Content about Pharmaceutical drug

May 22, 2013

Generic drug maker Par Pharmaceutical Cos. has started shipping an authorized generic version of a heart-disease medication made by AstraZeneca.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. has started shipping an authorized generic version of a heart-disease medication made by AstraZeneca.

Par said it had entered into an agreement with AstraZeneca to supply authorized generic Atacand (candesartan cilexetil) and had begun shipping the drug in the 4 mg, 8 mg, 16 mg and 32 mg strengths. Atacand has annual sales of about $113 million, according to IMS Health, and is used to treat certain kinds of heart failure and high blood pressure in children and adults.

May 21, 2013

Spending on specialty drugs is likely to increase by 67% over the next couple of years, according to a new study by pharmacy benefit manager Express Scripts.

ST. LOUIS — Spending on specialty drugs is likely to increase by 67% over the next couple of years, according to a new study by pharmacy benefit manager Express Scripts.

May 9, 2013

One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

WASHINGTON — One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

May 8, 2013

There is as much as $10 billion in branded pharmaceutical sales that could make the switch from prescription-only to over-the counter in the next five years, suggested Joseph Papa, Perrigo chairman, CEO and president, to analysts on Tuesday.

ALLEGAN, Mich. — There is as much as $10 billion in branded pharmaceutical sales that could make the switch from prescription-only to over-the counter in the next five years, suggested Joseph Papa, Perrigo chairman, CEO and president, to analysts on Tuesday. And as much as $5 billion in the next three years. 

May 6, 2013

Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.

NEW YORK — Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.

The drug maker announced that it had launched Viagra (sildenafil citrate) home delivery, a prescription-fulfillment website for the drug, which is powered by CVS/pharmacy and accessible through Viagra.com.

April 17, 2013

Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

WASHINGTON — Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

April 16, 2013

Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

Topicort topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

According to Taro, the corticosteroid spray market is approximately $100 million in annual sales in the United States.

April 12, 2013

The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

SAN DIEGO — The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

April 9, 2013

The new world of targeted, specialized medicines — many of them bioengineered and many of them aimed at smaller and smaller segments of the population — isn’t just on its way. It’s here. And it’s going to radically change the practice of pharmacy.

Here’s an eye-opener: Specialty drugs will likely account for 50% of all drug costs by 2018, up from 28.7% of total prescription drug costs in 2012.

The new world of targeted, specialized medicines — many of them bioengineered and many of them aimed at smaller and smaller segments of the population — isn’t just on its way. It’s here. And it’s going to radically change the practice of pharmacy.

Here’s an eye-opener: Specialty drugs will likely account for 50% of all drug costs by 2018, up from 28.7% of total prescription drug costs in 2012.

April 2, 2013

Specialty drugs are expected to account for 50% of all drug costs by 2018, according to two new studies.

SAN DIEGO — Specialty drugs are expected to account for 50% of all drug costs by 2018, according to two new studies.

By contrast, specialty drugs accounted for 20% of all drug costs in 2009, but increased to 28.7% by 2012. Pharmacy benefit manager Prime Therapeutics and Blue Cross and Blue Shield of Minnesota conducted the studies, and Prime is presenting them Tuesday at the Academy of Managed Care Pharmacy's 25th annual meeting and expo in San Diego.

March 25, 2013

More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

WASHINGTON — More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

March 22, 2013

The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

March 21, 2013

A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

March 11, 2013

Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

WASHINGTON — Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

March 8, 2013

Just about every healthcare practitioner recommends over-the-counter medicines to their patients. And nearly 3-out-of-4 make that OTC recommendation as the first therapy option, according to a recent survey released by the Consumer Healthcare Products Association.

This is another proof point that OTC medicines play an important role in holding down cost.

Just about every healthcare practitioner recommends over-the-counter medicines to their patients. And nearly 3-out-of-4 make that OTC recommendation as the first therapy option, according to a recent survey released by the Consumer Healthcare Products Association. 

This is another proof point that OTC medicines play an important role in holding down cost. 

March 4, 2013

The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said.

PHILADELPHIA — The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said Monday.

Iroko is seeking approval for a lower-dose, submicron diclofenac, a non-steroidal anti-inflammatory drug for treating mild to moderate acute pain in adults.

February 28, 2013

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

February 28, 2013

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

February 28, 2013

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers.

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers. A new report appearing in the Jan. 7 issue of JAMA Internal Medicine highlighted the powerful role played by branded drug advertising on consumer preferences and physicians' prescribing habits, and asserted that many doctors ignore the cost-saving benefits of generic drugs when writing prescriptions by acceding to patients' wishes.

February 26, 2013

A newly conducted study of millions of Medicare Part D prescription drug event data has found that community pharmacies provide 90-day medication supplies at lower cost than mail-order pharmacies and that local pharmacists substitute lower-cost generic drugs more often when compared with mail-order pharmacies.

ALEXANDRIA, Va. — A newly conducted study of millions of Medicare Part D prescription drug event data has found that community pharmacies provide 90-day medication supplies at lower cost than mail-order pharmacies and that local pharmacists substitute lower-cost generic drugs more often when compared with mail-order pharmacies.

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).

February 20, 2013

Lobbying groups for the retail pharmacy industry have a few suggestions for the Drug Enforcement Administration for drug take-back programs.

ARLINGTON, Va. — Lobbying groups for the retail pharmacy industry have a few suggestions for the Drug Enforcement Administration for drug take-back programs.

The National Association of Chain Drug Stores expressed support for a rule the DEA proposed in December to govern the secure disposal of controlled substances by DEA registrants - including pharmacies - and patients, as well as people acting on their behalf.

February 12, 2013

GlaxoSmithKline may be looking to buy a Brazilian drug maker for up to $4 billion, according to published reports.

NEW YORK — GlaxoSmithKline may be looking to buy a Brazilian drug maker for up to $4 billion, according to published reports.

Reuters, citing unnamed sources, said GSK was one of several drug companies looking to buy Ache Laboratorios Farmaceuticos for $3 billion to $4 billion. Other companies looking to buy the drug maker included Novartis, Pfizer and Abbott Labs.

Reuters noted that the company was attractive to drug makers looking to expand their footprints in Latin America and that it was a major producer of prescription and OTC medications.

February 8, 2013

A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International.

MONMOUTH BEACH, N.J. — A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International. 

February 8, 2013

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.

With growth in traditional pharmaceuticals expected to slow down significantly, a growing number of drug makers — branded and generic alike — see specialty drugs as their main sources of revenue for the foreseeable future. At the same time, those drug makers not invested in specialty may be looking for growth opportunities in consumer health.

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately