Hu­mana takes aim at Mallinck­rodt's 'ill-got­ten' Ac­thar gains in law­suit

Health insurer Humana has had enough of Mallinckrodt, and the drugmaker’s expensive, controversial treatment Acthar gel, which was first approved for a broad range of conditions by the FDA back in 1952.

Extracted from the pituitary glands of slaughtered pigs, the drug is a purified preparation of adrenocorticotropic hormone (ACTH) — and is manufactured essentially the same way as it was when it was first discovered in the late 1940s by the meat company Armour, as a byproduct of pork-processing operations.

However, its price has catapulted from $40 per vial in 2001 to a whopping $38,892 as of this July. “This is a 97,500% price increase. It is as if the price of milk increased from $3 to over $2,900 per gallon, or a mortgage payment rose from $2,000 to over $2 million per month,” Humana $HUM said in a lawsuit filed against Mallinckrodt $MNK last week.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford her­ald 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine, tout­ing eas­i­er dis­tri­b­u­tion, low­er price

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.

With an average efficacy of 70%, the headline number may appear 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 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.

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

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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Simeon George, SR One CEO (SR One)

Scoop: SR One crew com­pletes a com­pli­cat­ed spin­out from Glax­o­SmithK­line. And now they have a $500M fund to in­vest on their own

It’s taken close to 2 years, but Simeon George and his team at SR One have completed their spinout from GlaxoSmithKline, ending a saga as one of the longest running venture arms of Big Pharma as they go out on their own to forge the next chapter with a new and independent $500 million fund.

GSK is sticking with the spinout, this time as a minority investor — though a big one. And I’m told that the R&D group at GSK will remain involved in evaluating their new plays, helping with the scientific due diligence involved in scouting the world for new opportunities during a period of explosive growth in biotech investing.

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CEO Matthew Kane (Precision BioSciences)

In an ap­par­ent R&D about-face, Eli Lil­ly part­ners with Pre­ci­sion Bio­Sciences on genome edit­ing in a deal worth up to near­ly $2.7B

As a large multinational corporation, Eli Lilly has their hands in boundless projects, from cancer and immuno-oncology to diabetes, psoriasis and Crohn’s disease. But Friday they signaled a shift in their R&D focus toward genome editing, leaping into a cutting-edge field CEO Dave Ricks had shied away from as recently as January 2019.

The big pharma is ponying up $100 million upfront to partner with Precision BioSciences, focusing initially on Duchenne muscular dystrophy and two other undisclosed in vivo targets. Lilly is also acquiring $35 million worth of the biotech’s stock, and has the option to develop three additional in vivo therapies.

The pri­ma­ry failed. The key sec­ondary failed. But this biotech still be­lieves it can win an FDA OK in ALS

Two years after the executive team at BrainStorm Cell Therapeutics decided to back off a controversial attempt to sell their stem cell therapy for ALS under the new ‘Right to Try’ legislation, the biotech is back with the top-line data from Phase III. And the data aren’t good.

Researchers say the drug — with a once-proposed price of $300,000 — failed the primary endpoint as well as the key secondaries on disease progression. But the executive crew still thinks it’s approvable. And in fact, the biotech also insists the FDA is eager to review it.

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Joe Biden in Wilmington, DE, Nov. 16, 2020 (Andrew Harnik/AP Images)

Phar­ma lob­by­ist and long­time Biden loy­al­ist Steve Ric­chet­ti joins the in­ner cir­cle head­ed to the White House as drug pric­ing re­mains a hot top­ic

One of Joe Biden’s closest advisers has been tapped as the president-elect’s White House counselor, part of the inner circle that will craft West Wing policy initiatives for the next 4 years. And his record lobbying for several Big Pharma players is already drawing close scrutiny from the progressives in the Democratic Party — as well as the conservative opposition lining up to oppose their every move.

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Up­dat­ed: FDA gives Cel­lec­tis all clear af­ter pa­tient death halt­ed off-the-shelf CAR-T tri­al

Four months after a patient death forced Cellectis to halt one of their off-the-shelf CAR-T trials, the FDA has given them the OK to start dosing patients again.

The Paris-based biotech said they changed the study’s protocol to accommodate the agency’s concerns, although they will still have to work with investigators to obtain local approval to restart the trial and start recruiting patients again. Prior its halt, the Phase I had sites in New York, New Jersey and Texas.

Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

It's of­fi­cial: Pfiz­er and BioN­Tech have sub­mit­ted their Covid-19 vac­cine to the FDA -- and the agency cir­cled a date for the ad­comm

Pfizer and BioNTech’s request for emergency authorization of its Covid-19 vaccine is now in the FDA’s hands. Regulators caught the application Friday afternoon in an open field dash to the goal line.

The agency immediately marked Dec 10 on the calendar for an advisory committee meeting to discuss the request. Pfizer and BioNTech first announced the submission was coming on Friday morning, and Pfizer CEO Albert Bourla confirmed the filing in a video statement later that afternoon. The “historic day,” as Bourla called it, came just 248 days after the pharma first announced plans to develop the candidate with BioNTech — a process which typically takes years.

President Donald Trump speaks at a Nov. 20 news conference in the briefing room at the White House (Susan Walsh/AP)

With on­ly weeks left in his pres­i­den­cy, Trump makes a fi­nal, long-shot bid to re­make US drug pric­ing

As the curtain closes on his administration, President Donald Trump is using his final weeks in office to push one of his longest-running campaign promises of lowering prescription drug prices.

Trump announced in a brief Friday news conference that he would be instituting the “most favored nations” rule tying prices in the US to those in other developed countries, as well as ending certain rebates paid to middlemen, also known as pharmacy benefit managers, in Medicare. The two rules were part of a series of four executive orders Trump unveiled in July aimed at tackling high prescription costs.