BioPharma
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Alnylam FDA submission aims to expand biotech’s franchise of gene-silencing drugs
Alnylam Pharmaceuticals has filed for FDA approval of vutrisiran, which could become the biotech’s fourth drug that works by RNA interference. Meanwhile the company is responding to a federal subpoena seeking documents related to the company’s marketing and promotion of its first RNAi drug, Onpattro.
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BioPharma, MedCity Influencers, SYN
Precision medicine can close care gaps to reduce incidence of cancer
As researchers and clinicians understand and embrace the advanced insights genetic and genomic testing can deliver, the industry is poised to dramatically reduce the incidence and mortality associated with cancers.
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How are healthcare organizations shifting to digital documents?
In order to gain insight into how organizations are thinking about digitizing medical documents and the strategy behind those decisions, we’re conducting a brief survey of the MedCity News audience and will publish a report based on this survey’s findings.
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Covid-19 serves as catalyst for effort to diversify clinical trial enrollment
Covid-19 showed how technology can upend the old ways of clinical trials. Panelists at MedCity’s INVEST conference said it’s highlighting the importance of improving clinical trial diversity so that tests of new therapies and vaccines reflect the population of patients that they will treat in the real world.
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Biotech and medical device companies raise $913M in a five-IPO week
The five life sciences IPOs this week continues the steady march companies are making to the public markets this year. This week’s activity follows a first quarter that Renaissance Capital calculates was the busiest for newly public companies since 2000. Healthcare IPOs continued to dominate the stock offerings.
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FDA approves GSK drug for endometrial cancer with specific genetic signature
The FDA approved GlaxoSmithKline drug dostarlimab (Jemperli) for endometrial cancer that carries a particular genetic signature. The immunotherapy now joins Merck’s Keytruda as the checkpoint inhibitors approved for treating endometrial cancer.
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Medical Devices, BioPharma, Payers
Like it or not, value-based contracting is coming for drugs and medical devices
Value-based contracts covering the reimbursement of drugs and medical devices are slowly gaining acceptance. A panel at the MedCity News INVEST conference discussed the challenges and opportunities for these contracts, which aim to improve patient outcomes and control the cost of care.
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Vertex Pharma inks another R&D alliance to expand its gene-editing ambitions
Vertex Pharmaceuticals is collaborating with Obsidian Therapeutics to develop up to five new gene editing therapies. Obsidian’s technology precisely controls protein expression, a capability the partners plan to apply to several undisclosed serious diseases.
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Startups, MedCitizens, BioPharma
Serimmune CEO: Leveraging the functional antibody repertoire will transform healthcare
In response to emailed questions, the CEO and CTO talk about the immune intelligence startup’s Human Immunity Map — a growing database of immune interactions that can support the development of multiplex diagnostics, vaccines and therapeutics.
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MedCity Spotlight Video: JPMorgan executive provides insight into healthcare investment trends
Skip Kelly, a managing director at J.P. Morgan, provides a broad overview of how the healthcare investment landscape is shaping up in the midst of a historic pandemic, as part of MedCity’s 2021 INVEST conference.
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Bristol Myers Squibb SVP Ho Sung Cho highlights pioneering work with protein degradation in support of drug development
In a podcast with MedCity News, Cho talked about the company’s profile in the San Diego life science ecosystem, the need to fail fast and frequently in the early stages of drug development and the work BMS is doing to combat Covid-19.
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Stealthy biotech Janux nabs $125M and joins chase to direct T cells to solid tumors
Biotech startup Janux Therapeutics has a technology that selectively and safely directs T cells to strike cancer cells and an R&D partnership with Merck. Now it has $125 million in Series B financing as it joins the chase to bring these T cell engager drugs to solid tumors.
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Regulatory progress for two biotechs stalls as FDA requests more information
The FDA placed a clinical hold on a KalVista Pharmaceuticals drug being readied for mid-stage studies in a rare, inherited disorder. Meanwhile, the FDA has some questions about the historical data Y-mAbs used as the control in a clinical trial for its antibody cancer drug.
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Vertex to pay CRISPR Therapeutics $900M for bigger share of gene-editing alliance
Vertex Pharmaceuticals is amending its collaboration with CRISPR Therapeutics, paying $900 million now for chance to grab a bigger share of a gene-editing therapy’s profits later—if the treatment is approved. Clinical trials evaluating the CRISPR-based therapy are underway in sickle cell disease and beta thalassemia.
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McKesson Ventures highlights investment priorities amidst a trail of successful exits
McKesson Ventures is one of the most active investors in the biopharma software sector with Komodo Health, Evidation and M2Gen among its portfolio companies.
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Adagio adds $336M for pivotal tests of drug with potential to beat Covid variants
Antibody therapies are seen as one way to overcome the variants that continue to fuel the pandemic. With its Series C financing, Adagio Therapeutics, led by CEO Tillman Gerngross, will proceed with a pivotal clinical trial of an antibody that has neutralized SARS-CoV-2 variants in lab and animal tests.
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OrbiMed-incubated Theseus unveils $100M to beat cancer drug resistance
Incubated by OribMed and led by Ariad Pharmaceuticals veterans, Theseus Pharmaceuticals unveiled $100 million in Series B financing to develop the next generation of tyrosine kinase inhibitors, a type of cancer drug. The company expects to enter the clinic by the end of 2021.
Promoted
How Presbyterian Is Using Digital Health Tools to Address Pandemic Challenges
Timing is everything. In the case of Presbyterian Healthcare Services, its adoption of the Bright.MD platform in 2017 to facilitate telehealth appointments was fortuitous. Read now to learn more.
Promoted
Fruit Street Health launches employer advisory board to manage healthcare costs with digital health
The goal of Fruit Street Labs is to form a collaborative relationship between Fruit Street and employers so that they can jointly develop telemedicine and digital health solutions that address rising healthcare costs and chronic disease in employee populations.
