If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting ...
Nine new coronavirus cases are tied to the Biogen outbreak — as infections spread to 'close contacts'
Health officials in Massachusetts have identified 13 new presumptive cases of coronavirus, with 9 of them tied to the Biogen meeting at Boston Marriott Long Wharf. And this time they’re underscoring how staffers are spreading the disease outside the immediate group of 175 meeting attendees.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.
FDA approves ex-Novartis drug for Cushing’s disease
Two months after winning European approval, a one-time Novartis orphan drug for Cushing’s disease has been OK’d by the FDA.
Isturisa, known chemically as osilodrostat, has been approved as a twice-daily pill for those who have not undergone the pituitary gland surgery often used to treat Cushing’s disease, or for those whose symptoms persist after the operation. Novartis sold the compound alongside two other endocrine drugs to the Italian pharma Recordati last July for $390 million, plus Isturisa milestones.
As Biogen grapples with coronavirus crisis, Big Pharmas like Eli Lilly, Takeda hunker down, tell staffers to work from home
With the number of coronavirus cases spiraling upwards over the weekend at Biogen, other biopharma companies are hunkering down and adding new precautionary measures to help prevent infections on staff.
A spokesperson for Takeda — which has a big presence in the Boston/Cambridge area since closing the Shire buyout — tells me that they adopted new work guidelines on Sunday. And Indianapolis-based Eli Lilly reportedly did the same after 2 attendees at the Biogen meeting returned to Indiana with the new coronavirus. Lilly sent out word on Sunday that staffers should work remotely if at all possible, according to the Indianapolis Star.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.
European regulators expand use of AbbVie's two-month hep C regimen
The landscape of hepatitis C — once a devastating liver-damaging disease — has changed dramatically since 2014, when the first raft of new therapies ushered in an era that has culminated in potential cure rates of more than 90% today, regardless of the patient’s genotype. The first of these revolutionary but pricey drugs was Sovaldi — its maker Gilead debuted the three-month regimen at an eye-popping $1,000 a pill.
AstraZeneca's Imfinzi fails bladder cancer trial — in patient population covered by FDA's 2017 accelerated approval
A post-approval commitment testing Imfinzi in a late-stage bladder cancer population has gone pear-shaped for AstraZeneca, as the checkpoint inhibitor failed to help patients live longer in an open-label pivotal study.
Back in 2017, the PD-L1 drug was granted accelerated approval by the FDA for patients with locally advanced or metastatic bladder cancer whose disease has persisted despite platinum-containing chemotherapy on the basis of Phase I/II data.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.
More than half of its gross sales ultimately went to payers as rebates, Sanofi says
In a new report, Sanofi is adding another data point to one of pharma’s go-to defenses regarding their pricing practices.
As much as 55% of its gross sales in 2019 were given back to payers in the form of rebates, the pharma giant disclosed, including $5.5 billion in mandatory rebates to the government and $8.4 billion in discretionary rebates to insurance companies.
Once that is taken into account, the average aggregate net price of Sanofi’s portfolio of drugs — distinct from the list price, which went up by 2.9% — recorded a 11.1% decrease last year.
FDA requires boxed warning for Singulair and its generics
The FDA on Wednesday said it is requiring a boxed warning and medication guide for Merck’s asthma and allergy drug Singulair (montelukast) and its generics to strengthen existing warnings about the risk of neuropsychiatric events, including suicides, linked to the drug.
The agency also says that montelukast should not be used in patients with mild symptoms and should only be used to treat allergic rhinitis in patients have not responded to or who cannot take other treatments.
Vilified for high drug prices, what does the profitability of major US pharma companies look like?
Health care is a human right, not a privilege, global policymakers like to underscore. But in practice in the United States, affordability is one of the most crucial hurdles to accessing care. As the clarion call to lower US drug prices hits deafening heights, a new study suggests that major drugmakers aren’t necessarily raking in more profits than other industries that also depend on science and technology to develop their offerings.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.
AMAG CMO hits the exit just as biotech searches for new CEO to right a ship rocked by Makena controversy
Heading into 2020, AMAG Pharmaceuticals has sketched big plans to salvage its wobbly operations — battling a revenue squeeze and a critical FDA review of its preterm birth drug — under a new CEO. Today, it announced that the chief medical officer won’t be staying, either.
Julie Krop, who joined AMAG in 2015, will decamp by the end of the month, leaving a void in the biotech’s development group just as it pledges to persuade the FDA to keep Makena on the market and advance a “potentially exciting pipeline.”
March 4, 2020 07:01 AM ESTUpdated March 6, 09:01 AM
Add Takeda and Alnylam to the menu of global drugmakers looking to stymie the coronavirus epidemic
As the WHO declares that the global mortality rate of the infections caused by the new coronavirus stands at 3.4%, Takeda and Alnylam have joined the ranks of drugmakers working on an antidote.
Takeda is looking to develop a plasma-derived therapy — which it says has been shown to be effective in treating severe acute viral respiratory infections — for individuals at high risk of contracting Covid-19.
Julie Kim
The therapy, which is being referred to as TAK-888, will be derived from the blood of coronavirus patients who have recovered from the respiratory disease — using the rationale that antibodies cultivated by recovered patients should arm the immune systems of new patients with fresh ammunition to destroy the infection.
“What we are trying to develop here … will not prevent the disease, but hopefully we’ll be able to treat severe patients who are suffering from Covid-19, and potentially provide some protection to frontline healthcare workers,” Julie Kim, head of Takeda’s plasma-derived therapies business unit, told Endpoints News. “It’ll be great once the vaccine is available, then you can actually prevent the disease.”
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.
