Content about Branded

April 28, 2011

Merck has cleared a hurdle in its effort to buy eye care company Inspire Pharmaceuticals for $430 million, the company said Thursday.

WHITEHOUSE STATION, N.J. — Merck has cleared a hurdle in its effort to buy eye care company Inspire Pharmaceuticals for $430 million, the company said Thursday.

The expiration of the waiting period mandated by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 brings Merck one step closer to acquiring Inspire.

Merck announced its intention to buy Raleigh, N.C.-based Inspire for $5 per share on April 15.

April 27, 2011

AstraZeneca has launched a new technology on two of its products' websites to give consumers an option to contact a live AstraZeneca customer service representative with just a click of a button.

WILMINGTON, Del. — AstraZeneca has launched a new technology on two of its products' websites to give consumers an option to contact a live AstraZeneca customer service representative with just a click of a button.

April 27, 2011

A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

LIVINGSTON and PARSIPPANY, N.J. — A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

April 27, 2011

An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.

PARIS — An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.

The phase-3 trial combined the drug Zaltrap (aflibercept) with a combination of the chemotherapy drugs folinic acid (leucovorin), 5-fluorouracil and irinotecan, also known as the FOLFIRI regimen.

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.

April 26, 2011

The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

April 26, 2011

The New Life Agency has added a prescription progesterone supplement and RESOLVE: the National Fertility Association to the Fertility Pharmacy Care Card.

RANCHO MIRAGE, Calif. — The New Life Agency has added a prescription progesterone supplement and RESOLVE: the National Fertility Association to the Fertility Pharmacy Care Card.

April 25, 2011

Drug maker AP Pharma has appointed two new executives and may receive financing of up to $4.5 million, the company said Monday.

REDWOOD CITY, Calif. — Drug maker AP Pharma has appointed two new executives and may receive financing of up to $4.5 million, the company said Monday.

AP announced the appointment of John Whelan as president, CEO and director, and Michael Adam as SVP and COO.

April 25, 2011

Anglo-Swedish drug maker AstraZeneca has made the drug vandetanib available to certain thyroid cancer patients.

WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has made the drug vandetanib available to certain thyroid cancer patients.

The drug maker announced Monday that the drug would be available to patients with medullary thyroid cancer that could not be removed surgically or that had spread to other parts of the body. The Food and Drug Administration approved the drug on April 6, and it is available exclusively through the pharmacy business unit of Biologics Inc., an integrated cancer management company.

April 25, 2011

The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.

The FDA announced the approval of Menactra, made by Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis. Meningococcal disease is a life-threatening illness caused by Neisseria meningitidis bacteria that infect the bloodstream and the lining surrounding the brain and spinal cord.

April 25, 2011

A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.

CHAPEL HILL, N.C. — A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.

April 22, 2011

Valeant Pharmaceuticals International is taking its case directly to Cephalon’s shareholders in its effort to acquire the Frazer, Pa.-based drug maker.

MISSISSAUGA, Ontario — Valeant Pharmaceuticals International is taking its case directly to Cephalon’s shareholders in its effort to acquire the Frazer, Pa.-based drug maker.

In a letter to the shareholders Thursday, Valeant said its $73-per-share offer, totaling $5.7 billion, was a 29% premium over the 30-day stock price of Cephalon, noting that the price had declined over the last five years and that the average stock price in the month before the offer was $57, which Wall Street analysts didn’t expect to rise above $60.

April 21, 2011

Companies that make vaccines, drugs and diagnostic tests for influenza will become key stakeholders in the World Health Organization’s Global Influenza Surveillance Network under an agreement reached at the Open Ended Working Group that WHO coordinated to support global preparedness for a future influenza pandemic.

LONDON — Companies that make vaccines, drugs and diagnostic tests for influenza will become key stakeholders in the World Health Organization’s Global Influenza Surveillance Network under an agreement reached at the Open Ended Working Group that WHO coordinated to support global preparedness for a future influenza pandemic.

April 21, 2011

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

April 21, 2011

Merck and Sanofi Pasteur have started a late-stage clinical trial of a combination vaccine for six childhood diseases, the companies said Thursday.

WHITEHOUSE STATION, N.J. — Merck and Sanofi Pasteur have started a late-stage clinical trial of a combination vaccine for six childhood diseases, the companies said Thursday.

April 20, 2011

The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

WASHINGTON — The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

Elements of the plan include expansion of state-based prescription drug monitoring programs, recommendation of convenient and environmentally responsible drug-disposal methods, education and reduction of doctor shopping.

April 20, 2011

The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

April 20, 2011

The U.S. Patent and Trademark Office has awarded Salix Pharmaceuticals three patents related to a drug used for travelers’ diarrhea.

RALEIGH, N.C. — The U.S. Patent and Trademark Office has awarded Salix Pharmaceuticals three patents related to a drug used for travelers’ diarrhea.

Salix announced Wednesday that it had secured patents for the drug Xifaxan (rifaximin) covering its methods of treating travelers’ diarrhea, as well as two related to the drug’s chemical composition.

The patents are set to expire between 2024 and 2029.

April 19, 2011

Drug maker Forest Labs has acquired worldwide rights to a drug developed by Procter & Gamble Pharmaceuticals for treating arrhythmia.

NEW YORK — Drug maker Forest Labs has acquired worldwide rights to a drug developed by Procter & Gamble Pharmaceuticals for treating arrhythmia.

Forest said Tuesday that it had purchased the rights to azimilide from Blue Ash Therapeutics and had been assigned a license agreement between Blue Ash and Warner Chilcott. Forest will assume responsibility for all future development and commercialization, including costs. Financial terms of the deal were not disclosed.

April 19, 2011

U.S. spending on drugs grew 2.3% to $307.4 billion in 2010, according to a new report by the IMS Institute for Healthcare Informatics, part of industry research firm IMS Health.

PARSIPPANY, N.J. — U.S. spending on drugs grew 2.3% to $307.4 billion in 2010, according to a new report by the IMS Institute for Healthcare Informatics, part of industry research firm IMS Health.

April 19, 2011

Leading Edge Innovations, a laboratory that develops formulas based on emerging trends in the market for the over-the-counter, skin care, sun care and cosmetic industries, and product manufacturer San-Mar Labs on Tuesday announced a strategic partnership that makes LEI’s technology platform a part of San-Mar’s advanced research and technology, known as S.M.A.R.T.

BRANCHBURG, N.J. — Leading Edge Innovations, a laboratory that develops formulas based on emerging trends in the market for the over-the-counter, skin care, sun care and cosmetic industries, and product manufacturer San-Mar Labs on Tuesday announced a strategic partnership that makes LEI’s technology platform a part of San-Mar’s advanced research and technology, known as S.M.A.R.T.

April 19, 2011

The Food and Drug Administration has given approval to Sigma-Tau Pharmaceuticals to manufacture the main ingredient of a treatment for leukemia, the drug maker said.

GAITHERSBURG, Md. — The Food and Drug Administration has given approval to Sigma-Tau Pharmaceuticals to manufacture the main ingredient of a treatment for leukemia, the drug maker said.

Sigma-Tau was approved to manufacture L-asparaginase, the primary ingredient in the drug Oncaspar (pegaspargase). Sigma-Tau began seeking approval when the previous manufacturer ceased production. The drug is used to treat acute lymphoblastic leukemia, also known as ALL.

April 18, 2011

The Food and Drug Administration has approved a drug made by Genentech for treating a rare and severe form of arthritis that affects children, Genentech said.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug made by Genentech for treating a rare and severe form of arthritis that affects children, Genentech said.

The biotech company, the U.S. division of Swiss drug maker Roche, announced the FDA approval of Actemra (tocilizumab) for active systemic juvenile idiopathic arthritis. SJIA has the worst long-term prognosis of all varieties of childhood arthritis.

April 18, 2011

A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.

NEW YORK — A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.

Keryx Biopharmaceuticals and Torii Pharmaceutical, the pharmaceuticals subsidiary of Japan Tobacco, started a phase-3 trial of Zerenex (ferric citrate) in Japan for patients with hyperphosphatemia. The drug also is in phase-3 trials in the United States as a treatment for hyperphosphatemia in patients with end-stage kidney disease on dialysis.

April 18, 2011

The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.

INDIANAPOLIS — The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.