AACR: A ’tissue agnostic’ indication for Retevmo? Lilly says it’s possible with RET cancer win

MedicaloidApril 12, 2021

April 12, 2021

Eli Lilly’s Retevmo is already approved to treat lung and thyroid cancers driven by alterations in the RET gene. Now, the Indianapolis pharma believes it...

Servier found guilty of fraud, manslaughter in long-running case over deadly weight-loss pill

MedicaloidMarch 29, 2021March 29, 2021

March 29, 2021March 29, 2021

A major pharma scandal in France has culminated in a ruling against domestic firm Servier for its role in the hundreds of deaths caused by...

FDA slaps new warning on GlaxoSmithKline’s Shingrix based on post-marketing findings

MedicaloidMarch 25, 2021

March 25, 2021

GlaxoSmithKline’s vaccine cash cow Shingrix has a new safety warning on its label, although regulators still maintain the shot’s benefits outweigh risks. Wednesday, the FDA alerted...

Novo Nordisk’s high-dose Ozempic stalls at FDA’s door on lack of manufacturing data

MedicaloidMarch 23, 2021

March 23, 2021

Novo Nordisk’s been eyeing a weekly dosing regimen for its GLP-1 diabetes med Ozempic to better compete with Eli Lilly’s rival drug Trulicity. But that...

Incyte, Novartis aim to make Jakafi available in severe COVID-19 after narrow trial miss

MedicaloidMarch 19, 2021

March 19, 2021

Over the span of more than a year during the pandemic, pharma companies of all stripes have tested their existing medicines against COVID-19. Incyte is...

FDA’s toughness towards AbbVie, FibroGen and Acadia raise worries of more stringent drug reviews: analyst

MedicaloidMarch 18, 2021

March 18, 2021

The FDA recently sent out two head-scratching notices to FibroGen and Acadia Pharmaceuticals, delaying decisions on their drug applications. Is it a sign of more...

AstraZeneca sells hundreds of thousands more doses of COVID-19 antibody combo to U.S. for $205M

MedicaloidMarch 16, 2021March 16, 2021

March 16, 2021March 16, 2021

As AstraZeneca’s COVID-19 vaccine woes mount in Europe, the company is expanding its deal with the U.S. to tackle the pandemic fight on the treatment...

Novartis’ Sandoz, with Aubagio generic in its sights, sues FDA to launch copycat first

MedicaloidMarch 11, 2021

March 11, 2021

Here’s a hypothetical: What happens when the FDA grants exclusivity to a new drug ingredient that isn’t exactly new? Novartis’ generics unit claims the agency did just...

Roche’s Actemra adds another failure to spotty COVID-19 results—this time with Gilead’s remdesivir

MedicaloidMarch 11, 2021March 11, 2021

March 11, 2021March 11, 2021

As one of the earliest drugs proposed to treat COVID-19, Roche’s arthritis therapy Actemra has already amassed a large pool of data for that use—but it’s...

Ultrarare disease specialists top 2021’s pricey drugs list, but Takeda, Merck KGaA meds rank, too

MedicaloidMarch 9, 2021

March 9, 2021

Eiger BioPharmaceuticals in November snagged FDA clearance for Zokinvy for ultrarare rapid-aging diseases that affect an estimated 600 people worldwide. Orphan drugs that treat small...

Marketing

AACR: A ’tissue agnostic’ indication for Retevmo? Lilly says it’s possible with RET cancer win

Servier found guilty of fraud, manslaughter in long-running case over deadly weight-loss pill

FDA slaps new warning on GlaxoSmithKline’s Shingrix based on post-marketing findings

Novo Nordisk’s high-dose Ozempic stalls at FDA’s door on lack of manufacturing data

Incyte, Novartis aim to make Jakafi available in severe COVID-19 after narrow trial miss

FDA’s toughness towards AbbVie, FibroGen and Acadia raise worries of more stringent drug reviews: analyst

AstraZeneca sells hundreds of thousands more doses of COVID-19 antibody combo to U.S. for $205M

Novartis’ Sandoz, with Aubagio generic in its sights, sues FDA to launch copycat first

Roche’s Actemra adds another failure to spotty COVID-19 results—this time with Gilead’s remdesivir

Ultrarare disease specialists top 2021’s pricey drugs list, but Takeda, Merck KGaA meds rank, too

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