Bristol-Myers CEO Caforio wants M&A dissidents to know there’s been no ‘high level’ overtures about buying the company since ’17

March 12, 2019 06:06 PM EDT

Bristol-Myers CEO Caforio wants M&A dissidents to know there's been no 'high level' overtures about buying the company since '17

John Carroll

Editor & Founder

Bristol-Myers Squibb CEO Giovanni Caforio took to the center stage at the Cowen Health Care Conference today and tried his very best to kick out at least one of the legs holding up the persistent case being made against the big Celgene buyout.

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Ryan Watts, Denali CEO

August 6, 2020 08:42 AM EDTUpdated 02:14 PM

Deals

Biogen hands Denali $1B-plus in cash, $1B-plus in milestones to partner on late-stage Parkinson’s drug

John Carroll

Editor & Founder

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Younatsos, Biogen CEO (via YouTube)

August 7, 2020 07:47 AM EDTUpdated 08:10 AM

R&D

UPDATED: Biogen scores a priority review for its Alzheimer's drug aducanumab, moving one giant leap forward in its controversial quest

John Carroll

Editor & Founder

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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August 7, 2020 07:04 AM EDTUpdated 08:41 AM

Coronavirus

Covid-19 roundup: Pfizer teams with Gilead on remdesiivr; Japan, Brazil, Switzerland, India get vaccines

Max Gelman

Associate Editor

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself. – Jason Mast

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ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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President Trump (AP Images)

August 7, 2020 07:19 AM EDT

Outsourcing

Pharma

Regulatory

FDA takes the lead on defining essential under Trump's 'Buy American' executive order — as industry warns of supply chain disruption

Amber Tong

Editor

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

August 7, 2020 06:55 AM EDT

R&D

In surprising setback, combo of Roche’s Tecentriq and chemo fails to help patients with triple-negative breast cancer

Jason Mast

Associate Editor

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

August 6, 2020 04:33 PM EDT

Deals

R&D

AbbVie abandons a pioneering CRISPR R&D alliance with Editas as Brent Saunders' deal is cast out

John Carroll

Editor & Founder

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

August 6, 2020 04:01 PM EDT

Bioregnum

Coronavirus

'October is coming,' and everyone still wants to know if a Covid-19 vaccine will be whisked through the FDA ahead of the election

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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ENDPOINTS CAREERS

Director of Clinical Operations

Recursion Pharmaceuticals

Salt Lake City, UT

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

August 6, 2020 10:08 AM EDTUpdated 02:41 PM

People

Alnylam president Barry Greene leaves after 17 years, handing position over to Yvonne Greenstreet as biotech looks toward profitability

Jason Mast

Associate Editor

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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August 4, 2020 04:20 PM EDTUpdated August 5, 11:26 AM

Coronavirus

UPDATED: Novavax heralds the latest positive snapshot of early-stage Covid-19 vaccine — so why did its stock briefly crater?

John Carroll

Editor & Founder

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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