Bridgewater, N.J. – Sanofi US is voluntarily recalling all Auvi-Q® (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.
FDA approved ipilimumab (Yervoy Injection), for the additional indication of adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. October 28, 2015. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm470061.htm
Allergan plc Confirms Discussions Regarding Potential Business Combination Transaction With Pfizer Inc.
DUBLIN, Oct. 29, 2015 /PRNewswire/ — Allergan plc today confirmed that it has been approached by Pfizer Inc. and is in preliminary friendly discussions regarding a potential business combination transaction. Allergan stated that no agreement has been reached and there can be no certainty that these discussions will lead to a transaction, or as to the terms on which a transaction, if any, might be agreed. The company will not comment on speculation regarding the terms of a potential transaction. read more
Quest Medical, Inc. Issues Recall of MPS® Delivery Set
On October 28, 2015, Quest Medical, Inc. initiated a nationwide recall of Myocardial Protection System (MPS) Delivery Sets, Models 5001102, 5001102-AS, and 7001102 of specified lots. The product(s) have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss. read more
Valeant To Terminate Relationship With Philidor
LAVAL, Quebec, Oct. 30, 2015 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced today that it is severing all ties with Philidor Rx Services, LLC, and that Philidor has informed Valeant that it will shut down operations as soon as possible, consistent with applicable laws. read more
U.S. District Court Denies Perrigo’s Motion for Preliminary Injunction Related to Certain Mylan Disclosures
HERTFORDSHIRE, England and PITTSBURGH, Oct. 30, 2015 /PRNewswire/ — Mylan N.V. (Nasdaq: MYL) today announced that the U.S. District Court for the Southern District of New York has denied the motion by Perrigo Company plc (NYSE: PRGO; TASE) for a preliminary injunction concerning Mylan’s proposed acquisition of Perrigo, ruling that Mylan had provided adequate public disclosures regarding the synergies expected to be achieved from the combination. read more
MiMedx Comments on Recent FDA Draft Guidance on Homologous Use of HCT/Ps
MARIETTA, Ga., Oct. 29, 2015 /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 the Dental sectors of healthcare, commented on the proposed Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (“HCT/Ps”) that the Food and Drug Administration (“FDA”) published for comment on October 28, 2015 and the Notice of Public Hearing and Request for Comments released today indicating the agency would hold a public hearing on April 13, 2016 to obtain input on that Guidance as well as three other recently issued guidance documents on HCT/Ps .read more
Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall – Intermittent Seal Failure During Use
The identified lots of MPS Delivery sets have shown a possible seal failure along the blood source channel of main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery. The firm has received twenty complaints alleging this seal failure which have resulted in 16 instances of patient blood loss during surgery. There have been no reports of patient injuries as a result of the alleged issue to date.
Recalled Product(s) were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015. read more
AbbVie Outlines Long-Term Strategic and Financial Objectives; Company Positioned for Strong Performance
BOUDRY, Switzerland–(BUSINESS WIRE)–Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that the European Commission (EC) has approved VIDAZA® (azacitidine for injection) for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell transplantation (HSCT). read more
Sosei Confirms FDA Approvals of New Dual Combination Bronchodilator Utibron™ Neohaler® and Monotherapy Seebri™ Neohaler® for Patients with Chronic Obstructive Pulmonary Disease
TOKYO–(BUSINESS WIRE)–Sosei Group Corporation (TOKYO:4565) confirms today that the US Food and Drug Administration (FDA) has approved the new Novartis dual combination bronchodilator Utibron™ Neohaler® (indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The FDA also approved Seebri™ Neohaler® (glycopyrrolate) inhalation powder 15.6 mcg – which is one component of Utibron Neohaler – as a stand-alone monotherapy for COPD. Sosei is eligible to receive milestone payments of 22.5 million dollars for approval of both products. read more