Kadmon kicks off ‘real-time’ NDA submission with another look at ‘remarkable’ chronic graft-versus-host-disease data

Harlan Waksal, Kadmon CEO (Richard Drew, AP Images)

May 21, 2020 10:24 AM EDTUpdated May 22, 03:39 AM

Kadmon kicks off 'real-time' NDA submission with another look at 'remarkable' chronic graft-versus-host-disease data

Amber Tong

Senior Editor

Six months after reporting “knock-your-socks-off kind of results” for its chronic graft-versus-host-disease drug from an interim analysis, Kadmon is back with a final slate of data that it said retained, if not amplified, the wow factor.

The positive topline data have already been sent to the FDA, the company said, as part of a package filed under the Real-Time Oncology Review program. Kadmon expects to formally submit the NDA by the end of this year, complete with a final chunk of 12-month follow-on data.

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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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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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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.

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Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

May 25, 2022 02:14 PM EDTUpdated 03:14 PM

R&D

Almirall rolls out sales rep artificial intelligence system, cutting pre-call prep and 'windshield time'

Beth Snyder Bulik

Senior Editor

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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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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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.

Greg Mayes, Antios Therapeutics CEO

May 25, 2022 10:38 AM EDT

R&D

Antios' HBV collab axed after clinical hold, but biotech believes safety incident is not treatment-related

Kyle LaHucik

Associate Editor

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Tim Schoen, BioMed Realty CEO

May 25, 2022 07:29 AM EDT

R&D

Life sciences developer BioMed Realty buys San Francisco hotel for $75M — report

Amber Tong

Senior Editor

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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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.