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January 31, 2012
FDA approves Vertex's Kalydeco for cystic fibrosis

The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

The FDA announced the approval of Kalydeco (ivacaftor) for treating patients ages 6 years and older with CF who have a mutation called G551D in the cystic fibrosis transmembrane regulator gene.

January 25, 2012
FDA approves actinic keratosis treatment

The Food and Drug Administration has approved a topical treatment made by Leo Pharma for a skin condition that can lead to cancer, the drug maker said Wednesday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a topical treatment made by Leo Pharma for a skin condition that can lead to cancer, the drug maker said Wednesday.

Leo announced the FDA approval of Picato (ingenol mebutate) gel in the 0.015%/0.05% strength for actinic keratosis, also known as AK, which is a precancerous condition resulting from cumulative sun exposure that has the potential to lead to squamous cell carcinoma.

January 23, 2012
ReportersNotebook — Chain Pharmacy, 1/30/12

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product.

January 6, 2012
Achillion receives fast-track designation for hepatitis C drug

The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

NEW HAVEN, Conn. — The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

January 3, 2012
FDA approves Prevnar 13 in older adults

The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.

NEW YORK — The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.

Pfizer announced the FDA approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) as a single-dose for adults.

December 21, 2011
Merck's Isentress approved for children, adolescents

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

The FDA announced the approval of Merck's Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.

"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.

 

November 29, 2011
Qualitest receives FDA approval for Myzilra tablets

The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.

The generic drug maker announced approval of Myzilra tablets (levonorgestrel and ethinyl estradiol tablets, USP) in the 0.05-mg/0.03-mg, 0.075-mg/0.04-mg and 0.125-mg/0.03-mg (28-day triphasic regimen) strengths.

U.S. sales for Myzilra tablets totaled approximately $34.4 million for the 12 months ended Sept. 30, according to IMS Health.

November 28, 2011
Bayer, Regeneron start phase-3 trial of Eylea for wet AMD in China

Bayer HealthCare and Regeneron Pharmaceuticals have started a late-stage clinical trial in China to evaluate a drug for eye disorders, the companies said Monday.

TARRYTOWN, N.Y. — Bayer HealthCare and Regeneron Pharmaceuticals have started a late-stage clinical trial in China to evaluate a drug for eye disorders, the companies said Monday.

The drug makers announced the start of the phase-3 "SIGHT" trial of Eylea (aflibercept) injection for the treatment of the neovascular form of age-related macular degeneration, also known as wet AMD. The companies said the trial, which will include about 300 patients, will be the largest retinal trial conducted in China.

November 18, 2011
Ampro creates new Olive Oil styling gel for ethnic hair

Multicultural hair care company, Ampro Industries, whose products are sold in mass market and beauty supply stores, has announced the development of its newest formula: Ampro Pro Styl Olive Oil styling gel.

MEMPHIS, Tenn. — Multicultural hair care company Ampro Industries, whose products are sold in mass market and beauty supply stores, has announced the development of its newest formula: Ampro Pro Styl Olive Oil styling gel.

Made with 100% Olive Oil, the Olive Oil styling gel is reportedly the most moisturizing gel Ampro has ever made. It is slated to hit stores in December.

November 10, 2011
AstraZeneca, Targacept: TC-5214 'well-tolerated,' did not meet endpoint in phase-3 trial

AstraZeneca and Targacept released results of the first of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

NEW YORK — AstraZeneca and Targacept released results of the first of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

October 31, 2011
J&J submits new FDA application for Nucynta ER

A Johnson & Johnson subsidiary has sent a regulatory application to the Food and Drug Administration seeking approval for one of its drugs in treating diabetes-related pain.

TITUSVILLE, N.J. — A Johnson & Johnson subsidiary has sent a regulatory application to the Food and Drug Administration seeking approval for one of its drugs in treating diabetes-related pain.

October 24, 2011
FDA approves drug for severe epilepsy

The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

The FDA announced the approval of Onfi (clobazam) tablets, made by Catalent Pharma Solutions and Lundbeck, as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older. The agency gave the drug orphan drug designation because the disease affects fewer than 200,000 people in the United States.

October 19, 2011
Takeda launches late-stage trial program for Type 2 diabetes drug

Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

OSAKA, Japan — Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

October 11, 2011
Novartis stays focused on shipping, developing vaccinations

A lot has been happening at Swiss drug maker Novartis in the realm of vaccines.


BAGSVAERD, Denmark — A lot has been happening at Swiss drug maker Novartis in the realm of vaccines.


In July, the company began early shipment of its flu vaccine, Fluvirin, in order to ensure that patients can receive the earliest possible protection against influenza. The drug maker plans to ship more than 30 million doses.


October 4, 2011
Report: Lupin stands to benefit from drug patent expiries

A wave of patent expirations over the next several years will open up a broad swath of drugs to generic competition, and India's Lupin Pharmaceuticals is looking to benefit, according to published reports.

NEW YORK — A wave of patent expirations over the next several years will open up a broad swath of drugs to generic competition, and India's Lupin Pharmaceuticals is looking to benefit, according to published reports.

The Wall Street Journal reported that the Mumbai-based company planned to launch 25 to 30 new generic drugs each year over the next couple of years.

September 6, 2011
Armada Health Care, Hemispherx sign sales, distribution agreement for Alferon N Injection

Hemispherx Biopharma and Armada Health Care have entered a sales and marketing agreement for a drug designed to treat genital warts.

PHILADELPHIA — Hemispherx Biopharma and Armada Health Care have entered a sales and marketing agreement for a drug designed to treat genital warts.

The two companies announced Tuesday an agreement under which Hemispherx will manufacture and supply Alferon N injection (interferon alfa-n3 [human leukocyte derived]) to physicians and patients through Armada's national specialty pharmacy network. Specialty distributor BioRidge Pharma will warehouse, ship and distribute the drug, the companies said.

August 29, 2011
FDA approves Pfizer lung cancer drug

The Food and Drug Administration has approved a new cancer drug made by Pfizer, the drug maker said.

NEW YORK — The Food and Drug Administration has approved a new cancer drug made by Pfizer, the drug maker said.

The FDA approved Pfizer's Xalkori (crizotinib) capsules, a treatment for patients with non-small cell lung cancer that has advanced locally or spread to other parts of the body, also known as metastasis. The drug specifically is designed to target NSCLC containing the enzyme anaplastic lymphoma kinase, as determined by a companion test also approved by the FDA.

August 26, 2011
J&J drug approved for chronic pain

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.

The FDA approved Janssen Pharmaceuticals' Nucynta ER (tapentadol) tablets, an extended-release drug for moderate to severe chronic pain in adults for whom a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

August 15, 2011
Study: Investigational GSK, Impax drug reduces Parkinson's symptoms

Patients taking an experimental treatment for Parkinson's disease experienced greater reduction in symptoms than those taking standard therapies, according to results of a late-stage clinical trial.

HAYWARD, Calif. — Patients taking an experimental treatment for Parkinson's disease experienced greater reduction in symptoms than those taking a drug already on the market, according to results of a late-stage clinical trial.

August 11, 2011
GSK, XenoPort file sNDA for Horizant

Drug makers GlaxoSmithKline and XenoPort are seeking expanded approval for their restless legs syndrome treatment.

LONDON — Drug makers GlaxoSmithKline and XenoPort are seeking expanded approval for their restless legs syndrome treatment.

The drug makers this week announced the submission of a supplemental new drug application to the Food and Drug Administration, requesting approval for Horizant (gabapentin enacarbil) extended-release tablets as a treatment for postherpetic neuralgia, a nerve pain that commonly is seen in patients with shingles. GSK submitted the sNDA on behalf of the two companies.

August 2, 2011
FDA gives new approval to Novartis MS drug

The Food and Drug Administration has approved a new use for a drug made by Novartis for treating multiple sclerosis, the Swiss drug maker's U.S. subsidiary said Monday.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a new use for a drug made by Novartis for treating multiple sclerosis, the Swiss drug maker's U.S. subsidiary said Monday.

Novartis Pharmaceuticals announced the FDA's approval of Gilenya (fingolimod) for the reduction of T1 gadolinium-enhancing lesions, areas of inflammation in the central nervous system that mark disease activity in people with MS.

July 25, 2011
ReportersNotebook — Chain Pharmacy, 8/1/11

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said.

SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said. Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.


July 19, 2011
Graceway receives regulatory approval for Zyclara

The Food and Drug Administration has approved a drug made by Graceway Pharmaceuticals for actinic keratoses, Graceway said.

BRISTOL, Tenn. — The Food and Drug Administration has approved a drug made by Graceway Pharmaceuticals for actinic keratoses, Graceway said.

The agency approved Zyclara (imiquimod) cream in the 2.5% strength for AK, a precancerous lesion that affects about 10 million Americans and can develop into skin cancer later on.

July 18, 2011
Upsher-Smith commences late-stage trial for epilepsy treatment

Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

MAPLE GROVE, Minn. — Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

July 15, 2011
WHO increases number of approved seasonal flu vaccines

The World Health Organization on Thursday announced 11 new manufacturers of the seasonal flu vaccine, a development that is expected to double the number of influenza doses to 1.7 billion worldwide by 2015, according to published reports.

GENEVA — The World Health Organization on Thursday announced 11 new manufacturers of the seasonal flu vaccine, a development that is expected to double the number of influenza doses to 1.7 billion worldwide by 2015, according to published reports. 

In all, there now are 37 approved vaccine manufacturers that potentially could triple their annual production to make as much as 5.4 billion pandemic vaccinations in the event of another H1N1-type outbreak.