Pharma

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FDA denies approval for Neffy, ARS Pharmaceuticals’ needle-free EpiPen alternative, citing safety concerns

Anika Sharma

While positive votes from FDA advisory committees often bode well for drug approvals, ARS Pharmaceuticals experienced an unexpected setback when ...

Eli Lilly, Mounjaro, compounding, Novo Nordisk, Lawsuits, Ozempic, Wegovy

Eli Lilly Sues 8 Companies for selling fake Mounjaro versions

Anika Sharma

The surging demand for GLP-1 diabetes and weight loss medications has led to an inevitable influx of knockoff versions. Earlier ...

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Merck KGaA signs two deals with BenevolentAI and Exscientia to boost AI-driven drug discovery in oncology and immunology

Anika Sharma

Merck KGaA is making strategic moves in the field of AI-enabled drug discovery by entering into three-target partnerships with BenevolentAI ...

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Genentech and PeptiDream expand peptide collaboration to explore radiopharmaceuticals for cancer

Anika Sharma

Japanese biotech firm PeptiDream continues to attract significant interest from major pharmaceutical companies. Genentech, a long-term partner, has entered into ...

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Genentech and Orionis Biosciences team up to discover molecular glue drugs for oncology and neurodegeneration

Anika Sharma

Genentech, a subsidiary of Roche, is aggressively expanding its partnered portfolio into cutting-edge areas of research and development. Following a ...

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Taysha halts gene therapy for rare nerve disease after FDA and Astellas feedback

Anika Sharma

Astellas has declined the opportunity to exercise an option for an asset from Taysha Gene Therapies. Taysha, facing study design ...

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Biocon Biologics’ CEO reveals pricing strategy and device design for Hulio, its Humira biosimilar, in the US market

Anika Sharma

The competition in the biosimilar arena targeting AbbVie’s blockbuster drug Humira, also known as adalimumab, is heating up. However, for ...

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Debbie Allen joins Regeneron and Prevent Blindness to launch the Gr8 Eye Movement and raise awareness of serious retinal diseases

Anika Sharma

Regeneron is adding a touch of star power to its efforts to promote eye health by enlisting the renowned actress, ...

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Revance slashes Daxxify’s price to compete with AbbVie’s Botox in the cosmetic market

Anika Sharma

Nashville-based company Revance had high hopes for its new cosmetic dermal filler, Daxxify, which boasted a longevity twice that of ...

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Novo Nordisk’s semaglutide facility in North Carolina faces FDA scrutiny over quality issues

Anika Sharma

Novo Nordisk’s shares faced a decline following reports that the FDA had raised concerns about manufacturing issues at the company’s ...

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FDA issues guidance on single-trial evidence for drug approval

Anika Sharma

Biopharmaceutical companies seeking FDA approval based on a single clinical trial must provide comprehensive and transparent data, including both positive ...

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Scancell’s DNA vaccine shows promising results in phase 2 trial for skin cancer

Anika Sharma

Scancell’s shareholders are enjoying a prosperous week as the biotech company’s stock surged by 20%, driven by promising preliminary data ...

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Arcturus reports positive results for sa-mRNA COVID boosters in phase 1/2 trial

Anika Sharma

Amid a shrinking COVID-19 vaccine market, Arcturus Therapeutics is forging ahead with its mRNA candidate, revealing promising early data demonstrating ...

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Novo and Lilly’s obesity drugs face barriers of high price and low coverage, survey shows

Anika Sharma

A recent survey of 100 doctors in the United States who prescribe weight loss medications has revealed that over 75% ...

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Humira sales decline as biosimilars gain traction, but physicians remain wary of switching patients

Anika Sharma

In the race to capture a share of the $20 billion annual revenue generated by AbbVie’s blockbuster biologic, Humira biosimilars ...

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Astellas claims positive results for Izervay in geographic atrophy but remains vague on data

Anika Sharma

Astellas, having recently secured FDA approval for its drug Izervay to treat geographic atrophy (GA), is now in direct competition ...

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Guard shares soar as new data show clinical benefit despite missing primary endpoint

Anika Sharma

Guard Therapeutics is staging a remarkable recovery following a setback in its phase 2 clinical trial for kidney injury treatment. ...

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Novartis gives up on tislelizumab, BeiGene’s PD-1 inhibitor approved in Europe

Anika Sharma

Novartis has terminated its significant cancer immunotherapy collaboration with BeiGene, ending a partnership that had granted Novartis co-development and co-commercialization ...

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Biocon appoints Peter Bains as group CEO to lead its global expansion

Anika Sharma

Biocon has appointed Peter Bains as its new CEO as the company seeks to expand its presence in North America ...

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Novo Nordisk partners with Aspen to boost insulin supply in Africa

Anika Sharma

Novo Nordisk, a prominent player in the diabetes pharmaceutical industry, is taking significant steps to bolster insulin supplies in Africa. ...

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Kinnate slashes workforce and pipeline after disappointing clinical data

Anika Sharma

Kinnate Biopharma, a Californian biotech, is taking significant measures to manage its financial situation after disappointing cancer data results led ...

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Pfizer’s tafamidis faces competition from Alnylam and BridgeBio in rare disease market

Anika Sharma

Alnylam and BridgeBio are poised to enter the highly lucrative transthyretin amyloidosis cardiomyopathy (ATTR-CM) market with the backing of an ...

Catalent, Lonza, CDMO, biologics, Jean-Christophe Hyvert, CEO departure, bioscience

Catalent hires former Lonza bioscience chief to lead its biologics unit amid CEO departure

Anika Sharma

In a swift succession of leadership changes at Swiss contract development and manufacturing organization (CDMO) Lonza, David McErlane, the former ...

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BOTOX Cosmetic shows promise for neck and lower face rejuvenation in phase 3 trial

Anika Sharma

Allergan Aesthetics, a subsidiary of AbbVie, has unveiled positive top-line findings from the second out of three Phase 3 clinical ...

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Sandoz gets CHMP nod for biosimilar of Herceptin, a drug for HER2+ breast and gastric cancer

Anika Sharma

Sandoz, a leading global player in generic and biosimilar medications, has received a noteworthy endorsement from the Committee for Medicinal ...

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Pharmanovia buys 11 CNS drugs from Sanofi to expand its portfolio of repurposed medicines

Anika Sharma

Sanofi, in its ongoing effort to streamline its product portfolio, is divesting 11 central nervous system (CNS) medications to Pharmanovia, ...

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Motif Neurotech implants tiny device to stimulate brain and treat depression

Anika Sharma

Neurostimulation has emerged as a promising therapy for alleviating the symptoms of major depressive disorder, even in cases where traditional ...

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CEPI funds BioNTech’s mRNA-based mpox vaccine trial with $90 million

Anika Sharma

BioNTech, the German biotech renowned for its groundbreaking mRNA COVID-19 vaccine, is embarking on clinical trials for an mRNA vaccine ...

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Lonza CEO Ruffieux quits after less than a year, chairman steps in

Anika Sharma

Lonza, the Swiss Contract Development and Manufacturing Organization (CDMO), is once again on the hunt for a new CEO, marking ...

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Samsung Biologics expands antibody production deal with Bristol Myers Squibb for $242 million

Anika Sharma

Samsung Biologics, a leading biopharmaceutical contract manufacturing organization, has strengthened its partnership with Bristol Myers Squibb (BMS) by securing a ...