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Actithera draws new investors to radiopharma drug pitch

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Actithera draws new investors to radiopharma drug pitch The four-year-old biotech raised about $75 million in a Series A round that involved nine venture capital firms.

Drugs

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Arrowhead’s Subsidiary Visirna Sells China Rights for Plozasiran to Sanofi

The Pharma Data

AUGUST 1, 2025

The agreement centers around the investigational RNA interference (RNAi) therapy, plozasiran, which targets apolipoprotein C-III (APOC3) and is under development for the treatment of familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG). President and CEO of Arrowhead. “We

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Teva and Fosun Partner to Develop Novel Anti-PD1-IL2 Immunotherapy

The Pharma Data

JUNE 16, 2025

Fosun Pharma is granted an exclusive license to develop, manufacture, and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR, Taiwan, and select Southeast Asian countries. This collaborative framework specifies the respective responsibilities for each party.

Therapies

Therapies Licensing Licensing Treatment

The future of mental health treatment: Zelquistinel’s role

Drug Target Review

MARCH 17, 2025

Neuropsychiatric treatment is on the verge of a major transformation. Historically, treatment options have been limited, with patients relying on daily medications that have minimal efficacy and troublesome side effects. “Zelquistinel is a positive modulator of NMDA receptors,” Donello explains.

Treatment

Treatment Licensing Licensing Science

From siloed data to breakthroughs: multimodal AI in drug discovery

Drug Target Review

JUNE 11, 2025

Drug development faces significant challenges: long timelines, high costs , complex processes and low probabilities of success (PoS), exacerbated by the shift towards more complex molecules, biologics and cell and gene therapies, hindering patient access to vital treatments. Nature Medicine, 28, 1656–1661 (2022) [link]

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Revolution Medicines Secures $2B Funding from Royalty Pharma for RAS(ON) Cancer Drug Development

The Pharma Data

JUNE 24, 2025

For Revolution Medicines, the funding not only provides critical financial runway but also preserves full strategic autonomy—a rare combination in the biotechnology landscape where promising young companies often trade developmental control for capital through licensing or acquisition. Source link

Drug Development

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Viatris Announces Success in Second Pivotal Phase 3 Trial of MR-141 Targeting Presbyopia

The Pharma Data

JUNE 26, 2025

The encouraging data builds on the foundation established by earlier studies and further strengthens the clinical case for MR-141 as a potential non-invasive, once-daily ophthalmic solution for millions affected by the age-related decline in near vision. According to the company, MR-141 met its primary endpoint with statistical significance.

Trials

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Intellia Reports Positive 3-Year Phase 1 Data for Lonvo-z in Hereditary Angioedema

The Pharma Data

JUNE 15, 2025

The data, which encompass up to 3 years of follow-up after a single infusion of the treatment, were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held from June 13–16 in Glasgow, United Kingdom. Joshua Jacobs, Medical Director, Allergy and Asthma Clinical Research, Inc.

Treatment

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Royalty Pharma and Revolution Medicines Sign Funding Deals Worth Up to $2 Billion

The Pharma Data

JUNE 24, 2025

This significant financial infusion is designed to fuel Revolution Medicines’ ambitious clinical development and commercialization plans, with a particular focus on its groundbreaking RAS(ON) inhibitor programs for patients with RAS-addicted cancers.

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Bayer Expands Collaboration with Tsinghua University to Boost Pharma R&D in China

The Pharma Data

JUNE 24, 2025

We look forward to this strategic alliance continuing to expand the frontiers of cutting-edge science and translating groundbreaking discoveries into transformative treatments for patients.” This agreement grants Bayer exclusive global rights to develop, manufacture, and commercialize the MTA-cooperative PRMT5 inhibitor.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

JUNE 18, 2025

As clinical development progresses, pharmaceutical companies must submit periodic updates to regulatory agencies, reporting on patient safety data, adverse events, and protocol modifications. Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review.

Drug Development

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Why smarter financial planning could be key to clinical trial success

Drug Target Review

JULY 29, 2025

Kyle notes that “clinical trials face costly delays, inefficient resource allocation, and even standstill or stalling of trials, ultimately resulting in the failure to bring crucial treatments to market.” Jennifer has been a licensed CPA (California) since July 2014. Available from: [link]

Clinical Trials

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FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer.

FDA

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FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

The Pharma Data

JULY 2, 2025

and Canada, has announced a significant regulatory milestone for its pulmonary arterial hypertension (PAH) treatment, WINREVAIR™ (sotatercept-csrk). Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) and granted it priority review status, seeking to update the U.S.

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Trials FDA Licensing Licensing

Targeting HER3 – a little wave of drug development that’s about to get a lot bigger

SugarCone Biotech

JULY 6, 2025

HER3 plays a pivotal role in activating downstream signaling pathways through heterodimerization with other receptors like HER2 and can mediate resistance to therapies targeting EGFR and HER2, making it a compelling target for novel treatments in cancers that rely on oncogenic signaling via those related growth factor receptors.

Drug Development

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Leniolisib

New Drug Approvals

MAY 15, 2025

5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] 5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] 2] [5] It is a kinase inhibitor [2] [6] that is taken by mouth. [2] mmol) in CH 2 CI 2 (100 mL), was added TFA (41.8 24 March 2023.

FDA Approval

FDA Approval FDA Treatment International

GSK Licenses Shigella Vaccine Candidate to Bharat Biotech

The Pharma Data

JUNE 12, 2025

GSK Licenses Shigella Vaccine Candidate to Bharat Biotech in Push for Global Health Equity GSK today announced a significant step forward in the battle against Shigella a leading cause of diarrhoeal disease and death in children under five by licensing its Shigella vaccine candidate, altSonflex1-2-3 , to Bharat Biotech International Limited (BBIL).

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Soleno sales of new Prader-Willi drug rise faster than expected

BioPharma Drive: Drug Pricing

JULY 10, 2025

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. Until Vykat came along, though, no drug therapies were specifically approved to curb the all-consuming hunger that hallmarks the condition.

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Lexeo to help launch spinout around RNA drugs for the heart

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies. Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. Can they keep it?

RNA

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The rise of GLP-1 drugs: Transforming weight loss treatment

BioPharma Drive: Drug Pricing

JUNE 23, 2025

This shift raises ethical questions around prioritizing supply for diabetes patients versus those seeking treatment for obesity or cosmetic weight loss. The balance is complex, as obesity carries its own serious health risks.

Treatment

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EVOQ Therapeutics Announces a License And Collaboration Agreement with Amgen

The Pharma Data

JANUARY 12, 2021

13, 2021 /PRNewswire/ — EVOQ Therapeutics today announced a license and collaboration agreement with Amgen for the discovery and development of novel drugs for autoimmune disorders. EVOQ Therapeutics today announced a license and collaboration agreement with Amgen. ANN ARBOR, Mich. ,

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Identify and Validate Innovative Peptides for the Treatment of Obesity

The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We

Treatment

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Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults

The Pharma Data

APRIL 4, 2022

The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Chief Medical Officer and Head of Global Product Development, Roche. today announced that the U.S.

Treatment

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Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

The Pharma Data

NOVEMBER 11, 2020

Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. SLV213 was developed based on research from UC San Diego and the university exclusively licensed it to Selva Therapeutics.

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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.

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Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. GPCR – G protein-coupled receptors.

Small Molecule

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Looking for Opportunities to Accelerate Clinical Research in Rare Diseases

LifeSciVC

JULY 17, 2024

Reaching the end goal of delivering transformational new treatment options for patients can take a decade or more even when companies execute successfully and are well capitalized. Fortunately, AbbVie felt the same way, which is why we initiated discussions to in-license AbbVie’s most promising CF pipeline programs.

Clinical Research

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Advancing neurological therapies with Dr Bruce Leuchter

Drug Target Review

FEBRUARY 1, 2024

What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer.

Therapies

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Passage Bio Receives FDA Clearance of IND Application for PBFT02 Gene Therapy Candidate for Treatment of Patients with Frontotemporal Dementia with Granulin Mutations

The Pharma Data

JANUARY 27, 2021

– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. PHILADELPHIA, Jan.

Therapies

Therapies Treatment Clinical Trials FDA

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

Treatment

Treatment FDA Approval Pharmacokinetics FDA

FDA accepts application for Roche’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)

The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche’s Chief Medical Officer and Head of Global Product Development. “If

Treatment

Treatment FDA Therapies Clinical Trials

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,

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Harbour BioMed’s Batoclimab (HBM9161) Receives China CDE Breakthrough Therapy Designation for Treatment of Adult Patients with Myasthenia Gravis

The Pharma Data

JANUARY 27, 2021

HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). Harbour BioMed also licenses the platforms to companies and academic institutions.

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Inozyme Pharma Announces Authorization to Proceed in U.S. and U.K. with Phase 1/2 Clinical Trial of INZ-701 for the Treatment of ENPP1 Deficiency

The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. About Inozyme Pharma.

Clinical Trials

Clinical Trials Trials Treatment FDA

Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

The Pharma Data

APRIL 14, 2021

Xolair for self-injection offers healthcare providers and appr opriate patients another administration option for more flexibility in managing their treatment. Roche’s Chief Medical Officer and Head of Global Product Development. today announced that the U.S. indications. indications. with Xolair since its initial approval in 2003.

FDA Approval

FDA Approval Clinical Development FDA Treatment

LogicBio Therapeutics Receives FDA Fast Track Designation for LB-001 for the Treatment of Methylmalonic Acidemia (MMA)

The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. About LogicBio Therapeutics.

FDA

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Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

Clinical Trials

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Everest Medicines Announces Amended Agreement with Spero Therapeutics

The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. ” About SPR206.

Clinical Trials

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies

FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO)

The Pharma Data

MAY 15, 2023

FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Roche’s Chief Medical Officer and Head of Global Product Development. “If 1,2 Vabysmo’s safety profile was consistent with previous trials. mg) or aflibercept (2.0

Treatment

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BioInvent and Cantargia sign manufacturing agreement for monoclonal antibody CAN10

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.

Clinical Trials

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Bayer acquires Noria and PSMA Therapeutics to expand portfolio in prostate cancer

The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men. Noria) and PSMA Therapeutics Inc.

Small Molecule

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Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

MARCH 8, 2021

“We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” shared Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “At About Molnupiravir.

Trials

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AbbVie Snatches Up Antibody from Harbour BioMed to Fight COVID-19 and Related Mutations

The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. Kate Krav-Rude/Shutterstock.

Licensing

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Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19.

The Pharma Data

JULY 12, 2021

It continues to be critically important to advance potential antiviral treatments to address the devastating impact of COVID-19 globally,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “If View the full release here: [link]. “It

Clinical Trials

Clinical Trials Laboratories Research Laboratories Hospitals

Actithera draws new investors to radiopharma drug pitch

Arrowhead’s Subsidiary Visirna Sells China Rights for Plozasiran to Sanofi

Trending Sources

Teva and Fosun Partner to Develop Novel Anti-PD1-IL2 Immunotherapy

The future of mental health treatment: Zelquistinel’s role

From siloed data to breakthroughs: multimodal AI in drug discovery

Revolution Medicines Secures $2B Funding from Royalty Pharma for RAS(ON) Cancer Drug Development

Viatris Announces Success in Second Pivotal Phase 3 Trial of MR-141 Targeting Presbyopia

Intellia Reports Positive 3-Year Phase 1 Data for Lonvo-z in Hereditary Angioedema

Royalty Pharma and Revolution Medicines Sign Funding Deals Worth Up to $2 Billion

Bayer Expands Collaboration with Tsinghua University to Boost Pharma R&D in China

Navigating Regulatory Hurdles in Drug Development

Why smarter financial planning could be key to clinical trial success

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

Targeting HER3 – a little wave of drug development that’s about to get a lot bigger

Leniolisib

GSK Licenses Shigella Vaccine Candidate to Bharat Biotech

Soleno sales of new Prader-Willi drug rise faster than expected

Lexeo to help launch spinout around RNA drugs for the heart

The rise of GLP-1 drugs: Transforming weight loss treatment

EVOQ Therapeutics Announces a License And Collaboration Agreement with Amgen

Identify and Validate Innovative Peptides for the Treatment of Obesity

Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults

Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

Looking for Opportunities to Accelerate Clinical Research in Rare Diseases

Advancing neurological therapies with Dr Bruce Leuchter

Passage Bio Receives FDA Clearance of IND Application for PBFT02 Gene Therapy Candidate for Treatment of Patients with Frontotemporal Dementia with Granulin Mutations

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

FDA accepts application for Roche’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

Harbour BioMed’s Batoclimab (HBM9161) Receives China CDE Breakthrough Therapy Designation for Treatment of Adult Patients with Myasthenia Gravis

Inozyme Pharma Announces Authorization to Proceed in U.S. and U.K. with Phase 1/2 Clinical Trial of INZ-701 for the Treatment of ENPP1 Deficiency

Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

LogicBio Therapeutics Receives FDA Fast Track Designation for LB-001 for the Treatment of Methylmalonic Acidemia (MMA)

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

Everest Medicines Announces Amended Agreement with Spero Therapeutics

FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO)

BioInvent and Cantargia sign manufacturing agreement for monoclonal antibody CAN10

Bayer acquires Noria and PSMA Therapeutics to expand portfolio in prostate cancer

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

AbbVie Snatches Up Antibody from Harbour BioMed to Fight COVID-19 and Related Mutations

Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19.

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