Trasylol® - One Thousand Lives A Month
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EUSA Pharma Out-Licenses Preclinical-Stage Human Antibody to GlaxoSmithKline
FDA grants fast track designation for Boehringer Ingelheim's BIBW 2992
Boehringer Ingelheim's investigational cancer treatment BIBW 2992 has recently received a Fast Track Designation status by the FDA. Under this designation, Boehringer Ingelheim will conduct a pivotal trial programme studying BIBW 2992 in a non-small cell lung cancer (NSCLC) patient group where prior treatment with reversible EGFR inhibitors has failed. Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin)
Abbott received U.S. Food and Drug Administration (FDA) approval for SIMCOR(R), the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan(R) (Abbott's proprietary niacin extended-release) and simvastatin. SIMCOR is approved for use along with diet to lower levels of elevated total cholesterol, LDL "bad" cholesterol and triglycerides, and to raise HDL "good" cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate. Pharmion and MethylGene Announce U.S. Orphan Drug Designation
Pharmion Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Companies' histone deacetylase (HDAC) inhibitor, MGCD0103, as an Orphan Drug for the treatment of acute myelogenous leukemia (AML) in the United States. AstraZeneca and Nomura Phase4 Ventures Announce Creation of New Company "Albireo"
AstraZeneca and Nomura Phase4 Ventures today announced the signing of a deal to form Albireo, a company focused on developing new treatments for gastrointestinal (GI) disorders. The Medicines Company Reports Full Year and Fourth Quarter 2007 Financial Results
The Medicines Company (NASDAQ: MDCO) today announced its financial results for the full year and fourth quarter of 2007. Financial highlights for the full year of 2007:
- Net revenue increased by 20% to $257.5 million for 2007 from $214.0 million for 2006.
More Pharma News ...
Business & Industry
- Pfizer to supply Global Fund up to 6 million PAXLOVID™ treatment courses for low-and-middle-income countries
- WHO grants prequalification to GSK's Mosquirix - the first and only approved malaria vaccine
- Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in European Union
- Novartis invests in early technical development capabilities for next-generation biotherapeutics
- FDA grants Breakthrough Therapy Designation to Pfizer's Group B Streptococcus vaccine candidate
Research & Development
- Breakthrough brings potential glioblastoma drug into focus
- Similar medications cost more for humans compared to pets
- National CDC-funded study confirms that mRNA vaccines protect against serious COVID-19 during pregnancy
- 2nd Annual Next Generation Pharmaceutical Cleanrooms Conference
- Shutting down backup genes leads to cancer remission in mice
- Bird's enzyme points toward novel therapies
- WHO strongly advises against antibody treatments for COVID-19 patients
Conferences & Events
- Machine learning creates opportunity for new personalized therapies
- SAE Media Group proudly presents the 2nd Annual Aseptic Processing Conference
- Pharma join together to achieve new standards in digital and patient innovation for clinical transformation
- SMi's 22nd Annual Pain Therapeutics Conference
- SMi Group Introduces the 4th Annual Injectable Drug Delivery Conference 2022
- SMi's 5th Annual Pharmaceutical Microbiology East Coast Conference
- SMi's 3rd Annual AI in Drug Discovery Conference
Regulatory Affairs
- FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease
- FDA approves first systemic treatment for alopecia areata
- FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain
- FDA limits use of Janssen COVID-19 vaccine to certain individuals
- EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice