House committee wants to know a lot more about the cyberattack that damaged Merck

Up to now, Merck has been reluctant to go into much detail regarding just how damaging a recent cyberattack has been to operations. Now, though, it’s going to have to as the House Committee on Energy and Commerce has raised the matter to an issue involving national security.

Merck has acknowledged that the attack on June 27 roiled its manufacturing, sales and R&D ops. Drug and vaccine manufacturing was crimped weeks after the attack and Merck conceded that it would hamper annual revenue as the company continued to scramble to repair the crippling aftereffects.

Ken Frazier, the CEO of Merck, at the White House on July 20, 2017, one month prior to resigning from the President’s manufacturing council AFP PHOTO / SAUL LOEB

But the company has also been reluctant to spell out exactly how hard it was hit and where, leaving lawmakers looking to learn more about the impact and how a more effective cyberattack could wallop the entire healthcare sector.

The committee wrote:

While there is no evidence, to date, that Merck’s manufacturing disruption has created a risk to patients, it certainly raises concerns. For example, in a recent update on national vaccine supply, the CDC reported that Merck would not be distributing certain formulations of the Hepatitis B vaccine. While it is unclear if this is related to the NotPetya disruption, and much of the supply can be filled by other manufacturers, it does raise questions about how the nation is prepared to address a significant disruption to critical medical supplies.

In a statement to Endpoints News, Merck says supply issues with Recombivax HB are not related to the cyberattack and adds:

Merck is experiencing manufacturing constraints in 2017 related to the growing global demand for our vaccines and unexpected demand due to lack of competitive supply. Supply interruptions for the adult formulation of RECOMBIVAXHB began in the first quarter of 2017. Merck does not expect to be distributing RECOMBIVAXHB in the United States between now and the end of 2018. Additionally, Merck expects its pediatric formulation of RECOMBIVAXHB will be unavailable in the United States between early August 2017 until early 2018. The dialysis formulation of  RECOMBIVAXHB in the United States is not affected.

Lawmakers’ letter to Merck CEO Ken Frazier asks for a formal presentation detailing the cyberattack’s impact by October 4. The company says they’re in touch with the committee.

NotPetya was based on stolen NSA technology. Microsoft first encountered the virus with “worm capabilities” in 12,500 computers in Ukraine, which then spread laterally to another 64 counties including the United States, infecting computers that were not patched with critical updates.

Merck claims the patches were installed. At the time they said, “government authorities working with us have confirmed that the malware responsible for the attack contained a unique combination of characteristics that enabled it to infect company systems despite installation of recent software patches.”

 

Adaptive Design Methods Offer Rapid, Seamless Transition Between Study Phases in Rare Cancer Trials

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UPDATED: Roivant bumps stake in Immunovant with a $200M deal. But with M&A off the table, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multibillion-dollar buyout of an mRNA pioneer after falling behind in the race for a Covid-19 jab — report

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Bristol Myers pulls lymphoma indication for Istodax after confirmatory trial falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's oncology head Rick Pazdur defends the accelerated approval pathway, claiming it is 'under attack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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UPDATED: Watch out GlaxoSmithKline: AstraZeneca's once-failed lupus drug is now approved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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How the biopharma industry is helping to pay for the bipartisan infrastructure bill

Senators on Sunday finalized the text of a massive, bipartisan infrastructure bill that contains little that might impact the biopharma industry other than two ways the legislators are planning to pay for the $1.2 trillion deal.

On the one hand, senators are seeking to further delay a Trump-era Medicare Part D rule related to drug rebates, this time until 2026. Senators claim the rule could end up saving about $49 billion, but the PBM industry has attacked it as it would remove rebates from a safe harbor that provides protection from federal anti-kickback laws. The pharmaceutical industry, however, is in favor of the rule and opposes this latest delay as it continues to point its finger at the PBM industry for the rising cost of out-of-pocket expenses.

Not all mRNA vaccines are created equal. Does it matter?; Neuro is back; Private M&A affair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.