BioPharma Today

Coming In Monday's "The Pink Sheet" DAILY - EMA Panel Again Rejects Vivus' Obesity Drug Qsiva

The European Medicines Agency has knocked back Vivus Inc.’s Qsiva (phentermine/topiramate) for the treatment of obesity for a second time.  The decision from the Committee for Medicinal Products for Human Use is likely to delay EU approval of the drug by at least two years.

Financings of the Fortnight takes note of pending IPOs and a largely self-financed Series C round by San Diego’s Elcelyx. Plus news on recent financings by Jounce Therapeutics, Retrophin and e-Therapeutics.

Receptor tyronsine kinase-focused Kolltan Pharmaceuticals looks to move into a new stage as it readies its first candidate for an IND and names a Chief Business Officer, Jane Henderson. Although Kolltan once had an option arrangement with Celtic Therapeutics, the company says its technology now is unencumbered by any options or partnerships.

Compounding pharmacy association says its position on non-traditional manufacturing is “not a major departure” from previous statements.

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Latest News From "The Pink Sheet" DAILY - GPhA Objects To Amgen Push To Restrict Biosimilar Substitution

Biosimilar Diplomacy By Other Means: GPhA CEO Calls Out Amgen Guest During speech to the group's annual meeting, GPhA President Ralph Neas says he is disappointed that Amgen, which is among the firms attending the gathering, is pushing biosimilar substitution restrictions in state legislatures.

Coming In Wednesday's "The Pink Sheet" DAILY - Supreme Court Takes Up Monsanto Patented Plant Seed Case

Supreme Court hears oral arguments today in Bowman v. Monsanto, which addresses whether the authorized sale of one generation of a patented plant seed exhausts a patentee’s right to control subsequent generations of that seed. The biotechnology industry is concerned that a finding against Monsanto could affect the sale of such products as DNA preparations, nucleic acid preparations, stem cells and cell cultures since they are replicable in a lab or cell culture.

Roche is betting Chiasma’s daily oral drug Octreolin will prove a winner for treating the orphan disease acromegaly. It hopes the Israel-based biotech’s underlying Transient Permeability Enhancer technology can be used to develop other oral drugs that previously were only available by injection.

 

Latest News From "The Pink Sheet" DAILY - GPhA Is Focused On Generic User Fees, Biosimilar Patway

GPhA's Goals For 2013: Smooth GDUFA Implementation, Workable Biosimilar Pathway The generic drug trade association's cross-cutting priorities are the result of an extensive strategic planning process, CEO Ralph Neas says; the group is planning outreach to Congress and the executive branch to highlight the role generic drugs can play in helping to address the nation's fiscal problems.

Coming In Monday's "The Pink Sheet" DAILY - Actelion Prepares For Tracleer Patent Expiration

Dependent largely on the PAH drug Tracleer for most of its sales revenue, Actelion outlined a three-pronged strategy for moving ahead as the drug faces patent expirations in different markets. The biotech’s plans include launching a branded generic in Europe and developing a second specialty franchise.

Affymax CEO discusses the company’s business development strategy with “The Pink Sheet” DAILY, while the company deals with the news that the largest dialysis provider will not expand the use of Omontys at its centers.

GTx’s novel targeted estrogen therapy capesaris may prove efficacious at doses many times smaller than when it was put on clinical hold for a thrombosis signal this time last year. And if its safety profile holds, the company plans to test the drug in combination with androgen deprivation therapy in hormone naïve prostate cancer patients, a relatively wide-open market.

 

Coming In Monday's "The Pink Sheet" DAILY - FDA Cites Novo Nordisk For GMP Violations

FDA has sent a warning letter to diabetes specialist Novo Nordisk outlining good manufacturing practice violations at its plant in Bagsvaerd, Denmark. The agency is requesting a response to its concerns by April 11.

Latest News From "The Pink Sheet" DAILY - Amgen Plans To Launch Biosimilars of Humira, Remicade

Defender Or Opponent? Amgen Straddles The Biosimilar Line Amgen revealed plans to develop and launch biosimilar versions of Abbott's Humira and Johnson & Johnson's Remicade - two competitors to its blockbuster anti-TNF Enbrel - during an investor meeting in New York City Feb. 7.

Coming In Wednesday's "The Pink Sheet" DAILY - Hemispherx Objects To FDA Letter On Ampligen

In preliminary guidance issued on Feb. 1, the U.K.'s National Institute for Health and Clinical Excellence turned down Bristol-Myers Squibb/AstraZeneca’s Forxiga (dapagliflozin) in combination therapy to treat type 2 diabetes, citing uncertainties over both clinical and cost-effectiveness data. It represents an ominous, but not insurmountable setback in Europe for a drug that has already caused the troubled companies problems on the other side of the Atlantic.

Latest News From "The Pink Sheet" DAILY - Sun Pharma's Generic Doxil To Curtail Shortages

Sun's Generic Doxil Clears FDA; Janssen Uses Alternative Manufacturing Process FDA approval of the first generic version of Janssen's Doxil to curtail drug's shortage; agency also permits Janssen to use an alternative manufacturing process. 

Latest News From "The Pink Sheet" DAILY - Merck's Oxytrol For Women Is Approved For OTC Use

Once-Weekly Insulin Added To Novo Nordisk's Clinical Pipeline Novo Nordisk is evaluating new long-acting and quick-acting insulins in clinical trials as competitive pressure looks set to intensify in 2013 for its market-leading GLP-1 agonist, Victoza.