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2019 a 'trans­for­ma­tive year' for phar­ma M&A. Is that a good thing?

Big Pharma keeps getting bigger.

Fueled by the mega-mergers between Bristol-Myers Squibb and Celgene and between Allergan and AbbVie, the industry last year saw $350 billion worth of M&A, according to the new year-end report from the consultants at PwC.  That’s a more than 50% increase on 2018.

“I kind of look at 2019 as a transformational year,” report author Glen Hunzinger told Endpoints News. 

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Roche cracks Chi­na's ADC mar­ket open as Kad­cy­la scores its first breast can­cer OK in the coun­try

Roche’s Kadcyla has become the first antibody-drug conjugate to enter the Chinese market, marking a dramatic advance for both the Swiss pharma giant and the therapeutic class.

The local arm of Roche announced the approval late Tuesday, which covers the therapy’s use in the adjuvant setting in patients with early HER-2 positive breast cancer who still have residual invasive disease after receiving paclitaxel and Herceptin as neoadjuvant treatment.

Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

David Ricks (Eli Lilly via YouTube)

Eli Lil­ly re­serves $470M for new man­u­fac­tur­ing plant — and North Car­oli­na is more than pleased

Eli Lilly is adding an eighth site to its network of manufacturing plants in the US, investing $470 million to begin production of injectable products and delivery devices at Research Triangle Park, North Carolina.

Anchored by three of the state’s top research universities, RTP is also home to some of the world’s top contract research organizations as well as a growing group of biopharma companies.

Tim Walbert (via Twitter)

FDA hands off its lat­est whirl­wind drug OK as Hori­zon hus­tles would-be block­buster to the mar­ket

The FDA isn’t letting its foot off the gas pedal just because it’s January.

The agency came through with an approval for Horizon Therapeutics’ $HZNP new thyroid eye drug Tepezza (teprotumumab), close to two months ahead of the PDUFA date — which was already set early in the year due to a priority review designation. But that sort of thing is becoming routine at the agency, especially if it has a designated “breakthrough therapy” on its hands.

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Pascal Soriot (AP Images)

As­traZeneca plans to spend $535M-plus to ex­pand its R&D net­work and man­u­fac­tur­ing ops in France

UK-based AstraZeneca is steering a significant amount of R&D and manufacturing spending to France,

On the Monday holiday, the pharma giant made a splash with its French release outlining plans by CEO Pascal Soriot — a native of France — to invest $275 million in additional R&D partnering with its growing network of French biotech and research groups. In particular, AstraZeneca execs want to amp up their work involving French researchers in their global clinical trial network.

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Bernie Sanders goes af­ter Bio­Mar­in's shot at a record drug price, threat­en­ing to break the patent

Bioregnum Opinion Column by John Carroll

Last week at JP Morgan, BioMarin CEO JJ Bienaimé laid out his thoughts on pricing the leading gene therapy for hemophilia A at $2 million to $3 million a shot. Payers would support that, he said, putting the biotech on track to launching a treatment that could top the price of Novartis’s $2.1 million gene therapy for spinal muscular atrophy.

And with that, he earned some high-level attention from a would-be president of the United States.

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Nick Leschly at Endpoints News' panel at the 2020 JP Morgan Healthcare Conference. Credit: Jeff Rumans

At #JPM20, two CEOs, two rad­i­cal­ly dif­fer­ent ther­a­pies, and a fight to chase down sick­le cell

SAN FRANCISCO – Few CEOs tell a story better than bluebird’s Nick Leschly.

He cuts a Jeff Bezos figure on stage at the Colonial Room, the JP Morgan presentation hall for A-list biotechs: lean and bald, fast-talking and vest-wearing. He explains in simple language, apologizing when he has to brush on the data. It helps that he has a good story to tell.

“We treated them one time,” Leschly tells a packed crowd, gesturing to the slide behind him. “Look what happened.”

The slide shows 9 horizontal bars studded with diamonds. Each bar, he explained, represented a sickle cell patient, and each diamond represented a severe medical event, such as a pain crisis. The diamonds stud one side – before the therapy – and vanish on the other, afterward.

“A 99% reduction in these events — this is a functional cure for sickle cell disease,” Leschly says. “This is unprecedented data.”

Upstairs and an hour later, Ted Love stands before a narrow conference room in his suit and polka-dot tie. Love, the CEO of Global Blood Therapeutics, is a 60-year-old physician. His voice trails off at the end of sentences, and the story he tells is less compelling. There are no cured patients.

“This is the first drug that addresses the root cause of sickle cell disease,” Love says, speaking in front of a slide showing a white pill bottle for GBT’s new drug Oxbryta. “Right in the label, it says that this drug inhibits polymerization.”

In the 60 years after scientists discovered the cause of sickle cell, almost no treatments emerged, even as the condition debilitated hundreds of thousands of Americans, most of them black or Hispanic. But the last few years have seen a resurgence of interest as new technologies have made the disease seem newly beatable.

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GSK, Pfiz­er con­tra­dict on the fu­ture of con­sumer health JV — re­port

It appears GSK and Pfizer — who run a consumer health JV together — forgot to get their story straight ahead of this year’s JP Morgan conference.

On Tuesday, Pfizer chief Albert Bourla said he expected the JV’s majority owner GSK to work toward an IPO within three to four years.

The following day, GSK’s chief strategy officer David Redfern told Bloomberg that the consumer business needs to integrate and grow and that an IPO wasn’t the only viable option.

Elizabeth Warren and Amy Klobuchar, AP Images

War­ren and Klobuchar say they can low­er drug prices with­out Con­gress’ help

On Tuesday, two Democrats running for president promised to do — each by herself — what Washington has so far proven unable to do: lower the prices of prescription drugs.

Speaking during the last Democratic debate before the Iowa caucus on Feb. 3, Sen. Elizabeth Warren of Massachusetts and Sen. Amy Klobuchar of Minnesota said, if elected president, they would each act immediately to directly reduce the cost of certain drugs.