A central hurdle in computational protein design is the mismatch between proteins designed in silico and their actual behavior after synthesis. “You can design millions of proteins on a computer over the course of a week or a month, but computational approaches are just not good enough,” explained David Younger, co-founder and CEO of A-Alpha…
AbbVie and Janssen receive positive CHMP opinions for novel cancer therapies
The European Medicines Agency (EMA) could soon change the face of cancer treatment with its potential approval of two novel bispecific antibodies, epcoritamab and talquetamab. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization for two novel cancer therapies — AbbVie’s epcoritamab and Janssen’s talquetamab. Epcoritamab for relapsed/refractory…
Take a global tour of 19 major biotech hubs with our interactive map
The international biotech sector clocked in at $1.37 trillion in 2022 despite headwinds such as slow launches, long-term drug pricing shifts and changing consumer behavior. Recent biotech breakthroughs include the development of an Ebola vaccine, progress in genetic testing and drug treatments and advances in artificial tissue growth. This article explores several leading biotech…
Illumina’s record EU fine could drive smaller M&A pharma deals
Illumina, the world’s largest gene sequencing company, faces a record fine from the E.U. for acquiring startup Grail without approval. The $8 billion deal closed in August 2021 despite ongoing EU. and U.S. investigations. A year later, the EU prohibited the merger, citing reduced innovation and choice. The expected $453 million fine, which would be…
Seven biologics walking the approval tightrope in 2023
As we venture into the second half of 2023, the global biologics market continues to hover between robust growth and unpredictability. Valued at $461.74 billion in 2022, it’s projected to grow at a compound annual rate of 10.3% from 2023 to 2030, according to Grand View Research. In 2022, biologics edged past small molecules for…
Guselkumab could offer hope for psoriatic arthritis patients resistant to TNF inhibitors
Janssen continues to strengthen the case that its interleukin-23 inhibitor TREMFYA (guselkumab) offers promise to many patients with psoriatic arthritis (PsA). The company’s phase 3b COSMOS clinical trial involving 189 patients with active PsA and an inadequate response to one to two previous tumor necrosis factor (TNF) inhibitors, guselkumab showed sustained improvements in measures of…
Guselkumab offers sustained improvements for psoriatic arthritis patients in phase 3b trial
Data from Janssen’s phase 3b COSMOS clinical trial reveals that guselkumab (Tremfya), an inhibitor of interleukin-23 (IL-23), provides improvements in all minimal disease activity (MDA) domains for adults with active psoriatic arthritis (PsA). The benefits persist through week 48, even in patients who have seen inadequate responses to one or two tumor necrosis factor inhibitors…
Amgen v. Sanofi: A Supreme Court decision steers drug developers into uncharted waters
The Supreme Court’s recent decision in the case of Amgen Inc. v. Sanofi (No. 21-757) could chart a new course for both the pharmaceutical industry and patent law. In this decision, the Supreme Court provided clarity on what the Patent Act means by ‘enablement,’ raising the bar for the level of detail needed in certain…
Pharma M&A resurgence: An overview of recent deal-making trends
After something of a slow year in 2022, mergers and acquisition (M&A) activity is ramping back up in the pharma and biotech sector. There have been several especially large M&A deals in the past few months. Examples include Pfizer’s (NYSE:PFE) $43 billion acquisition of Seagen, and Merck’s (NYSE:MRK) $11 billion purchase of Prometheus Biosciences. In December…
Unraveling the impact of FDORA and PREVENT Pandemics Acts on the life sciences
As the world continues to grapple with global health challenges, the role of science and biotech law has taken center stage in shaping public health policy and innovation. The FDORA and PREVENT Pandemics Acts are poised to help shape the landscape. In a recent interview, life sciences attorney Barbara Binzak Blumenfeld offers insights into significant…
Lonza and ABL Bio partner on bispecific antibody development for immuno-oncology and neurodegenerative diseases
Lonza (LON:0QNO) and South Korea-based ABL Bio (KOSDAQ:298380) have joined forces to accelerate bispecific antibody development for immuno-oncology and neurodegenerative diseases. Over email, Basel, Switzerland–headquartered Lonza noted that its experience with novel molecular formats enables the company to handle ABL Bio’s unique challenges. In the partnership, Lonza will provide submission-ready chemistry, manufacturing and controls (CMC) data…
BioTheryX’s Prodegy platform takes center stage in cancer research partnership with Incyte
BioTheryX, a privately-held company, and Incyte (Nasdaq:INCY) have formed a research collaboration and license agreement. Their focus is on discovering and developing molecular glue targeted protein degraders for oncology targets. Several other privately-held companies also focus on protein degradation. Examples include Kymera Therapeutics (Cambridge, Massachusetts), Arvinas (New Haven, Connecticut), Nurix Therapeutics (San Francisco), Cullgen (San…
Accelerating biologics R&D with unified software and data flows
Biologics are changing the way we treat disease, affecting where companies invest and, most importantly, impacting patients’ lives. Last year, nearly half of the 37 new drugs approved by FDA’s Center for Drug Evaluation and Research (CDER) were biologics. Its partner agency — the agency’s Center for Biologics Evaluation and Research (CBER)—approved a dozen additional…
XOMA acquires Ixinity’s commercial payment and milestone rights in $9.6M
Biotech royalty aggregator XOMA (Nasdaq:XOMA) has acquired the commercial payment and part of the milestone rights to Ixinity (trenonacog alfa), a hemophilia B therapy originally from Aptevo Therapeutics (Nasdaq:APVO). The aggregator expects the move to bolster its royalty and milestone portfolio, potentially providing consistent cash flow and ramping up its royalty aggregation strategy. The acquired…
Vericel’s unique biopharma focus: Tackling unmet needs in sports medicine and burn treatment
Vericel (Nasdaq:VCEL), a biopharma focused on sports medicine and severe burn care therapies, has a portfolio including the cartilage repair treatment MACI and the burn treatments Epicel and NexoBrid. Focal cartilage defects, which occur in approximately 60% of arthroscopies, can lead to debilitating osteoarthritis if left untreated. Vericel’s flagship product, MACI, tackles this medical challenge…
San Francisco mayor hopes to woo biotech to fill office vacancies
San Francisco Mayor London Breed has suggested that vacant downtown office spaces should be made available for biotech companies to expand, according to the San Francisco Business Times. The biotech industry could help breathe new life into the area, Breed argued. She highlighted a 5% life sciences vacancy rate in the city in contrast to…
Genentech says new Oceanside biologics plant will be one of the world’s most modern
Roche (SWX:ROG) division Genentech recently announced that it would build a new biologics manufacturing facility in Oceanside, California. Optimizing for both speed and modularity, the facility will use the latest digital technologies and in-house process improvements to maximize production volumes. Genentech is also designing the facility with sustainability in mind. The plant will reduce energy…
And the most innovative biotechnology and pharma products are…
The Galien Foundation has selected Regeneron’s (Nasdaq:REGN) Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the best biotechnology product of 2022 and Amgen’s (Nasdaq:AMGN) Lumakras as the best pharmaceutical agent. The organization announced the news last week as part of the Prix Galien USA 2022 awards series in a ceremony in New York City. The antibody cocktail Inmazeb…
Genentech’s clinical supply center rethinks biologics manufacturing
Genentech has opened a novel clinical supply center at its birthplace in South San Francisco. The planning for the new $250 million center began in 2019 when Genentech, a member of the Roche Group, began earnest efforts to imagine what the future of biomanufacturing looks like. “We were looking at where we are going in…
The 22 most innovative biotech products of 2022
The Galien Foundation has rounded up its picks for the most innovative biotech products for its 2022 Prix Galien USA Awards, showcasing advances in biotechnology and health products. The foundation does not include financial information in its nomination process. Consequently, its biotech roundup included few products that have reached blockbuster status. The Galien Foundation will announce the…
How the CMS decision to limit Aduhelm coverage could impact Medicare pricing
Since winning approval for the Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq: BIIB) has faced a punishing string of setbacks. As a result, the company’s share price is currently trading near $200 per share — less than half of its $414.71 peak on June 10, 2021. In April 2022, the Centers for Medicare…
How PolarityTE aims to help heal chronic wounds
Founded in 2016, PolarityTE (Nasdaq:PTE), a company focused on developing regenerative tissue products to address unmet medical needs in chronic wounds, has recently commenced a Phase 3 pivotal study involving patients with diabetic foot ulcers (DFUs). In addition, the FDA granted its investigational SkinTE product Regenerative Medicine Advanced Therapy (RMAT) designation. PTE shares, however, skidded…
Axogen announces positive topline data from Phase 3 nerve graft study
Focused on developing peripheral nerve regeneration and repair products, Axogen (Nasdaq:AXGN) announced that the Phase 3 RECON study met its primary endpoint in comparing its Avance nerve graft to conduits in digital nerve injuries. The primary endpoint was the return of sensory function based on static two-point discrimination. This test measures the ability to detect…
Janssen’s company group chairman dishes on growth strategy
In 2021, Johnson & Johnson’s (NYSE:JNJ) pharmaceutical segment Janssen reported revenue of more than $50 billion in fiscal 2021 and operational growth of 13.1%. Janssen’s pathway approach could fuel future growth. Janssen exec Tom Cavanaugh‘s next big goal for Janssen is ensure Janssen is a $60 billion pharmaceutical company by 2025. Heavy reliance on R&D will…
Imfinzi with chemotherapy gets FDA priority review for locally advanced or metastatic biliary tract cancer
AstraZeneca (LON:AZN) has announced that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has received Priority Review from FDA when used with chemotherapy in patients with locally advanced or metastatic biliary tract cancer (BTC). The company had submitted data from the TOPAZ-1 Phase 3 study indicating an improvement in overall survival compared to standard-of-care chemotherapy.…