FDA takes a pass on pegvaliase panel; Flexion terminates an old AstraZeneca pact

September 15, 2017 10:09 AM EDT

Shehla Shakoor

FDA takes a pass on pegvaliase panel; Flexion terminates an old AstraZeneca pact

⇨ BioMarin says that the FDA is indicating that it won’t be holding a panel review for pegvaliase as a new treatment for phenylketonuria (PKU). That is likely to somewhat improve its odds of success, with a priority review and a PDUFA date of February 28, 2018.

⇨ Flexion Therapeutics has sent a notice to AstraZeneca terminating their deal on FX005’s sustained-release p38 MAP, or mitogen-activated protein, kinase inhibitor development program. Flexion has dumped the drug from its pipeline.

⇨ Canada’s AbCellera Biologics has forged a deal with GSK where it will apply its high-throughput single-cell antibody screening platform to identify antibodies against an undisclosed membrane protein target.

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Shehla Shakoor

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Hal Barron, GSK

July 22, 2019 09:27 AM EDT

John Carroll

People

R&D

Breaking the death spiral: Hal Barron talks about transforming the moribund R&D culture at GSK in a critical year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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July 22, 2019 05:06 PM EDTUpdated 05:47 PM

John Carroll

Pharma

R&D

Acadia is making the best of it, but their latest PhIII Nuplazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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ENDPOINTS CAREERS

Associate Director CMC

Elektrofi

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July 22, 2019 10:10 AM EDT

John Carroll

R&D

Regulatory

Some Big Pharmas stepped up their game on data transparency — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

July 22, 2019 09:00 AM EDT

John Carroll

Deals

Busy Gilead crew throws struggling biotech a lifeline, with some cash upfront and hundreds of millions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

July 22, 2019 07:27 AM EDTUpdated 08:53 AM

John Carroll

R&D

Intec blitzed by PhIII flop as lead program fails to beat Merck's standard combo for Parkinson’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time.

ENDPOINTS CAREERS

Director Process Development

Elektrofi

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July 22, 2019 07:12 AM EDTUpdated 07:35 AM

Amber Tong

Deals

Pharma

Celgene racks up third Otezla approval, heating up talks about who Bristol-Myers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

July 18, 2019 07:02 PM EDT

John Carroll

Venture

Medicxi is rolling out its biggest fund ever to back Europe's top 'scientists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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July 18, 2019 05:20 PM EDT

John Carroll

People

R&D

After a decade, ViiV CSO John Pottage says it's time to step down — and he's handing the job to longtime colleague Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Head of Business Development and Corporate Strategy

Mytide Therapeutics

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Vlad Coric (Biohaven)

July 20, 2019 09:28 AM EDT

John Carroll

R&D

In another disappointment for investors, FDA slaps down Biohaven’s revised version of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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