Content about Biotechnology

April 16, 2014

Polaner All Fruit, a brand from B&G Foods, announced that it is now Non-GMO Project Verified.

PARSIPPANY, N.J. — Polaner All Fruit, a brand from B&G Foods, announced that it is now Non-GMO Project Verified. To recognize its new verification, the company is reviving the "Don't Dare Call it Jelly!" campaign, complete with an interactive digital initiative which encourages consumers to vote for their favorite commercial.

April 14, 2014

The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

WASHINGTON — The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

The Delaware State Senate passed Senate Substitute 1 for Senate Bill 118. 

March 10, 2014

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines.

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines. By the end of this decade, a significant number of blockbuster drugs will go off patent, paving the way for biosimlar market entrance.

March 10, 2014

Lifeway Foods, a supplier of cultured dairy products known as kefir, announced the introduction of Veggie Kefir, a new veggie-kefir smoothie in tomato, cucumber and beet varieties.

MORTON GROVE, Ill. — Lifeway Foods, a supplier of cultured dairy products known as kefir, announced the introduction of Veggie Kefir, a new veggie-kefir smoothie in tomato, cucumber and beet varieties. The smoothies pack a full serving of vegetables, along with 12 probiotic cultures, into every 8-oz. bottle.

February 18, 2014

Novartis on Monday announced that it is broadening its cancer immunotherapy research program with the acquisition of CoStim Pharmaceuticals, a Cambridge, Mass.-based, privately held biotechnology company focused on harnessing the immune system to eliminate immune-blocking signals from cancer.

BASEL, Switzerland — Novartis on Monday announced that it is broadening its cancer immunotherapy research program with the acquisition of CoStim Pharmaceuticals, a Cambridge, Mass.-based, privately held biotechnology company focused on harnessing the immune system to eliminate immune-blocking signals from cancer.

February 11, 2014

The Generic Pharmaceutical Association announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1, because it will allow unimpeded patient access to interchangeable biologics.

WASHINGTON — The Generic Pharmaceutical Association on Tuesday announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1,  because it will allow unimpeded patient access to interchangeable biologics. The bill mirrors current pharmacy practice for interchangeable generic substitution language, and is aligned with Food and Drug Administration definitions, the association noted.

January 31, 2014

The imminent entry of several companies — including big pharma, small biotech and generic participants — into the global biosimilars space will propel the market toward exponential growth. The market is expected to soar from $1.2 billion in 2013 to $24 billion in 2019, reported Frost & Sullivan in research released earlier this week.

LONDON — The imminent entry of several companies — including big pharma, small biotech and generic participants — into the global biosimilars space will propel the market toward exponential growth. The market is expected to soar from $1.2 billion in 2013 to $24 billion in 2019, reported Frost & Sullivan in research released earlier this week. 

January 31, 2014

The Biotechnology Industry Organization and the Indiana Health Industry Forum commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

WASHINGTON — The Biotechnology Industry Organization and the Indiana Health Industry Forum on Thursday commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

The policies outlined in the identical SB 262 align with BIO’s principles on biologic substitution, therefore BIO and IHIF support passage of this bill as it moves along for consideration by the Indiana House of Representatives.

January 16, 2014

The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

WASHINGTON — The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

November 18, 2013

The global market for biosimilars is expected to be worth nearly $2 billion before the end of the decade, according to a new study.

DALLAS — The global market for biosimilars is expected to be worth nearly $2 billion before the end of the decade, according to a new study.

MarketsandMarkets, a Dallas-based research company, looked at the global market for biosimilars - knock-off versions of biotech drugs - including monoclonal antibodies, erythropoietins, recombinant proteins and peptides, forecasting $1.954 billion in market value by 2018.

November 5, 2013

A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

LAKE FOREST, Ill. — A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

October 29, 2013

In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

October 25, 2013

Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.

NEW YORK — Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.

October 25, 2013

Pure Encapsulations on Thursday introduced PureHeart Probiotic, the newest addition to the PureHeart Protocol: Screening + Supplements = Success line of nutritional supplements.

SUDBURY, Mass. — Pure Encapsulations on Thursday introduced PureHeart Probiotic, the newest addition to the PureHeart Protocol: Screening + Supplements = Success line of nutritional supplements. 

“With the proprietary probiotic strain Lactobacillus reuteri NCIMB 30242, PureHeart Probiotic offers evidence-based support from a new angle in clinical cardiology,” stated Kelly Heim, nutritional pharmacologist at Pure Encapsulations. “This exclusive formulation addresses basic aspects of lipid metabolism and vascular function.” 

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

October 18, 2013

The Food and Drug Administration has approved a drug made by UCB for treating a form of arthritis.

ATLANTA — The Food and Drug Administration has approved a drug made by UCB for treating a form of arthritis.

The drug maker said Friday that the FDA had approved Cimzia (certolizumab pegol) for adults with active ankylosing spondylitis, though it declined to approve the drug for axial spondyloarthritis, or axSpA. UCB said it was working with the agency to determine how to get the drug approved for axSpA.

October 17, 2013

As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

NEW YORK — The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

October 10, 2013

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

Last month, the company — which specializes in making generic injectable drugs — announced that European Union regulators had approved the continent’s first biosimilar monoclonal antibody.

October 7, 2013

A trade group of generic drug makers is hoping that California's governor vetoes a bill that it says would restrict patients' access to biosimilars.

NEW YORK — A trade group of generic drug makers is hoping that California's governor vetoes a bill that it says would restrict patients' access to biosimilars.

September 30, 2013

The Food and Drug Administration has approved a new usage for a drug made by UCB, the drug maker said Monday.

BRUSSELS — The Food and Drug Administration has approved a new usage for a drug made by UCB, the drug maker said Monday.

UCB announced the approval of Cimzia (certolizumab pegol) for psoriatic arthritis in adults. Psoriatic arthritis is an inflammatory, autoimmune condition that causes pain, swelling and stiffness around the joints, usually combined with the skin lesions of psoriasis. The drug was already approved to treat rheumatoid arthritis and Crohn's disease.

September 10, 2013

The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

September 10, 2013

European regulators have approved the European Union's first biosimilar monoclonal antibody. The new product, made by U.S.-based Hospira, comes seven years after the approval of Europe's first biosimilar.

LEAMINGTON SPA, United Kingdom — European regulators have approved the European Union's first biosimilar monoclonal antibody. The new product, made by U.S.-based Hospira, comes seven years after the approval of Europe's first biosimilar.

Hospira announced Tuesday the European Medicines Agency's approval of Inflectra (infliximab) for the treatment of autoimmune disorders like rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis.

August 29, 2013

The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

NEW YORK — The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

Biopharma-Reporter.com quoted an FDA spokeswoman as saying "efforts to undermine trust in these products" were cause for worry and did not serve the interests of patients.

August 27, 2013

AstraZeneca has bought Maryland-based biotech company Amplimmune, the drug maker said.

LONDON — AstraZeneca has bought Maryland-based biotech company Amplimmune, the drug maker said.

AstraZeneca announced the acquisition of privately owned Amplimmune through its MedImmune biologics research and development subsidiary, saying it would boost its cancer drug pipeline. Amplimmune's pipeline includes several experimental treatments, such as AMP-514, a monoclonal antibody currently in preclinical development for which the company hopes to apply to start clinical trials before the end of the year.