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RSS FeedPosted by Michael Wonder on 30 Jan 2019
FDA approves first generic Advair Diskus
30 January 2019 - The U.S. FDA today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation ...
Posted by Michael Wonder on 30 Jan 2019
Merck receives breakthrough therapy designation from FDA for V114, the company’s investigational 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease, in infants, children, and adolescents
30 January 2019 - Merck today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation ...
Posted by Michael Wonder on 30 Jan 2019
Statement from FDA Commissioner on the agency’s efforts to enhance the utility of the Orange Book to foster drug competition
30 January 2019 - One of our key policy priorities is encouraging the timely development and approval of generics and ...
Posted by Michael Wonder on 30 Jan 2019
Duchesnay receives approval of supplemental new drug application to add moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy due to menopause, to the indication of Osphena (ospemifene)
29 January 2019 - Duchesnay announced today that the FDA has approved its supplemental new drug application seeking to add moderate ...
Posted by Michael Wonder on 29 Jan 2019
America’s love affair with cheap drugs has a hidden cost
29 January 2019 - Data, documents and interviews show how a focus on cutting prices has come with risks to consumer ...
Posted by Michael Wonder on 28 Jan 2019
AbbVie announces U.S. FDA approval of Imbruvica (ibrutinib) plus obinutuzumab (Gazyva) - first chemotherapy-free, anti-CD20 combination regimen approved for chronic lymphocytic leukaemia/small lymphocytic lymphoma in previously untreated patients
28 January 2019 - FDA approval is based on positive Phase 3 iLLUMINATE (PCYC-1130) study results, which demonstrated Imbruvica plus obinutuzumab ...
Posted by Michael Wonder on 25 Jan 2019
Using the E value to assess the potential effect of unmeasured confounding in observational studies
24 January 2019 - Randomised trials serve as the standard for comparative studies of treatment effects. ...
Posted by Michael Wonder on 24 Jan 2019
FDA statement from Commissioner announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications
24 January 2019 - In making decisions about whether the benefits of a drug outweighs its risks, there are many ...
Posted by Michael Wonder on 24 Jan 2019
BMS announces voluntary withdrawal of U.S. application for Opdivo plus low dose Yervoy for treatment of first-line lung cancer in patients with tumor mutational burden ≥10 mutations/megabase, following discussions with the U.S. FDA
24 January 2019 - Following recent discussions with the U.S. FDA, the company today announced the voluntary withdrawal of the ...
Posted by Michael Wonder on 24 Jan 2019
U.S. FDA accepts sNDAs for Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate)
23 January 2019 - Potential new indication would expand use to allow treatment-experienced adults living with HIV-1 whose virus is suppressed ...
Posted by Michael Wonder on 24 Jan 2019
Genmab announces initiation of U.S. FDA regulatory submission for label expansion of daratumumab in combination with lenalidomide and dexamethasone in front line multiple myeloma
22 January 2019 - First part of regulatory package submitted to the U.S. FDA for label expansion of daratumumab in combination ...
Posted by Michael Wonder on 24 Jan 2019
FDA approves use of 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) in children as young as 6 months of age
23 January 2019 - The 0.5 mL dose is now approved for use in children 6 months through 35 months of ...
Posted by Michael Wonder on 24 Jan 2019
Toward an effective innovation agenda
23 January 2019 - Digital technologies have transformed the U.S. and global economies, offering tremendous benefits to consumers and financial success ...
Posted by Michael Wonder on 23 Jan 2019
Modernising clinical trials for patients with cancer
23 January 2019 - Clinical trials involve evaluating and validating new therapies in humans and represent the fundamental means of making ...
Posted by Michael Wonder on 23 Jan 2019
Physicians’ perspectives on FDA approval standards and off-label drug marketing
22 January 2019 - Recently, two fundamental aspects of the US FDA’s pharmaceutical market oversight have become controversial. ...