Boom­ing rare dis­ease play­er Shire adding a trendy new R&D hub in Kendall Square for 1,000-plus

Shire CEO Flem­ming Orn­skov

Shire CEO Flem­ming Orn­skov has al­ready made it clear that he in­tends to make the com­pa­ny a lead­ing force in rare dis­ease drug de­vel­op­ment and mar­ket­ing. Now he’s mov­ing to al­so make it one of the most vis­i­ble play­ers in the field.

Orn­skov has inked a lease for the 343,000-square-foot build­ing at 500 Kendall Street, right next to the 650 Kendall Street ad­dress it al­ready owns. The plan is to turn Gen­zyme’s old fa­cil­i­ty in­to a rare dis­ease in­no­va­tion hub with more than 1,000 staffers. And it plans to move in cross-dis­ci­pli­nary teams in­volved in re­search, clin­i­cal de­vel­op­ment, med­ical af­fairs, busi­ness de­vel­op­ment and more.

A Shire spokesman notes that the new hub will like­ly house more than 1,000 staffers, with 350 al­ready on site in Kendall Square and room for more than 900 staffers in the soon-to-be-for­mer Gen­zyme cen­ter.

Shire is still keep­ing its big cam­pus in Lex­ing­ton, MA, where it’s been pulling in work­ers from var­i­ous satel­lite fa­cil­i­ties since Orn­skov took the helm. The com­pa­ny added 750 new jobs last year and has an­oth­er 400 open in Mass­a­chu­setts. It’s al­so un­der­tak­ing a strate­gic re­view to con­sid­er where every­one be­longs.

Kendall Square in Cam­bridge has be­come ground ze­ro in the biotech world for in­no­va­tion and new re­search over the past few years. Close to MIT and Har­vard, phar­ma com­pa­nies like Pfiz­er have been mi­grat­ing in­to the neigh­bor­hood, adding new fa­cil­i­ties and gleam­ing new labs to il­lus­trate their com­mit­ment to the lat­est tech­nolo­gies. When George Scan­gos took over Bio­gen 6 years ago, he made the point of mov­ing in­to Cam­bridge, where the re­search was, re­vers­ing the sub­ur­ban shift trig­gered by his pre­de­ces­sor at the com­pa­ny.

For Shire, it’s a chance to glean more in­fo while spot­light­ing its tal­ent and busi­ness strat­e­gy. Shire ac­quired a pres­ence in Cam­bridge with its buy­out of Bax­al­ta.

Staffers will start mov­ing in in about two years.

Orn­skov had this to say in a state­ment:

“By ex­pand­ing our pres­ence in Cam­bridge, with its close prox­im­i­ty to best-in-class hos­pi­tals, re­search in­sti­tu­tions, uni­ver­si­ties and a thriv­ing biotech­nol­o­gy com­mu­ni­ty, we will strength­en our ties with the ear­ly in­no­va­tors around us to shape the next gen­er­a­tion of break­through ther­a­pies for pa­tients with high un­met needs. These plans sig­ni­fy our con­tin­ued growth and our deep and en­dur­ing com­mit­ment to serv­ing pa­tients, fam­i­lies and care­givers across the globe who are af­fect­ed by rare dis­eases and high­ly spe­cial­ized con­di­tions.”

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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