BioPharma Today

Coming in Friday's "The Pink Sheet" DAILY - AstraZeneca Forms Branded Generics Alliance With India's Torrent Pharmaceuticals

AstraZeneca’s emerging markets ambitions take on a new dimension as the company today announced an 18-drug, nine-territory branded generics alliance with India’s Torrent Pharmaceuticals.

Latest News From "The Pink Sheet" DAILY - FDA Tells Congress It Needs More Authority Over Drug Safety

REMS In Review: FDA's Sharfstein Sees Need For Additional Authority

Coming in Friday's "The Pink Sheet" DAILY - Rep. Sander Levin takes helm of House Ways and Means Committee

Congressman Sander Levin becomes interim chair of House Ways and Means Committee after Rep. Charles Rangel steps down due to ethics violations. Levin, D-Mich. has a record of supporting U.S. intellectual property protection abroad and promoting access to generic drugs in needy populations as former Trade Subcommittee chairman.

Latest News from "The Pink Sheet" DAILY - FDA Drug Safety Subject of Congressional Hearing

BMS Buys Into Promising Neuropathic Pain Market Via Allergan Deal

Coming in Friday's "The Pink Sheet" DAILY - President Obama Meets with Congressional Leaders to push forward health care reform bill

President Obama meets with administration officials and Democrat and Republican leaders of the House and Senate during the anticiapted bipartisan health care reform summit, where both sides will try and find some common ground to move legislation forward.

Latest News From "The Pink Sheet" DAILY - Pfizer's Prevnar 13 Vaccine Clears FDA

ACIP's Support Of FDA-Approved Prevnar 13 Creates Opportunity For Larger Market

Coming in Monday's "The Pink Sheet" DAILY - Shire plans to price its Gaucher disease drug 15 percent below Cerezyme

Shire said it hopes to launch its Gaucher disease drug velaglucerase this year and plans to compete with Genzyme’s Cerezyme by pricing its product at $1,350 per 400-unit vial, 15 percent below Cerezyme’s wholesale price. The specialty pharma company also reported in its earnings call that it recorded about 150 patient switches from Genzyme’s Fabrazyme to its Replagal during the fourth quarter due to shortages of the Genzyme drug.

Latest News from "The Pink Sheet" DAILY - LABA Asthma Drugs Hit With REMS

FDA Calls For Class-Wide REMS For LABA Asthma Drugs

Coming in Friday's "The Pink Sheet" DAILY - FDA Sends Cadence Pharmaceuticals "Complete Response" Letter for Ofirmev

Cadence Pharmaceuticals receives a “complete response” letter from FDA for its already delayed new drug application for intravenous acetomimophen (Ofirmev) but the letter cites no safety or efficacy issues and the San Diego specialty pharma does not expect to have to do any further studies. FDA raised concerns about deficiencies at Cadence’s third-party manufacturer, Baxter Healthcare.

Coming in Tuesday's "The Pink Sheet" DAILY

Canadian specialty pharma IntelGenx received a "complete response" letter from FDA for its antidepressant candidate CPI-300, a high-strength formulation of bupropion, the active ingredient in GlaxoSmithKline's venerable mood disorder therapy Wellbutrin XL. The hang-up appears to be more about IntelGenx's late-in-the-game switch of contract manufacturing organizations than the bioequivalence issues that have dogged Teva's generic version of the drug.

FDA's Oncologic Drugs Advisory Committee on Feb. 10 is to review Cell Therapeutics' Pixuvri (pixantrone) injection for treatment of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma who have received two or more prior lines of therapy.