As GSK and Sanofi promise to produce a Covid-19 vaccine at Indy 500 speed, some experts start to push back on timelines

April 14, 2020 04:11 PM EDT

As GSK and Sanofi promise to produce a Covid-19 vaccine at Indy 500 speed, some experts start to push back on timelines

John Carroll

Editor & Founder

GlaxoSmithKline and Sanofi turned a few heads today as the two giant vaccine rivals joined hands and technologies as they set off on what they promised would be a lightning-fast development program for a new Covid-19 vaccine — something billions of people around the world have been devoutly praying for.

But this latest promise to move mountains and do something that would have been widely considered impossible just 2 months ago is beginning to garner some pushback from skeptics who believe these players are probably making promises they can’t keep.

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The Factors Driving a Rapid Evolution of Gene & Cell Therapy and CAR-T Clinical Research in APAC

Kasey Kime

Director of Regulatory Affairs at Novotech

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region.

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

September 24, 2022 06:00 AM EDT

Weekly

The Endpoints 11; bluebird's $3M gene therapy; Biogen tout new neuro data; Harsh reviews for cancer drugs; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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September 23, 2022 12:30 PM EDT

Pharma

Manufacturing

EMA warns of shortages of two Boehringer heart drugs due to a spike in demand

Tyler Patchen

News Reporter

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

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Head of Site Finance mRNA - Cell & Gene

Lonza

Geleen, Netherland

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September 22, 2022 07:01 AM EDTUpdated September 23, 04:21 AM

Special

The Endpoints 11: The top private biotechs in pursuit of new drugs. Pushing the envelope with powerful new technologies

John Carroll

Editor & Founder

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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September 23, 2022 02:38 PM EDTUpdated 03:37 PM

R&D

AstraZeneca, Merck cull one Lynparza indication in heavily pretreated ovarian cancer patients

Paul Schloesser

Associate Editor

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Solicitor General Elizabeth Prelogar

September 23, 2022 01:17 PM EDT

Pharma

Law

Should SCOTUS hear Amgen's Repatha case? Solicitor general says no

Nicole DeFeudis

Editor

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Mene Pangalos (AstraZeneca via YouTube)

September 23, 2022 07:29 AM EDT

R&D

AstraZeneca shuts the PhIII door for Ionis' PCSK9 drug despite positive PhIIb

Amber Tong

Senior Editor

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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Head of Quality Systems

Lonza

Lexington, MA, USA

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September 22, 2022 11:40 AM EDTUpdated September 22, 08:34 PM

R&D

Updated: Biogen throws itself back into muddled data arguments with more details on its antisense ALS drug

Lei Lei Wu

News Reporter

With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.

Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.

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September 23, 2022 02:29 PM EDTUpdated 04:16 PM

Manufacturing

Fujifilm continues CDMO expansion, breaking ground on $435M UK site

Tyler Patchen

News Reporter

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.