Content about Genentech

March 24, 2014

Genentech announced that the Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, or CIU, which is a form of chronic hives.

SOUTH SAN FRANCISCO, Calif. — Genentech announced that the Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, or CIU, which is a form of chronic hives.

CIU is diagnosed when hives occur without cause, spontaneously present and reoccur for more than six weeks, the company said. The symptoms include swelling, severe itch, pain and discomfort that may last for months and, in some cases, years. 

February 3, 2014

The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.

WASHINGTON — The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization. 

December 19, 2013

Diplomat has become a distributor of a new cancer drug made by Genentech, Diplomat said Thursday.

FLINT, Mich. — Diplomat has become a distributor of a new cancer drug made by Genentech, Diplomat said Thursday.

The specialty pharmacy company said it had received a distribution contract for Gazyva (obinutuzumab) for chronic lymphocytic leukemia, which received Food and Drug Administration approval on Nov. 1. CLL is a slowly advancing blood and bone marrow disease that, according to the National Cancer Institute, part of the National Institutes of Health, will be diagnosed in 15,680 Americans this year and cause 4,580 deaths.

December 3, 2013

Rite Aid has appointed healthcare executive Myrtle Potter to its board of directors, the retail pharmacy chain said Tuesday.

CAMP HILL, Pa. — Rite Aid has appointed healthcare executive Myrtle Potter to its board of directors, the retail pharmacy chain said Tuesday.

Potter is currently CEO of Myrtle Potter & Co., a Silicon Valley-based consulting firm focused on life sciences and health care, as well as the head of consumer healthcare content company Myrtle Potter Media. She previous served as president of commercial operations and COO at Genentech and has worked at companies like Bristol-Myers Squibb and Merck.

December 2, 2013

The Food and Drug Administration has designated a drug made by Teva Pharmaceutical Industries as an orphan drug, the company said.

JERUSALEM — The Food and Drug Administration has designated a drug made by Teva Pharmaceutical Industries as an orphan drug, the company said.

Teva said the drug, Treanda (bendamustine hydrochloride), received the designation for indolent B-cell non-Hodgkins lymphoma through October 2015 that has progressed during or within six months of treatment with a regimen containing Rituxan (rituximab), marketed by Genentech and Biogen Idec. The FDA gives orphan drug designation to treatments for diseases affecting fewer than 200,000 people in the United States.

November 1, 2013

The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

The FDA announced the approval of Gazyva (obinutuzumab) for treating patients with previously untreated chronic lymphocytic leukemia, in combination with the chemotherapy drug chlorambucil. The drug works by helping certain cells in the immune system attack cancer cells.

October 24, 2013

The Food and Drug Administration has approved a new formulation of a drug made by Genentech for rheumatoid arthritis that can be injected into the skin.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new formulation of a drug made by Genentech for rheumatoid arthritis that can be injected into the skin.

Genentech announced the approval of a subcutaneous formulation of Actemra (tocilizumab) in adults for adults with moderate RA who have not found sufficient relief by taking such disease-modifying antirheumatic drugs as methotrexate. Like the intravenous formulation of Actemra, the new version can be used alone or with drugs like methotrexate.

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

NEW YORK — The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

September 30, 2013

The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

September 17, 2013

The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

JERUSALEM — The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

The Israeli drug maker announced the approval of a liquid formulation of Treanda (bendamustine hydrochloride), which it said would eliminate the need for reconstitution.

The drug is used to treat indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with Rituxan (rituximab), which is made by Genentech and Biogen Idec, and in patients with chronic lymphocytic leukemia.

September 16, 2013

The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

The FDA announced the approval of Teva Pharmaceutical Industries' capecitabine tablets in the 150-mg and 500-mg strengths. The drug is used to treat cancers that have metastasized, meaning they've spread to other parts of the body.

The drug is a generic version of Xeloda, made by Roche division Genentech. According to IMS Health, Xeloda had sales of $706.2 million last year.

 

August 29, 2013

The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

NEW YORK — The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

Biopharma-Reporter.com quoted an FDA spokeswoman as saying "efforts to undermine trust in these products" were cause for worry and did not serve the interests of patients.

August 27, 2013

Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

NEW YORK — Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

August 19, 2013

Specialty pharmacy CareMed Pharmaceutical Services has been added to a limited-distribution network for a cancer drug sold by Genentech and Astellas Pharma, the company said.

LAKE SUCCESS, N.Y. — Specialty pharmacy CareMed Pharmaceutical Services has been added to a limited-distribution network for a cancer drug sold by Genentech and Astellas Pharma, the company said.

CareMed said it had been selected to supply the drug, Tarceva (erlotinib). The two drug makers stopped distributing the drug, a once-daily treatment for advanced lung cancer, through retail pharmacies at the beginning of July.

July 24, 2013

Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said.

PITTSBURGH — Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said Wednesday.

Mylan said it had entered an agreement with Pfizer, Genentech and OSI that would allow their suit against Mylan over the drug Tarceva (erlotinib) to be dismissed. All other terms and conditions of the settlement are confidential, and the agreement is subject to Department of Justice and Federal Trade Commission review, Mylan said.

July 22, 2013

The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

Astellas announced through a U.S. subsidiary that the FDA had approved Astagraf XLTM (tacrolimus) extended-release capsules for preventing rejection of transplanted kidneys, for use with Genentech's CellCept (mycophenolate mofetil) and corticosteroids, with or without Simulect (basiliximab), a biotech drug made by Swiss drug maker Novartis.

July 2, 2013

BioPlus Specialty Pharmacy has been added to the limited-distribution network for a Genentech drug used to treat lung and pancreatic cancers.

ALTAMONTE SPRINGS, Fla. — BioPlus Specialty Pharmacy has been added to the limited-distribution network for a Genentech drug used to treat lung and pancreatic cancers.

BioPlus announced that it had become a distributor for the drug Tarceva (erlotinib) starting Monday, when the drug, made by Genentech and Astellas, ceased to be available in retail pharmacies.

July 2, 2013

A cancer drug made by Genentech and Astellas is no longer available through ordinary retail channels and is now available only through a limited-distribution network.

NEW YORK — A cancer drug made by Genentech and Astellas is no longer available through ordinary retail channels and is now available only through a limited-distribution network.

Cancer-focused specialty pharmacy Onco360 said that effective Monday, the drug Tarceva (erlotinib) would no longer be available through retail pharmacies and that had joined a limited-distribution network that the drug makers had set up for the drug. Tarceva is used for treating advanced non-small cell lung cancer and pancreatic cancer.

June 18, 2013

Avella Specialty Pharmacy will be included in the limited-distribution network for a cancer drug made by Genentech, Avella said Tuesday.

PHOENIX — Avella Specialty Pharmacy will be included in the limited-distribution network for a cancer drug made by Genentech, Avella said Tuesday.

The specially pharmacy company said it would be included in the network to sell Tarceva (erlotinib), an orally administered drug used to treat non-small cell lung cancer and pancreatic cancer. Genentech will shift distribution of Tarceva to a select group of pharmacies starting July 1 to align its distribution with that of similar cancer drugs.

June 4, 2013

The Center for Healthcare Supply Chain Research, HDMA’s nonprofit research foundation, and Genentech on Tuesday honored Robert Belknap, executive director of trade sales and operations for Boehringer Ingelheim Pharmaceuticals, with the 2013 Nexus Award for Lifetime Achievement.

ARLINGTON, Va. — The Center for Healthcare Supply Chain Research, HDMA’s nonprofit research foundation, and Genentech on Tuesday honored Robert Belknap, executive director of trade sales and operations for Boehringer Ingelheim Pharmaceuticals, with the 2013 Nexus Award for Lifetime Achievement.

June 3, 2013

Another bill to limit dispensing of biosimilars lost Monday, this time in Illinois.

WASHINGTON — Another bill to limit dispensing of biosimilars lost Monday, this time in Illinois.

The state's legislature voted not to advance S.B. 1934, supported by such biotech companies as Amgen and Genentech, which would slow patients' access to knock-off versions of biotech drugs by restricting pharmacists' ability to dispense them. Illinois is the 13th state to defeat such a bill; a similar bill died in Texas' state legislature last week.

May 15, 2013

The Food and Drug Administration has approved a drug for a type of lung cancer.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug for a type of lung cancer.

Roche subsidiary Genentech and the U.S. subsidiary of Japan's Astellas Pharma announced the approval of Tarceva (erlotinib) for advanced non-small cell lung cancer whose tumors have mutations that activate the epidermal growth factor receptor. The FDA also approved a test to detect the mutation.

The drug was already approved for advanced NSCLC that did not exhibit the mutation.

 

April 30, 2013

The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

Genentech, a subsidiary of Swiss drug maker Roche, announced the approval of Actemra (tocilizumab) for polyarticular juvenile idiopathic arthritis in children ages 2 years and older, either alone or combined with the generic drug methotrexate.

March 22, 2013

The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

March 21, 2013

A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.