Matrixx Appoints Scerene Healthcare Executive To Lead Turnaround / M’lou Arnett talks about how her experience, including designing the “Mr. Mucus” advertising icon for the Mucinex cough treatment line, has prepared her for the challenge of growing Matrixx’s revenues in the wake of removing the Zicam gel and swab products from the market. / “The Pink Sheet” DAILY Feb. 22, 2012

Former Yaupon Therapeutics Raises $15 Million In Debt To Prepare To Commercialize Its First Product / Now called Ceptaris, the company is awaiting FDA approval of Clearazide, a topical gel formulation of a cytotoxin, for early-stage CTCL. / “The Pink Sheet” DAILY Feb. 22, 2012

FDA Drug Shortage Strategy: Enforcement Discretion, Patient Public Relations / Rapid approval of a new, preservative-free generic methotrexate and permission to import an unapproved version of doxorubicin touted at press conference as FDA emphasizes the success of administrative efforts. / “The Pink Sheet” DAILY Feb. 21, 2012

Gene Therapy Firm AMT Forced To Go Private, Backed By Forbion / Amsterdam Molecular Therapeutics plans to be acquired by a newly formed private company, uniQure, and to delist from Euronext. / “The Pink Sheet” DAILY Feb. 21, 2012

J&J Taps Gorsky To Be Its Next CEO / Alex Gorsky was one of two internal candidates who had been vying for the position, which will become available as William Weldon yields the position on April 26. / “The Pink Sheet” DAILY Feb. 21, 2012

China To Further Squeeze Distribution Margins And Limit Drug Markups In Hospitals / The National People’s Congress and Chinese Peoples’ Political Consultative Conference will bring in March a variety of new policies and regulations that will impact the industry. / “The Pink Sheet” DAILY Feb. 21, 2012

Supreme Court Abstains From Drugs: Will Not Review J&J Vs. Abbott; Takes No Action On Gene Patents / The high court denied J&J’s request for review of a Federal Circuit decision that overturned a $1.67 billion jury verdict against Abbott’s Humira; it made no decision on ACLU’s petition for review of Myriad Genetics’ BRCA gene patents. / “The Pink Sheet” DAILY Feb. 21, 2012

FDA Panel Will Weigh Northera’s Short-Term Benefit Vs. Lack Of Durable Effect, Safety Concerns / At its Feb. 23 review of Chelsea Therapeutics’ investigational orthostatic hypotension drug droxidopa, FDA’s Cardiovascular and Renal Drugs Advisory Committee will be asked to discuss sufficiency of the short-term efficacy data, clinical meaningfulness of the effect size and safety issues, including Japanese post-marketing reports of neuroleptic malignant syndrome. / “The Pink Sheet” DAILY Feb. 21, 2012

Somewhat Late To The HCV Race, Novartis Licenses NS5A Inhibitor From Enanta / The Phase I-ready compound joins alisporivir, a cyclophilin inhibitor licensed from Debiopharm in 2010, in Novartis’ rather slight portfolio of HCV candidates. / “The Pink Sheet” DAILY Feb. 21, 2012

FDA Questions CV Events, Small Database Heading Into Aclidinium Bromide Advisory Committee / Persistent cardiovascular events across the clinical trials for Forest Laboratories Inc.’s aclidinium bromide may not represent a definite safety signal, according to FDA, but there is enough concern that an advisory committee will be asked for input on its significance. Forest wants approval of aclidinium bromide for long-term maintenance treatment of bronchospasm from chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. / “The Pink Sheet” DAILY Feb. 21, 2012

NICE Doubtful On Cost-Effectiveness Of Tarceva / The U.K.’s National Institute for Health and Clinical Excellence is asking for a further cost-effectiveness analysis of Roche’s Tarceva to weigh against the cost effectiveness of AstraZeneca’s Iressa. / “The Pink Sheet” DAILY Feb. 17, 2012

EU's CHMP Warns About Boceprevir In HIV, Aliskiren In Diabetes, But Clears Orlistat And Reinstates Trasylol / The EU's scientific advisory panel, the CHMP, recommends prescribing information changes for drug/drug interactions with Merck's Victrelis and adverse events with Novartis' aliskiren, but clears obesity therapy orlistat of causing liver injury and reverses its 2007 negative opinion on Bayer's Trasylol. / “The Pink Sheet” DAILY Feb. 17, 2012

A Setback In Its High-Profile “Nuc” Trial Creates An Overhang For Gilead’s HCV Pipeline / Gilead concedes that 12 weeks of treatment with ribavirin and GS-7977, the high-profile “nuc” asset it obtained when it bought Pharmasset late in 2011 is suboptimal for genotype 1 null responders; general expectation is that longer duration of therapy might suffice. / “The Pink Sheet” DAILY Feb. 17, 2012

Corcept’s Voluntary Central Distribution Helps Korlym Evade REMS / FDA required no REMS, though Korlym (mifepristone), also known as RU-486, will carry a boxed warning that the therapy for Cushing’s syndrome will terminate pregnancy; Corcept has set up distribution through a central pharmacy. / “The Pink Sheet” DAILY Feb. 17, 2012

A Closer Look: Alogliptin's Delay Accelerated Takeda's Pursuit Of Nycomed / Takeda found itself desperate to fill gaps with Actos LOE looming and alogliptin faltering, hastening a 10-year conversation with Nycomed. / “The Pink Sheet” DAILY Feb. 17, 2012

FDA Says Qnexa Needs CV Outcome Trial, Asks Cmte. To Consider Pre- Or Post-Approval Timeframe / Endocrinologic and Metabolic Drugs Advisory Committee also will weigh in on a teratogenicity risk management strategy for Vivus’ weight-loss drug during a Feb. 22 meeting. / “The Pink Sheet” DAILY Feb. 17, 2012

Teva’s U.S. Generic Sales Rebound With Late-Year Launches, Ranbaxy Lipitor Deal / The Israel-based manufacturer saw its full-year U.S. generic revenues drop 32% due to expired marketing exclusivities and manufacturing problems at two plants. However, the fourth quarter brought a rebound, thanks to launches of generic Zyprexa and Combivir and a profit-sharing agreement on atorvastatin. / “The Pink Sheet” DAILY Feb. 16, 2012

Challenging Lucentis: Eylea’s Early Progress Prompts $250 Mil.-$300 Mil. Sales Forecast For 2012 / Eylea manufacturer Regeneron says the new treatment for wet AMD is being reimbursed by all regional Medicare claims contractors. / “The Pink Sheet” DAILY Feb. 16, 2012

Acorda Expands Pipeline With Neuronex And New Ampyra Indications / Acorda Therapeutics reports strong Ampyra results in the fourth quarter and highlights the other indications it’s pursuing for the drug, as well as the consumer marketing campaign the company is about to undertake. Acorda also announced its intention to acquire privately-held Neuronex Inc. for $2 million upfront plus $500,000 in R&D funding. / “The Pink Sheet” DAILY Feb. 16, 2012

“Arimidex Direct” Program Will Provide Branded Cancer Drug To U.S. Patients For $40 A Month / Spurred on by patient requests for affordable access to the branded version of now generic anastrozole, AstraZeneca will partner with Express Scripts to provide the drug direct to patients at a fixed co-payment. / “The Pink Sheet” DAILY Feb. 16, 2012