Follow-on Biologics

FACTBOX-Winners, losers in U.S. Senate health bill
Reuters | 8 hours 31 minutes ago
Nov 21 (Reuters) - Democrats in the U.S. Senate cleared the first procedural hurdle for sweeping healthcare reform on Saturday by voting to open debate on the historic legislation.


Winners, losers in U.S. Senate health bill
Edmonton Journal (Canada), The | 11 hours 34 minutes ago
Democrats in the U.S. Senate cleared the first procedural hurdle for sweeping healthcare reform on Saturday by voting to open debate on the historic legislation.The Senate debate due to start on Nov. 30 is expected to last for at least three weeks.


Senate health bill helps chiropractors, biologic drugmakers but whacks insurance executives
Sun (Baltimore), The | 1 day 8 hours 16 minutes ago
Chiropractors get a lift in the Senate health care bill, thanks to a senator from the state practitioners consider the birthplace of their profession ? Iowa.


FDA Expert Panel Declines to Endorse New Influenza Vaccine
Medscape (free registration) | 1 day 13 hours 16 minutes ago
The Food and Drug Administration's (FDA) Vaccines and Related Biologic Products Advisory Committee sent Protein Sciences Corporation back to the drawing board at a hearing yesterday, saying it needed more safety and efficacy data before it could wholeheartedly endorse the company's bid for licensure of its novel influenza vaccine.


Senate Healthcare Bill Preserves Biologics Exclusivity, Drugmaker Fee
FDAnews | 1 day 15 hours 17 minutes ago
The Senate’s $849 billion healthcare overhaul legislation, like the House version, gives biologics innovators 12 years of exclusivity and requires a 50 percent discount on negotiated prices for brand drugs in Medicare formularies when beneficiaries fall into a coverage gap.


Merck Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA(R) [Press Release]
PRNewswire | 1 day 18 hours 47 minutes ago
...treatments, among others.(3) Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative...


Pfizer Receives FDA Approval For Geodon (Ziprasidone HCI) Capsules For The Adjunctive Maintenance Treatment Of Bipolar Disorder In Adults [Press Release]
Business Wire | 1 day 19 hours 36 minutes ago
Pfizer today announced that the U.S. Food and Drug Administration (FDA) has approved Geodon® (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.


FDA Approves Intravenous Formulation Of Pfizer s Revatio (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension [Press Release]
Business Wire | 2 days 24 minutes ago
Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.


Peter Orszag: Bills offer clear path to better health care
Washington Post, The | 2 days 7 hours 40 minutes ago
The nation stands on the verge of achieving fundamental health-care reform.


We can deliver health reform
Washington Post, The | 2 days 8 hours 43 minutes ago
The nation stands on the verge of achieving fundamental health-care reform.


FDA Advisory Committee Finds Data Support the Claim That SPIRIVA HandiHaler Reduces COPD Exacerbations [Press Release]
Business Wire | 2 days 16 hours 18 minutes ago
The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application (sNDA) provide substantial and convincing evidence to support the claim that SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) reduces exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD).


VisEn Launches New OsteoSense(R) 800 and VivoTag(R) 800 Fluorescence Molecular Imaging Agents [Press Release]
PRNewswire | 2 days 18 hours 54 minutes ago
...readouts in vivo. VisEn now offers over 30+ different fluorescence molecular agents for imaging key disease-associated biologic targets, processes and pathways. VisEn agent brands include ProSense(R), IntegriSense(TM), AngioSense(TM), OsteoSense...


Research and Markets: Pharmaceutical Market Access, Pricing, and Reimbursement News in the Second Quarter of 2009 [Press Release]
Business Wire | 2 days 20 hours 24 minutes ago
Research and Markets (http://www.researchandmarkets.com/research/68a204/pharmaceutical_mar) has announced the addition of Decision Resources, Inc.'s new report "Pharmaceutical Market Access, Pricing, and Reimbursement News in the Second Quarter of 2009" to their offering.


Fact or Fiction: Generic Drugs Are Bad for You
ScientificAmerican.com | 2 days 21 hours 30 minutes ago
As we cope with the economic recession, we've all had to make concessions. It's been "good-bye" to European vacations, organic milk and magazine subscriptions. But there are those things we can't give up without risking serious illness or death, one of which is prescription medication.


Week of Nov. 16, 2009: GSK and Nabi Form Nicotine Vaccine Agreement; Eli Lilly Research Exec to Retire; More... - Pharmaceutical Technology [Press Release]
PharmTech.com | 2 days 22 hours 15 minutes ago
Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more...





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