Roche to present updated data confirming Tecentriq in combination with Avastin substantially improves overall survival in people with the most common form of liver cancer
Basel, 12 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present updated overall survival (OS) data from the Phase III IMbrave150 study evaluating Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. (Source: Roche Media News)
Source: Roche Media News - January 12, 2021 Category: Pharmaceuticals Source Type: news

Roche to present updated data confirming Tecentriq in combination with Avastin substantially improves overall survival in people with the most common form of liver cancer
Basel, 12 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present updated overall survival (OS) data from the Phase III IMbrave150 study evaluating Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. (Source: Roche Investor Update)
Source: Roche Investor Update - January 12, 2021 Category: Pharmaceuticals Source Type: news

USFDA informs Biocon Biologics, Mylan of deferred action on Avastin biosimilar license application
"To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the standard review process. However, due to restrictions on travel related to COVID-19, the agency is unable to conduct an inspection during the current review cycle. We await the dates for the inspection," Biocon said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 25, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 2 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Tecentriq in combination with Avastin is the first treatment to be approved in over a decade that has improved overall survival for people with previously untreated advanced or unresectable hepatocellular carcinoma,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical O...
Source: Roche Investor Update - November 2, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 2 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Tecentriq in combination with Avastin is the first treatment to be approved in over a decade that has improved overall survival for people with previously untreated advanced or unresectable hepatocellular carcinoma,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical O...
Source: Roche Media News - November 2, 2020 Category: Pharmaceuticals Source Type: news

Biomarker Predicts Severe Hypertension With Bevacizumab Biomarker Predicts Severe Hypertension With Bevacizumab
A new biomarker may identify the 40% of patients with cancer who develop potentially life-threatening severe hypertension when treated with bevacizumab.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - October 30, 2020 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Roche ’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer
             Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changin...
Source: Roche Media News - October 29, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer
             Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changin...
Source: Roche Investor Update - October 29, 2020 Category: Pharmaceuticals Source Type: news

Bevacizumab Less Effective for Diabetic Macular Edema in Blacks
WEDNESDAY, Oct. 28, 2020 -- Black patients with diabetic macular edema are significantly less likely to show short-term visual improvement after one or three injections of bevacizumab, according to a study published online Oct. 9 in the American... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 28, 2020 Category: Pharmaceuticals Source Type: news

Response to adjuvant bevacizumab among patients with resected melanoma may vary by age
(American Association for Cancer Research) Younger patients with resected melanoma had some benefit from adjuvant treatment with the anti-VEGF therapeutic bevacizumab (Avastin) while older patients with resected melanoma did not. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 23, 2020 Category: Cancer & Oncology Source Type: news

Researchers identify genetic variants linked to toxic side effects from bevacizumab
(European Organisation for Research and Treatment of Cancer) In the largest study of its kind, researchers have found two common genetic variants that can be used to predict whether or not cancer patients might suffer severe adverse side-effects, such as high blood pressure, from the drug bevacizumab. The genome-wide association study is the largest such study in patients being treated with bevacizumab and it is to be presented at the 32th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 21, 2020 Category: Cancer & Oncology Source Type: news

Tecentriq in combination with Avastin in 1L HCC approved in Japan
Dear Investor, Please find attached a press release by Chugai:https://www.roche.com/200925_IR_eTecentriq_Avastin_HCC_approval.pdf Do not hesitate to contact us for any further questions. With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - September 25, 2020 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemi c therapy. Based on this recommendation, a final decision regarding approval of Tecentriq in combination with Avastin in this disease setting, along with the full details of the approved indication, is expe...
Source: Roche Media News - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemi c therapy. Based on this recommendation, a final decision regarding approval of Tecentriq in combination with Avastin in this disease setting, along with the full details of the approved indication, is expe...
Source: Roche Investor Update - September 18, 2020 Category: Pharmaceuticals Source Type: news

Zirabev (Bevacizumab-bvzr Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 21, 2020 Category: Drugs & Pharmacology Source Type: news

Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer
Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-fr ee survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population. The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoi...
Source: Roche Investor Update - August 6, 2020 Category: Pharmaceuticals Source Type: news

Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer
Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-fr ee survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population. The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoi...
Source: Roche Media News - August 6, 2020 Category: Pharmaceuticals Source Type: news

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers
             Basel, 14 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), today announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China*. In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine ’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered ...
Source: Roche Media News - July 14, 2020 Category: Pharmaceuticals Source Type: news

Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer
Basel, 13 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer. Topline safety data indicate that safety for Tecentriq in combination with Avastin, paclitaxel and carboplatin was consistent with the known safety profile of the combination.“Ovarian cancer remains one of the most aggressive cancers a...
Source: Roche Media News - July 13, 2020 Category: Pharmaceuticals Source Type: news

Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer
Basel, 13 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer. Topline safety data indicate that safety for Tecentriq in combination with Avastin, paclitaxel and carboplatin was consistent with the known safety profile of the combination.“Ovarian cancer remains one of the most aggressive cancers a...
Source: Roche Investor Update - July 13, 2020 Category: Pharmaceuticals Source Type: news

Regeneron Funneled Kickbacks Through a Patient Charity, Federal Lawsuit Claims
The case is the latest inquiry into pharmaceutical companies ’ donations to patient assistance charities, which have been blamed for inflating the cost of drugs. (Source: NYT Health)
Source: NYT Health - June 24, 2020 Category: Consumer Health News Authors: Katie Thomas Tags: Regeneron Pharmaceuticals Inc Eylea (Drug) Drugs (Pharmaceuticals) Suits and Litigation (Civil) Bribery and Kickbacks Avastin (Drug) Lucentis (Drug) Nonprofit Organizations Chronic Disease Fund Genentech Inc your-feed-healthcare Source Type: news

Roche ’s Tecentriq in combination with chemotherapy (including Abraxane) meets primary endpoint of improved pathological complete response, regardless of PD-L1 status, as initial treatment for people with early triple-negative breast cancer
Basel, 18 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion031 study, evaluating Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chem otherapy (including Abraxane), met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression.“Tripl...
Source: Roche Media News - June 18, 2020 Category: Pharmaceuticals Source Type: news

Roche Pharma India expands partnership with Cipla for key oncology medicines
Roche Pharma India has signed a "distribution agreement with Cipla to expand the scope of the partnership to include, marketing and distribution of its trademark oncology drugs - trastuzumab (Herclon), bevacizumab (Avastin) and rituximab (Ristova) in India," the company said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 17, 2020 Category: Pharmaceuticals Source Type: news

Ramucirumab Shows Promise in Mesothelioma Clinical Trial
Patients with pleural mesothelioma cancer experienced a significant survival advantage when ramucirumab, a novel immunotherapy drug, was added to chemotherapy in a treatment regimen. Ramucirumab, marketed by Eli Lilly and Company as Cyramza, is a monoclonal antibody that works by targeting and restricting a protein that stimulates blood vessel growth within tumors. An ongoing phase II clinical trial in Italy recently reported almost double overall survival rates when ramucirumab was added to gemcitabine in second-line mesothelioma treatment. “These positive data may be the beginning to change the clinical practice in...
Source: Asbestos and Mesothelioma News - June 9, 2020 Category: Environmental Health Authors: Fran Mannino Source Type: news

Niraparib-Bevacizumab Combo Improves Clinical Outcomes in Recurrent Ovarian Cancer
The combination use of niraparib plus bevacizumab significantly improved clinical outcomes, compared with niraparib alone, in patients with recurrent ovarian cancer. (Source: CancerNetwork)
Source: CancerNetwork - June 5, 2020 Category: Cancer & Oncology Authors: Audrey Sternberg Source Type: news

FDA approves Roche ’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
Basel, 2 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. (Source: Roche Investor Update)
Source: Roche Investor Update - June 2, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
Basel, 2 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received p rior systemic therapy.“We’re excited that today’s approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer,” said Levi Garraway, M.D., Ph....
Source: Roche Media News - June 2, 2020 Category: Pharmaceuticals Source Type: news

Mirvetuximab Soravtansine Combination Yields Encouraging Response Rates in Ovarian Cancer
A study presented at the 2020 ASCO Scientific Program combining mirvetuximab soravtansine with bevacizumab to treat platinum-agnostic ovarian cancer demonstrated an encouraging overall response rate and tolerability profile regardless of platinum status. (Source: CancerNetwork)
Source: CancerNetwork - May 30, 2020 Category: Cancer & Oncology Authors: Matthew Fowler Source Type: news

FDA approves Roche immunotherapy cocktail in liver cancer
Swiss drugmaker Roche said on Friday that the U.S. Food and Drug Administration (FDA) approved its immunotherapy Tecentriq in combination with its drug Avastin for the most common kind of liver cancer. (Source: Reuters: Health)
Source: Reuters: Health - May 29, 2020 Category: Consumer Health News Tags: healthNews Source Type: news

FDA Approves Genentech ’s Tecentriq in Combination With Avastin for People With Hepatocellular Carcinoma
South San Francisco, CA -- May 29, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq ® (atezolizumab) in combination... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 29, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Atezolizumab/Bevacizumab Combination for HCC
The FDA approved atezolizumab in combination with bevacizumab for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. (Source: CancerNetwork)
Source: CancerNetwork - May 29, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

Cardiff Oncology Announces Fast Track Designation Granted by the FDA to Onvansertib for Second-Line Treatment of KRAS-Mutated Colorectal Cancer
The U.S. Food and Drug Administration reviewed the Company's request for Fast Track designation and concluded that investigation of onvansertib, in combination with FOLFIRI/bevacizumab, for second-line treatment of patients with KRAS-mutated metastatic col... Biopharmaceuticals, Oncology, FDA Cardiff Oncology, Onvansertib, Colorectal Cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 28, 2020 Category: Pharmaceuticals Source Type: news

' Momentous' Data for First-Line Combo in Liver Cancer'Momentous' Data for First-Line Combo in Liver Cancer
The combination of atezolizumab and bevacizumab for the first-line treatment of unresectable hepatocellular carcinoma is set to become the new standard of care for this poor-prognosis cancer.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - May 14, 2020 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

New treatment extends lives of people with most common type of liver cancer
For the first time in over a decade, scientists have identified a first-line treatment that significantly improves survival for people with hepatocellular carcinoma, the most common type of liver cancer.Researchers found that a  combination of atezolizumab, an immunotherapy drug that boosts the body ’s natural defenses, and bevacizumab, an anti-angiogenesis drug that inhibits the growth of tumors’ blood vessels, improved overall survival and reduced the risk of death by 42%. It also decreased the risk of the disease worsening by 41%, and the percentage of patients whose cancer shrank or disappeared more th...
Source: UCLA Newsroom: Health Sciences - May 13, 2020 Category: Universities & Medical Training Source Type: news

Atezolizumab-Bevacizumab Beats Sorafenib in Liver Cancer
WEDNESDAY, May 13, 2020 -- Atezolizumab plus bevacizumab improves survival outcomes versus sorafenib in patients with unresectable hepatocellular carcinoma, according to a study published in the May 14 issue of the New England Journal of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 13, 2020 Category: Pharmaceuticals Source Type: news

FDA Approves Olaparib/Bevacizumab Maintenance FDA Approves Olaparib/Bevacizumab Maintenance
The FDA has announced a new approved indication for olaparib in adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - May 12, 2020 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers
Hematology / Oncology Drug Approvals (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 11, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Expanded Olaparib Indication to Include Combination with Bevacizumab
The FDA expanded the indication of olaparib to include a combination regimen with bevacizumab for the first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. (Source: CancerNetwork)
Source: CancerNetwork - May 8, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

Lynparza (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer
KENILWORTH, N.J.--(BUSINESS WIRE)--May 8, 2020 -- AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Lynparza in combination with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 8, 2020 Category: Drugs & Pharmacology Source Type: news

Low Doses of Bevacizumab Tested for Retinopathy of Prematurity
FRIDAY, April 24, 2020 -- For treatment of retinopathy of prematurity (ROP), 0.004 mg may be the lowest effective dose of bevacizumab, according to a study published online April 23 in JAMA Ophthalmology. David K. Wallace, M.D., from the Jaeb Center... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 24, 2020 Category: Pharmaceuticals Source Type: news

Very low-dose Avastin effective for preventing blindness in preterm infants
NIH-funded study finds very low doses effective for treating retinopathy of prematurity. (Source: National Institutes of Health (NIH) News Releases)
Source: National Institutes of Health (NIH) News Releases - April 23, 2020 Category: American Health Source Type: news

Bevacizumab plus paclitaxel not cost effective for HER2 − MBC
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - March 31, 2020 Category: Drugs & Pharmacology Source Type: news

Phase II Trial of Bevacizumab/Trebananib Combo Fails to Demonstrate Improvements
Though the combination of bevacizumab and trebananib was found to be well tolerated, it did not significantly improve survival outcomes for patients with recurrent glioblastoma over bevacizumab alone. (Source: CancerNetwork)
Source: CancerNetwork - March 17, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Bevacizumab for Review
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, March 9, 2020 -- (Healthcare Sales & Marketing Network) -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA... Biopharmaceuticals, Oncology, FDA Mylan, Biocon, biosimilar, Avastin, bevacizumab (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 9, 2020 Category: Pharmaceuticals Source Type: news

FDA Accepts BLA for Proposed Biosimilar to Bevacizumab, MYL-1402O
The biologics license application was supported by findings from a global, randomized, controlled phase III clinical trial, evaluating the efficacy, safety, and immunogenicity of MYL-1402O versus bevacizumab. (Source: CancerNetwork)
Source: CancerNetwork - March 9, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

US FDA accepts Biocon's cancer drug application for review
Biocon and Mylan ’s proposed biosimilar bevacizumab, a cancer drug, is expected to be the third biosimilar from the partnered portfolio for patients in the US. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 8, 2020 Category: Pharmaceuticals Source Type: news

FDA grants Breakthrough Therapy Designation for Roche ’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease
Basel, 3 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Esbriet ® (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). The designation was granted based on data from a Phase II trial, which studied the efficacy and safety of Esbriet in uILD[1]. The study represented the first randomised controlled trial to exclusively enroll patients with progressive fibrosing uILD.“Today’s milestone for Esbriet builds on our continued commitment to improving the standard of care ...
Source: Roche Investor Update - March 3, 2020 Category: Pharmaceuticals Source Type: news

China National Medical Products Administration grants approval of Roche ’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer
Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).“Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “This approval makes Tecentriq the first cancer immunotherapy...
Source: Roche Investor Update - February 14, 2020 Category: Pharmaceuticals Source Type: news

China National Medical Products Administration grants approval of Roche ’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer
Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).“Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “This approval makes Tecentriq the first cancer immunotherapy...
Source: Roche Media News - February 14, 2020 Category: Pharmaceuticals Source Type: news

Roche to present new data on Tecentriq in combination with Avastin that shows improvement in overall survival for Chinese patients with the most common form of liver cancer
Basel, 7 February 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that additional data will be presented from a cohort of Chinese patients in the Phase III IMbrave150 study that evaluated Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Data from 194 Chinese patients who took part in the IMbrave150 study were consistent with the global results, that showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free...
Source: Roche Investor Update - February 7, 2020 Category: Pharmaceuticals Source Type: news