DUBLIN and SAN FRANCISCO, May 31, 2016 /PRNewswire/ — Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, and Medicines360, a nonprofit women’s health pharmaceutical company with a mission of expanding access to quality medicines, today announced that they will donate 10,000 units of their hormonal IUD, LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg, to the CDC Foundation. In addition, Allergan will donate over 40,000 one-month cycle packs of oral contraceptives. The contributions are in response to the outbreak of the Zika virus and are designed to help reduce unintended pregnancies in Puerto Rico, while the risk of the Zika virus is prevalent. Research has shown that pregnant women infected with the Zika virus are at risk of giving birth to infants born with microcephaly, a condition where babies’ heads and brains are smaller and may not have developed properly during pregnancy. read more
Medtronic Strengthens Commitment to Asia Pacific
– Medtronic plc (NYSE:MDT), a global leader in medical technology, services and solutions, today announced the opening of its new Asia Pacific regional headquarters in Singapore. The new facility, which houses the Asia Pacific Service and Repair Centre of Excellence, will strengthen and support Medtronic operations across 80 locations in Asia Pacific. This will further help Medtronic deliver on the growing demand for medical products and services. read more
U.S. FDA Approves Once-daily Jentadueto(R) XR (linagliptin and metformin hydrochloride extended-release) Tablets for Adults with Type 2 Diabetes
New formulation of medicines that helps lower blood sugar in type 2 diabetes can be taken once a day
RIDGEFIELD, Conn. and INDIANAPOLIS, May 31, 2016 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Jentadueto® XR (linagliptin and metformin hydrochloride extended-release) tablets for the treatment of type 2 diabetes (T2D) in adults. JENTADUETO XR, which is marketed by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), is the seventh new treatment from the Boehringer Ingelheim-Lilly Diabetes alliance to be approved by the FDA in the last five years.
JENTADUETO XR combines 2.5 mg or 5 mg of linagliptin with 1000 mg of metformin. Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, works by increasing hormones that stimulate the pancreas to produce more insulin and the liver to produce less glucose. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine. read more
U.S. FDA Accepts for Priority Review Supplemental New Drug Application for the Use of ORKAMBI(R) (lumacaftor/ivacaftor) in Children with Cystic Fibrosis Ages 6 to 11 who have Two Copies of the F508del Mutation
-Approximately 2,400 children ages 6 to 11 have two copies of the F508del mutation in the U.S. –
-Target review date of September 30, 2016 set for the FDA’s decision on the application-
BOSTON –(BUSINESS WIRE)– Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the use of ORKAMBI® (lumacaftor/ivacaftor) in people with cystic fibrosis (CF) ages 6 to 11 who have two copies of the F508delmutation. The FDA granted Vertex’s request for Priority Review of this sNDA, and a target review date of September 30, 2016 was set under the Prescription Drug User Fee Act (PDUFA).
Allergan Receives FDA Approval of TEFLARO® (ceftaroline fosamil) for Pediatric Patients
DUBLIN, May 31, 2016 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) for TEFLARO® (ceftaroline fosamil), granting new indications for pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria. read more
ContraVir Initiates Head-to-Head Phase 2a Clinical Study of CMX157 vs. Viread® for Treating Hepatitis B
EDISON, N.J., June 1, 2016 /PRNewswire/ — ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that following a positive recommendation from an independent Data Safety Monitoring Board (DSMB), the Company has begun screening patients with chronic hepatitis B (HBV) for enrollment in a head-to-head Phase 2a study comparing ContraVir’s CMX157 to tenofovir DF (TDF, marketed by Gilead Sciences as Viread®). The study will compare sequentially escalating doses of CMX157, beginning at a 5 mg daily CMX157 dose compared to 300 mg daily dose of TDF which is the standard daily dose of Viread®. The study is expected to conclude in the fourth quarter of 2016.
Bayer Collaborates with U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP) to Investigate Stivarga® (Regorafenib) Tablets as Additional Adjuvant Therapy in Colon Cancer
WHIPPANY, N.J., June 1, 2016 /PRNewswire/ — Bayer and the U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP), a leading clinical trials cooperative group, are collaborating on a new Phase III study to investigate Stivarga® (regorafenib) tablets as an additional adjuvant therapy in colon cancer. The ARGO trial will investigate regorafenib as a single agent for the adjuvant treatment of Stage IIIB and IIIC colon cancer following completion of standard adjuvant chemotherapy. In this stage, the tumor has started to invade the wall of the colon, but not yet spread to other distant organs. read more
Specialty CROs, WCCT Global and Medelis, Announce Merger to Deliver Expanded Oncology and Clinical Research Services
CYPRESS, Calif., June 1, 2016 /PRNewswire/ — WCCT Global, an international specialized clinical research organization (CRO), and Medelis, Inc., a specialty oncology CRO, announced today that the companies have merged to offer US and international clients access to an expanded depth and breadth of clinical research offerings.
“The complex and rapidly growing oncology drug development market in the US, Europe, and Asia requires unique insight and expertise and an eye toward the future, all of which we now offer through this merger,” said Dr.Kenneth Kim, founder and CEO of WCCT Global. “We’re committed to delivering world-class clinical research solutions to achieve our vision of becoming the global leader in the development of specialized medicines and therapies.”
Oncternal Therapeutics Merges with Tokalas to Form Clinical-Stage Biotechnology Company with Promising Oncology Pipeline
SAN DIEGO, June 1, 2016 /PRNewswire/ — Oncternal Therapeutics, Inc. and Tokalas, Inc., today announced that the two companies have completed a merger to create a new world-class clinical-stage oncology company with two promising, first-in-class pipeline products. The transaction was approved by both companies’ shareholders, and results in the combination of all assets, research and developments programs and operations under the name Oncternal Therapeutics, Inc. read more
Myriad Acquires Sividon Diagnostics
Strengthens Market Leading Oncology Product Portfolio with Breast Cancer Prognostic Test EndoPredict®
(GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that it has acquired Sividon Diagnostics, a leading breast cancer prognostic company, for €35 million upfront with the potential for €15 million in additional performance-based milestones. The transaction closed on May 31, 2016. Myriad expects the deal to be neutral to both revenue and earnings in fiscal year 2017. A discussion on the details and strategy underlying the transaction will be provided on a conference call today at 4:30 pm EDT.
“Sividon brings to Myriad the best-in-class breast cancer prognostic test and strengthens our market leading oncology portfolio of high value personalized medicine products,” said Mark C. Capone, president and CEO, Myriad Genetic Laboratories. “The EndoPredict® test will be the foundational product of our newly initiated kit-based strategy and allow Myriad to leverage its global oncology distribution to bring this important test to patients worldwide.”