HAYWARD, Calif., Feb. 8 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, announced today that it reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3 clinical study named VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome - 16 Weeks) for its lead product candidate, A-002, an oral sPLA2 inhibitor, in combination with HMG-CoA reductase inhibitor, or statin, therapy for short-term (16-week) treatment of patients experiencing an acute coronary syndrome. [more]
ROCKVILLE,Md., Feb. 5, 2010--The FDA is alerting the public that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with the use of Tysabri (natalizumab), increases with the number of Tysabri infusions received. [more]
QUEBEC CITY, Feb. 3 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (Nasdaq: AEZS; TSX: AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrinology, today announced that its partner, Keryx Biopharmaceuticals (NASDAQ:KERX) , has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, perifosine (KRX-0401), in patients with refractory metastatic colorectal cancer. [more]
EMERYVILLE, Calif., Feb. 2 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. today announced that the company reached agreement with the FDA on a SPA for the Phase 3 international randomized trial. This pivotal trial, which is expected to begin in the first half of 2010, will enroll patients with relapsed multiple myeloma following treatment with one to three prior regimens. It is designed to evaluate the efficacy of carfilzomib in combination with lenalidomide and low dose dexamethasone, versus lenalidomide and low dose dexamethasone alone. [more]
EMERYVILLE, Calif., Feb. 2 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. today announced that the company reached agreement with the FDA on a SPA for the Phase 3 international randomized trial. This pivotal trial, which is expected to begin in the first half of 2010, will enroll patients with relapsed multiple myeloma following treatment with one to three prior regimens. It is designed to evaluate the efficacy of carfilzomib in combination with lenalidomide and low dose dexamethasone, versus lenalidomide and low dose dexamethasone alone. [more]
SILVER SPRING, Md., Feb. 1 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine). [more]
BRISBANE, Calif., Feb. 1 /PRNewswire-FirstCall/ -- InterMune, Inc. (NASDAQ:ITMN) announced today that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) is scheduled to discuss the company's New Drug Application (NDA) for pirfenidone on March 9, 2010. Pirfenidone is InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF). [more]
Cambridge, Mass. – February 1, 2010 – Pervasis Therapeutics, Inc. today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 clinical trial for Vascugel, an investigational new drug for the prevention of hemodialysis access graft failure. [more]
ROCKVILLE, Md., Jan. 30, 2010 -- Lilly and FDA notified healthcare professionals of changes to the Prescribing Information for Zyprexa related to its indication for use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder. [more]
ROCKVILLE, Md., Jan. 29, 2010--The Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine). Didanosine is a medication used to treat human immunodeficiency virus (HIV) infection. [more]
ROCKVILLE, Md., Jan. 28, 2010--On January 27, 2010, FDA approved revisions to the Prezista (darunavir) product labeling to include the 96 week data from two trials; one trial in treatment-experienced patients (TMC114-C214) and one trial in treatment-naïve patients (TMC114-C211). [more]
ROCKVILLE, Md., Jan. 26, 2010--Takeda Oncology and FDA notified healthcare professionals about revisions to the Prescribing Information for Velcade, section 2.5, pertaining to patients with hepatic impairment at the start of Velcade therapy. [more]
RICHARDSON, Texas & McLEAN, Va.--(BUSINESS WIRE)--Jan 26, 2010 - More than 7,000 workers at the U.S. Food and Drug Administration's (FDA) new White Oak campus have complete wireless connectivity to all four national carriers – AT&T, Sprint/Nextel, T-Mobile and Verizon – for their government-issued and personal smartphones and BlackBerry® devices thanks to the InnerWireless distributed antenna system (DAS) chosen and installed by the FDA's master contractor, SMS Data Products Group, Inc. (SMS) of McLean, Va. The White Oak campus currently has 10 buildings with more than 2 million square feet of in-building wireless coverage; the campus is slated for ongoing expansion and could reach a total of 14 buildings throughout which up to 12,000 users would have ubiquitous wireless access. [more]
Montreal, Canada – January 25, 2010 – Theratechnologies (TSX:TH) today announced that the U.S. Food and Drug Administration (“FDA”) will reschedule its meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to review Theratechnologies’ New Drug Application (“NDA”) for tesamorelin. Originally scheduled for Wednesday, February 24, 2010, the meeting will be rescheduled due to an administrative delay at the FDA. The FDA informed Theratechnologies that this delay is entirely procedural and is not related to the tesamorelin NDA. A new meeting date will be announced shortly in the Federal Register. [more]
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jan 25, 2010 - Calibra Medical announced today that the U.S. Food and Drug Administration (FDA) has cleared Finesse, the company's insulin patch-pen. Finesse represents a new category of simple mechanical devices intended to make insulin therapy adherence easier for patients to achieve at an affordable price point. 93% of type 1 and type 2 diabetes patients on insulin in the U.S. and E.U., estimated at over 10 million patients, use syringes and pens and are challenged to overcome the difficulty, and often the social stigma, associated with delivering bolus, or mealtime, insulin. [more]
ROCKVILLE, Md., Jan. 21, 2010--FDA notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. Based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including: [more]
MUMBAI, India, Jan. 20 /PRNewswire/ -- Pharma major, Lupin Ltd announced today that it has received official communication from the US FDA on the satisfactory resolution of the Warning Letter issued earlier to its Mandideep site. The company had received a Warning letter for its Mandideep site in May 2009. In the ensuing seven months, the company made significant enhancements and took appropriate corrective actions. The facility was re-inspected in November 2009 and the company was able to satisfactorily address all of the concerns related to the Warning Letter and the site compliance status was found to be acceptable. [more]
ROCKVILLE, Md., Jan. 18. 2010--The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). [more]
Montreal, Canada – January 18, 2010 – Theratechnologies (TSX:TH) today announced that the U.S. Food and Drug Administration (“FDA”) has confirmed that the Endocrinologic and Metabolic Drugs Advisory Committee will meet to review Theratechnologies’ New Drug Application (“NDA”) for tesamorelin on Wednesday, February 24, 2010. [more]
ROCKVILLE, Md., Jan. 14, 2010--The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine. [more]
Mergers & Acquisitions, Partnerships, & Collaborations 2010 – Review and Outlook
This PharmaLive Special Report analyzes the healthcare industry’s M&As of 2009, providing a comprehensive listing of companies’ M&A activity and detailing the top 20 deals within each of the Pharmaceutical, Biotechnology, Specialty, and Medical Device sectors, and previews potential M&A activity within the healthcare arena for 2010.
The introductory rate of $395 expires February 17, 2010.
