AbbVie hands Voyager a mega-billions gene therapy deal, with $310M in near-term cash

February 22, 2019 09:55 AM EST

AbbVie hands Voyager a mega-billions gene therapy deal, with $310M in near-term cash

Natalie Grover

Reporter

Gene therapy company Voyager Therapeutics has kicked off 2019 in style. After forging an up to $1.8 billion pact with Neurocrine last month, the Parkinson’s drug developer expanded its partnership with AbbVie on Friday, days following the anniversary of their original pact.

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Biogen CEO Michel Vounatsos (via Getty Images)

November 27, 2020 09:56 AM ESTUpdated 01:36 PM

Deals

With aducanumab caught on a cliff, Biogen’s Michel Vounatsos bets billions on another high-risk neuro play

John Carroll

Editor & Founder

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

November 23, 2020 05:43 AM ESTUpdated 02:00 PM

Coronavirus

AstraZeneca, Oxford on the defensive as skeptics dismiss 70% average efficacy for Covid-19 vaccine

Amber Tong

Editor

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

November 23, 2020 08:04 PM ESTUpdated 09:21 AM

Pharma

Regulatory

Alnylam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

John Carroll

Editor & Founder

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bahija Jallal (file photo)

November 23, 2020 02:00 AM ESTUpdated 06:47 AM

R&D

TCR pioneer Immunocore scores a first with a landmark PhIII snapshot on overall survival for a rare melanoma

John Carroll

Editor & Founder

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

November 25, 2020 11:48 AM EST

Coronavirus

Manufacturing

After Kodak debacle, US lends $1.1B to a synthetic biology company and their big Covid-19, mRNA plans

Jason Mast

Associate Editor

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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November 25, 2020 10:08 AM EST

Pharma

Manufacturing

Baxter continues on-shoring push with $50M Indiana expansion

Jason Mast

Associate Editor

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

November 25, 2020 09:54 AM EST

Pharma

European Union aims to establish patent workaround in case of emergencies while trying to strengthen its own IP

Max Gelman

Associate Editor

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Vivek Ramaswamy (Jeff Rumans/JPM 2020)

November 25, 2020 07:28 AM EST

R&D

Urovant's lead drug disappoints in mid-stage study as first big FDA decision looms

Amber Tong

Editor

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

November 24, 2020 03:53 PM EST

Pharma

Purdue Pharma pleads guilty in federal OxyContin probe, formally recognizing it played a part in the opioid crisis

Max Gelman

Associate Editor

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.