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January 21, 2014

Actavis confirmed that the U.S. District Court for the District of New Jersey found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets).

DUBLIN — Actavis last week confirmed that the U.S. District Court for the District of New Jersey found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets).  

Lo Loestrin Fe is a prescription birth control pill used for the prevention of pregnancy.

January 21, 2014

Greenstone, a U.S.-based generic pharmaceutical subsidiary of Pfizer, on Tuesday announced the introduction of Sirolimus to its generic pharmaceutical product line.

PEAPACK, N.J. — Greenstone, a U.S.-based generic pharmaceutical subsidiary of Pfizer, on Tuesday announced the introduction of Sirolimus to its generic pharmaceutical product line. The product is offered in dosage strengths of 0.5mg x 100. 

Greenstone’s Sirolimus product is the authorized generic of, and equivalent to, Pfizer's Rapamune (sirolimus). 

January 21, 2014

With the role of social media rapidly expanding, nearly half of pharmaceutical manufacturers are now actively using this channel to engage with patients on healthcare-related topics, according to a new report by the IMS Institute for Healthcare Informatics.

PARSIPPANY, N.J. — With the role of social media rapidly expanding, nearly half of pharmaceutical manufacturers are now actively using this channel to engage with patients on healthcare-related topics, according to a new report released Tuesday by the IMS Institute for Healthcare Informatics. 

January 21, 2014

Novo Nordisk has launched a new insulin pen designed for children with diabetes.

NEW YORK — Novo Nordisk has launched a new insulin pen designed for children with diabetes.

The new NovoPen Echo is the first and only prefilled pen device in the United States that allows for half-unit dosing in combination with a memory function, the company said.

January 21, 2014

Teva Pharmaceutical announced that it has entered into a definitive agreement under which Teva will acquire NuPathe for $3.65 per share in cash.

JERUSALEM — Teva Pharmaceutical on Tuesday announced that it has entered into a definitive agreement under which Teva will acquire NuPathe for $3.65 per share in cash, or approximately $144 million. In addition to the upfront cash payment, NuPathe shareholders will receive rights to receive additional cash payments of up to $3.15 per share if specified net sales of NuPathe's migraine treatment, Zecuity, are achieved over time.

January 21, 2014

Vivus and Auxilium Pharmaceuticals announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction."

MOUNTAIN VIEW, Calif. — Vivus and Auxilium Pharmaceuticals on Tuesday announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." 

The PDUFA date for the supplemental filing is Sept. 20, 2014.

January 20, 2014

The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week.

NEW YORK — The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week. 

Both Mekinist and Tafinlar are only available in limited distribution, and Onco360 is one of the few pharmacies with access to both medications.

January 17, 2014

The Consumer Healthcare Products Association responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

WASHINGTON — The Consumer Healthcare Products Association on Thursday responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

January 17, 2014

A survey released by the National Consumers League found that more than 1-in-5 (22%) U.S. parents surveyed admitted they’ve never received a flu shot, and only half (53%) of parents with children ages 17 years and younger have received a flu vaccination within the last year.

WASHINGTON — A survey released by the National Consumers League found that more than 1-in-5 (22%) U.S. parents surveyed admitted they’ve never received a flu shot, and only half (53%) of parents with children ages 17 years and younger have received a flu vaccination within the last year. 

January 17, 2014

The National Community Pharmacists Association on Thursday expressed its support behind the Diabetic Testing Supply Access Act (S. 1935).

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday expressed its support behind the Diabetic Testing Supply Access Act (S. 1935). 

The legislation would allow independent community pharmacies to provide same-day delivery of diabetes testing supplies to Medicare beneficiaries and was introduced by Senss Jerry Moran, R-Kan., and John Thune, R-S.D. 

Since July 1, 2013 community pharmacies have been banned from delivering DTS to beneficiaries, including those who are homebound or in long-term care or assisted living facilities. 

January 17, 2014

The Medicare Part D program and taxpayers often pay more when prescription drugs are obtained through "preferred" pharmacies and mail order than they would if the same prescriptions were filled through other, "non-preferred" pharmacies, according to a cost comparison made by the National Community Pharmacists Association released Thursday using the Medicare Plan Finder website.

ALEXANDRIA, Va. — The Medicare Part D program and taxpayers often pay more when prescription drugs are obtained through "preferred" pharmacies and mail order than they would if the same prescriptions were filled through other, "non-preferred" pharmacies, according to a cost comparison made by the National Community Pharmacists Association released Thursday using the Medicare Plan Finder website. The findings come shortly after recently proposed requirements that officials with the U.S.

January 17, 2014

Nuvo Research on Friday announced that the U.S. Food and Drug Administration approved Mallinckrodt's new drug application for Pennsaid (diclofenac sodium topical solution) 2%

MISSISSAUGA, Ontario — Nuvo Research on Friday announced that the U.S. Food and Drug Administration approved Mallinckrodt's new drug application for Pennsaid (diclofenac sodium topical solution) 2%.

January 17, 2014

Par Pharmaceutical on Thursday announced that it has entered into an exclusive U.S. supply and distribution agreement with Covis Pharma S.a.r.l. to distribute the authorized generic version of Covis's Lanoxin (digoxin) tablets.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical on Thursday announced that it has entered into an exclusive U.S. supply and distribution agreement with Covis Pharma S.a.r.l. to distribute the authorized generic version of Covis's Lanoxin (digoxin) tablets. 

According to IMS Health data, annual U.S. sales of digoxin tablets are approximately $44 million. 

January 16, 2014

An analysis released Tuesday by the Trust for America's Health found that only 35.7% of adults ages 18 to 64 years got the flu shot last season.

WASHINGTON — An analysis released Tuesday by the Trust for America's Health found that only 35.7% of adults ages 18 to 64 years got the flu shot last season. By comparison, 56.6% of children ages 6 months to 17 years old and 66.2% of seniors were vaccinated.  

"The trend of low vaccination rates among younger adults is particularly troubling this year, when they are more at risk than usual for the effects of the H1N1 strain of flu that's circulating," stated Jeffrey Levi, executive director of TFAH.

January 16, 2014

Easton Pharmaceuticals on Thursday announced it is speeding up negotiations with an Ontario-based company toward forming a possible investment/partnership toward their medical marijuana initiatives, which includes participating in their government application for both a growers and distributorship license in Canada and other possible international initiatives.

TORONTO — Easton Pharmaceuticals on Thursday announced it is speeding up negotiations with an Ontario-based company toward forming a possible investment/partnership toward their medical marijuana initiatives, which includes participating in their government application for both a growers and distributorship license in Canada and other possible international initiatives. 

January 16, 2014

Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar.

WHITEHOUSE STATION, N.J. — Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack.

January 15, 2014

Drug maker AbbVie has started a late-stage clinical trial of an experimental drug for treating triple-negative breast cancer, the company said Wednesday.

NORTH CHICAGO, Ill. – Drug maker AbbVie has started a late-stage clinical trial of an experimental drug for treating triple-negative breast cancer, the company said Wednesday.

January 15, 2014

A new drug for autoimmune diseases from Antares Pharma that the company calls the first of its kind is now available, the drug maker said Wednesday.

EWING, N.J. — A new drug for autoimmune diseases from Antares Pharma that the company calls the first of its kind is now available, the drug maker said Wednesday.

Antares announced the availability of Otrexup for rheumatoid arthritis and psoriasis in adults and polyarticular idiopathic arthritis in children. The company said the drug is the first Food and Drug Administration-approved subcutaneous methotrexate product for once-weekly self-administration. Otrexup, which the FDA approved in October, is available with a single-dose auto injector.

January 15, 2014

The Food and Drug Administration recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit. 

January 15, 2014

Zafgen on Wednesday announced initial results from its Phase 2a study of beloranib, a selective inhibitor of methionine aminopeptidase 2 (MetAP2), in patients with Prader-Willi syndrome, a severe form of genetic obesity.

CAMBRIDGE, Mass — Zafgen on Wednesday announced initial results from its Phase 2a study of beloranib, a selective inhibitor of methionine aminopeptidase 2 (MetAP2), in patients with Prader-Willi syndrome, a severe form of genetic obesity. These results showed improvements in body weight, hunger-related behaviors and body composition, including reductions in body fat content and preserved lean body mass following four weeks of treatment. 

January 15, 2014

Nearly three-quarters of osteoporosis patients prefer to take their medication in a form other than an oral solid, according to a new survey.

SAN ANTONIO — Nearly three-quarters of osteoporosis patients prefer to take their medication in a form other than an oral solid, according to a new survey.

January 15, 2014

Walgreens on Wednesday announced it is donating the value of 3 million vaccines for children in developing countries upon successful completion of its immunizations campaign developed in partnership with the UN Foundation’s Shot@Life campaign.

DEERFIELD, Ill. — Walgreens on Wednesday announced it is donating the value of 3 million vaccines for children in developing countries upon successful completion of its immunizations campaign developed in partnership with the UN Foundation’s Shot@Life campaign.

Walgreens pledged to donate the value of one vaccine through Shot@Life for each immunization the company administered from Sept. 4 through Oct. 14, with a goal to reach three million vaccines to benefit children in developing countries by protecting them against such diseases as measles and polio. 

January 13, 2014

According to this week's FluView report, overall flu activity continued to be high across the nation, with activity continuing to spread from state to state, the Centers for Disease Control and Prevention reported Friday.

ATLANTA — According to this week's FluView report, overall flu activity continued to be high across the nation, with activity continuing to spread from state to state, the Centers for Disease Control and Prevention reported Friday. Thirty-five states are now experiencing widespread activity, and 20 states are reporting high levels of influenza-like illness. 

January 13, 2014

More than three-dozen pharmacists in 41 states will receive the 2013 National Alliance of State Pharmacy Associations' Excellence in Innovation Award, which is designed to recognize pharmacists who have demonstrated significant innovation in their practice.

MAPLE GROVE, Minn. — More than three-dozen pharmacists in 41 states will receive the 2013 National Alliance of State Pharmacy Associations' Excellence in Innovation Award, which is designed to recognize pharmacists who have demonstrated significant innovation in their practice.

The award, sponsored by drug maker Upsher-Smith Labs, focuses on those innovations in practice, method or service that directly or indirectly improve patient care and the advancement of the pharmacy profession.

January 13, 2014

A drug maker has started a program to find the genetic determinants of human disease and speed the discovery and development of new drugs. The program includes a five-year project that it said would be one of the largest of its kind in terms of the number of patients involved.

TARRYTOWN, N.Y. — A drug maker has started a program to find the genetic determinants of human disease and speed the discovery and development of new drugs. The program includes a five-year project that it said would be one of the largest of its kind in terms of the number of patients involved.