ASCO: J&J's multiple myeloma toolkit expands with bispecifics data Sponsored: Agilex Biolabs Doubles in Size with Launch of New Large Molecule Facility as It Expands Its U.S. Presence ASCO: Mirati cedes to Amgen's Lumakras on durability in tight KRAS battle Iovance sinks 50% as pivotal cell therapy data disappoint investors, but approval plan pushes ahead anyway Addex's eyelid data fail to make clear case for spasm expansion ASCO: I-Mab, Junshi's cancer combo performs best as a first-line NSCLC treatment, with signals for CD73 as a biomarker ASCO: Merck's Keytruda combo data could spark hope for lymphoma patients who lack options 'The Top Line' podcast: How biopharma is tackling the monkeypox outbreak, insight on nominations for our Fierce 15 list, plus this week's headlines Senate Finance Committee details telehealth 'Bill of Rights' for mental health care services Pfizer and Moderna rapidly falling out of favor as Americans' favorite brands: report Medtronic joins forces with DaVita to launch new kidney tech company GSK's ViiV to work with Medicines Patent Pool, generic manufacturers to bolster access to long-acting HIV prevention med Apretude Abbott’s imaging catheter recall hit with FDA’s Class I designation Chutes & Ladders—Alchemab CEO resigns immediately citing 'personal reasons' Fierce Pharma Asia—J&J, Legend's new CAR-T data; Junshi's antiviral tops Pfizer's Paxlovid; Vir, WuXi end COVID pact Featured Story | By Annalee Armstrong Multiple myeloma is still an uncurable cancer, but Johnson & Johnson’s Janssen unit is building a toolkit to fight back. The latest additions are the bispecific antibodies teclistamab and talquetamab, both being tested in heavily pretreated patients. Janssen will showcase data on both therapies at the American Society of Clinical Oncology meeting in June. read more |
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| Sponsored by: Agilex Biolabs Bioanalytical Laboratory Offers Qualified U.S. Clients a 43.5% Cash Rebate for Conducting Studies in its Australia-based FDA-Inspected Labs read more |
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| | TREM Proteins: Emerging Targets of Immunotherapy TREM proteins are promising targets in neurodegenerative diseases, inflammatory diseases and cancers. Sino Biological has developed a panel of recombinant TREM protein and antibody reagents to support the study of the biology of this protein family. Learn more. |
Top Stories By Annalee Armstrong Mirati seems to have gotten what it needed in terms of efficacy for its KRAS inhibitor, notching an objective response rate of 43% in non-small cell lung cancer, compared to Amgen’s 37% for its already approved med Lumakras. But the problem lies with how long the effect lasts. On that measure, Amgen appears to have taken the win. read more By Nick Paul Taylor Iovance Biotherapeutics trumpeted a 29% response rate and a 10.4-month median duration of response in a pivotal advanced melanoma trial of its tumor-infiltrating lymphocyte candidate—and saw its stock plummet almost 50% on an unfavorable comparison to earlier data. read more By Nick Paul Taylor Addex Therapeutics’ attempt to expand use of dipraglurant into muscle spasms has stumbled at the first hurdle. A phase 2a clinical trial of the mGluR5 negative allosteric modulator has delivered “inconclusive” data in an eyelid disorder, raising doubts about a broader push beyond Parkinson’s disease. read more By Max Bayer Early phase 2 data of I-Mab’s antibody coupled with Junshi Biosciences’ immuno-oncology drug shows it performed best among untreated non-small cell lung cancer patients, and a biomarker may help identify the ideal patient pool. Results from the China-based trial, which tests I-Mab’s CD73 antibody uliledlimab alongside Junshi's PD-1 inhibitor toripalimab, were released Thursday at ASCO. read more By Annalee Armstrong For Merck, the show has been all about Keytruda, as well as Lynparza and Lenvima, in oncology for the past few years. But the New Jersey pharma is hoping to soon have some supporting players to add to the playbill. read more By Teresa Carey This week on "The Top Line," we discuss the new monkeypox outbreak, what the treatment options are and why health officials don’t seem concerned. We also talk about Dexcom's potential megamerger with Insulet, the upcoming ASCO meeting and the week's other big headlines. Plus, we have a special announcement about the prestigious Fierce 15 competition. read more By Robert King The Senate Finance Committee released details on what telehealth flexibilities should be made permanent as part of an effort to increase mental health coverage. read more By Ben Adams What a difference a year makes: Pfizer and Moderna were riding high in Americans' minds last year, but a new report from The Harris Poll shows how both have fallen from grace. read more By Andrea Park The joint venture will develop a range of new kidney care tech, with a specific focus on at-home treatments that’ll make dialysis more easily accessible, offering an alternative to the typical schedule of in-clinic sessions three times a week. read more By Fraiser Kansteiner ViiV has pledged to work with the Medicines Patent Pool to license its patents on long-acting cabotegravir for HIV pre-exposure prophylaxis (PrEP), the company said Friday. The parties are working to bring a voluntary license to fruition “as quickly as possible to help enable at scale access to cabotegravir LA for PrEP in low- and middle-income countries,” ViiV said in a release. read more By Andrea Park The recall covers more than 14,500 Dragonfly OpStar imaging catheters that had been distributed around the world, including 4,800 that were sold in the U.S. alone. read more By Max Bayer Alchemab taps CBO to be new CEO after Treco suddenly resigns due to "personal reasons." Civeta builds out scientific leadership, naming a CSO and head of chemistry. Rajangam jumps to Senti Bio as new chief medical officer, joining from rival Nkarta as the race to develop natural killer cell therapies heats up. read more By Angus Liu Johnson & Johnson and Legend Biotech further pad the case of their CAR-T therapy Carvykti. Junshi Biosciences said its oral COVID antiviral, VV116, bettered Pfizer's Paxlovid at alleviating symptoms in a phase 3 trial. WuXi Biologics and Vir Biotechnology have ended their COVID antibody collaboration. And more. read more Resources Sponsored by: Catalent In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. Sponsored by: Blue Matter, strategic consultants in the life sciences Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve. Sponsored By Catalent: Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored By Catalent: Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities By Dave Muoio COVID-19 surges, high labor costs and investment losses have brought the Catholic health system’s to-date net income down from 2021's $3.2 billion to just $43 million in 2022. Sponsored By Catalent: What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 