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Check out this week's Editors' (re)View. Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 14.
This week, Andrea Corona discusses the future of weight loss drugs as drug makers are shifting to oral formulations for their treatments.
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 14
Roche's Genentech presented two-year phase 3 data at the ASRS 2024 Annual Meeting demonstrating that Susvimo, a refillable eye implant, showed sustained efficacy in treating diabetic macular edema (DME) and diabetic retinopathy (DR).
Genentech Roche
https://www.pharmamanufacturing.com/development/clinical-trials/news/55127206/genentech-refillable-eye-implant-shows-efficacy-for-dme-and-dr
Paratek Pharmaceuticals has announced positive results from a post-marketing study of Nuzyra (omadacycline), a broad-spectrum antibiotic, in treating moderate to severe community-acquired bacterial pneumonia (CABP).
Nuzyra is approved for once-daily oral and IV use to treat bacterial pneumonia and serious skin infections
While the FDA has agreed on the phase 3 dosing regimen for Agenus' BOT/BAL immunotherapy combination for relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC), it has advised against seeking accelerated approval.
U.S. Food and Drug Administration
https://www.pharmamanufacturing.com/development/drug-approvals/news/55126843/fda-rejects-accelerated-approval-for-agenus-colorectal-cancer-drug
Orexo AB has received a complete response letter (CRL) from the FDA regarding its New Drug Application (NDA) for OX124, a high-dose naloxone rescue medication for opioid overdose.
U.S. Food and Drug Administration
https://www.pharmamanufacturing.com/development/drug-approvals/news/55126852/orexo-nasal-opioid-overdose-rescue-drug-is-rejected-by-fda-again
Genentech, a member of the Roche Group, has announced positive phase 1 clinical trial results for its recently-acquired investigational oral GLP-1 receptor agonist, CT-996.
Genentech Roche
https://www.pharmamanufacturing.com/industry-news/news/55126605/genentech-shares-promising-data-for-oral-weight-loss-drug
Bayer has announced positive topline results from its phase 3 ARANOTE trial, which tested Nubeqa (darolutamide) combined with androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC).
Bayer
https://www.pharmamanufacturing.com/development/clinical-trials/news/55126620/bayers-prostate-cancer-combo-drug-boosts-survival-in-phase-3
Vertex Pharmaceuticals has partnered with Orum Therapetics in a multi-target license and option agreement to develop degrader-antibody conjugates (DACs) for gene editing.
Vertex
In a deal worth up to $325 million, the two will work on developing degrader-antibody conjugates for gene editing
Sionna Therapeutics announced this week that it has acquired multiple clinical-stage compounds for cystic fibrosis (CF) through a license agreement with AbbVie.
AbbVie
https://www.pharmamanufacturing.com/industry-news/news/55126348/abbvie-sells-cystic-fibrosis-compounds-to-sionna-therapeutics
Catch up on last week's news from the pharma industry with a new episode of Off Script: A Pharma Manufacturing Podcast, the good, the bad, the ugly.
Listen with the link below or find us on your favorite podcast app.
Up this week:
The good — Pfizer advances once-daily obesity pill
The bad — FDA rejects Novo Nordisk once-weekly insulin
The ugly — Federal Trade Commission releases long-awaited report on PBMs
https://pharmamanu.podbean.com/e/pfizer-advances-obesity-pill-fda-rejects-novo-insulin-ftc-releases-pbm-report-the-good-the-bad-the-ugly/
Lexeo Therapeutics announced positive interim phase 1 and 2 clinical data for LX2006, a gene therapy targeting Friedreich ataxia (FA) cardiomyopathy.
While management of Friedreich ataxia cardiomyopathy typically involves medications, there are no treatments targeting the root cause
Lupin Limited announced it has divested its U.S. Commercial Women's Health Specialty Business to Evofem Biosciences.
Evofem Biosciences
Lupin could earn up to $84 million based on future performance milestones
Check out this week's Editors' (re)View. Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 8.
This week we saw two drugmakers betting on second chances: Roche is making a comeback with its neovascular or 'wet' age-related macular degeneration (nAMD) treatment while Elevar Therapeutics is gearing up to resubmit its liver cancer drug. This week also covers the FTC release of a long-awaited report on the prescription drug middleman industry.
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 8
AbbVie has submitted regulatory applications to both the FDA and the EMA for the approval of upadacitinib, branded Rinvoq, for treating giant cell arteritis (GCA) in adults.
AbbVie U.S. Food and Drug Administration
https://www.pharmamanufacturing.com/development/drug-approvals/news/55125680/abbvie-seeks-new-indication-for-blockbuster-jak-inhibitor
Pfizer has picked a preferred once-daily modified release formulation for its oral glucagon-like peptide-1 (GLP-1) receptor agonist, danuglipron, based on results from an ongoing pharmacokinetic study.
Pfizer
https://www.pharmamanufacturing.com/development/clinical-trials/news/55125655/pfizer-advances-once-daily-obesity-pill
Ipsen and Foreseen Biotechnology have announced an exclusive global licensing agreement for Foreseen's potential first-in-class antibody-drug conjugate (ADC), FS001.
Ipsen
In its second ADC deal this year, Ipsen will pick up a potential first-in-class ADC that targets a novel tumor associated antigen
The U.S. FDA has issued a complete response letter to Novo Nordisk's BLA for its once-weekly basal insulin icodec for diabetes treatment.
U.S. Food and Drug Administration Novo Nordisk
https://www.pharmamanufacturing.com/development/drug-approvals/news/55125317/fda-rejects-novo-nordisk-once-weekly-insulin
The U.S. FDA will convene an AdComm meeting to discuss Zevra Therapeutics' orally delivered, potential first-in-class treatment for the ultra-rare neurodegenerative lysosomal storage disorder, Niemann-Pick disease type C (NDC).
U.S. Food and Drug Administration
https://www.pharmamanufacturing.com/development/drug-approvals/news/55124963/zevra-edges-closer-to-fda-review-of-resubmitted-rare-disease-drug
Elevar Therapeutics announced its plans to resubmit its application to the FDA for rivoceranib in combination with camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC).
U.S. Food and Drug Administration
https://www.pharmamanufacturing.com/development/drug-approvals/news/55124997/elevar-to-resubmit-liver-cancer-drug-to-fda
Catch up on last week's news from the pharma industry with a new episode of Off Script: A Pharma Manufacturing Podcast, the good, the bad, the ugly.
Listen with the link below or find us on your favorite podcast app.
Up this week:
The good — FDA grants Eli Lilly and Company Alzheimer’s drug full approval
The bad — FDA rejects Rocket gene therapy
The ugly — Eisai, BMS end ADC partnership
https://pharmamanu.podbean.com/e/eli-lilly-alzheimer-s-drug-granted-full-approval-rocket-gene-therapy-is-rejected-eisai-and-bms-end-adc-partnership-the-good-the-bad-the-ugly/
Roche announced that the FDA has approved updates to Susvimo, a treatment for neovascular or 'wet' age-related macular degeneration (nAMD).
Roche U.S. Food and Drug Administration
https://www.pharmamanufacturing.com/development/drug-approvals/news/55094350/fda-approves-updated-roche-namd-drug
The Federal Trade Commission has published an interim report on the prescription drug middleman industry, underscoring the impact pharmacy benefit managers (PBMs) have on the accessibility and affordability of prescription drugs.
Federal Trade Commission
https://www.pharmamanufacturing.com/industry-news/news/55094322/ftc-releases-long-awaited-report-on-pbms-and-drug-affordability
By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset, drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase, thereby reducing the need for prolonged probe stability testing and potential reformulations or packaging redesign.
To understand more about the issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America in this episode of Off Script: A Pharma Manufacturing Podcast.
Listen with the link below or on your favorite streaming service.
https://pharmamanu.podbean.com/e/solutions-spotlight-streamlining-oral-dose-packaging-design/
Eli Lilly has agreed to acquire Massachusetts-based biotech Morphic, in a bid to expand the company's immunology pipeline with oral integrin therapies.
Eli Lilly and Company
https://www.pharmamanufacturing.com/industry-news/news/55093984/eli-lilly-to-buy-morphic-picking-up-ibd-asset
Novo Holdings has co-led a $114 million (£90 million) Series A financing round for UK biotech company Myricx Bio, marking the largest European biotech Series A this year.
Backed by the largest European biotech Series A this year, Myricx will advance its proprietary ADC platform
The U.S. FDA has approved Roche's bispecific antibody, Vabysmo, in a single-dose prefilled syringe (PFS) for the treatment of three leading causes of vision loss.
U.S. Food and Drug Administration Roche
https://www.pharmamanufacturing.com/development/drug-approvals/news/55093805/fda-oks-roche-vision-loss-drug-in-prefilled-syringe
It's that time again for Editors' (re)View. Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 1.
This week covers Moderna's announcement that it had received a $176 million project award and the FDA approval of Eli lilly's donanemab, branded as Kisunla, a once-monthly IV infusion therapy for early symptomatic Alzheimer's disease.
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 1
The European Medicines Agency (EMA) has granted approval to Sanofi and Regeneron's blockbuster biologic Dupixent (dupilumab) as the first-ever targeted therapy in the EU for adults with uncontrolled chronic obstructive pulmonary disease (COPD) marked by raised blood eosinophils.
Sanofi Regeneron
https://www.pharmamanufacturing.com/development/drug-approvals/news/55093779/ema-approves-sanofis-dupixent-for-copd
Emergent BioSolutions has been awarded over $250 million in contract modifications from the Administration for Strategic Preparedness and Response (ASPR) to deliver millions of doses of four medical countermeasures for addressing biological threats like anthrax, smallpox and botulism.
https://www.pharmamanufacturing.com/industry-news/news/55093372/emergent-awarded-250m-to-supply-medical-countermeasures
GSK has acquired full rights to develop, manufacture and commercialize mRNA vaccines for influenza and COVID-19 from CureVac, restructuring a 2020 collaboration to focus on their respective mRNA development activities.
GSK
https://www.pharmamanufacturing.com/industry-news/news/55093380/gsk-buys-curevac-influenza-and-covid-vaccines
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By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset, drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase, thereby reducing the need for prolonged probe stability testing and potential reformulations or packaging redesign. To understand more about the issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America in this episode of Off Script: A Pharma Manufacturing Podcast. Listen with the link below or on your favorite streaming service. https://pharmamanu.podbean.com/e/solutions-spotlight-streamlining-oral-dose-packaging-design/ #qualitybydesign #oraldosepackaging #oraldose #offscript #pharmamanufacturing
Get quick answers to all your pharma manufacturing industry related questions on various topics from regulatory compliance to drug development: https://hubs.li/H0Sp1Q00.
Congratulations to Jim Agalloco for his winning cartoon caption for the month of May! If your cartoon caption was not selected this time, submit your “Funny Pharm” captions for this month: https://hubs.li/H0Szjp20. 🏆 The winner has a choice of two prizes! #pharma Jerry King Cartoonist
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