shareholders fell to 9.33B francs ($10.34B) from 11.16B francs a year earlier, despite rising sales of its cancer treatments.
- The company said it was hit by impairments, restructuring costs and debt restructuring.
- Roche expects sales this year to grow in low-to-mid single digits range, while core earnings per share should grow more than sales.
- Roche shares are down 1.3% in Switzerland.
Mon, Jan. 19, 5:26 PM
- As expected, the European Commission approves Boehringer Ingelheim's OFEV (nintedanib) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in November backing approval.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug (Nov. 21, 2014)
- IPF-related tickers: (NYSE:BMY) (OTCQX:RHHBY) (NASDAQ:FGEN) (NYSE:AZN) (OTCPK:ALPMF) (OTCPK:ALPMY)
Fri, Jan. 16, 6:14 AM
- Looking to gain access to an experimental drug to treat spinal muscular atrophy, Roche (OTCQX:RHHBY) has agreed to buy privately-held Trophos.
- The acquisition is the latest in a spate of deals by Roche, following its purchase of a $1B stake in Foundation Medicine and licensing agreement with Genome pioneer J. Craig Venter.
- Under the terms of the agreement with Trophos, the French firm's shareholders will receive an upfront payment of €120M ($140M), plus further payments based on predetermined milestones worth up to €350M.
- OTCQX:RHHBY -2.2% premarket
Thu, Jan. 15, 8:40 AM
- "Words fail me," says Swatch (OTCPK:SWGAY) CEO Nick Hayek. "Today's SNB action is a tsunami; for the export industry and for tourism, and finally for the entire country." Swatch is lower by 15.75% in European action.
- Previously: Swiss shares crater after SNB abandons cap on euro (Jan. 15)
- A sampling of others: Cement maker Holcim (OTCPK:HCMLY) is down 11.2%, Novartis (NYSE:NVS) is down 9%, Roche (OTCQX:RHHBY) is down 7.9%, Credit Suisse (NYSE:CS) is down 11.7%, and UBS (NYSE:OUBS) is down 10.8%.
- The good news for ADR players is that's all action in Switzerland. Thanks to the franc's now 13.5% gain, the ADRs trading in the U.S. are likely all to be higher.
Thu, Jan. 15, 7:50 AM
- Roche's (OTCQX:RHHBY) Genentech unit signs a multi-year deal with genome pioneer J. Craig Venter's Human Longevity start-up to sequence and analyze tens of thousands of human genomes. The data will be used to identify new drug targets and biomarkers.
- Human Longevity's goal is to sequence 1M genomes by 2020. The transaction will enable it to have access to both genomic and clinical information from patients enrolled in clinical trials. The DNA will be stripped of personal identifying details but will be linked to clinical information.
- Financial terms are undisclosed.
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Tue, Jan. 13, 7:06 AM
- Roche (OTCQX:RHHBY) enters into a development and commercialization deal with Japan's Meiji Seika Pharma and Canada's Fedora for OP0595, a beta-lactamase inhibitor in Phase 1 development. Beta-lactamase inhibitors restore or potentiate the activity of beta-lactam antibiotics (e.g., penicillins, cephalosporins, monobactams) which is of keen interest from the medical community considering the ever-increasing threat of bacterial resistance.
- Under the terms of the agreement, Roche obtains worldwide rights to OP0595 except Japan where Meiji retains rights. Meiji and Fedora will receive upfront payments and various milestones potentially up to $750M plus tiered royalties on commercial sales.
Mon, Jan. 12, 2:14 AM
- Roche (OTCQX:RHHBY) is acquiring a majority of Foundation Medicine (NASDAQ:FMI) for more than $1B, by buying a combination of outstanding and newly issued shares for a 52.4%-56.3% stake on a fully diluted basis.
- Foundation is the leader in the growing area of sequencing the genes of tumor samples, looking for mutations that can help predict which drug will be most effective for a particular patient.
Sun, Jan. 11, 10:29 PM
- Based on an assessment by the independent Data Monitoring Committee, Bristol-Myers Squibb (NYSE:BMY) stops its Phase 3 trial, CheckMate-017, evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced squamous cell non-small cell lung cancer (NSCLC). The committee concluded that the study met its primary endpoint of demonstrating superior overall survival (OS) compared to docetaxel. This is the first time a PD-1 inhibitor has shown a survival advantage in lung cancer.
- Eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension.
- The company will complete a full analysis of the data and work with investigators on the future presentation and publication of the results.
- PD-1-related tickers: (NASDAQ:MDVN) (NYSE:MRK) (NASDAQ:FPRX) (NASDAQ:CELG) (OTCQX:RHHBY) (NYSE:AZN)
Fri, Jan. 9, 8:01 AM
- The FDA approves Roche's (OTCQX:RHHBY) cobas TaqScreen MPX Test, v2.0 for the detection and identification of HIV, HCV and HBV in donations of human whole blood and blood components including source plasma. The test, which delivers increase sensitivity, is the only FDA-approved diagnostic that simultaneously detects and identifies the three viruses in one assay.
- The assay can be performed on a fully automated system which saves time and labor by eliminating the need for consecutive rounds of testing.
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Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and... More
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