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Biologics in Medical News

ReGen Biologics Clarifies Recent Press about the Menaflex Device

HACKENSACK, N.J., Aug 5 /PRNewswire/ -- ReGen Biologics, a Hackensack, NJ based orthopedic products company seeks to clarify several statements regarding its Menaflex collagen meniscus implant that were made in a press release that was issued on Tuesday, August 4, by a party unaffiliated...

Intravenous Immune Biologics Will Suffer from the Pending Shift in Coverage from the Medical to the Pharmacy Benefit

NASHVILLE, Tenn. and GLEN ROCK, N.J., July 15 /PRNewswire/ -- HealthLeaders-InterStudy and Fingertip Formulary find that surveyed pharmacy directors of both national and single state plans say coverage of immune biologics will shift from a medical benefit to a pharmacy benefit by 20...

Hospira Launches Biologics 'Clock' and Web Resource to Raise Awareness of Potential Biogenerics' Impact

- Clock Shows $1,331 Per Second In Biologic Drug Sales - LAKE FOREST, Ill., May 5 /PRNewswire-FirstCall/ -- Hospira, Inc. (NYSE: HSP ), the world leader in generic injectable pharmaceuticals, today launched a clock tracking real-time U.S. prescription sales of costly biologic drugs as part ...

Althea Technologies Completes New State-of-the-Art, Commercial-Scale, Biologics and Injectables Manufacturing Facility

SAN DIEGO, May 1 /PRNewswire/ -- Althea Technologies, Inc., a leading provider of services for biopharmaceutical development and manufacturing, hosted a ribbon cutting ceremony today to mark the opening of its newly constructed state-of-the-art, commercial-scale cGMP manufacturing facility in San ...

Avoiding No Man's Land: New Deloitte Study on Follow-on Biologics Investigates Proposed Legislation and Possible Unintended Consequences

SAN FRANCISCO, April 14 /PRNewswire/ -- Deloitte today released a study, Avoiding no man's land: Potential unintended consequences of follow-on biologics, that explores the debate on creating a regulatory pathway for the approval of follow-on biologics (FOBs), drugs that are envisioned as the bi...

Insmed Completes Sale of Follow-On Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million

RICHMOND, Va., March 31 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM ), a biopharmaceutical company, announced today that it has successfully closed the sale of all of the Company's assets related to its follow-on biologics business to a subsidiary of Merck & Co., Inc. As a result of...

ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema

EXTON, Pa., Dec. 1 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM ) today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Cinryze(TM) C1 Inhibitor (human) as a treatment for acute attacks...

Decision Resources' White Paper Discusses Increasing Reality of Biosimilars and their Impact on Biologics Market

WALTHAM, Mass., Nov. 5 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, today announced that it is making available its white paper, From Biologics to Biosimilars - How Will the Market Evolve? Addressin...

RTI Biologics Sees Expanded Surgeon User Base of Fresh OC Allografts

RTI Biologics, Inc. (RTI) (Nasdaq:RTIX), the Florida-based processor of orthopedic, dental, hernia and other biologic implants, today announced the company is seeing expansion of its user base of RTI’s fresh-stored osteochondral (OC) allografts since its first implant in May. To date, more ...

Humira to Replace Remicade as First Choice Among Biologics for the Treatment of Crohn's Disease

Oral 5-Aminosalicylates Will Continue to be Used in Early Lines of Therapy, According to a New Report from Decision Resources WALTHAM, Mass., Oct. 27 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, f...
Biologics in Medical Technology

Human Genome Sciences Submits Biologics License Application to FDA for ABthrax(TM)

- First-in-class treatment for inhalation anthrax - ROCKVILLE, Md., May 21 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI ) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its human monoclona...

CMC ICOS Biologics and Implicit Bioscience Ltd Announce IC14 Antibody Manufacturing Agreement and Patent License

BOTHELL, Wash. and BRISBANE, Australia, May 8 /PRNewswire/ -- Implicit Bioscience Ltd and CMC ICOS Biologics today announced the execution of a manufacturing contract to support the next stage of development and commercialization of IC14, a clinical-stage monoclonal antibody for acute lung injury ...

Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review

EXTON, Pa., May 8 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (NYSE Amex: ILE ) today announced that the United States Food and Drug Administration ("FDA") has completed its initial review of the Company's Biologics License Application ("BLA") related to its Nasolabial Fold/Wrinkles product can...

Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration

EXTON, Pa., March 9 /PRNewswire-FirstCall/ -- Isolagen, Inc. (Amex: ILE ) today announced that the Company has submitted a Biologics License Application (BLA) for Isolagen Therapy(TM), a novel, first-in-class cellular therapy for the treatment of wrinkles/nasolabial folds, to the U.S. Food and ...

Bone Biologics Announces Significant Milestone for Spinal Fusion Surgery Using Recombinant Protein and Demineralized Bone Matrix

Primate trials validate efficacy of the process THOUSAND OAKS, Calif., Feb. 24 /PRNewswire/ -- Bone Biologics, Inc. announced today that it has successfully completed the initial primate trials validating the efficacy of the proprietary bone growth regeneration UCB-1 (NELL-1) protein in spina...

FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)

- PDUFA Date for Cinryze for Acute HAE Indication is June 3, 2009 - EXTON, Pa., Feb. 3 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM ) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Cinryze C1 Inhibitor (human) as a trea...

CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

September meeting to focus on use of Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma SEATTLE, July 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced toda...

Insmed Provides Update on Follow-On Biologics and IPLEX(TM) Programs

- Company on Schedule to Have Two Follow-on Biologics in Clinical Studies by Year-End - Enrollment On Track in MMD Clinical Study - ALS Expanded Access Program Continues to Enroll - Insmed Generates $2.3 million in Cost Recovery Revenue Through...

ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review

NEW YORK, Aug. 7 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY ) today announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the supplemental biologics license application (sBLA) for ORENCIA(R) (abatacept) for the treatment of pedi...

Insmed CEO to Present at Congressional Briefing on Follow-On Biologics

CEO Geoffrey Allan Will Stress the Importance to Patients of Passing a Follow- On Biologics Approval Pathway RICHMOND, Va., July 22 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq CM: INSM) a developer of follow-on biologics and biopharmaceuticals, today announced that Geoffrey ...
Biologics in Medical Products

Procleix HIV-1/HCV Assay

Description:...ed and manufactured by Gen-Probe and is marketed worldwide as the Procleix System by Chiron Corporation. In 2002, Gen-Probe received approval of its biologics License Application (BLA) for the first FDA-approved nucleic acid test for HIV-1 and HCV in donated human blood. In the U.S. alone, the American Red C...
Company:Gen-Probe
Biologics in Medical Definition

Medical writing

...ng is writing documents for regulatory agencies so that drugs, devices and biologics are approved, and stay approved for marketing to humans. Regulatory documen... Educational medical writing is writing documents about drugs, devices and biologics for general audiences,and specific audiences such as professional healthcar...
Biologics in Medical Dictionary

Rabies

... Hershey Medical Center provides world class care and services to patients. ... Rabies is caused by the rod- or bullet-shaped Rhabdoviridae. ... biologics for Human Rabies Prevention. Evaluation Guidance for Animal Bite Treatment. Rabies Treatment Algorithm. Specimen Submissions and Reports. Links to...
Biologics in Biological News

Scientists link immune system's natural killer cells to infant liver disease

...d Nutrition at Cincinnati Children's. "The next steps for translating these findings into clinical application would include pre-clinical trials of biologics to halt disease progression by blocking the Nkg2d receptor and depleting NK cells at the time biliary atresia is diagnosed," he added. Very little ...

Versartis presents positive preclinical data on 2 product candidates at ENDO 09

... Washington, DC June 10, 2009 Versartis, Inc., an emerging company developing novel biologics with enhanced properties for patients with metabolic diseases, today presented data for its long-acting product candidates, VRS-317 (hGH-rPEG) for tre...

NEWSLETTER: Antibody Fragment Production Breakthrough with 2nd Generation EBA

...enhagen, Denmark, May 12th, 2009 / b3c newswire / – Richter-Helm biologics GmbH & Co. KG announces today a technological breakthrough in the field...tion of antibody fragments from an E. coli expression system. Richter-Helm biologics has finalized the downstream process for Phase III clinical trial material...

Canadian biomedical engineering pioneer receives international award

...ing, at Ohio State University. Discoveries by Prof. Brash can be found in some of Canada's most successful biomedical companies including Interface biologics Inc. of Toronto and Angiotech Inc. in Vancouver. "The latter part of the 80s and early 90s ushered in the concept of designing biomaterials that we...

CEL-SCI Corporation to Launch Aseptic Filling for Stem Cell Produced Therapies and Other Biological Products

...Rituxan, Herceptin, Copaxon, etc.) are biologics. biologics are usually very sensitive to heat and quickly los...t find desirable. However, stem cell products and biologics do not generally lose activity when kept at 4 degr...rtance to companies that produce the latest drugs, biologics and stem cell therapies. It is an absolute requir...

La Jolla Institute signs exclusive license agreement with Medimmune on major asthma discovery

...licensed the discovery to explore its use in the development of a potential biologics drug for treating asthma. Under the agreement, MedImmune was granted ...cal development, as demonstrated by its successful track record of bringing biologics to market. ...

New orthopaedic society launched to promote research, use of biologic treatments

...nationally-renowned orthopaedic researchers. "Regenerative medicine and biologics are pushing orthopaedics into new and exciting directions," Dr. Mishra said...effort of several eminent scientists who recognize the immense potential of biologics to improve orthopaedic care," added Dr. Randelli. "We want to share what w...

Gene therapy demonstrates benefit in patients with rheumatoid arthritis

...llen and inflamed. If the disease is inadequately controlled, the tissues of the joint are eventually destroyed. Although anti-inflammatory agents and biologics can help to mitigate symptoms, there is no cure for the condition, estimated to affect more than 2 million individuals in the U.S. alone. Evans has...

Life Sciences Discovery Fund awards health research program grants

... of Social and Health Services Patrick Stayton, University of Washington, $7,163,794 Program title: Center for Intracellular Delivery of biologics Program focus: To better deliver drugs to their site of action within cells With mainstream delivery methods a drug often gets 'lost' and does...

Musculoskeletal center wins $2.2 million for drug safety

...e award will allow the UAB CERTs to pinpoint which biologics have potential safety concerns. Additionally, researchers will examine which biologics work best for specific groups of patients, includi... children, minorities and the disabled. All of the biologics being studied are U.S. Food and Drug Administratio...
Biologics in Biological Technology

Mylan Announces Strategic Collaboration with Biocon to Enter the Global Generic Biologics Market

PITTSBURGH, June 29 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that it has executed a definitive agreement with Biocon Limited, a publicly traded company on the Indian stock exchanges, for an exclusive collaboration on the development, manufacturing, supply and commercia...

ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema

- Company Also Granted Expansion of Prophylaxis Therapy Label to Include Patient Labeling for Self-Administration - EXTON, Pa., June 4 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM ) today announced that it has received a Complete Response letter from the U.S. Food and Dr...

BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for XIAFLEX(TM) for the Treatment of Dupuytren's Disease

LYNBROOK, N.Y., April 28 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC ), a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (B...

Bone Biologics Announces UCB-1 (NELL-1) Bone Growth Protein Production Process With Aragen Biosciences

Produces 98% pure protein THOUSAND OAKS, Calif., Feb. 24 /PRNewswire/ -- Bone Biologics, Inc. announced today that it's contract research and development organization, Aragen Bioscience, has completed development of a recombinant cell line and initial production process for UCB-1 (NELL-1) rec...

FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab

THOUSAND OAKS, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN ) today announced that the U.S. Food and Drug Administration (FDA) has accepted Amgen's submission and filed a Biologics License Application (BLA) for denosumab, an investigational RANK Ligand inhibitor. Th...

Insmed Sells Follow-on Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million

RICHMOND, Va., Feb. 12 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM ), a developer of follow-on biologics and biopharmaceuticals focused on niche markets with unmet medical needs, announced today that it has entered into a definitive agreement with Merck & Co., Inc. whereby Merck,...

Interface Biologics secures $5mm financing and appoints Thomas P. Reeves President and Chief Executive Officer

TORONTO, Dec. 9 /PRNewswire/ - Interface Biologics Inc. - a privately held developer of novel biomedical-polymers for use in implantable medical devices - is announcing that it has secured a $5mm financing round. Participating in the round were existing investors Covington Capital, VG Partners and...

DSM Biologics and Crucell Announce Commercial PER.C6(R) Licensing Agreement with Gedeon Richter

PARSIPPANY, N.J. and LEIDEN, Netherlands, Nov. 25 /PRNewswire/ -- DSM Biologics, a business unit of DSM Pharmaceutical Products, and Dutch biotechnology company Crucell N.V. (Euronext, Nasdaq: CRXL ; Swiss Exchange: CRX), today announced that Hungary-based Gedeon Richter Plc. signed a commercial...

Savient Submits Biologics License Application (BLA) for pegloticase

EAST BRUNSWICK, N.J., Oct. 31 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT ) today announced the submission of its BLA to the U.S. Food and Drug Administration (FDA) seeking approval to market pegloticase in the United States along with its request for a priority revi...

Therapure Biopharma Inc. announces collaboration with Induce Biologics Inc.

Ontario biotech companies work together on innovative bone protein technology TORONTO, Oct. 28 /PRNewswire/ - Thomas Wellner, President and CEO of Therapure BioPharma Inc. and Dr. Cameron Clokie, President and CEO of Induce Biologics Inc. today announced a development partnership utilizing an...
Biologics in Biological Dictionary

Biologics

Biologics include a wide range of medicinal products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins created by biological processes . Vaccines, Blood & Biologics . 2009 CBER Foreign Regulators S...
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