Content about Pharmaceutical industry

December 11, 2012
Reports: SCOTUS to take up branded-generic patent settlements

The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

NEW YORK — The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

Politico reported that the justices had agreed to hear three cases, including Federal Trade Commission v. Watson Pharmaceuticals, involving settlements between branded and generic drug companies that critics deride as "pay-for-delay" deals.

December 10, 2012
Amgen buys DeCode Genetics for $415 million

Amgen is buying an Iceland-based biotech company for $415 million, the two said Monday.

THOUSAND OAKS, Calif. — Amgen is buying an Iceland-based biotech company for $415 million, the two said Monday.

Amgen announced it would acquire DeCode Genetics, based in Reykjavik, Iceland, in a deal that Amgen's board of directors unanimously approved. Founded in 1996, DeCode focuses its business on finding links between the human genome and disease susceptibility. The acquisition is expected to close before the end of 2012 and does not require regulatory approval.

December 10, 2012
FDA grants Astellas NDA for tacrolimus extended-release capsules

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

December 3, 2012
Merck starts Alzheimer's drug trial

Merck has started a clinical trial that it hopes will eventually enroll 1,700 patients to evaluate an experimental drug for Alzheimer's disease, the company said.

WHITEHOUSE STATION, N.J. — Merck has started a clinical trial that it hopes will eventually enroll 1,700 patients to evaluate an experimental drug for Alzheimer's disease, the company said.

Merck announced the start of "EPOCH," a combined phase-2 and phase-3 study of the drug MK-8931, a 78-week trial in which patients will take either the drug in the 12-mg, 40-mg or 60-mg doses or placebo.

November 29, 2012
Eclipsing off-patent Lipitor, Humira tops Rx sales list

Just how much of an impact the loss of patent protection can have on a blockbuster drug became clear earlier this year.


Just how much of an impact the loss of patent protection can have on a blockbuster drug became clear earlier this year.


November 29, 2012
FDA approves Mylan overactive bladder drug

The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

PITTSBURGH — The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

Mylan announced the approval and launch of tolterodine tartrate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Detrol, made by Pharmacia and Upjohn, now owned by Pfizer.

Used to treat overactive bladder, tolterodine tartrate tablets had sales of about $61.5 million during the 12-month period ended in September, according to IMS Health.

November 29, 2012
Industry divided over patent settlements

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


November 29, 2012
NewsBytes — Chain Pharmacy, 12/10/12

Watson Pharmaceuticals is changing its name to Actavis following its acquisition of the Swiss drug maker, Watson said.

Watson to change brand in 2013
PARSIPPANY, N.J. — Watson Pharmaceuticals is changing its name to Actavis following its acquisition of the Swiss drug maker, Watson said. Watson, whose $5.6 billion acquisition of Actavis received approval from the Federal Trade Commission in October, said it would adopt the new name starting in 2013, with plans to start a multi-year rebranding campaign and trade under a new symbol on the New York Stock Exchange.


November 29, 2012
Record patent expirations roil Rx market

In 2011 and 2012, the steady surge of blockbuster pharmaceuticals falling off the patent cliff became a stampede. An astonishing number of big-selling drugs that had established and sustained branded drug makers’ profits for years fell victim to the expiration of their patent lives and market exclusivity, roiling the pharmaceutical marketplace and redefining the pricing model for many of the most widely prescribed classes of medicines.


In 2011 and 2012, the steady surge of blockbuster pharmaceuticals falling off the patent cliff became a stampede. An astonishing number of big-selling drugs that had established and sustained branded drug makers’ profits for years fell victim to the expiration of their patent lives and market exclusivity, roiling the pharmaceutical marketplace and redefining the pricing model for many of the most widely prescribed classes of medicines.


November 29, 2012
Study forecasts steady generics growth through 2023

The global market for generic drugs will reach more than $125 billion next year, according to a new report by a British market-research firm.

LONDON — The global market for generic drugs will reach more than $125 billion next year, according to a new report by a British market-research firm.

November 29, 2012
User fee re-authorization 
fuels generics’ outlook

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


November 28, 2012
Novo Nordisk app designed to help hemophilia patients, families

Novo Nordisk has launched a mobile app for hemophilia patients, the drug maker said.

PRINCETON, N.J. — Novo Nordisk has launched a mobile app for hemophilia patients, the drug maker said.

HemaGo — available for iPhone, iPad and Android devices — is designed to track hemophilia treatment, bleeding episodes and life events, helping people with the condition and their caregivers monitor the details of treatment, including medications, dosing, bleeding information and the disease's effects on life events.

November 27, 2012
Ranbaxy recalls several lots of generic Lipitor

Ranbaxy Labs has recalled more than three dozen lots of its generic version of a cholesterol-lowering statin drug due to the possible presence of foreign particles, the company said.

NEW YORK — Ranbaxy Labs has recalled more than three dozen lots of its generic version of a cholesterol-lowering statin drug due to the possible presence of foreign particles, the company said.

November 27, 2012
Wockhardt receives three FDA approvals

Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

SILVER SPRING, Md. — Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

November 26, 2012
Medication nonadherence costs drug makers $188 billion per year in U.S., report finds

When it comes to medication nonadherence, the most oftcited statistic illustrating its effect on the healthcare system is the New England Healthcare Institute's estimate that it costs the healthcare system $290 billion per year. But a new report shows how much drug makers lose as well.

NORWALK, Conn. — When it comes to medication non-adherence, the most oft-cited statistic illustrating its effect on the healthcare system is the New England Healthcare Institute's estimate that it costs the healthcare system $290 billion per year. But a new report shows how much drug makers lose as well.

November 19, 2012
Shire launches rare-disease research project

Drug maker Shire has started a research program focused on rare diseases and their effects on patients and healthcare professionals, the company said Monday.

LEXINGTON, Mass. — Drug maker Shire has started a research program focused on rare diseases and their effects on patients and healthcare professionals, the company said Monday.

Shire announced the launch of the Shire Rare Disease Impact Report, which includes surveys of patients, caregivers, physicians, payers and others in the United States and United Kingdom, with results expected in the first half of 2013.

November 15, 2012
Branded generics transform the old into the new

In the classic Arabian Nights tale “Aladdin and the Magic Lamp,” the sorcerer who sold Aladdin the lamp containing the genie attempts to get it back by walking through the town where Aladdin and his wife live disguised as a merchant, trading “new lamps 
for old.” 


In the classic Arabian Nights tale “Aladdin and the Magic Lamp,” the sorcerer who sold Aladdin the lamp containing the genie attempts to get it back by walking through the town where Aladdin and his wife live disguised as a merchant, trading “new lamps 
for old.” 


Rubbing pill bottles isn’t likely to bring forth any genies ready to grant three wishes, but the idea of inputting something old and outputting something shiny and new is sort of the gist behind 
branded generics.


November 15, 2012
Generic drugs compete in game of differentiation

The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


November 15, 2012
Generics target specialty pharmacy with biosimilars

Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


November 15, 2012
NewsBytes — Chain Pharmacy, 11/19/12

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.


The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.



 

November 15, 2012
Report outlines challenges in pharma industry through 2020

Spurred by health reform and other factors, a "golden era" could be approaching for drug companies as they reinvent themselves, according to a new report by PwC.

NEW YORK — Spurred by health reform and other factors, a "golden era" could be approaching for drug companies as they reinvent themselves, according to a new report by PwC.

The report, "Pharma 2020: From Vision to Decision," said that the industry was on the verge of an era of renewed productivity and prosperity, but its success was not guaranteed.

November 15, 2012
Shipments of generic version of Bontril PDM begins

Initial shipment of a generic appetite suppressant has started, the drug's manufacturer said Thursday.

NORTHVALE, N.J. — Initial shipment of a generic appetite suppressant has started, the drug's manufacturer said Thursday.

Elite Pharmaceuticals announced the initial shipment of phendimetrazine tartrate tablets in the 35-mg strength, a generic version of Valeant's Bontril PDM, under a manufacturing and supply agreement with Mikah Pharma. Actavis, recently acquired by Watson Pharmaceuticals, will distribute the drug as part of a distribution agreement between Mikah and Actavis.

November 14, 2012
NCPA submits comments in support of compounding to congressional committees

The National Community Pharmacists Association on Wednesday submitted comments to two congressional committees holding separate hearings examining the meningitis outbreak at the New England Compounding Center, including the the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations and to the U.S. Senate Committee on Health, Education, Labor & Pensions, respectively.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday submitted comments to two congressional committees holding separate hearings examining the meningitis outbreak at the New England Compounding Center, including the the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations and to the U.S. Senate Committee on Health, Education, Labor & Pensions, respectively.

November 14, 2012
Novartis Consumer launches My Migraine Triggers app

Novartis Consumer Health on Wednesday announced the development of a convenient migraine trigger tracking tool, My Migraine Triggers App, with a neurologist.

PARSIPPANY, N.J. — Novartis Consumer Health on Wednesday announced the development of a convenient migraine trigger tracking tool, My Migraine Triggers App, with a neurologist. The company also partnered with Jordin Sparks, singer, actress and Broadway performer, and Keri Peterson, an internist at Lenox Hill Hospital, on the launch of "Managing Migraines: Know Your Triggers. Know Your Treatment," an educational campaign to raise awareness around the importance of knowing individual migraine triggers. 

November 13, 2012
Reports: AMA supports legislation against 'pay-for-delay' deals

The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

NEW YORK — The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

Forbes reported that the AMA would support federal legislation to ban so-called "pay-for-delay" settlements. The AMA joins the Federal Trade Commission, which has strongly criticized the settlements