Paul Chaplin, Bavarian Nordic CEO

UP­DAT­ED: J&J ends he­pati­tis B and HPV por­tions of Bavar­i­an Nordic col­lab

John­son & John­son’s Janssen end­ed its col­lab­o­ra­tion and li­cens­ing agree­ments with Bavar­i­an Nordic con­cern­ing vac­cines for he­pati­tis B virus and hu­man pa­pil­lo­mavirus­es.

J&J and the Dan­ish vac­cines biotech will con­tin­ue their tie-up as it re­lates to HIV and Ebo­la, Janssen said Mon­day. The duo an­nounced the HPV pact in De­cem­ber 2015 at a to­tal po­ten­tial val­ue of $171 mil­lion, and the he­pati­tis B and HIV work came via a Ju­ly 2017 agree­ment worth up to $879 mil­lion.

The Big Phar­ma cit­ed the “wide­spread up­take of ef­fec­tive, pre­ven­tive vac­cines” against HPV as rea­son­ing for drop­ping that por­tion of the pair’s col­lab. The com­pa­ny will not con­tin­ue R&D ef­forts on HPV, an in­fec­tious area large­ly cor­nered by Mer­ck’s Gar­dasil.

Mean­while, J&J will con­tin­ue to in­ves­ti­gate he­pati­tis B through its ex­ist­ing pipeline, which in­cludes two Phase II com­bi­na­tion ther­a­py stud­ies. The two com­pa­nies nev­er be­gan a clin­i­cal study us­ing Bavar­i­an Nordic’s so-called MVA-BN vac­cine tech.

“They were not part of our ac­tive pipeline and there was no progress,” a Bavar­i­an Nordic spokesper­son, re­fer­ring to the HPV and he­pati­tis B projects, told End­points News in an emailed state­ment. “We con­tin­ue to have a strong col­lab­o­ra­tion with Janssen via our joint Ebo­la fran­chise as well as the ear­ly stage HIV project.

The small­pox vac­cine mak­er al­so has a Phase III study in res­pi­ra­to­ry syn­cy­tial virus, a late-stage Covid-19 vac­cine boost­er and an ear­ly-stage open-la­bel tri­al for var­i­ous can­cers.

This comes weeks af­ter Finch Ther­a­peu­tics paused its he­pati­tis B pro­gram and laid off work­ers. Mean­while, Sil­ver­back Ther­a­peu­tics end­ed work on its im­muno-on­col­o­gy pro­gram to shift its fo­cus to­ward a pre­clin­i­cal he­pati­tis B can­di­date as part of the biotech’s own lay­offs weeks ago.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

UP­DAT­ED: As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In an interview with Endpoints News, ARCH managing director and co-founder Bob Nelsen brushed off concerns about the broader market troubles, saying the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels won’t impact ARCH’s mindset too much because it typically focuses on company formation.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”