Blog
RSS FeedPosted by Michael Wonder on 14 May 2019
Celgene Corporation announces Pomalyst granted breakthrough therapy designation from FDA for HIV positive and negative Kaposi sarcoma
13 May 2019 - Celgene plans to submit sNDA by end of 2019. ...
Posted by Michael Wonder on 13 May 2019
Novartis pitches discounts on pricey gene therapy for deadly muscle disorder
11 May 2019 - Novartis is offering price discounts in negotiations with U.S. health insurers on its gene therapy for spinal ...
Posted by Michael Wonder on 13 May 2019
Considerations in demonstrating interchangeability with a reference product guidance for industry
9 May 2019 - This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable ...
Posted by Michael Wonder on 13 May 2019
Safety, efficacy, and quality remain top priorities as we continue our work to expand access to cost-saving generic drugs for the American public
13 May 2019 - Millions of Americans have difficulty paying for their prescription medications. ...
Posted by Michael Wonder on 13 May 2019
Two words to help Ned Sharpless revolutionise clinical trials: data standards
13 May 2019 - In the classic 1967 film “The Graduate,” young Benjamin Braddock was given one word of advice ...
Posted by Michael Wonder on 13 May 2019
Grandstanding, not real change: why drug prices in TV ads will be confusing and irrelevant
13 May 2019 - In a fit of hubris, President Trump believes he is making drug makers “come clean” by ...
Posted by Michael Wonder on 13 May 2019
Lilly's Cyramza (ramucirumab) becomes first FDA approved biomarker-driven therapy in patients with hepatocellular carcinoma
13 May 2019 - This new indication - the fifth FDA approval for Cyramza in an advanced or metastatic cancer - ...
Posted by Michael Wonder on 13 May 2019
Intellipharmaceutics announces FDA approval for generic Pristiq
10 May 2019 - Intellipharmaceutics announced today that it has received approval from the U.S. FDA for the Company's abbreviated new ...
Posted by Michael Wonder on 12 May 2019
Teva and other generic drug makers inflated prices up to 1,000%, State prosecutors say
11 May 2019 - According to a new lawsuit, generic medications including oral antibiotics, blood thinners, cancer drugs, contraceptives and HIV ...
Posted by Michael Wonder on 12 May 2019
U.S. FDA accepts Takeda’s biologics license application for a subcutaneous formulation of vedolizumab (Entyvio) for maintenance therapy in moderately to severely active ulcerative colitis
9 May 2019 - An additional treatment modality would provide more flexibility in how patients receive vedolizumab, a biologic with a ...
Posted by Michael Wonder on 12 May 2019
FDA approves prior approval supplement for Bivigam
10 May 2019 - ADMA Biologics announces that the U.S. FDA has approved the Company’s prior approval supplement for Bivigam (immune ...
Posted by Michael Wonder on 10 May 2019
Sunovion and PsychoGenics announce that SEP-363856 has received FDA breakthrough therapy designation for the treatment of people with schizophrenia
10 May 2019 - SEP-363856 offers an innovative approach to the treatment of schizophrenia including the potential to be the first ...
Posted by Michael Wonder on 10 May 2019
Allegations of widespread fraud raise questions about the safety of generic drugs made overseas
10 May 2019 - It is something we've all heard before: generic drugs are the same as brand-name drugs. They ...
Posted by Michael Wonder on 10 May 2019
Statement from Acting FDA Commissioner on policy advancements to help bring interchangeable biosimilars to market
10 May 2019 - The U.S. FDA plays an important role in helping to address the high cost of medicines ...
Posted by Michael Wonder on 09 May 2019
Novartis confident of Zolgensma supply, calls $2 million price 'speculation'
8 May 2019 - Novartis is confident it has adequate production capacity for its Zolgensma gene therapy should regulators this ...