Content about Biotechnology

January 21, 2013

While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

NEW YORK — While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

In a post Friday on FDA Law Blog, the official blog of the law firm Hyman, Phelps & McNamara, attorney Kurt Karst wrote that several states were laying the groundwork for such legislation, recalling state-level antisubstitution laws targeting generics that were adopted in the 1970s.

January 8, 2013

Biotech companies saw a decline in project delays due to regulations over the past year, as more than half have said insurance coverage and reimbursement issues have become more difficult, according to a new report.

SAN FRANCISCO — Biotech companies saw a decline in project delays due to regulations over the past year, as more than half have said insurance coverage and reimbursement issues have become more difficult, according to a new report.

The 2013 California Biomedical Industry Report — by PwC, the California Healthcare Institute and BayBio — looked at California's biotech industry and how it faired in 2012.

January 7, 2013

While pressure to grow will drive more large drug makers to pursue mergers and acquisitions, diminished resources and competition from biotech and specialty pharmaceutical companies will challenge their ability to do so, according to a new report.

SAN FRANCISCO — While pressure to grow will drive more large drug makers to pursue mergers and acquisitions, diminished resources and competition from biotech and specialty pharmaceutical companies will challenge their ability to do so, according to a new report.

December 18, 2012

A majority of prescribers would prescribe biosimilar versions of two treatments for rheumatoid arthritis within a year of their approval, according to a new study.

BURLINGTON, Mass. — A majority of prescribers would prescribe biosimilar versions of two treatments for rheumatoid arthritis within a year of their approval, according to a new study.

November 16, 2012

Kroger announced Thursday it will acquire the outstanding shares of Axium Pharmacy Holdings, a leading specialty pharmacy, and merge the two companies. By now, it should be clear that specialty is becoming an increasingly important part of the retail pharmacy mix, having grown more than sixfold in revenues between 2000 and 2011, with everyone from Rite Aid to Costco to Hy-Vee biting off a piece for themselves.

As Specialty Pharmacy magazine reported in its fall 2012 issue, specialty drug development is starting to play a much bigger role in drug development overall than traditional pharmaceuticals. According to the IMS Institute for Healthcare Informatics, seven of the top 20 drug therapy classes will be in specialty by 2016, including cancer, autoimmune disorders and antivirals, and specialty and bioengineered drugs remain one of the few growth centers in the drug industry in 2012. And according to Express Scripts, the market for specialty and bioengineered drugs is expected to grow from 2011's 17.1% to 22% by 2014.

Kroger announced Thursday it will acquire the outstanding shares of Axium Pharmacy Holdings, a leading specialty pharmacy, and merge the two companies. By now, it should be clear that specialty is becoming an increasingly important part of the retail pharmacy mix, having grown more than sixfold in revenues between 2000 and 2011, with everyone from Rite Aid to Costco to Hy-Vee biting off a piece for themselves.

November 9, 2012

A Food and Drug Administration panel has voted to support two experimental insulin treatments made by Novo Nordisk, the Danish drug maker said Thursday.

BAGSVÆRD, Denmark — A Food and Drug Administration panel has voted to support two experimental insulin treatments made by Novo Nordisk, the Danish drug maker said Thursday.

Novo Nordisk said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee had voted 8-to-4 in favor of approval for insulin degludec and a combination treatment containing insulin degludec and insulin aspart.

October 17, 2012

A cancer drug made by Bristol-Myers Squibb has received an award from Galien Foundation, the drug maker said Wednesday.

PRINCETON, N.J. — A cancer drug made by Bristol-Myers Squibb has received an award from Galien Foundation, the drug maker said Wednesday.

The company said Yervoy (ipilimumab) received the 2012 Prix Galien USA Prize in the Best Biotechnology Product category. Yervoy — used to treat melanoma that has spread to other parts of the body, known as metastasis — is the first new drug for melanoma that is metastatic or can't be removed through surgery in more than a decade.

October 9, 2012

While much of the focus on pharmacist-administered vaccinations has been on influenza and shingles, there also have been efforts to significantly expand the number of diseases against which customers at the local pharmacy can get protection.


While much of the focus on pharmacist-administered vaccinations has been on influenza and shingles, there also have been efforts to significantly expand the number of diseases against which customers at the local pharmacy can get protection.


August 23, 2012

A division of Johnson & Johnson has started a late-stage clinical trial program for a drug for rheumatoid arthritis under a partnership with British drug maker GlaxoSmithKline.

SPRING HOUSE, Pa. — A division of Johnson & Johnson has started a late-stage clinical trial program for a drug for rheumatoid arthritis under a partnership with British drug maker GlaxoSmithKline.

August 20, 2012

Winn-Dixie Stores on Monday kicked off its “Shield Yourself” flu vaccination campaign offering consumers three options in getting this year’s influenza vaccine.

JACKSONVILLE, Fla. — Winn-Dixie Stores on Monday kicked off its “Shield Yourself” flu vaccination campaign offering consumers three options in getting this year’s influenza vaccine.

Guests at any of the grocer’s in-store pharmacies can choose from the standard vaccination, a high-dose vaccine recommended for those 65 years and older or an Intradermal flu vaccination administered with a microneedle that is 90% smaller than traditional needles, Winn-Dixie stated.

August 17, 2012

The U.S. healthcare system presents a paradox: It’s the most expensive system in the world, and yet it produces among the worst results among developed countries.

The U.S. healthcare system presents a paradox: It’s the most expensive system in the world, and yet it produces among the worst results among developed countries. According to the most recent report from the National Health Expenditure Accounts, spending on health care reached $2.6 trillion in 2010, or more than $8,400 per person and around 18% of the country’s gross domestic product.


August 8, 2012

Drug makers Teva Pharmaceutical Industries and Active Biotech will start a third late-stage clinical trial of an experimental drug for treating multiple sclerosis, the companies said Wednesday.

JERUSALEM — Drug makers Teva Pharmaceutical Industries and Active Biotech will start a third late-stage clinical trial of an experimental drug for treating multiple sclerosis, the companies said Wednesday.

Israel-based Teva and Sweden-based Active Biotech said they would start a phase-3 trial of laquinimod for relapsing-remitting multiple sclerosis, also known as RRMS, following an agreement with the Food and Drug Administration.

August 6, 2012

Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

Amneal said it would spend the money over a two-year period lasting through 2014 to "significantly" grow operations at research-and-development, manufacturing and distribution plants in New York, New Jersey and Kentucky. The company, which employs more than 1,100 people in the United States, said the expansion would create 500 more jobs.

August 2, 2012

Use of generic drugs has saved consumers and the healthcare system $1 trillion over the past decade, according to a new study released Thursday by a generic drug industry trade organization.

WASHINGTON — Use of generic drugs has saved consumers and the healthcare system $1 trillion over the past decade, according to a new study released Thursday by a generic drug industry trade organization.

The Generic Pharmaceutical Association said that between 2002 and 2011, generics saved the country $1 billion every other day, totaling $193 billion in 2011.

July 31, 2012

AmerisourceBergen on Tuesday announced that it has signed a three-year agreement to supply approximately $18.5 billion in pharmaceuticals to Express Scripts on an annual basis.

VALLEY FORGE, Pa. — AmerisourceBergen on Tuesday announced that it has signed a three-year agreement to supply approximately $18.5 billion in pharmaceuticals to Express Scripts on an annual basis. The agreement is effective Oct. 1.

“We are honored that Express Scripts has chosen AmerisourceBergen to supply the brand pharmaceuticals it needs for its recently combined mail-order and specialty pharmacy business,” said Steven Collis, AmerisourceBergen president and CEO.

July 31, 2012

Following regulatory approval by the Food and Drug Administration's Center for Biologics Evaluation and Research, GlaxoSmithKline confirmed it has begun shipping the first lots of its 2012-2013 seasonal influenza vaccines to healthcare providers and Centers for Disease Control and Prevention distribution centers.

PHILADELPHIA — Following regulatory approval by the Food and Drug Administration's Center for Biologics Evaluation and Research, GlaxoSmithKline confirmed it has begun shipping the first lots of its 2012-2013 seasonal influenza vaccines to healthcare providers and Centers for Disease Control and Prevention distribution centers.

June 22, 2012

Makucell — a regenerative biotechnology company that develops, manufactures and distributes anti-aging skin care — has unveiled its new Renewnt brand. The product line uses a proprietary ingredient known as Asymmtate, which the company said energizes the skin's stem cells, encouraging youthful cell behavior for firmer and smoother skin.

Makucell — a regenerative biotechnology company that develops, manufactures and distributes anti-aging skin care — has unveiled its new Renewnt brand. The product line uses a proprietary ingredient known as Asymmtate, which the company said energizes the skin's stem cells, encouraging youthful cell behavior for firmer and smoother skin.

June 21, 2012

The beer category wants its mojo back. After losing share to wine, spirits and small breweries for several years, major brewers are out to win consumers back to the category with new products that are a big departure from their classic offerings.

The beer category wants its mojo back. After losing share to wine, spirits and small breweries for several years, major brewers are out to win consumers back to the category with new products that are a big departure from their classic offerings.

The success of Bud Light Platinum, with its higher alcohol content and sweeter taste, has sparked a flurry of flavored malt beverages into the beer market. This year alone, Anheuser-Busch InBev is launching nearly 20 new products to the U.S. market.

June 13, 2012

Upsher-Smith Labs on Wednesday announced that it has agreed to acquire Proximagen Group, a European biotechnology company focused on the development and commercialization of novel therapeutics for diseases of the central nervous system and inflammation.

MAPLE GROVE, Minn. — Upsher-Smith Labs on Wednesday announced that it has agreed to acquire Proximagen Group, a European biotechnology company focused on the development and commercialization of novel therapeutics for diseases of the central nervous system and inflammation.

Upsher-Smith intends to retain operations in Cambridge and London, England, the company reported.

June 6, 2012

A generic drug maker in India and a German pharmaceutical company will collaborate to develop biosimilars.

HYDERABAD, India — A generic drug maker in India and a German pharmaceutical company will collaborate to develop biosimilars.

Dr. Reddy's Labs and Merck KGaA subsidiary Merck Serono announced a partnership to develop biosimilar cancer treatments, most of them monoclonal antibodies, for global markets. Based in Darmstadt, Germany, Merck KGaA operates in the United States under the name EMD to distinguish itself from U.S. drug maker Merck.

June 1, 2012

WebMD has tapped Pfizer's group president of animal health, consumer health care and corporate strategy to serve as its new chief executive.

NEW YORK — WebMD has tapped Pfizer's group president of animal health, consumer health care and corporate strategy to serve as its new chief executive.

Cavan Redmond was appointed CEO of WebMD, as well as a member of the company's board of directors on Thursday. He brings to his new role more than 20 years of healthcare experience, encompassing a broad range of global healthcare businesses, including biotechnology, pharmaceuticals, consumer health care and infant nutritionals.

May 15, 2012

Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

NEW YORK — Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

The Pittsburgh Post-Gazette reported that the bills, sponsored by Republican Rep. Tim Murphy of Pennsylvania, would create an expedited FDA approval pathway for follow-on versions of biogenetic medications such as vaccines and drugs made from human tissue and plasma.

May 11, 2012

Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

THOUSAND OAKS, Calif. — Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

May 10, 2012

Scientists at Children’s Hospital Oakland Research Institute’s Nutrition and Metabolism Center have developed a low-calorie, fruit-based high-fiber vitamin and mineral nutrition bar called the CHORI-bar that improves biological indicators — the bar increased HDL cholesterol and glutathione but lowered homocysteine — linked to the risk of cardiovascular disease, cognitive decline and associated decline in antioxidant defenses, the group reported Wednesday.

OAKLAND, Calif. — Scientists at Children’s Hospital Oakland Research Institute’s Nutrition and Metabolism Center have developed a low-calorie, fruit-based high-fiber vitamin and mineral nutrition bar called the CHORI-bar that improves biological indicators — the bar increased HDL cholesterol and glutathione but lowered homocysteine — linked to the risk of cardiovascular disease, cognitive decline and associated decline in antioxidant defenses, the group reported Wednesday.

May 9, 2012

The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

HOLZKIRCHEN, Germany — The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.