Peer Re­view: J&J woos Mer­ck’s Math­ai Mam­men to helm of phar­ma R&D; Mer­ri­mack, Bay­er, and Ax­o­vant ex­pand lead­er­ship teams

→  Mer­ri­mack ex­pand­ed its team with a new CMO and head of hu­man re­sources. The new CMO, Ser­gio San­til­lana comes from Ari­ad, and Ellen For­est, head of hu­man re­sources, pre­vi­ous­ly served at Bax­al­ta. “With fund­ing in­to the sec­ond half of 2019 to sup­port our cor­po­rate ob­jec­tives, a re­fined strate­gic fo­cus and ex­pe­ri­enced teams in place to ex­e­cute, we are poised to de­liv­er on the long-term po­ten­tial of our pipeline for can­cer pa­tients and our share­hold­ers,” said pres­i­dent and CEO Richard Pe­ters in a press re­lease.

→  Te­va is nom­i­nat­ing four new board mem­bers, who will need to be ap­proved by share­hold­ers at the com­pa­ny’s an­nu­al meet­ing on Ju­ly 13. Among their first or­der of busi­ness will be the choose a new CEO for the strug­gling gi­ant.

→  J&J is chang­ing lead­er­ship in their R&D group. The com­pa­ny re­cruit­ed Mer­ck SVP Math­ai Mam­men to take Bill Hait’s role as phar­ma R&D chief, ac­cord­ing to a state­ment out Wednes­day night. Hait, mean­while, is switch­ing to a new job as glob­al head of ex­ter­nal in­no­va­tion.

→  Christoph West­phal is leav­ing the helm of his lat­est biotech flop. A lit­tle more than two years af­ter de­but­ing their IPO with a $16 share price, tiny Flex Phar­ma $FLKS an­nounced that se­r­i­al en­tre­pre­neur West­phal is hand­ing the lead role to R&D chief William McVicar, at least on an in­ter­im ba­sis, and stay­ing on as chair­man.

→  Bay­er ex­pand­ed its on­col­o­gy team by adding Re­bec­ca Jol­ley as se­nior vice pres­i­dent and com­mer­cial head, on­col­o­gy and Scott Fields, se­nior vice pres­i­dent and phar­ma­ceu­ti­cal de­vel­op­ment head, on­col­o­gy.

→  Ax­o­vant hired six new ex­ec­u­tive team mem­bers: Stephen Mohr, gen­er­al coun­sel; Er­ic Floyd, se­nior vice pres­i­dent, reg­u­la­to­ry af­fairs; Thomas Tem­ple­man, se­nior vice pres­i­dent, phar­ma­ceu­ti­cal op­er­a­tions and qual­i­ty as­sur­ance; Mark Wadley se­nior vice pres­i­dent, U.S. busi­ness; and Sam­i­na Bari, vice pres­i­dent, cor­po­rate com­mu­ni­ca­tions. Last­ly, Shankar Ra­maswamy, al­ready an ex­ec­u­tive team mem­ber, stepped in­to the role of vice pres­i­dent, glob­al and med­ical af­fairs.

→  UniQure has ap­point­ed Steven Ze­lenkofske as its new chief med­ical of­fi­cer. Last year, the com­pa­ny went through a slew of staffing changes, in­clud­ing an abrupt de­par­ture of their CEO.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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The Modulo Bio team with CEO Michael Horowitz (fourth from right in semicircle)

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al mis­sion

Embarking on a personal mission after his best friend’s mother was diagnosed with a mutation-driven case of frontotemporal dementia, Michael Horowitz has pulled together $8 million in venture funding at Modulo Bio to create small molecules for neurodegenerative diseases.

The San Diego and Bay Area biotech will select its lead development candidate and some backup options within six months and then raise a Series A to investigate therapeutics for C9orf72 mutation-driven cases of ALS and frontotemporal dementia, Horowitz told Endpoints News.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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