Biologics Drug / Agent News and Research

RSS

Arthritis, rheumatism and total joint arthroplasty: an interview with Dr Ravi and Dr Hawker

Arthritis translates to “joint inflammation.” The most common form of arthritis is osteoarthritis (OA), which affects 12-15% of North Americans over the age of 60, and will increase in prevalence as our population ages.

19 Dec 2012

Preeclampsia risk higher for women with Lupus

New research reports that women with systemic lupus erythematosus (SLE) have a two-fold increase in risk of preeclampsia—a dangerous condition in which pregnant women develop high blood pressure (hypertension) and protein in their urine (proteinuria) after 20 weeks of gestation

30 Oct 2012

K2M to exhibit comprehensive product portfolio at the North American Spine Society (NASS) Annual Meeting

K2M, Inc., the largest privately held spinal device company in the world focused on developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced that with the recent addition of multiple breakthrough technologies, K2M offers a market leading comprehensive product portfolio to be exhibited at the North American Spine Society (NASS) Annual Meeting.

23 Oct 2012

Contract Manufacturing Offering introduced to the biopharmaceutical market by Olympus Biotech

Olympus Biotech, an Olympus Corporation company, today announced its new Contract Manufacturing Offering (CMO) at its state-of-the-art facility in Lebanon, New Hampshire.

From Evident Corporation - Life Sciences 5 Oct 2012

Treating complex spinal pathologies: an interview with Eric Major

In the approximate $8 billion global spine market, the most specialized and demanding $1 billion complex spine segment includes deformity, trauma, and tumor pathologies.

20 Jul 2012

K2M expands biologics portfolio

K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced a major expansion of the company’s U.S. biologics offering with the launch of its VESUVIUS™ Osteobiologic Systems and new additions to its VIKOS® Allograft Systems. K2M is working with LifeNet Health®, a leading allograft bio-implant and regenerative medicine company, to bring to market quality implants to enhance bone regeneration and osteoconductivity.

10 Jul 2012

English Rheumatoid Arthritis care standards out of step with Europe

A 12-country comparative analysis of rheumatoid arthritis (RA) treatment guidelines reveals that there is considerable variation in patient access to care, with England out of step with standards adopted by its European counterparts.

6 Jun 2012

Hitting the target: IntelliCap provides reliable and accurate regional drug delivery

Medimetrics, recently certified to ISO 13485, has successfully developed the IntelliCap system, specifically designed to target delivery of small molecule drugs and biologics to the gastrointestinal (GI) tract. The technology is capable of achieving controlled release of drugs to specific GI sites in a fast, cost-effective and convenient manner (Shimizu et al., 2008).

16 May 2012

Pfizer seeks FDA support for its new anti-rheumatoid arthritis pill

Pfizer is waiting for the Food and Drug Administration to approve its new pill for rheumatoid arthritis (RA) - the first oral biologic for treating this ailment.

8 May 2012

FDA lays guidelines for “biosimilar” biotech drugs

The proposed rules, issued on Thursday, require studies showing that the generic copies are “highly similar” to the originals, but there are several ways that might be proven. Because of their complexity, generic copies of biotech drugs - first introduced in the 1980s - are known as “biosimilars.” The worldwide market for copies of biotech medicines will grow to $3.7 billion by 2015, from just $243 million in 2010, as more than 30 branded biologics with sales of $51 billion lose patent exclusivity, according to market analysis firm Datamonitor.

12 Feb 2012

Malaria vaccine shows early success

An experimental vaccine for malaria has been developed by British scientists. It has shown early potential to neutralize many, perhaps all, strains of the deadliest malaria parasite.

21 Dec 2011

Amgen and Watson to collaborate on biosimilar anti-cancer drugs

Amgen, the largest standalone biotechnology company, and generic drug firm Watson Pharmaceuticals will collaborate on developing biosimilar drugs for cancer.

20 Dec 2011

AusBiotech supports ‘Raising the Bar’

AusBiotech welcomes a legislative Bill that has been introduced into the Australian Parliament today - The Intellectual Property Laws Amendment (Raising the Bar) Bill 2011.

21 Jun 2011

CSL Biotherapies statement on FDA warning letter

Today the US Food and Drug Administration (FDA) published a Warning Letter issued by its Office of Compliance and Biologics Quality to CSL Biotherapies, a division of CSL Limited. The FDA regulates the manufacture, marketing and distribution of CSL Biotherapies’ influenza vaccine, Afluria®, in the US market.

21 Jun 2011

Key U.S. patents increase commercial rights and clinical indications

Australian regenerative medicine company, Mesoblast Limited (ASX:MSB; OTC ADR: MBLTY), today announced that the company’s product development strategy has been significantly strengthened by novel composition of matter claims granted by the United States Patent and Trade Mark Office (USPTO) in two distinct patent families to which Mesoblast has exclusive worldwide commercial rights.

23 May 2011

Anti-cancer drug discovery partnership formed between UMMC Cancer Institute and Natural Products Center

A new partnership to search for cancer-fighting drugs combines compound-identification and screening expertise at the University of Mississippi’s National Center for Natural Products Research with the drug development and clinical-trials capabilities at the University of Mississippi Medical Center Cancer Institute.

18 May 2011

Milk allergy successfully treated with Xolair

A latest study suggests that children with severe milk allergies may be able to rapidly overcome their sensitivities with the help of a biologic drug that helps to quiet an overly aggressive immune response. This is a small study still waiting to be proved in larger populations say researchers.

22 Mar 2011

Boost for biologics manufacturing in Australia

AusBiotech has welcomed the news that Australia’s first major contract manufacturing facility for biologic medicines has secured backing and is set to be built in Queensland by 2012.

3 May 2010

FDA approves Hiberix Haemophilus influenzae type b vaccine

In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae type b (Hib), GlaxoSmithKline (NYSE: GSK) has received accelerated approval from the FDA (Food and Drug Administration) for Hiberix((R)) [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] as a booster dose in children 15 months through four years of age. Hib is an often severe and potentially deadly bacterial infection that can cause meningitis.

19 Aug 2009

Costly biologics drugs prompt exclusivity debate

"A bitter Congressional fight over the cost of superexpensive biotechnology drugs has come down to a single, hotly debated number: How many years should makers of those drugs be exempt from generic competition?" The New York Times reports.

22 Jul 2009