FDA stiff-arms Aveo on ti­vo, again; Sunovion Parkin­son's drug re­ject­ed

Aveo On­col­o­gy was hit with a fresh set­back on Thurs­day. Its 2013-re­ject­ed tivozanib is still not ready for a new mar­ket­ing ap­pli­ca­tion, the com­pa­ny said, cit­ing FDA feed­back. The agency rec­om­mend­ed that the drug de­vel­op­er not sub­mit the ap­pli­ca­tion as pre­lim­i­nary over­all sur­vival da­ta — re­port­ed last No­vem­ber — did not al­lay their con­cerns about the drug’s use in re­nal cell car­ci­no­ma out­lined in their re­jec­tion let­ter in 2013. The new ap­pli­ca­tion will be made once ma­ture OS re­sults are avail­able. “We are hope­ful that the pos­i­tive PFS (pro­gres­sion-free sur­vival) out­come will trans­late in­to an im­proved haz­ard ra­tio when we eval­u­ate a more ma­ture in­ter­im OS out­come in the fourth quar­ter of 2019,” said Aveo chief Michael Bai­ley said in a state­ment. The com­pa­ny’s shares $AVEO cratered more than 55% in ear­ly trad­ing.

Sunovion’s high hopes for its Parkin­son’s drug — bought at a pre­mi­um more than two years ago — is crash­ing down as it got slammed with a com­plete re­sponse let­ter from the FDA. De­spite pos­i­tive Phase III da­ta re­port­ed last year, the FDA punt­ed its NDA for the apo­mor­phine sub­lin­gual film APL-130277 and re­quest­ed more in­for­ma­tion and analy­ses, though the com­pa­ny said no new clin­i­cal stud­ies are re­quired. The drug is de­signed to treat OFF episodes of Parkin­son’s, re­fer­ring to the re-emer­gence or wors­en­ing of symp­toms nor­mal­ly con­trolled by med­ica­tions.

→ Madrid-based Sylen­tis has had to con­cede that its drug tivanisir­an flopped in a Phase III study for dry eye dis­ease, beat­en out in a head-to-head with ar­ti­fi­cial tears. The drug failed to hit the pri­ma­ry end­point on oc­u­lar pain and to­tal corneal stain­ing. Sylen­tis, though, spot­light­ed a sec­ondary end­point that did qual­i­fy for suc­cess: “re­duc­ing cen­tral corneal stain­ing in pa­tients with mod­er­ate to se­vere dry eye dis­ease af­ter one month of treat­ment with tivanisir­an.” The biotech is a sub­sidiary of Phar­ma­Mar.

→ Jerusalem-based An­chi­ano Ther­a­peu­tics has set terms for a $35 mil­lion IPO, ac­cord­ing to Re­nais­sance Cap­i­tal. They plan to sell 2.4 mil­lion shares at $14.55 each. In­sid­ers agreed to buy half of that.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

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.

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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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Check­point ends tri­al due to Russ­ian in­va­sion; Terns lines up more cash for NASH

You can count a Phase III program at Checkpoint Therapeutics as the latest collateral damage from Russia’s invasion of Ukraine.

The biotech $CKPT reported this morning that it has had to scrap the late-stage CONTERNO trial combining cosibelimab with pemetrexed and platinum chemotherapy for non-squamous non-small cell lung cancer after the conflict slowed enrollment for the study.

According to Checkpoint:

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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