Medical Tidbits,The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation

pharmaceuticals
The U.S. Food and Drug Administration today announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop and has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs). read more

Baxalta Announces Priority Review Status Granted by Health Canada for irinotecan liposome injection (nal-IRI) for New Drug Submission

ANNOCKBURN, Ill.–(BUSINESS WIRE)–Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that Health Canada has granted Priority Review status for its New Drug Submission (NDS) for irinotecan liposome injection, also known as “nal-IRI”. Baxalta is seeking marketing approval of nal-IRI from Health Canada for the treatment of patients with metastatic adenocarcinoma of the pancreas previously treated with gemcitabine-based therapy. read more

BioInvent announces FDA acceptance of the Investigational New Drug application for the phase I/IIa study with TB-403

BioInvent International (OMXS: BINV) today announces that the FDA has completed the safety review of its Investigational New Drug (IND) application and have concluded that the proposed pediatric clinical investigation can proceed. The IND application is for a Phase I/IIa study that will evaluate the efficacy and safety of TB-403 for the treatment of relapsed or refractory medulloblastoma. This is a rare, life-threatening brain tumor that mainly affects children. read more

MiMedx Receives Certificate From FDA Allowing The Export Of MiMedx Allografts PRODUCTS CERTIFIED TO BE MARKETED IN, AND LEGALLY EXPORTED FROM, THE U.S.

MARIETTA, Ga., Jan. 6, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced that it has recently posted an updated “Certificate to Foreign Government” on its website that describes all of the MiMedx  sheet form allografts and the Food and Drug Administration FDA’scertification that the listed products are HCT/P’s.

Charles River Laboratories to Acquire WIL Research

WILMINGTON, Mass.–(BUSINESS WIRE)–Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has entered into a definitive agreement to acquire WIL Research for approximately $585 million in cash, subject to customary closing adjustments.

WIL Research is a premier provider of safety assessment and contract development and manufacturing (CDMO) services to biopharmaceutical and agricultural and industrial chemical companies worldwide. Acquiring WIL Research will enhance Charles River’s position as a leading global early-stage contract research organization (CRO) by strengthening its ability to partner with global clients across the drug discovery and development continuum.

Novo Nordisk files for regulatory approval of long-acting factor IX in the EU for the treatment of haemophilia B

Novo Nordisk today announced the submission to the European Medicines Agency of the Marketing Authorisation Application for the approval of long-acting factor IX, nonacog beta pegol. Nonacog beta pegol is a glycopegylated recombinant factor IX with a significantly improved pharmacokinetic (PK) profile, developed for patients with haemophilia B. Novo Nordisk expects to file the Biologics License Application (BLA) for nonacog beta

Novo Nordisk expects to file the Biologics License Application (BLA) for nonacog beta pegol to the US Food and Drug Administration during first half of 2016.

The filing of nonacog beta pegol is based on the results from the paradigm clinical trial programme, which involved 115 patients with severe or moderately severe haemophilia B. Nonacog beta pegol was found to be efficacious in routine prophylaxis, treatment of bleeding episodes and surgery for adults, adolescents and children. Furthermore, nonacog beta pegol appeared to be well-tolerated and no safety concerns were identified. 

Compared to standard factor IX products, nonacog beta pegol has a five times longer half-life. Patients in the paradigm study achieved a higher level of factor IX in the blood despite less frequent dosing of nonacog beta pegol. In the phase 3 trials, once-weekly administration of 40 IU/kg nonacog beta pegol maintained factor IX activity levels above 15%, reduced the median annualised bleeding rate (ABR) to 1.0 and showed a potential to prevent bleeds in target joints. Furthermore, these patients reported an improvement in quality of life during the trial. 

Hospira Issues a Voluntary Nationwide Recall of One Lot of Magnesium Sulfate in Water for Injection Due to Incorrect Barcode Labeling on the Primary Container

Hospira, Inc., a Pfizer company, has announced a voluntary recall of one lot of, MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016) to the user level due to a confirmed customer report of an incorrect barcode on the primary bag labeling.  read more

Evotec and UCB Sign Multi-Year Sample Management Agreement

HAMBURG, Germany–(BUSINESS WIRE)–Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) today announced an EVT Execute collaboration aimed at providing a complete solution to UCB’s global sample management requirements. read more

Dräger Evita V500 and Babylog VN500 Ventilators.

A recall has been posted regarding Dräger Evita V500 and Babylog VN500 Ventilators.  Dräger is recalling the PS500 battery power supply because a software issue causes shorter than expected battery run times.  The software issue with the power supply also prevents the appropriate alarm from sounding 5 minutes before the battery runs out of power and the device shuts down.  If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.

Calman Prussin, M.D., Joins Knopp Biosciences to Lead Clinical Development of Dexpramipexole in Eosinophilic Asthma

PITTSBURGH–(BUSINESS WIRE)–Knopp Biosciences LLC announced today that Calman Prussin, M.D., formerly a senior investigator in eosinophil-associated inflammatory diseases at the National Institutes of Health and the outgoing chair of the American Board of Allergy and Immunology, has joined Knopp to head clinical and translational medicine in immunology. read more

MERCK AND BIOCARTIS TO COLLABORATE ON NEW LIQUID BIOPSY TECHNOLOGY FOR RAS BIOMARKER TESTING

Merck, a leading science and technology company, today announced that it has signed a collaboration agreement with Biocartis for the development and commercialization of a new liquid biopsy RAS biomarker test for patients with metastatic colorectal cancer (mCRC). The test will be developed on Biocartis’ innovative, fully automated molecular diagnostics system, Idylla™, which is designed to offer accurate and reliable molecular information from virtually any biological sample in virtually any setting. read more

 

 

 

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