Recent Posts
Deals•Mar 2, 2026
Zymeworks Secures $250M Royalty‑Backed Note From Royalty Pharma
Zymeworks has raised $250 million from Royalty Pharma through a non‑recourse royalty‑backed note, with repayments tied to a share of worldwide royalties on its Ziihera product sold by Jazz Pharmaceuticals and BeOne Medicines. The note will be repaid until Royalty Pharma receives 1.65 × the principal by Dec 31 2033, after which full royalty rights revert to Zymeworks.
PharmaShots
News•Feb 25, 2026
Evolution Summit By Marcus Evans | May 7-8, 2026 | The Ritz-Carlton, Fort Lauderdale, Florida
The Evolution Summit, organized by Marcus Evans, will take place May 7‑8, 2026 at the Ritz‑Carlton in Fort Lauderdale. The invitation‑only event convenes senior clinical‑trial executives with innovative suppliers to discuss pressing challenges in clinical operations and drug development. Featured speakers include...
By PharmaShots
News•Feb 25, 2026
J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia
Johnson & Johnson has filed a supplemental Biologics License Application (sBLA) with the U.S. FDA for Imaavy (nipocalimab‑aahu), a monoclonal antibody intended to treat warm autoimmune hemolytic anemia (wAIHA). The filing is supported by the Phase II/III ENERGY trial, which demonstrated...
By PharmaShots
News•Feb 24, 2026
Sciwind Biosciences and Pfizer China Partner to Commercialize Ecnoglutide in China
Sciwind Biosciences granted Pfizer China exclusive rights to commercialize ecnoglutide injection in Mainland China. Sciwind will keep the marketing authorization and handle R&D, registration, manufacturing, and supply, receiving up to $495 million in milestone payments. Ecnoglutide, a cAMP‑biased GLP‑1 receptor agonist,...
By PharmaShots
News•Feb 24, 2026
Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal
Sebela Pharmaceuticals has licensed its hormone‑free copper intrauterine device, Miudella, to Organon for exclusive global rights. The agreement provides Sebela with a $27.5 million cash payment at closing and up to $505 million in sales‑based milestone payments, plus double‑digit royalties on net...
By PharmaShots
News•Feb 23, 2026
A New Era in Neuropsychiatry: Dr. Velichka Valcheva on GH Research’s Rapid-Acting Breakthrough, GH001
GH Research’s inhaled mebufotenin (GH001) demonstrated ultra‑rapid, profound antidepressant effects in a Phase 2b trial for treatment‑resistant depression, with 73% of patients in remission after six months versus ~11% for standard oral therapies. Early‑stage studies in postpartum depression and bipolar disorder...
By PharmaShots
News•Feb 23, 2026
Partner Therapeutics Reports P-II (eNRGy) Post-Hoc Results on Zenocutuzumab for NRG1+ NSCLC
Partner Therapeutics presented post‑hoc data from its Phase II eNRGy study of zenocutuzumab (Bizengri) in 27 patients with advanced NRG1‑positive non‑small cell lung cancer who received at least three doses beyond radiographic progression. Eight patients stayed on therapy for six months...
By PharmaShots
News•Feb 23, 2026
Vanda Pharmaceuticals Reports the US FDA’s Approval of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia
Vanda Pharmaceuticals announced that the U.S. FDA has approved Bysanti (milsaperidone), an active metabolite of iloperidone, as a first‑line therapy for acute manic or mixed episodes in bipolar I disorder and for schizophrenia. The approval is based on demonstrated bioequivalence...
By PharmaShots
News•Feb 20, 2026
The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer
The U.S. FDA has accepted Roche’s new drug application for giredestrant combined with everolimus to treat ER‑positive, HER2‑negative, ESR1‑mutated advanced breast cancer. Phase III evERA data show a 44% reduction in disease progression or death overall and a 62% reduction in...
By PharmaShots
News•Feb 20, 2026
Candel Therapeutics and RTW Enter Royalty Funding Agreement to Support the Launch Aglatimagene Besadenovec in Localized Prostate Cancer
Candel Therapeutics has secured a $100 million royalty‑funding agreement with RTW Investments, contingent on FDA approval of its gene‑therapy candidate aglatimagene besadenovec for intermediate‑ to high‑risk localized prostate cancer. Under the deal, RTW will receive a capped, tiered single‑digit percentage of...
By PharmaShots
News•Feb 20, 2026
NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 Into P-II/III Study for Vernal Keratoconjunctivitis
U.S. FDA has granted IND clearance for NexEos Bio’s ophthalmic solution NTX-1024, allowing the company to commence a combined Phase II/III clinical trial in vernal keratoconjunctivitis (VKC). The upcoming study will assess safety and efficacy after an open‑label investigator‑initiated trial...
By PharmaShots
News•Feb 20, 2026
Boehringer Ingelheim Secures US FDA’s EUA for NexGard and NexGard COMBO to Treat NWS
Boehringer Ingelheim received an Emergency Use Authorization (EUA) from the U.S. FDA for its NexGard chewable tablets to treat New World screwworm (NWS) infestations in dogs and puppies, and for NexGard COMBO topical solution to treat NWS in cats and...
By PharmaShots
Deals•Feb 20, 2026
Candel Therapeutics Secures $100M Royalty Funding From RTW Investments
Candel Therapeutics announced a $100 million royalty financing agreement with RTW Investments to support the launch of its gene therapy Aglatimagene Besadenovec for localized prostate cancer. The deal grants RTW a capped, tiered royalty on U.S. net sales, contingent on...
PharmaShots
News•Feb 19, 2026
ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients
ViiV Healthcare presented results from the Phase III LATITUDE trial evaluating Cabenuva, a long‑acting injectable of cabotegravir and rilpivirine, in 453 adults with adherence challenges. Among 306 virally suppressed participants, the quarterly injection reduced cumulative regimen failure to 22.8% versus...
By PharmaShots
News•Feb 19, 2026
Covetrus to Merge with Cencora’s MWI Animal Health in a $3.5B Deal
Covetrus and Cencora have signed a definitive agreement to merge Covetrus with MWI Animal Health, creating a unified animal‑health platform valued at $3.5 billion. Cencora will receive $1.25 billion in cash, $800 million of preferred equity and $1.45 billion of common equity, securing a...
By PharmaShots