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February 14, 2012

Bristol-Myers Squibb has completed its acquisition of a developer of hepatitis C treatments.

NEW YORK — Bristol-Myers Squibb has completed its acquisition of a developer of hepatitis C treatments.

Bristol said it successfully completed its tender offer for all of the outstanding shares of common stock of Alpharetta, Ga.-based Inhibitex, at a purchase price of $26 per share via a “short form merger” in which all such shares were converted into the right to receive the aforementioned share price in cash and without interest, less any applicable withholding taxes.

February 13, 2012

Amylin Pharmaceuticals and Alkermes announced that their Type 2 diabetes treatment now is available by prescription in U.S. pharmacies.

SAN DIEGO — Amylin Pharmaceuticals and Alkermes announced that their Type 2 diabetes treatment now is available by prescription in U.S. pharmacies.

Bydureon (exenatide extended-release for injectable suspension) received approval from the Food and Drug Administration on Jan. 27 as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

February 13, 2012

Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

LIVINGSTON, N.J. and PARSIPPANY, N.J. — Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

Columbia Labs said Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to the application for progesterone vaginal gel 8%. Late last month, the drug received a thumbs-down from an FDA panel that declined to recommend approval for it.

The FDA is expected to take action on the NDA by Feb. 26.

February 13, 2012

The Food and Drug Administration has approved a Merck drug designed to reduce elevated intraocular pressure in patients with certain eye conditions, the company announced.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a Merck drug designed to reduce elevated intraocular pressure in patients with certain eye conditions, the company announced.

Zioptan (tafluprost ophthalmic solution), a preservative-free prostaglandin analog ophthalmic solution, is designed to reduce IOP in those with open-angle glaucoma or ocular hypertension, which respectively are the most common form of glaucoma and increases in pressure inside the eye.

February 13, 2012

Valeant Pharmaceuticals is set to acquire a privately owned ophthalmic biotechnology company, the drug maker said Monday.

MISSISSAUGA, Ontario — Valeant Pharmaceuticals is set to acquire a privately owned ophthalmic biotechnology company, the drug maker said Monday.

Valeant said it will acquire Eyetech upfront payment and potential future milestones. The transaction, which is subject to customary closing conditions, is expected to close this week. Additional details were not disclosed.

February 10, 2012

An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

DUBLIN, Calif. — An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

The FDA's Oncologic Drugs Advisory Committee voted 10-3 with one abstention not to support the risk-benefit profile of Dacogen (decitabine) in certain elderly patients with acute myeloid leukemia. The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them.

February 8, 2012

An antiplatelet medication created by Boehringer Ingelheim is not affected when co-administered with a proton-pump inhibitor, according to results of a drug interaction study.

RIDGEFIELD, Conn. — An antiplatelet medication created by Boehringer Ingelheim is not affected when co-administered with a proton-pump inhibitor, according to results of a drug interaction study.

February 8, 2012

While the financial burden that families face due to prescription drugs has declined, costs nevertheless remain a challenge for many of them, according to a new study by nonprofit research organization Rand Corp.

NEW YORK — While the financial burden that families face due to prescription drugs has declined, costs nevertheless remain a challenge for many of them, according to a new study by nonprofit research organization Rand Corp.

February 8, 2012

The Food and Drug Administration has approved a head lice treatment made by Sanofi, the drug maker said.

BRIDGEWATER, N.J. — The Food and Drug Administration has approved a head lice treatment made by Sanofi, the drug maker said.

Sanofi announced the approval of Sklice (ivermectin) lotion in the 0.5% strength for patients ages 6 months and older. According to Sanofi, head lice infest an estimated 6 to 12 million children ages 3 to 11 years and costs as much as $1 billion in lost school days and lost work for parents.

February 8, 2012

Takeda Pharmaceutical has launched a drug for treating high blood pressure in adults, the company said.

DEERFIELD, Ill. — Takeda Pharmaceutical has launched a drug for treating high blood pressure in adults, the company said.

Takeda announced the availability of Edarbyclor (azilsartan medoxomil and chlorthalidone), a once-daily tablet for the condition, also known as hypertension.

February 8, 2012

Specialty pharmacy provider The Apothecary Shops has inked a deal with Pfizer to distribute a new drug for treating kidney cancer.

PHOENIX — Specialty pharmacy provider The Apothecary Shops has inked a deal with Pfizer to distribute a new drug for treating kidney cancer.

The specialty provider announced Wednesday that Pfizer had granted it distribution rights for Inlyta (axitinib), which the Food and Drug Administration approved on Jan. 27 for advanced renal cell carcinoma in patients who have failed one systemic therapy.

February 7, 2012

The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.

Shire announced the FDA approval of Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance treatment for adults with ADHD. The drug already was approved for use in children and was approved for treating ADHD in adults in 2008.

The company said the approval was based on a clinical trial that showed more ADHD patients controlling their symptoms with Vyvanse than with placebo.

February 7, 2012

A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.

WHITEHOUSE STATION, N.J. — A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.

February 7, 2012

Cardinal Health was granted a temporary restraining order Friday against the Drug Enforcement Administration's suspension order of its Lakeland, Fla., distribution center.

DUBLIN, Ohio — Cardinal Health was granted a temporary restraining order Friday against the Drug Enforcement Administration's suspension order of its Lakeland, Fla., distribution center.

A preliminary injunction hearing is currently scheduled for Feb. 13.

February 6, 2012

In the five years since he has led the National Association of Chain Drug Stores, president and CEO Steve Anderson has operated under a sound policy; so simple, it is the advice he gives his own children: “We don’t start any fights — but we sure are going to finish them.” On Monday, Anderson and NACDS chairman Bob Loeffler, who also serves as H-E-B chief administrative officer, told NACDS Regional Chain Conference attendees that now they are going to take that fight to the PBM lobby.

NAPLES, Fla. — In the five years since he has led the National Association of Chain Drug Stores, president and CEO Steve Anderson has operated under a sound policy; so simple, it is the advice he gives his own children: “We don’t start any fights — but we sure are going to finish them.” On Monday, Anderson and NACDS chairman Bob Loeffler, who also serves as H-E-B chief administrative officer, told NACDS Regional Chain Conference attendees here, that now they are going to take that fight to the PBM lobby.

February 3, 2012

Endocrinologists would prescribe a newly approved weekly treatment for Type 2 diabetes to one-fifth of their patients, a new survey showed.

BURLINGTON, Mass. — Endocrinologists would prescribe a newly approved weekly treatment for Type 2 diabetes to one-fifth of their patients, a new survey showed.

February 2, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.

February 2, 2012

More than 50 drugs are under development for treating a respiratory disease that is the third-leading cause of death in the United States.

WASHINGTON — More than 50 drugs are under development for treating a respiratory disease that is the third-leading cause of death in the United States.

The Pharmaceutical Research and Manufacturers of America released a list Thursday of 54 drugs in clinical development for chronic obstructive pulmonary disease, or COPD.

February 1, 2012

The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

The FDA approved Novartis' Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors.

The drug was originally approved in 2001 for a type of leukemia.

February 1, 2012

Impax Pharmaceuticals said Wednesday that it obtained exclusive U.S. commercial rights to a drug for migraine headaches made by AstraZeneca.

HAYWARD, Calif. — Impax Pharmaceuticals said Wednesday that it obtained exclusive U.S. commercial rights to a drug for migraine headaches made by AstraZeneca.

February 1, 2012

A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

NEW YORK — A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

Pfizer announced the voluntary nationwide recall of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 additional lots of the drug's generic version. Pfizer manufactured and packaged the drugs, while Akrimax Pharmaceuticals commercialized them, and they were sold under the Akrimax brand.

February 1, 2012

A former Johnson & Johnson executive has been appointed to serve as interim CEO for Savient Pharmaceuticals.

EAST BRUNSWICK, N.J. — A former Johnson & Johnson executive has been appointed to serve as interim CEO for Savient Pharmaceuticals.

Savient's board of directors appointed David Norton to serve as interim CEO, succeeding current CEO John Johnson, who is leaving the company to become president, CEO and chairman-elect of biotechnology company Denderon. Savient's board said it will conduct a search process for a permanent CEO.

Norton, who is a member of Savient's board, formerly served as J&J company group chairman of global pharmaceuticals.

January 31, 2012

The Food and Drug Administration has approved a new treatment for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim, the drug makers said.

INDIANAPOLIS — The Food and Drug Administration has approved a new treatment for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim, the drug makers said.

The FDA approved Jentadueto (linagliptin and metformin) tablets, designed to be taken twice daily. The approval marks the second since the two companies announced their collaboration to develop diabetes drugs in January 2011; the first drug approved under the Lilly-BI partnership was Tradjenta (linagliptin), approved in May 2011.

January 31, 2012

A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country's main chain retail pharmacy lobby.

ALEXANDRIA, Va. — A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country's main chain retail pharmacy lobby.

The National Association of Chain Drug Stores submitted written testimony Tuesday ahead of a congressional hearing on the reauthorization of PDUFA, originally enacted in 1992.

January 30, 2012

Iceland-based drug maker Actavis and Poland-based Bioton have formed a partnership that they said would "shake up" the diabetes market.

WARSAW, Poland — Iceland-based drug maker Actavis and Poland-based Bioton have formed a partnership that they said would "shake up" the diabetes market.

Actavis and Bioton announced the signing of a $73.3 million deal to develop, manufacture and commercialize insulin products, including insulin analogues. Of that, Actavis will pay $29.4 million to Bioton when the deal is signed, while the rest will consist of milestone payments.