Company Company Deal Value Inspiration Biopharmaceuticals Inc. Baxter International Inc. $700M Chiasma Inc. Roche AG $595M Edison Pharmaceuticals Inc. Dainippon Sumitomo Pharma Co. $545M Moderna Therapeutics Inc. AstraZeneca plc $420M Isis Pharmaceuticals Inc. Roche AG $392M Ambrx Inc. Astellas Pharma Inc. $300M Resolve Therapeutics LLC Takeda Pharmaceutical Co. Ltd. $255M Opexa Therapeutics Inc. Merck Serono SA $225M BIND Therapeutics Inc. Pfizer Inc. $210M Ra Pharmaceuticals Inc. Merck & Co

Congress is running out of patience with the SEC's continued delay in implementing part of the Jumpstart Our Business Startups Act that was supposed to be in place last year. The FDA said it won't approve generics based on Purdue Pharma LP's original OxyContin, which has been replaced with a formulation less prone to abuse. Amgen Inc. agreed to pay $24.9 million to settle federal allegations that it gave kickbacks to long-term care pharmacy providers to switch Medicare and Medicaid beneficiaries

"We believe this is getting the attention it deserves. We believe the FDA is engaged in this in the way we would like to see them engaged. They're asking very good questions." – Chris Garabedian, president and CEO of Sarepta Therapeutics Inc., discussing the FDA's request for additional information from its eteplirsen dataset before determining the new drug application filing pathway "We have a fairly unique platform. I know everybody says the same thing, but we have found a way that allows for

Financings Agenus Inc. retired its outstanding $39 million 8 percent senior secured convertible notes issued in 2006. Allecra Therapeutics GmbH raised $19.6 million in a Series A round. Auris Medical AG landed $50.8 million in its Series C funding round. ChemoCentryx Inc. commenced its underwritten public offering of $60 million in common stock. Durata Therapeutics Inc. priced a $50 million public offering, selling 7.15 million shares at $7 each. Kamada Ltd. filed for an IPO to gain a U.S

According to data from Deloitte Recap LLC, cancer drugs are the most popular compounds to partner, making up 33 percent of all deals in 2012. The popularity has increased from the five years prior to that when oncology drugs made up 24 percent of the licensing deals. In the first quarter of 2013, the fraction held steady at one third of all deals. Part of the popularity for partnering cancer drugs comes simply from the number of firms developing drugs in the space, which Christian Dokomajilar

CHICAGO – The opening of the 2013 Biotechnology Industry Organization's (BIO) annual International Convention in Chicago not only marks a celebration of the event's 20th anniversary but also is the second return to the Windy City during the past three years. When BIO 2010 convened here at the beginning of May the biotechnology industry was still reeling from the unprecedented global economic perturbations that tanked the capital markets in 2009. However, there was some promising news to help

"We know that patient foundations, historically, have driven research and evaluation of potential therapeutic approaches in rare diseases, and pharma has joined them more recently, with the exception of Genzyme [Corp.], of course, which has been there since the very beginning." – Cristina Csimma, CEO, Cydan LLC "We're at a very interesting moment in time in the antibody drug conjugate space. The older technology wasn't the most robust, so there were some failures preclinically and clinically

The Arkansas Supreme Court is being asked to overturn the $1.2 billion penalty assessed against Janssen Pharmaceuticals Inc. in a case that could open other drugmakers to hefty penalties when the state decides FDA-approved labeling is inadequate. The lawsuit, filed by the state of Arkansas, stemmed from the placement of risk information on the FDA-approved label for Risperdal (risperidone). Concerned that uninsured patients are not getting the intended benefit of the federal 340B drug discount

Company (Location) Product Description Indication Status Date Actavis Inc. (Parsippany, N.J.) Fortesta Testosterone 2% gel Deficiency or absence of endogenous testosterone Filed an abbreviated NDA 3/4/13 Astellas Pharma Inc. (Tokyo) Myrbetriq Mirabegron, extended-release tablets Overactive bladder Won Health Canada approval 3/11/13 Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (Indianapolis) Empagliflozin Sodium glucose co-transporter-2 inhibitor Type II diabetes

Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) Tecfidera Dimethyl fumarate Multiple sclerosis Was approved by the FDA 3/28/13 CANCER Acceleron Pharma Inc. (Cambridge, Mass.) ACE-536 A protein therapeutic that increases red blood cells Beta-thalassemia and myelodysplastic syndromes FDA granted orphan designation 3/27/13 A.P. Pharma Inc. (Redwood City, Calif.) APF530 A long-acting formulation of granisetron To prevent chemotherapy-induced

Company (Location) Product Description Indication Status Date AUTOIMMUNE Trophos SA (Marseille, France) Olesoxime A mitochondrial-targeted, cholesterol-like compound Multiple sclerosis Started a Phase Ib study 3/15/13 CANCER Anaeropharma Science Inc. (Tokyo) APS001F A living recombinant bifidobacterium Advanced or metastatic solid tumors Started a Phase I trial 3/29/13 Bio-Path Holdings Inc. (Houston) BP-100-1.01 Liposomal Grb-2 Blood cancers Started enrolling patients in the fifth dosage

Financings Anthera Pharmaceuticals Inc. secured a $20 million debt financing facility through a syndicate. Chimerix Inc. priced its initial public offering (IPO) of 7.3 million shares at $14 each, at the midpoint of its proposed range. Cleave Biosciences Inc. raised $10 million in an extension of its Series A financing. Coronado Biosciences Inc. netted $9.9 million through its at-the-market program. GenSight Biologics raised $41.6 million in a Series A funding. MedDay raised $10.5 million to

Resverlogix Corp. announced last week that it's spinning out its epigenetics platform into RVX Therapeutics Inc., leaving its ApoA-I stimulating drug candidate, RVX-208, with the parent company. The plan has been in the works for eight years since RVX Therapeutics was established as a subsidiary, Donald McCaffrey, president and CEO of Resverlogix, told BioWorld Insight. "We always felt that if the lead drug was of interest to someone and acquired we really didn't want to give up all the other

Company (Location) Product Description Indication Status Date Kythera Biopharma-ceuticals Inc. (Calabasas, Calif.) ATX-101 Injectable drug To reduce submental fat Phase IIIb data showed it is well tolerated and may be effective 3/5/13 Merz North America (Greensboro, N.C.) Naftifine hydrochloride Gel 2% Tinea pedis Company reported the ability of the gel to be both efficacious and tolerable in the treatment for interdigital-type and moccasin-type Tinea pedis 3/5/13 Sanofi SA (Paris) and

Company (Location) Product Description Indication Status Date AUTOIMMUNE Halozyme Therapeutics Inc. (San Diego) and Baxter International Inc. (London) HyQvia Combination of human normal immunoglobulin and recombinant human hyaluronidase designed as a replacement therapy Primary and secondary immunodeficiencies Received a positive opinion from the EMA's CHMP 3/25/13 Biogen Idec Inc. (Weston, Mass.) Tecfidera Dimethyl fumarate Relapsing-remitting multiple sclerosis Received a positive opinion