David Veitch, Basilea CEO

Basilea toss­es an on­col­o­gy drug back to Mer­ck, dou­bling down on an­tibi­otics in re­vamp

Swiss biotech Basilea Phar­ma­ceu­ti­ca has shed one of its last pipeline ties with on­col­o­gy as it makes a move to con­cen­trate on an­tibi­otics in a race to prof­itabil­i­ty next year. And they’ve fol­lowed up on that with news of a Phase III suc­cess they be­lieve can help ex­pand prospects for a key fran­chise play­er.

Thomas Hol­land

The com­pa­ny put out word on Mon­day that the ex­ecs are hand­ing rights to the FGFR in­hibitor de­r­azan­ti­nib back to Mer­ck by the end of this year as it shuts down clin­i­cal work on the tu­mor check­point con­troller lisa­van­bu­lin. They’re still work­ing on part­ner­ing that out along with their TTK/PLK1-in­hibitor BAL0891 and pre­clin­i­cal on­col­o­gy as­sets.

Basilea $BSLN de­cid­ed to re­vamp its R&D work sev­er­al months ago, say­ing they were care­ful­ly fo­cused on a Phase III for cefto­bip­ro­le — a fifth-gen­er­a­tion cephalosporin sold by Basilea in Eu­rope as Zevtera — for bac­te­r­i­al blood­stream in­fec­tions caused by Staphy­lo­coc­cus au­reus.

Duke Uni­ver­si­ty’s Thomas Hol­land her­ald­ed that suc­cess to­day, not­ing:

Com­pli­cat­ed Staphy­lo­coc­cus au­reus blood­stream in­fec­tions are com­mon and as­so­ci­at­ed with high mor­bid­i­ty and sig­nif­i­cant mor­tal­i­ty and avail­able an­tibi­ot­ic treat­ment op­tions are lim­it­ed, es­pe­cial­ly when me­thi­cillin-re­sis­tant Staphy­lo­coc­cus au­reus is in­volved. The ERAD­I­CATE study pro­vides strong sup­port for the ef­fi­ca­cy and safe­ty of cefto­bip­ro­le in com­pli­cat­ed SAB.

Adesh Kaul

In go­ing the an­tibi­otics route and turn­ing its back on on­col­o­gy, Basilea is ditch­ing one of the hottest are­nas in drug R&D for a field that has proven bit­ter­ly dis­ap­point­ing for a host of play­ers. But Basilea be­lieves this is the best way for the 22-year-old Roche spin­out to cross the line in­to prof­itabil­i­ty as the bear mar­ket rips up biotech stocks. And they plan to keep work­ing on deals for what re­mains in the on­col­o­gy are­na.

“Our broad part­ner­ing out­reach has re­sult­ed, as in­tend­ed, in dis­cus­sions on a va­ri­ety of pos­si­ble part­ner­ing struc­tures,” says CFO Adesh Kaul. “We con­clud­ed that en­ter­ing in­to sep­a­rate trans­ac­tions for our on­col­o­gy as­sets would gen­er­ate most long-term val­ue. With re­gard to de­r­azan­ti­nib, the chang­ing com­pet­i­tive land­scape and the evolv­ing clin­i­cal da­ta from our open-la­bel stud­ies led us to con­clude that a trans­ac­tion could not be closed at the terms and with­in the time­lines re­quired. We be­lieve that based on the part­ner­ing progress and our port­fo­lio de­ci­sions we are now well on track to en­sure that Basilea gen­er­ates sus­tain­able pos­i­tive op­er­at­ing cash flow and prof­its as of 2023.”

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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.

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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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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