Content about Branded

March 25, 2013
CDC: Of the 105 flu-related pediatric deaths this season, 9-in-10 did not get a flu shot

An early look at this season’s reports indicates that about 90% of flu-related pediatric deaths occurred in children who had not received a flu vaccination this season, the Centers for Disease Control and Prevention reported.

ATLANTA — An early look at this season’s reports indicates that about 90% of flu-related pediatric deaths occurred in children who had not received a flu vaccination this season, the Centers for Disease Control and Prevention reported Friday. 

The number of influenza-associated pediatric deaths reported to the CDC during the current season surpassed 100 as an additional 6 deaths were reported in FluView last week. To date, this brings the total number of influenza-associated pediatric deaths reported to the CDC to 105 for the 2012-2013 season.

March 25, 2013
Drug makers ramp up treatments for chronic conditions in the elderly, PhRMA report finds

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 25, 2013
FDA approves Novartis antibacterial treatment for cystic fibrosis

The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.

March 25, 2013
Lilly, BI apply for diabetes drug approval

Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said.

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

March 25, 2013
Supreme Court hears patent-settlement case

The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

NEW YORK — The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

The case, Federal Trade Commission v. Actavis, marks the latest attempt by federal authorities to put an end to what they say are deals between branded and generic drug companies that delay release of generic drugs to consumers.

March 22, 2013
AstraZeneca, Moderna Therapeutics to develop drugs using RNA technology

AstraZeneca will pay $420 million to Moderna Therapeutics in a deal to develop drugs for a variety of diseases using a technology developed by Moderna, AstraZeneca said.

NEW YORK — AstraZeneca will pay $420 million to Moderna Therapeutics in a deal to develop drugs for a variety of diseases using a technology developed by Moderna, AstraZeneca said.

March 22, 2013
Novo Nordisk drug produces significant weight loss in study

A drug made by Novo Nordisk for Type 2 diabetes produced a 6% loss of weight in a trial of the drug in obese patients, the company said.

BAGSVÆRD, Denmark — A drug made by Novo Nordisk for Type 2 diabetes produced a 6% loss of weight in a trial of the drug in obese patients, the company said.

The Danish drug maker announced results of a 56-week phase-3 trial to investigate the potential of Victoza (liraglutide) to produce and maintain weight loss in overweight and obese patients with Type 2 diabetes.

March 21, 2013
Alcon launches mobile website

Alcon has launched a mobile website designed to facilitate dialogue between patients and pharmacists about eye and ear treatments, the company said.

NEW YORK — Alcon has launched a mobile website designed to facilitate dialogue between patients and pharmacists about eye and ear treatments, the company said Thursday.

Alcon announced the launch of Drops101 Web Tools, which offers access to information about two of its products: Ciprodex Otic (ciprofloxacin and dexamethasone), for acute otitis externa and acute otitis media in children with tymponostomy tubes; and Moxeza ophthalmic solution (moxifloxacin hydrochloride) for bacterial conjunctivitis.

March 18, 2013
Galena buys rights to cancer-pain drug from Orexo

Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

LAKE OSWEGO, Ore. — Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

Galena, which specializes in cancer-related drugs, said it acquired Abstral (fentanyl) sublingual tablets for sale and distribution in the United States from Orexo AB. Breakthrough cancer pain, or BTcP, affects between 40% to 80% of cancer patients, with reported episodes of four per day and a median duration of 30 minutes, according to Galena.

March 18, 2013
GSK donates $500,000 to Philadelphia Children's Hospital Cancer Center

Drug maker GlaxoSmithKline's philanthropic arm has donated $500,000 to the Children's Hospital of Philadelphia as part of a fund that provides assistance to families for travel and living expenses they may incur while their children are enrolled in experimental or novel treatments offered at the hospital's Cancer Center.

PHILADELPHIA — Drug maker GlaxoSmithKline's philanthropic arm has donated $500,000 to the Children's Hospital of Philadelphia as part of a fund that provides assistance to families for travel and living expenses they may incur while their children are enrolled in experimental or novel treatments offered at the hospital's Cancer Center.

March 15, 2013
FDA approves new packet version of AbbVie testosterone gel

The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

CHICAGO — The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

AbbVie announced the approval of the new version of AndroGel (testosterone) 1.62%, available in a packet containing 40.5 mg of testosterone in 2.5 g of gel and a packet with 20.25 mg of testosterone in 1.25 g of gel. The drug is used to raise testosterone levels in men with low or no testosterone, known as hypogonadism, estimated to affect nearly 14 million men in the United States.

March 14, 2013
FDA to review experimental opioid drug

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

March 12, 2013
State, territorial attorneys general call for anti-tampering measures in opioids

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

March 11, 2013
PhRMA: 907 biotech drugs, vaccines under development

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
ESI report notes fall in spending on traditional drugs

While the country's spending on specialty drugs increased by 18.4% in 2012, spending on traditional drugs fell for the first time in 20 years, according to a report by Express Scripts.

ST. LOUIS — While the country's spending on specialty drugs increased by 18.4% in 2012, spending on traditional drugs fell for the first time in 20 years, according to a report by Express Scripts.

March 8, 2013
Fla. bill allows biosimilar, branded substitution

A new bill (HB 365) in Florida's state legislature would allow pharmacists to substitute biosimilars for branded biotech drugs, according to published reports.

A new bill (HB 365) in Florida's state legislature would allow pharmacists to substitute biosimilars for branded biotech drugs, according to published reports. The Sarasota Herald-Tribune reported that the Health Quality Subcommittee of the Florida House of Representatives approved a bill that would allow for substitution while requiring pharmacists to notify prescribing physicians within five days and require the doctor and pharmacist to maintain a record for at least four years. A similar bill (SB 732) is pending in the Florida Senate, according to reports.

March 8, 2013
Leticia Moreinos Schwartz to promote Type 2 diabetes awareness among Hispanics

Drug maker Merck has hired celebrity chef and cookbook author Leticia Moreinos Schwartz as a spokeswoman to reach out to Hispanics living with Type 2 diabetes, the drug maker said.

WHITEHOUSE STATION, N.J. — Drug maker Merck has hired celebrity chef and cookbook author Leticia Moreinos Schwartz as a spokeswoman to reach out to Hispanics living with Type 2 diabetes, the drug maker said Friday.

March 8, 2013
Study: Colder days may contribute to more virulent flu season

Global warming could spell the end of flu seasons, research released by the National Institution of Health suggests, because the influenza virus better propagates and is more sustainable in colder climates.

BETHESDA, Md. — Global warming could spell the end of flu seasons, research released Friday by the National Institution of Health suggests, because the influenza virus better propagates and is more sustainable in colder climates. 

March 7, 2013
Multiple cost-management programs can reduce specialty drug spending, report finds

Employers that use multiple cost-management programs have a 50% lower specialty drug trend than those that don't use them, according to a new study by pharmacy benefit manager Express Scripts.

WASHINGTON — Employers that use multiple cost-management programs have a 50% lower specialty drug trend than those that don't use them, according to a new study by pharmacy benefit manager Express Scripts.

The study, presented Thursday at the National Business Group on Health's Business Health Agenda 2013 conference in Washington, was described as one of the first to examine the effect of multiple utilization management programs on the cost of specialty medications, which is expected to account for $1 out of every $4 spent on prescription drugs by 2014.

March 5, 2013
Ranbaxy to market antidepressant drug

Ranbaxy Labs will market a drug for depression under an agreement with another company, the drug maker said Tuesday.

PRINCETON, N.J. — Ranbaxy Labs will market a drug for depression under an agreement with another company, the drug maker said Tuesday.

Ranbaxy said it had entered an in-licensing agreement with Alembic Pharmaceuticals to market desvenlafaxine base extended-release tablets. Alembic is the sponsor of a new drug application filed with the Food and Drug Administration for the drug, which is bioequivalent to Pfizer's Pristiq. Pristiq had sales of $590 million during the 12-month period that ended in January.

March 5, 2013
Senators encourage GAO to investigate ways to collaborate on prescription drug abuse

Several senators have requested that the Government Accountability Office look for ways to coordinate the efforts of law enforcement and public health agencies at various levels and nonprofit organizations to address prescription drug abuse.

WASHINGTON — Several senators have requested that the Government Accountability Office look for ways to coordinate the efforts of law enforcement and public health agencies at various levels and nonprofit organizations to address prescription drug abuse.

March 4, 2013
FDA accepts application for NSAID painkiller

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.

March 4, 2013
WSJ: CDC sets stage for a four-strain flu shot for the next flu season

The Centers for Disease Control and Prevention set the stage for the first quadrivalent influenza vaccine to be introduced in the 2013-2014 flu season, according to a report in The Wall Street Journal.

NEW YORK — The Centers for Disease Control and Prevention last week set the stage for the first quadrivalent influenza vaccine to be introduced in the 2013-2014 flu season, according to a report in The Wall Street Journal. 

Quadrivalent vaccines will contain two A strains and two B strains of flu. The triumvirate vaccines in use today contain two A strains and one B strain of flu. 

March 1, 2013
FDA approves Abilify Maintena for schizophrenia

The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

TOKYO — The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

Otsuka Pharmaceutical and H. Lundbeck announced the FDA approval of Abilify Maintena (aripiprazole) for extended-release injectable suspension, an intramuscular depot formulation indicated for the treatment of schizophrenia.

The companies described Abilify Maintena as the first dopamine D2 partial agonist approved as a once-monthly injection, contributing to a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia.

March 1, 2013
Supreme Court to hear patent settlements case

The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

WASHINGTON — The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

The high court will hear arguments in the case, Federal Trade Commission v. Actavis, on March 25. The case was originally titled FTC v. Watson, but has changed since Watson Pharmaceuticals changed its name following its acquisition of Swiss generic drug maker Actavis.