Keytru­da bo­nan­za in­spires a facelift and plans to in­vest more than $600M in trans­la­tion­al re­search

Dave Tapol­czay, CEO Life Arc

Sci­en­tists with the UK’s MRC Tech­nol­o­gy played a key role in hu­man­iz­ing the an­ti­body that would go on to be­come Keytru­da, Mer­ck’s new flag­ship check­point in­hibitor. And the wind­fall of cash that they get in a roy­al­ty stream from that ef­fort is fi­nanc­ing a makeover and a mis­sion to in­vest the cash, to fund the ig­ni­tion of new dis­cov­ery work aimed at spawn­ing a wave of new biotech prod­uct de­vel­op­ment projects.

As of to­day, MRC Tech­nol­o­gy is LifeArc, and the game plan there is to fund £500 mil­lion of new work on an­timi­cro­bials, neu­ro­science, per­son­al­ized on­col­o­gy and res­pi­ra­to­ry med­i­cine.

“The name LifeArc bet­ter re­flects what we achieve in be­ing the arc or bridge be­tween great sci­ence and its ap­pli­ca­tion to help pa­tients,” said LifeArc CEO Dave Tapol­czay.

The cash stream from Mer­ck has been swelling as the phar­ma gi­ant has rushed to stake out a lead­ing role in the PD-(L)1 field, jump­ing ahead of Bris­tol-My­ers Squibb — at least for the mo­ment — in key ar­eas like lung can­cer.

Now the new­ly dubbed LifeArc al­so has the cash to set up two small funds that will back aca­d­e­m­ic re­searchers fi­nanced by oth­er or­ga­ni­za­tions as well as an ear­ly-stage fund for new drugs. And the Mer­ck mon­ey has fi­nanced new digs as well for its 80 sci­en­tists in­volved in an­ti­body and small mol­e­cule re­search at Steve­nage, with a new fa­cil­i­ty in Ed­in­burgh as well.

The an­nounce­ment at LifeArc came just ahead of Medicxi’s news that it is rolling out a new $300 mil­lion late-stage biotech fund, adding fur­ther to the amount of cash avail­able for biotechs in the re­gion. The UK’s Gold­en Tri­an­gle has tra­di­tion­al­ly lagged be­hind the big glob­al hubs in Boston/Cam­bridge and the Bay Area, but it re­mains a vi­tal part of the glob­al life sci­ence R&D scene with stel­lar sci­ence at top in­sti­tu­tions.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

Although it’s exceedingly rare for the FDA to rescind a breakthrough designation once it’s granted, there has been a recent uptick — as in 2020 and 2021 combined, the agency rescinded 17 BTDs, compared to just 18 rescinded from 2015 to 2019 combined.

Protagonist Therapeutics saw this reality up close and personal in April after a clinical hold lifted on its experimental blood cancer drug, as the company revealed that the FDA sought to revoke the BTD. The decision, Protagonist says, stems from “observed malignancies” related to the hold, initially imposed in September 2021.

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