Tetanus-diphtheria-acellular pertussis (Tdap) vaccine is recommended for all pregnant women in the U.S. as the key medical intervention to protect newborn infants from pertussis (whooping cough). However, the safety of giving the Tdap vaccine to pregnant women has not been fully determined. According to a study published in Human Vaccines & Immunotherapeutics , the Tdap vaccine is safe for both mothers and infants. read more
The launch of JLABS @ Toronto on May 11 marks Johnson & Johnson Innovation’s first JLABS site outside of the United States. Located within Toronto’s bustling MaRS Discovery District, one of the world’s largest urban innovation hubs, JLABS @ Toronto will serve as an incubator for emerging entrepreneurs across a range of healthcare specialties.
The 40,000-square-foot facility will support start-ups with cutting-edge modular and scalable lab space, state-of-the-art equipment, programs and access to potential investment partners as they work to build successful early-stage companies. It also features the JLABS device and digital prototype lab, providing entrepreneurs with access to highly specialized tools and skills-building programs to design and develop smart health technologies.
JLABS @ Toronto joins a network of life science facilities in San Diego, San Francisco, Boston and Houston that are home to more than 100 early-stage companies advancing bio/pharmaceutical, medical device, consumer and digital health programs.
SELUMETINIB GRANTED ORPHAN DRUG DESIGNATION IN US
SELUMETINIB granted Orphan Drug Designation in the US for ADJUVANT treatment of Differentiated thyroid cancer AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). read more
Takeda Appoints New Chief Financial Officer, James Kehoe
OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (“Takeda”) (TOKYO:4502) today announced the appointment of James Kehoe as Takeda’s new Chief Financial Officer and Corporate Officer, effective on June 15, 2016. Mr. Kehoe will be based in Tokyo and reports directly to Christophe Weber, President & CEO of Takeda.
PixarBio Corporation Continues Infrastructure Expansion for Commercialization
CAMBRIDGE, Mass.–(EON: Enhanced Online News)–PixarBio Corporation today announced that it is adding 5,000 Sq. feet of office space in Fort Lee, NJ. The space will support 10 current staff and up to 40 future staff and will it be home for PixarBio-New York for the next 7 years. There are only three companies at the US FDA with non-addictive, post-operative pain treatments and PixarBio’s NeuroRelease is the only treatment that can extend past 5 days to prevent “Rebound Pain”, which contributes to the cycle of opiate addiction. Recent FDA Black Labels for ALL opiates and the CDC’s April 2016 actions around the limitations of opiate usage for chronic pain patients, have triggered significant demand and interest for NeuroRelease Pain. read more
MEDIAN Technologies Boosts Its Presence in the US and Announces Major Expansion of Its Subsidiary MEDIAN Technologies Inc.
MEDIAN Technologies (ALMDT.PA) (Paris:ALMDT), a leading medical imaging solutions and service provider for image interpretation and management in oncology, today announced its US expansion plans with the opening of a major facility for its US subsidiary MEDIAN Technologies Inc. The new site in Woburn, Massachusetts will bring together all of the teams located around the Boston area and has the capacity to handle the ambitious US recruitment plan over the coming months. With this new space and expected employee growth, MEDIAN Technologies Inc. demonstrates a major increase in its operational capacity for the management of imaging projects in clinical trials. read more
Colorado Becomes 20 State to Pass Law Protecting Children Who Need Medical Nutrition to Survive
ROCKVILLE, Md.–(BUSINESS WIRE)–Children’s Milk Allergy and Gastrointestinal Coalition U.S. (MAGIC) is pleased to announce that as the result of its coalition and lobbying efforts, Colorado is the 20th state to require private insurers and Medicaid to cover special formulas for children unable to consume a natural, life-sustaining diet due to allergies or diseases. These amino acid-based formulas can cost a family $3,000 to $5,000 a year or more. read more
Bristol-Myers Squibb and AbbVie Announce European Commission Approval of Empliciti™ (elotuzumab) for the Treatment of Multiple Myeloma in Adult Patients Who Have Received at Least One Prior Therapy
PRINCETON, N.J.–(EON: Enhanced Online News)–Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) announced today that the European Commission has approved Empliciti™ (elotuzumab) for the treatment of multiple myeloma as combination therapy with Revlimid® (lenalidomide) and dexamethasone in patients who have received at least one prior therapy. Empliciti is now the first and only immunostimulatory antibody approved for multiple myeloma in the European Union (EU). read more
CASI Pharmaceuticals Receives Approval From CFDA To Conduct Phase 2 Clinical Trial With ENMD-2076 For Fibrolamellar Carcinoma (FLC)
PRNewswire/ — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces that China’s Food and Drug Administration (CFDA) has approved the Company’s application to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076. read more
Corvia Medical Announces CE Mark Approval And Enrollment Of First Patients In Randomized Clinical Study
Corvia Medical, Inc., a privately-held medical device company that has developed a first-in-class structural heart device to treat heart failure, today announced CE Mark approval of its InterAtrial Shunt Device (IASD®). The IASD is the world’s first transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF), previously called diastolic heart failure. CE Mark approval allows the company to market the IASD in the European Union. read more