Articles By Cyndi Root
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U.S. Lawmakers To Add Ebola Drugs To Priority Review Voucher Program
11/3/2014
Lawmakers in the U.S. seek to add the Ebola virus to the priority review voucher program that extends benefits to pharmaceutical companies for developing treatments for certain diseases.
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New EMA Guidance On Biosimilars
11/3/2014
The European Medicines Agency (EMA) has enacted new guidelines to help industry navigate biosimilar regulation. It says that regulators face challenges in regulating biosimilars because, unlike chemical medicines, biologics are nearly impossible to duplicate.
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Bristol-Myers Squibb's Opdivo Succeeds Again In Lung Cancer Phase 2 Trial
11/3/2014
Bristol-Myers Squibb (BMS) has succeeded again in the CheckMate -063 Phase 2 trial testing Opdivo (nivolumab) against advanced squamous cell non-small cell lung cancer (NSCLC).
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Boehringer Ingelheim, Lilly Revise Diabetes Alliance
10/31/2014
Boehringer Ingelheim and Eli Lilly have revised their Diabetes Alliance in an effort to enhance efficiency and focus on product launches.
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Bristol-Myers Squibb Acquires Option To Buy F-star Alpha, FS102 For HER2 Cancers
10/31/2014
Bristol-Myers Squibb Company (BMS) may opt to buy F-star Alpha and its lead HER2 oncology candidate, FS102. The exclusive option to acquire F-star Alpha and its assets was announced in a press release, which disclosed that the aggregate deal is worth $475 million.
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Takeda Licenses Mersana's Fleximer-ADC Candidate For Onco-Targets
10/31/2014
Takeda’s Millennium Pharmaceuticals has licensed Mersana Therapeutics’ Fleximer- antibody-drug conjugate (ADC) candidate for oncology indications.
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FDA Approves Baxter's Obizur For Acquired Hemophilia A
10/29/2014
Patients with acquired hemophilia A (AHA), a rare bleeding disorder, have a new treatment, as the Food and Drug Administration (FDA) has approved Baxter’s Obizur.
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Celgene Partners With Sutro On ADCs, Acquires Option To Buy Sutro
10/29/2014
Celgene Corporation has expanded its partnership with Sutro Biopharma and has obtained an exclusive option to acquire Sutro.
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WHO Urges More R&D In Tuberculosis
10/28/2014
Tuberculosis (TB) incidence is higher than previously estimated, according to the World Health Organization (WHO).
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FDA Accepts Merck's, Sanofi's BLA For Pediatric Hexavalent Vaccine
10/23/2014
Merck and Sanofi are a step closer to approval of their pediatric hexavalent vaccine, (DTaP5-IPV-Hib-HepB1), as the Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA). The two companies announced the application acceptance in a press release, stating that the pediatric combination vaccine helps protect against six diseases.