Valeant Pharmaceuticals International Inc., of Laval, Quebec, said it obtained the requisite lender approval for an amendment to its credit facility to reduce the interest coverage maintenance covenant to 2x for additional headroom, to provide additional flexibility to sell assets, to permit the issuance of secured notes with shorter maturities to repay term loans and to permit the incurrence of other debt to repay term loans. Read More

Eiger Biopharmaceuticals Inc., of Palo Alto, Calif., priced an underwritten public offering of 1.25 million common shares at $16 apiece, a discount of approximately 7 percent to the stock's (NASDAQ:EIGR) closing price of $17.19 on Wednesday. The offering was expected to generate proceeds of $20 million, and Eiger granted underwriters a 30-day option to purchase up to 187,500 additional common shares, potentially adding $3 million to the raise. The company said net proceeds will fund continued development of its portfolio. Jefferies LLC is sole book-running manager, with Oppenheimer & Co. Inc. and Wedbush Pacgrow as co-managers. On Thursday, the company's shares closed at $15.70 for a loss of $1.49. Read More

CMS released its second annual dataset Thursday on prescription drugs paid for under the U.S. Medicare Part D program. The new data contain information from more than 1 million providers who collectively prescribed about $121 billion in Part D prescription drugs in 2014 – a 17 percent increase compared with 2013 data, CMS said. The dataset includes the total number of prescriptions dispensed for each drug and the total drug cost. However, the costs do not reflect manufacturer rebates paid to Part D plan sponsors. The 10 drugs with the highest number of prescriptions were generics, while the 10 with the highest total cost were brand drugs. Read More

PERTH, Australia – Drug manufacturers with operations in Australia will have four years to transition to new labeling requirements for medicines in Australia, long-awaited changes that may align with 21st century practices but, industry argued, likely won't solve the entire problem of medication errors. Read More

The FDA co-development draft guidance for companion diagnostics and their associated therapeutics tackled a largely novel area of regulatory science for the practice of 21st Century medicine, but an Aug. 18, 2016, webinar clarified that a companion diagnostic (CDx) need not be a market-ready test, but need only offer "market-ready performance" to qualify for use in the therapeutic pivotal trial. Read More

Dendrimers are highly branched nanoparticles that are being explored in a variety of biomedical settings. They have been tested clinically to deliver chemotherapy and imaging agents, and are being tested preclinically with payloads that include small molecules and nucleic acids. (See BioWorld Today, March 18, 2009, and May 11, 2011.) Read More

An FDA complete response letter (CRL) for Portola Pharmaceuticals Inc.'s factor Xa inhibitor antidote, Andexxa (andexanet alfa), left the company "significantly surprised," said CEO Bill Lis. Read More

DUBLIN – Shares in Auris Medical AG took a pounding Thursday on news that its lead drug, Keyzilen (AM-101, esketamine hydrochloride gel), failed the first of two phase III trials in acute inner ear tinnitus. Read More

Scarx Therapeutics Inc., of Toronto, said it received approval from Health Canada to begin a phase I trial of its SCX-001 nefopam cream, a topical treatment developed to reduce surgical scarring. Read More