David Hung, Nuvation Bio president and CEO (Nuvation Bio)

FDA places par­tial clin­i­cal hold on David Hung biotech af­ter cer­tain can­cer pa­tients ex­pe­ri­ence eye in­flam­ma­tion

Two and a half years af­ter set­ting out on an­oth­er for­ay in­to on­col­o­gy R&D, a biotech head­ed by David Hung — of Medi­va­tion fame — has run in­to its first set­back.

San Fran­cis­co-based Nu­va­tion Bio an­nounced ear­ly Mon­day the FDA placed a par­tial clin­i­cal hold on a Phase I dose-es­ca­la­tion study of NUV-422, its CDK in­hibitor pro­gram for cer­tain types of sol­id tu­mors. The tri­al be­gan en­rolling pa­tients in De­cem­ber 2020, and, ac­cord­ing to Nu­va­tion, re­searchers were in the mid­dle of ex­plor­ing dose es­ca­la­tion and defin­ing the max­i­mum dose tol­er­a­ble in pa­tients.

The in­di­ca­tions be­ing in­ves­ti­gat­ed in­clude high-grade glioma, HR+/HER2- ad­vanced breast can­cer and metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer.

Nu­va­tion came out of stealth in 2019 af­ter be­ing found­ed by the for­mer head at Medi­va­tion, which was snapped up by Pfiz­er in 2016 for $14.3 bil­lion in an all-cash deal. Medi­va­tion is large­ly known for in-li­cens­ing and de­vel­op­ing the block­buster prostate can­cer drug Xtan­di, rack­ing up more than $1.1 bil­lion last year for Pfiz­er.

When Nu­va­tion of­fi­cial­ly came out of stealth, Hung had $275 mil­lion in VC back­ing and claimed to have sev­en pro­grams in its pipeline. Hung found­ed Nu­va­tion Bio af­ter his 10-month stint as CEO at Vivek Ra­maswamy’s Ax­o­vant, which tried and failed to take an Alzheimer’s drug in­to a piv­otal study and in­fa­mous­ly re­port­ed an in­cor­rect p-val­ue back in 2018.

Re­gard­ing the Nu­va­tion hold, some pa­tients in the study came down with uveitis, a type of in­flam­ma­tion in the eye, and Nu­va­tion said it paused en­roll­ment in the tri­al and reached out to the FDA. The com­pa­ny did not give specifics on the sever­i­ty of uveitis in those pa­tients, nor did it say how many pa­tients got uveitis.

With the par­tial hold in place, no new pa­tients will be en­rolled. How­ev­er, cur­rent­ly, en­rolled par­tic­i­pants can con­tin­ue treat­ment with NUV-442.

“We are com­mit­ted to pa­tient safe­ty across all of our stud­ies and to work­ing col­lab­o­ra­tive­ly with the FDA to de­vel­op, as ef­fi­cient­ly as pos­si­ble, new med­i­cines where ex­ist­ing ther­a­pies are in­ad­e­quate,” Hung said in a state­ment. The pres­i­dent and CEO added that the biotech is “well po­si­tioned to con­tin­ue de­vel­op­ing all of our in­ter­nal prod­uct can­di­dates.”

Even though Hung tout­ed the com­pa­ny’s near-$740 mil­lion in cash re­serve, in­vestors weren’t ap­peased by his at­tempts to as­suage the sit­u­a­tion. The biotech’s share price $NU­VB sank about 6% in ear­ly Mon­day trad­ing.

Nu­va­tion de­clined to com­ment fur­ther on the sto­ry fol­low­ing an End­points News in­quiry.

The biotech said in a press re­lease that it will pro­vide up­dates on what di­rec­tion the com­pa­ny will take on NUV-422 af­ter it has com­plet­ed an in­ter­nal risk-ben­e­fit analy­sis. While Nu­va­tion said that analy­sis will fac­tor in FDA’s com­ments, it did not say when that analy­sis is ex­pect­ed to be com­plet­ed.

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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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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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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.

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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