Kalamazoo, Michigan – February 16, 2016 – Stryker Corporation (NYSE: SYK) announced today a definitive agreement to acquire 100% of the stock of Physio-Control International, Inc. (“Physio-Control”) in an all cash transaction for $1.28 billion. Physio-Control, which is a portfolio company of Bain Capital Private Equity, develops, manufactures and markets monitors/defibrillators, automated external defibrillators (AEDs) and CPR-assist devices along with data management and support services. The company was founded in 1955 and has a long history of innovation with products that target urgent patient care, specifically designed to improve survival rates and patient outcomes. The company’s portfolio is highly complementary to Stryker Medical’s EMS (Emergency Medical Services) offering and will drive a greater balance between capital and disposables. Physio-Control also brings an enhanced presence and infrastructure that will expand Stryker’s global footprint. Physio-Control sales for fiscal 2015 totaled $503 million, up 6% in constant currency over the prior year
U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis. – read more
FDA Accepts Supplemental New Drug Application (sNDA) for TEFLARO® (ceftaroline fosamil)
/PRNewswire/ — Allergan plc (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for TEFLARO® (ceftaroline fosamil). If approved, this filing will expand the label of TEFLARO beyond adults to include the treatment of children two months of age and older 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 Staphylococcus pneumoniae and other designated susceptible bacteria. read more
Durvalumab granted BTD by FDA for cancer patients
DURVALUMAB granted Breakthrough Therapy designation by US FDA for treatment of patients with PD-L1 positive urothelial bladder cancer
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen.
Acorda Announces Expiration of the Hart-Scott-Rodino Waiting Period for Its Tender Offer for Biotie Therapies
ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (HSR), for its tender offer for Biotie Therapies Corp. (Nasdaq Helsinki: BTH1V; Nasdaq: BITI) has expired.
Acorda announced on January 19, 2016 that it entered into an agreement to acquire Biotie for €0.2946 per share and €23.5680 per ADS in cash. Pursuant to the terms of the agreement, Acorda will offer to acquire all outstanding shares, American Depositary Shares, and other equity securities of Biotie through a public tender offer. read more
FDA Grants Breakthrough Therapy Designation for Genentech’s Investigational Medicine Ocrelizumab in Primary Progressive Multiple Sclerosis
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUSTM) for the treatment of people with primary progressive multiple sclerosis (PPMS). There are currently no approved treatments for PPMS, a debilitating form of MS characterized by steadily worsening symptoms and typically without distinct relapses or periods of remission.1 read more
Bone Therapeutics Treats 12 Patients without Safety Concerns in ALLOB® Phase IIA Spinal Fusion Trial
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, today announces it has now treated 12 patients in its ALLOB® Phase IIA spinal fusion trial without any safety concerns. The trial is progressing quickly with only one more patient cohort of four patients to treat. Further information is available at www.bonetherapeutics.com.
BioTime and Asterias Sign Share Transfer Agreement and Cross-License Agreement for Pluripotent Stem Cell Related Patents
FREMONT, Calif. & ALAMEDA, Calif.–(EON: Enhanced Online News)–Asterias Biotherapeutics, Inc. (NYSE MKT:AST) and BioTime, Inc. (NYSE MKT and TASE:BTX), both clinical-stage regenerative medicine companies with a focus on pluripotent stem cell technology, and BioTime’s wholly owned subsidiary ES Cell International Pte Ltd (“ESI”), have entered into a Share Transfer Agreement through which BioTime will re-acquire from Asterias shares of capital stock of BioTime subsidiaries Cell Cure Neurosciences Ltd and OrthoCyte Corporation. As a result, OrthoCyte will once again become a wholly-owned subsidiary of BioTime. Asterias will re-acquire from BioTime warrants to purchase 3,150,000 shares of Asterias Series A Common Stock. Under the Asset Transfer Agreement BioTime has agreed that, if Asterias distributes new warrants to its shareholders that will entitle them to purchase additional shares of Asterias Series A Common Stock, BioTime will waive its rights as an Asterias shareholder to receive a pro rata portion of those new warrants. read more
Eisai and PIQUR Sign Landmark Collaboration Agreement to Investigate Halaven® (Eribulin) and PQR309 in Hard to Treat Form of Breast Cancer
HATFIELD, England and BASEL, Switzerland, February 17, 2016 /PRNewswire/ —
Agreement will see eribulin used in combination with novel PI3K/mTOR inhibitor in patients with triple negative breast cancer
Eisai and PIQUR Therapeutics today announce a landmark agreement to conduct a Phase 1/2b clinical study to investigate PQR309 in combination with Halaven® (eribulin) in patients with triple-negative breast cancer (TNBC).
A significant number of HER2-negative breast cancer patients are expected to have activated PI3K, de novo or induced by prior chemotherapy administration. PQR309 is currently engaged in multiple Phase 1 and Phase 2 studies as a single agent and has shown promising activity. The combination of a PI3K/mTOR inhibitor with eribulin may prove to be an effective treatment in second line therapy for locally advanced or metastatic TNBC patients.