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Home » Topics » Pharmaceuticals » Research and Development

Research and Development
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EU, Australia to Collaborate on Orphan Medicines

April 7, 2014
The EMA says that it already shares much information with its Australian counterpart, such as GMP standards. Read More

BMS Files for Approval of Daclatasvir, Asunaprevir for Hepatitis C

April 7, 2014
The EMA validated BMS’ application earlier this year, the company says, with priority review underway in Japan. Read More

Safety Concerns Set Back Another Halozyme Mid-Stage Trial

April 4, 2014
Halozyme has temporarily halted another trial due to safety concerns. This time, the drugmaker decided to hit the brakes after patients treated with PEGPH20, a pegylated form of its anti-cancer enzyme rHuPH20, showed increased risk for certain blood clots. Read More

Merck, Ferring, WHO Join Forces Against Postpartum Hemorrhage

April 4, 2014
Merck, Ferring Pharmaceuticals and the World Health Organization have partnered up to study a drug aimed at preventing excess bleeding during childbirth — the leading cause of maternal deaths during childbirth in developing countries. Read More

FDA Expands Indication for Dyax’s Kalbitor

April 4, 2014
Dyax is working on a second plasma kallikrein inhibitor as well. Read More

FDA Accepts IND for Monoclonal Antibody in Thrombotic Microangiopathies

April 3, 2014
Omeros owns the worldwide rights to MASP-2 inhibition, as well as to any other therapies targeting MASP-2. Read More

Another NSCLC Drug Fails Phase III

April 2, 2014
GlaxoSmithKline has joined a list of drugmakers whose non-small cell lung cancer (NSCLC) drug candidates have failed in Phase III trials in the past year. Read More

TGA Updates Guidelines for Transmissible Spongiform Encephalopathies

April 2, 2014
Australia uses European Pharmacopeia practices and recommendations as its default standard. Read More

Celgene and Forma Enter Into New Multi-Year Collaboration

April 2, 2014
Celgene and Forma Therapeutics are expanding their strategic collaboration with a multi-year agreement that includes a buyout option. Read More

Stakeholders Urge ‘Carrot and Stick’ Approach to Boost Subgroup Research

April 1, 2014
Advocates for minorities and other patient groups that are underrepresented in clinical trials want the FDA to create incentives for drugmakers that include those groups in studies and become more aggressive in delaying drugs that don’t include them. Read More

Sanofi & Regeneron Trumpet Phase II Results of Alirocumab in Japan

April 1, 2014
Sanofi and Regeneron’s investigational monoclonal antibody alirocumab met its primary endpoint in a Japanese Phase II study. Read More

Novartis Halts Heart Trial, Touts Positive Phase III Results

March 31, 2014
Novartis said Monday it has halted the Phase III trial of its chronic heart failure drug LCZ696 after being notified by a data monitoring committee that the drug met its composite primary endpoint of delayed cardiovascular death and reduced heart failure hospitalizations. Read More
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