NIAID and Moderna spell out a ‘robust’ immune response in PhI coronavirus vaccine test — but big questions remain to be answered

Tal Zaks, Moderna CMO (Moderna via YouTube)

July 14, 2020 05:00 PM EDTUpdated July 15, 06:26 AM

NIAID and Moderna spell out a 'robust' immune response in PhI coronavirus vaccine test — but big questions remain to be answered

John Carroll

Editor & Founder

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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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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Adam Russell, ARPA-H's incoming acting deputy director

May 26, 2022 07:16 AM EDT

R&D

NIH's new, independent breakthrough drug accelerator ARPA-H gets its first employee

Zachary Brennan

Senior Editor

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

May 25, 2022 02:19 PM EDTUpdated 59 minutes ago

Coronavirus

Updated: 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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ProFound Therapeutics founding team

May 26, 2022 06:00 AM EDT

Financing

Startups

Flagship's latest biotech could turn some of the thousands of new proteins it discovered into therapies — and it has $75M to start

Kyle LaHucik

Associate Editor

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

May 26, 2022 05:19 AM EDTUpdated 06:31 AM

Startups

This time around, Lyrica's inventor is developing his Northwestern discoveries at his own biotech

Kyle LaHucik

Associate Editor

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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May 24, 2022 01:29 PM EDT

Coronavirus

Law

Moderna seeks to dismiss Alnylam suit over Covid-19 vaccine component, claiming wrong venue

Zachary Brennan

Senior Editor

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Michael Corbo, Pfizer CDO of inflammation & immunology

May 24, 2022 10:37 AM EDTUpdated 01:33 PM

R&D

UPDATED: Planning ahead for crowded ulcerative colitis market, Pfizer spells out PhIII data on $6.7B Arena drug

Amber Tong

Senior Editor

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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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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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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