Medical Tidbits,Medline Industries, Inc. Issues a Voluntary Nationwide Recall of One Lot of Acetaminophen Tablets, 500mg, Due to Mislabeling with Incorrect Strength

New drug study approved by FDA

MUNDELEIN, Ill.–(EON: Enhanced Online News)–Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets. This error is not easily identifiable by the user or prescriber. If the product is taken at the maximum labeled dose, every four hours, five doses a day, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure. To date, Medline Industries, Inc. has not received any reports of adverse events associated with this product. read more

Hemophilia Therapy from Largest Multi-Year Donation Now Available to Patients in Developing World

DAKAR, Senegal–(BUSINESS WIRE)–The first shipments of much-needed hemophilia therapy have started to arrive at treatment centers across the developing world Biogen (NASDAQ: BIIB), Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) and the World Federation of Hemophilia (WFH) announced today. These shipments are part of the largest humanitarian aid pledge of its kind to help people with hemophilia in developing countries. read more

Lilly and Innovent Biologics Expand Their Strategic Alliance to Include Immuno-Oncology Bispecific Antibodies in China and Globally

Lilly exercises its rights to potential cancer treatments outside China, while Innovent will now have rights to those potential treatments inside China

INDIANAPOLIS and SHANGHAI, Oct. 11, 2015 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Innovent Biologics, Inc. (Innovent) today announced an expansion of their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company. read more

New Data Show Greater Bone Mineral Density Gains With Prolia® (Denosumab) Compared With Zoledronic Acid

THOUSAND OAKS, Calif., Oct. 11, 2015 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced findings from a randomized, double-blind, double-dummy, multicenter Phase 4 study showing that Prolia® (denosumab) achieved greater gains in bone mineral density (BMD) than the intravenous bisphosphonate zoledronic acid in postmenopausal women with osteoporosis following previous treatment with oral bisphosphonates. The findings were presented today at the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting in Seattle. read more


Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received marketing approval of its novel in-house developed anticancer agent Lenvima® (lenvatinib mesylate) as a treatment for patients with progressive, locally recurrent or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI) from the regulatory authority in South Korea (Ministry of Food and Drug Safety). The marketing authorization application for Lenvima in South Korea was submitted in November 2014, and through the approval of this application, South Korea is the first country in Asia where Lenvima has been approved following Japan, the United States and Europe. read more

One Year Data from Phase III Study Evaluating Oral OTEZLA® (apremilast) or Injectable etanercept versus Placebo in Patients with Moderate to Severe Plaque Psoriasis Presented at EADV

BOUDRY, Switzerland–(EON: Enhanced Online News)–Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that results from its ongoing phase III LIBERATEtrial evaluating Otezla® (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with moderate to severe plaque psoriasis were presented as a late-breaker at the 24th European Academy of Dermatology and Venereology (EADV) Congress in Copenhagen, Denmark, October 7-11, 2015. read more

Pfizer’s Phase 2 Study Demonstrates Safety, Tolerability and Immunogenicity of TRUMENBA® When Coadministered with Meningococcal A, C, Y and W-135 Polysaccharide Conjugate (MCV4) and Tetanus, Diphtheria and Pertussis (Tdap) Vaccines in Adolescent

Pfizer Inc. (NYSE:PFE) announced today that researchers presented for the first time data from a randomized, controlled Phase 2 study of its meningococcal serogroup B vaccine, TRUMENBA®, coadministered with routine meningococcal (groups A, C, Y and W) (MCV4) and tetanus, diphtheria and pertussis (Tdap) vaccines in adolescents. The data, which were released today in an oral presentation at IDWeek 2015TM in San Diego, are based on a study conducted in more than 2,600 healthy individuals 10 through 12 years of age that evaluated the safety, tolerability and immunogenicity of TRUMENBA when coadministered with MCV4 and Tdap. Data demonstrated that immune responses following TRUMENBA, MCV4 and Tdap vaccines given concomitantly were noninferior to immune responses to MCV4 and Tdap alone or TRUMENBA alone. read more

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