Vivek Ramaswamy’s ‘vant’ brainchildren keep bearing fruit with Urovant’s FDA nod for incontinence med vibegron

December 23, 2020 04:31 PM ESTUpdated December 24, 07:14 AM

Vivek Ramaswamy's 'vant' brainchildren keep bearing fruit with Urovant's FDA nod for incontinence med vibegron

Max Gelman

Senior Editor

Christmas has come early for Urovant Sciences as the former Vivek Ramaswamy outfit scored an FDA approval for its lead program.

The biotech’s overactive bladder candidate vibegron will be the newest drug to hit the market, the agency said Wednesday, giving Urovant its first approved product. Vibegron, a beta-3 agonist that’s taken as a once-daily pill, will be sold as Gemtesa. The drug is likely to launch in early 2021, CEO James Robinson has previously said.

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May 24, 2022 08:49 AM EDTUpdated 03:54 PM

R&D

In Focus

A new era of treatment: How biomarkers are changing the way we think about cancer

Nicole DeFeudis

Editor

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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May 25, 2022 12:46 PM EDT

Pharma

FDA+

FDA spells out the rules and restrictions for states seeking to import drugs from Canada

Zachary Brennan

Senior Editor

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

May 25, 2022 02:21 PM EDTUpdated 03:08 PM

Pharma

Manufacturing

Eli Lilly set to invest $2.1B in home state manufacturing boost

Tyler Patchen

News Reporter

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Gilead Sciences

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May 25, 2022 02:19 PM EDTUpdated 03:11 PM

Coronavirus

US sees spike in Paxlovid usage as Merck's molnupiravir and AstraZeneca's Evusheld are slower off the shelf

Zachary Brennan

Senior Editor

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

May 25, 2022 02:09 PM EDTUpdated 03:21 PM

Pharma

Manufacturing

Pfizer and CDMOs ramp up Paxlovid manufacturing with Kalamazoo plant expansion leading the way

Tyler Patchen

News Reporter

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

May 25, 2022 07:12 AM EDT

Pharma

All about access: Pfizer moves to a non-profit model for drug sales in 45 lower-income countries

Zachary Brennan

Senior Editor

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Ted White, Verrica Pharmaceuticals CEO

May 25, 2022 06:33 AM EDT

FDA+

'Hands may be tied': FDA slaps Verrica with 3rd CRL due to problems with contract manufacturer

Amber Tong

Senior Editor

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

May 24, 2022 02:29 PM EDT

FDA+

Pharma company continues its FDA lawsuit spree, this time after agency denies fast-track designation

Zachary Brennan

Senior Editor

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

May 24, 2022 06:56 AM EDT

China

FDA+

House Republicans attack China-only data in FDA submissions, seek new investigation into research inspections

Zachary Brennan

Senior Editor

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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