Look­ing at a ground­break­ing ad­vance, My­ovant gets a pri­or­i­ty re­view at FDA; Agenus, G1 forge new Chi­na deals

→ Just weeks af­ter post­ing promis­ing piv­otal re­sults for re­l­u­golix in prostate can­cer, My­ovant has picked up a pri­or­i­ty re­view from the FDA, which isn’t plan­ning an ex­pert com­mit­tee re­view be­fore mak­ing its de­ci­sion. While much of the at­ten­tion in this class is fo­cused on uter­ine fi­broids, an OK here would make this the first GnRH re­cep­tor an­tag­o­nist treat­ment for men with ad­vanced prostate can­cer.

A cou­ple of new Chi­na deals ar­rived in to­day’s news feed. Agenus struck an agree­ment with Bet­ta Phar­ma­ceu­ti­cals for an ex­clu­sive col­lab­o­ra­tion and li­cense agree­ment for the de­vel­op­ment and com­mer­cial­iza­tion of bal­stil­imab and za­l­ifre­limab in Greater Chi­na. Agenus will re­ceive $35 mil­lion, which in­cludes $15 mil­lion in up­front cash and a $20 mil­lion eq­ui­ty in­vest­ment. The agree­ment al­so in­cludes $100 mil­lion in po­ten­tial mile­stones plus roy­al­ties on net sales. Al­so, G1 Ther­a­peu­tics and Genor Bio­phar­ma an­nounced an ex­clu­sive li­cense agree­ment for the de­vel­op­ment and com­mer­cial­iza­tion of le­ro­ci­clib in the Asia-Pa­cif­ic re­gion (ex­clud­ing Japan). G1 will re­ceive an up­front cash pay­ment of $6 mil­lion and be el­i­gi­ble to re­ceive up to an ad­di­tion­al $40 mil­lion in de­vel­op­ment and com­mer­cial mile­stone pay­ments.

→ Shang­hai’s STAR board has wel­comed its largest biotech, as Sinocell­Tech lands on the sci­ence and tech­nol­o­gy-fo­cused board with a $181 mil­lion raise in hand and sport­ing a $5 bil­lion mar­ket cap. Qim­ing Ven­ture Part­ners led its Se­ries A back in 2017, and many of its ex­per­i­men­tal prod­ucts — span­ning mon­o­clon­al an­ti­bod­ies, re­com­bi­nant pro­teins and vac­cines — have now en­tered Phase III.

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.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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BioCryst re­sumes en­roll­ment for im­mune dis­eases drug; Ea­gle buys stake in res­pi­ra­to­ry dis­ease biotech

In April, the FDA hit BioCryst with a partial hold, leading the biotech to pause enrollment on three of its rare disease clinical trials and sending its shares down 30%.

Last week, BioCryst said the partial clinical hold had been resolved and that it would resume enrolling its clinical trials for its drug, dubbed BCX9930, but with new protocols at a lower 400 mg dose.

BioCryst’s drug is a factor D inhibitor, which was being tested in an array of immune diseases. The biotech is running two pivotal trials for paroxysmal nocturnal hemoglobinuria, as well as a third trial looking at a set of three diseases — C3 glomerulopathy, IgA nephropathy and primary membranous nephropathy.

Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.