Content about Bayer HealthCare Pharmaceuticals

November 22, 2013

The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.

August 26, 2013

Biotech company Amgen is buying Onyx Pharmaceuticals, the companies said Sunday.

THOUSAND OAKS, Calif. — Biotech company Amgen is buying Onyx Pharmaceuticals, the companies said Sunday.

Onyx, based in South San Francisco, Calif., has a portfolio of cancer drugs, including the injected multiple myeloma drug Kyprolis (carfilzomib), as well as Nexavar (sorafenib) tablets, developed with Bayer HealthCare Pharmaceuticals; Stivarga (regorafenib) tablets, developed by Bayer; and palbociclib, developed by Pfizer.

April 18, 2013

A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

PARSIPPANY, N.J. — A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

February 25, 2013

The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

The FDA announced the approval of Stivarga (regorafenib) for gastrointestinal stromal tumors that could not be removed through surgery or had spread to other parts of the body and were no longer responding to treatment with Novartis' Gleevec (imatinib) or Pfizer's Sutent (sunitinib).

January 10, 2013

The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

WAYNE, N.J. — The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

Bayer announced the approval of Skyla (levonorgestrel-releasing uterine system), which can prevent pregnancy for up to three years. The IUD contains 13.5 mg of levonorgestrel.

Nearly 50% of pregnancies in the United States are unintended, according to the National Center for Health Statistics.

September 5, 2012

Bayer HealthCare and Onyx Pharmaceuticals are seeking approval for a new drug to treat tumors of the gut, the companies said.

WAYNE, N.J. — Bayer HealthCare and Onyx Pharmaceuticals are seeking approval for a new drug to treat tumors of the gut, the companies said.

Bayer and Onyx announced the submission to the Food and Drug Administration of an application seeking approval for regorafenib in patients with gastrointestinal stromal tumors, or GIST. Bayer developed the drug and formed a partnership with Onyx in 2011, whereby Onyx will receive a royalty on future global net sales of the drug in cancer-related indications. Both companies will promote the drug in the United States.

June 13, 2012

Bayer on Tuesday announced that on July 1, Philip Blake will become senior Bayer representative USA, following a common company practice of assigning this oversight role to a senior executive already holding a significant business role or roles within the region.

PITTSBURGH — Bayer on Tuesday announced that on July 1, Philip Blake will become senior Bayer representative USA, following a common company practice of assigning this oversight role to a senior executive already holding a significant business role or roles within the region.

“Phil Blake is a highly valued and respected leader at Bayer,” stated Richard Pott, member of the management board of Bayer. “Having been with Bayer for more than 30 years, he brings a wealth of experience to this new role.”

March 15, 2012

The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

WAYNE, N.J. — The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

Bayer HealthCare Pharmaceuticals announced Wednesday the approval of Natazia (estradiol valerate and estradiol valerate and dienogest) tablets for heavy menstrual bleeding not caused by any conditions of the uterus. The drug was originally approved as an oral contraceptive in May 2010.

March 6, 2012

The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

WAYNE, N.J. — The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

Bayer HealthCare Pharmaceuticals said the FDA approved a lower-dose formulation of Angeliq (drospirenone and estradiol) tablets, used to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25-mg drospirenone and 0.5-mg estradiol, while the previously approved formulation contained 0.5-mg drospirenone and 1-mg estradiol.

January 19, 2012

Generic drug maker Watson Pharmaceuticals has launched its version of a contraceptive made by Bayer HealthCare Pharmaceuticals, Watson said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has launched its version of a contraceptive made by Bayer HealthCare Pharmaceuticals, Watson said.

The company announced the launch of Vestura (drospirenone and ethinyl estradiol), a generic version of Bayer's Yaz.

Yaz and its generic versions had sales of about $510 million during the 12-month period ended in November, according to IMS.

June 8, 2011

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of Syeda (drospirenone and ethinyl estradiol) tablets in the 3-mg/0.03-mg strength.

The drug is a generic version of Bayer HealthCare Pharmaceuticals’ Yasmin. Yasmin and generic versions of the drug had sales of about $365 million during the 12-month period ended in April, according to IMS Health.

June 1, 2011

The Food and Drug Administration is investigating a possible link between a class of birth control pills and a higher risk of blood clots in the women taking them, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration is investigating a possible link between a class of birth control pills and a higher risk of blood clots in the women taking them, the agency said.

May 10, 2011

The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.

WAYNE, N.J. — The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.

May 4, 2011

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

Sandoz announced the approval of Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg) tablets, a generic version of Bayer HealthCare Pharmaceuticals’ Yaz.

April 28, 2011

Bayer HealthCare Pharmaceuticals and the World Federation of Hemophilia announced Thursday a three-year extension of Bayer’s sponsorship agreement with the WFH.

MONTVILLE, N.J. — Bayer HealthCare Pharmaceuticals and the World Federation of Hemophilia announced Thursday a three-year extension of Bayer’s sponsorship agreement with the WFH.

The agreement calls for Bayer to serve as the sole sponsor of the WFH’s International Hemophilia Training Centre program and provide support for other activities of the organiztion, such as its website and Congress. The program trains healthcare professionals in developing countries in diagnosis and management of hemophilia and related bleeding disorders.

April 26, 2011

The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.

WAYNE, N.J. — The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.

Bayer announced that Kogenate FS (antihemophilic factor [recombinant]) now can be stored at room temperature, up to 77 degrees, for up to one year. Previously, it could be stored at room temperature for three months, and most Factor VIII products must be stored in a refrigerator.

March 16, 2011

Bayer HealthCare Pharmaceuticals on Tuesday announced it is working with the March of Dimes and television personality Vanessa Minnillo on a public health message to help educate all women of reproductive age about the importance of folate and folic acid through a national educational campaign called Girlfriends for Folate.

WHITE PLAINS, N.Y. — Bayer HealthCare Pharmaceuticals on Tuesday announced it is working with the March of Dimes and television personality Vanessa Minnillo on a public health message to help educate all women of reproductive age about the importance of folate and folic acid through a national educational campaign called Girlfriends for Folate.

DailyCandy.com also has committed to engaging its extensive membership of women to help spread the word about daily folate supplementation, Bayer said.

January 11, 2011

Bayer HealthCare Pharmaceuticals sought to reassure healthcare professionals and their patients that a recall of alcohol prep pads distributed with its multiple sclerosis drug did not affect the drug itself.

WAYNE, N.J. — Bayer HealthCare Pharmaceuticals sought to reassure healthcare professionals and their patients that a recall of alcohol prep pads distributed with its multiple sclerosis drug did not affect the drug itself.

The drug maker’s MS treatment Betaseron (interferon beta-1b) is distributed with prep pads made by Triad Group, which recently staged a recall of prep products due to potential contamination with Bacillus cereus bacteria, which would lead to life-threatening infections.

September 26, 2010

The Food and Drug Administration has approved a new oral contraceptive from Bayer HealthCare Pharmaceuticals....

SILVER SPRING, Md. The Food and Drug Administration has approved a new oral contraceptive from Bayer HealthCare Pharmaceuticals.

 

The FDA announced Friday the approval of Beyaz (estrogen and progestin) tablets. The pills also contain a folate known as levomefolate calcium. Low folate levels in the body are associated with such conditions as spina bifida, and physicians recommend that women of childbearing age supplement their diets with folate.

 

 

June 17, 2010

Teva Pharmaceutical Industries admitted before a federal court Thursday to making false statements about the...

June 14, 2010

Two divisions of Bayer have filed a lawsuit against Teva Pharmaceutical Industries and two of...

June 13, 2010

A drug made by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals failed to extend overall survival...

June 9, 2010

Bayer HealthCare Pharmaceuticals trade relations director Michael Catanio received the Nexus Award for Lifetime Achievement...

June 6, 2010

Actavis and Sagent Pharmaceuticals have agreed to develop and market a group of injectable drugs...

March 10, 2010

The Food and Drug Administration has given orphan drug designation to an investigational treatment for...