Content about Biotechnology

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

April 7, 2011

Marukome has introduced an easy-to-use miso product.

NEW YORK — Marukome has introduced an easy-to-use miso product.

New Miso & Easy is an all-natural liquid that comes in an unbreakable squeeze bottle and is available in original and ginger-tomato flavors. Miso is a seasoning made with soybeans and rice or barley and is cultured or fermented for a period of time.

Formerly only available in Asian markets, Marukome Miso & Easy now is available at such retailers as Ralph’s, Safeway and Fairway.

April 6, 2011

Generex Biotechnology has revamped its corporate website to underscore the company's focus on the development and approval of its diabetes and immunotherapeutic vaccine products pipeline.

WORCESTER, Mass. — Generex Biotechnology has revamped its corporate website to underscore the company's focus on the development and approval of its diabetes and immunotherapeutic vaccine products pipeline.

The company said that the site will provide improved descriptions of products, technologies, scientific research in progress, trial results and new corporate relationships as they unfold. Generex also will boost its social media presence through Twitter and Facebook.

March 29, 2011

Any manufacturer that has the necessary resources and still is hesitating about whether to tap into biosimilars might want to go ahead and do it, if projections by British market analysis firm Datamonitor come true.

LONDON — Any manufacturer that has the necessary resources and still is hesitating about whether to tap into biosimilars might want to go ahead and do it, if projections by British market analysis firm Datamonitor come true.

The firm released a report Monday showing that the global biosimilars market, whose value stood at $243 million in 2010, will increase to $3.7 billion by 2015.

March 11, 2011

While failing to improve overall survival, an investigational treatment for non-small cell lung cancer made by Sanofi-Aventis and Regeneron Pharmaceuticals did keep the disease from worsening and, overall, caused patients to respond to treatment, according to results of a late-stage clinical trial.

TARRYTOWN, N.Y. — While failing to improve overall survival, an investigational treatment for non-small cell lung cancer made by Sanofi-Aventis and Regeneron Pharmaceuticals did keep the disease from worsening and, overall, caused patients to respond to treatment, according to results of a late-stage clinical trial.

Sanofi and Regeneron announced Thursday results of the phase-3 “VITAL” trial of aflibercept. Patients were administered either the drug or placebo in addition to docetaxel chemotherapy.

February 18, 2011

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


February 17, 2011

The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.

February 15, 2011

Watson's global generics business drove the drug maker's net revenue in the fourth quarter, according to a financial earnings release.

MORRISTOWN, N.J. — Watson's global generics business drove the drug maker's net revenue in the fourth quarter, according to a financial earnings release.

February 14, 2011

An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

PHILADELPHIA — An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

According to the report, “Gaining Market Share in the Generic Drug Industry Through Acquisitions and Partnerships,” generic drug makers face competition, as well as government-mandated price cuts in Europe and such policies as lowest-price tendering. As a result, many could seek deals that would cause them to diversify their portfolios.

February 9, 2011

Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

NEW YORK — Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

Reuters, citing an interview with Sandoz head Jeff George in the German newspaper Handelsblatt, said the generics arm of Swiss drug maker Novartis had eight to 10 new biosimilar molecules in development.

February 1, 2011

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.


February 1, 2011

Optivia Biotechnology on Tuesday announced that the company and the Food and Drug Administration have signed a collaboration agreement to assess the effect of dietary supplements on key drug transporters.

MENLO PARK, Calif. — Optivia Biotechnology on Tuesday announced that the company and the Food and Drug Administration have signed a collaboration agreement to assess the effect of dietary supplements on key drug transporters.

Drug transporters are proteins on the surface of cells that either facilitate or hinder the transport of nutrients or pharmaceuticals. Drug transporters can increase or decrease the absorption of drugs into the body, as well as limit or facilitate the exposure of certain organs.

February 1, 2011

SUPPLIER NEWS — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related breakthrough pain, Watson said. The drug is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November 2010, according to IMS Health.


February 1, 2011

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

January 21, 2011

Lifeway Foods is kicking off its 25th anniversary with a new birthday-cake flavor of its creamy, smoothie-like beverage.

MORTON GROVE, Ill. — Lifeway Foods is kicking off its 25th anniversary with a new birthday-cake flavor of its creamy, smoothie-like beverage.

Lifeway's Kefir birthday-cake-flavored smoothie, which features probiotics, will be adorned with special 25th anniversary packaging and celebrated with a nationwide promotional tour.

Lifeway's Kefir line is available at more than 5,000 retailers nationwide.

January 18, 2011

Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.

January 12, 2011

Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

WHITEHOUSE STATION, N.J. — Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

Under the agreement, Parexel will give Merck BioVentures access to clinical and regulatory services for the development of biosimilars. Financial terms of the agreement were not disclosed.

January 7, 2011

Pfizer has paid Seattle Genetics $8 million to license its antibody technology, Seattle Genetics said Thursday.

BOTHELL, Wash. — Pfizer has paid Seattle Genetics $8 million to license its antibody technology, Seattle Genetics said Thursday.

Seattle Genetics, based in Bothell, Wash., said Pfizer would pursue antibodies for treating an unspecified form of cancer using its antibody-drug conjugate technology. ADCs are monoclonal antibodies that selectively deliver anti-cancer agents to tumor cells. Seattle Genetics has developed anti-tumor drugs called auristatins, which are attached to antibodies and then used to kill the cancer cells while sparing noncancer cells.

January 7, 2011

State health authorities in Colorado are promoting immunization to parents through a broad media campaign.

DENVER — State health authorities in Colorado are promoting immunization to parents through a broad media campaign.

The Colorado Department of Public Health and the Vaccine Advisory Committee of Colorado, a coalition of vaccination research and policy leaders, announced Thursday the “Immunize for Good” program, which they described as a way to communicate to parents vaccinating their children that they’re making the right decision and preventing serious illnesses.

January 4, 2011

Pfizer will pay Danish biotech company Santaris Pharma $14 million for access to its development platform for RNA-based therapies, Pfizer said Tuesday.

SAN DIEGO — Pfizer will pay Danish biotech company Santaris Pharma $14 million for access to its development platform for RNA-based therapies, Pfizer said Tuesday.

The drug maker said the deal would expand on an existing one between Hoersholm, Denmark-based Santaris and Wyeth, which Pfizer acquired in 2009. Santaris could take in up to $600 million in milestone payments, as well as royalties on products developed under the collaboration.

January 3, 2011

This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.

December 20, 2010

Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

December 17, 2010

Frank Baldino, the founder, chairman and CEO of Cephalon, has died, the company said.

FRAZER, Pa. — Frank Baldino, the founder, chairman and CEO of Cephalon, has died, the company said.

Cephalon announced that Baldino, 57, had died Thursday evening while on medical leave, calling him a pioneer in the biotechnology industry and an inspirational leader who would be “sorely missed.” Baldino, who received his doctorate in pharmacology from Temple University, founded the company in 1987 after several years at E.I. duPont de Nemours & Co.

December 7, 2010

Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.

CAMBRIDGE, Mass. — Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.

November 14, 2010

William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and...

WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”

He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.