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RSS FeedPosted by Michael Wonder on 18 Jun 2019
FDA approves Merck’s Keytruda (pembrolizumab) as monotherapy for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
18 June 2019 - Marks first approval for Keytruda in small cell lung cancer. ...
Posted by Michael Wonder on 18 Jun 2019
FDA releases new data to help generic drug competitors
18 June 2019 - Generic drug applicants will now have more information from the US FDA when deciding whether to ...
Posted by Michael Wonder on 18 Jun 2019
Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
18 June 2019 - The U.S. FDA is committed to helping facilitate American patients’ access to lower-cost generic medicines by ...
Posted by Michael Wonder on 17 Jun 2019
Eiger announces breakthrough therapy designation granted by FDA for avexitide for treatment of post-bariatric hypoglycemia
17 June 2019 - Third Eiger pipeline program granted breakthrough therapy designation. ...
Posted by Michael Wonder on 17 Jun 2019
FDA approves new treatment for paediatric patients with type 2 diabetes
17 June 2019 - The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of paediatric patients 10 ...
Posted by Michael Wonder on 15 Jun 2019
Blueprint Medicines submits new drug application to U.S. FDA for avapritinib for the treatment of PDGFRA exon 18 mutant GIST and fourth-line GIST
14 June 2019 - Blueprint Medicines Corporation today announced it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 14 Jun 2019
Pharma blockchains AI for drug development
15 June 2019 - The venture would allow AI to be trained on millions of datapoints across databases from several drug ...
Posted by Michael Wonder on 14 Jun 2019
Ensuring innovation and competition for biologics leads to more timely products for patients
13 June 2019 - Today, the FDA approved the agency’s 20th biosimilar product, Kanjinti (trastuzumab-anns), for the treatment of patients with ...
Posted by Michael Wonder on 13 Jun 2019
Amgen wins FDA approval for Kanjinti injection for treatment of breast cancer, gastro-esophageal junction adenocarcinoma
13 June 2019 - U.S. FDA says Kanjinti (trastuzumab-anns) is biosimilar to Herceptin (trastuzumab). ...
Posted by Michael Wonder on 13 Jun 2019
FDA grants priority review to Genentech’s Rituxan (rituximab) in children with two rare blood vessel disorders
12 June 2019 - If approved, this would be the first paediatric indication for Rituxan. ...
Posted by Michael Wonder on 12 Jun 2019
Catalyst Pharma sues FDA over approval of cheaper rival drug
12 June 2019 - Catalyst Pharmaceuticals Inc, which has come under fire for the high price tag on its rare ...
Posted by Michael Wonder on 11 Jun 2019
Should the FDA disclose new filings for drugs, biologics and biosimilars?
11 June 2019 - In 2010, the FDA issued draft recommendations on increasing the transparency of the FDA’s processes and ...
Posted by Michael Wonder on 11 Jun 2019
Jacobus prices its rare disease drug at half of what Catalyst charges, but will doctors prescribe it?
10 June 2019 - After weeks of anticipation, Jacobus Pharmaceutical, a small, family-run drug maker, has priced its rare disease ...
Posted by Michael Wonder on 11 Jun 2019
FDA approves two new indications for Merck’s Keytruda (pembrolizumab)
11 June 2019 - Keytruda now approved for first-line treatment of patients with metastatic or with unresectable, recurrent head and neck ...
Posted by Michael Wonder on 10 Jun 2019
The $2.1 million question: what are the medical, ethical implications of the world's priciest drug?
10 June 2019 - With last month’s FDA approval, Zolgensma became the world’s most expensive medication. ...