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Home » Authors » Brian Orelli

Articles by Brian Orelli

Winners and losers from the FDA approval class of 2014

Nov. 27, 2017
By Brian Orelli
Immuno-oncology drugs Keytruda (pembrolizumab, Merck & Co. Inc.) and Opdivo (nivolumab, Bristol-Myers Squibb Co.) came in first and third in the latest edition of the Trinity Drug Index, with hepatitis C drug Harvoni (sofosbuvir/ledipasvir, Gilead Sciences Inc.) taking the second spot. This version of the annual index scores the 41 drugs approved by the FDA in 2014 based on commercial, therapeutic and R&D categories.
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Winners and losers from the FDA approval class of 2014

Nov. 27, 2017
By Brian Orelli
Immuno-oncology drugs Keytruda (pembrolizumab, Merck & Co. Inc.) and Opdivo (nivolumab, Bristol-Myers Squibb Co.) came in first and third in the latest edition of the Trinity Drug Index, with hepatitis C drug Harvoni (sofosbuvir/ledipasvir, Gilead Sciences Inc.) taking the second spot. This version of the annual index scores the 41 drugs approved by the FDA in 2014 based on commercial, therapeutic and R&D categories.
Read More

Single-source manufacturing faster, cheaper in long run

Nov. 13, 2017
By Brian Orelli
The old saying "many hands make quick work" doesn't apply to drug manufacturing for use in clinical trials, according to a new study from The Tufts Center for the Study of Drug Development (CSDD) looking at single-source vs. multivendor manufacturing at contract development and manufacturing organizations (CDMOs).
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Oncology drugs move to China seeking patients and approvals

Oct. 30, 2017
By Brian Orelli
With a third of the world's cancer patients residing in China and upward of half of them enrolling in clinical trials, small U.S.-based companies are looking across the Pacific to test their oncology drug candidates.
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AI drug development lands endorsements from pharma, VC

Oct. 20, 2017
By Brian Orelli
The use of artificial intelligence (AI) in drug development has increased substantially over the last few years. And both large pharmaceutical companies and venture capital are starting to take notice.
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AI drug development lands endorsements from pharma, VC

Oct. 16, 2017
By Brian Orelli
The use of artificial intelligence (AI) in drug development has increased substantially over the last few years. And both large pharmaceutical companies and venture capital are starting to take notice.
Read More

Palleon lands $47.6M Series A round to target glycoimmune checkpoints

Oct. 5, 2017
By Brian Orelli
T-cell checkpoint inhibitors, such as drugs targeting PD-1/PD-L1 and CTLA-4, have been successful at helping the immune system attack certain tumors, but the drugs fail to spur a response in many tumor types. Palleon Pharmaceuticals Inc. is taking a different approach, developing drugs to inhibit glycoimmune checkpoints that allow tumors to evade the innate immune system – dendritic cells, macrophages and NK cells – as well as T cells.
Read More

Liver drug with liver toxicity? Not the best combination

Oct. 4, 2017
By Brian Orelli
It was a rough couple of weeks for Intercept Pharmaceuticals Inc.
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Liver drug with liver toxicity? Not the best combination

Oct. 2, 2017
By Brian Orelli
It's been a rough couple of weeks for Intercept Pharmaceuticals Inc. In the middle of September, Intercept issued a Dear Healthcare Provider letter stressing the importance of proper dosing of its primary biliary cholangitis (PBC) treatment, Ocaliva (obeticholic acid), in patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis) who are supposed to take 5 mg of Ocaliva once weekly, with the possibility to gradually increase to a maximum of 10 mg twice weekly. Instead, some doctors were giving the dose for patients with no or mild hepatic impairment (noncirrhotic or Child-Pugh A cirrhosis), which starts at 5 mg once daily – seven times the dose for patients with moderate or severe hepatic impairment.
Read More

Bad combo for heart drugs: Approvals down, taking longer

Sep. 22, 2017
By Brian Orelli
It's a double whammy for cardiovascular drug developers, according to a new study from the Tufts Center for the Study of Drug Development. It's taking longer to get a cardiovascular drug through the clinic and onto market. And more drugs are failing along the way.
Read More
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