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Cytokinetics gets an 'incremental' win for delayed heart drug

Cytokinetics’s aficamten is better than the standard of care in a heart muscle disease, the company said Tuesday. The development is positive, but with aficamten’s approval submission delayed, it will...

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Arcturus to prioritize mRNA therapeutics in bid to boost rare disease programs

Arcturus Therapeutics is doubling down on mRNA technology. The biotech said Monday that it's prioritizing its experimental self-amplifying mRNA drugs, with a focus on programs for cystic fibrosis and a...

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Some generics, biosimilar drugmakers say they can withstand tariff impact

A handful of generic and biosimilar manufacturers have said they feel prepared to ride out President Donald Trump’s potential pharma-specific tariffs due to their domestic production footprints and not...

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HHS issues guidance for third round of drug price negotiations

The Trump administration laid out for the first time how Part B drugs could be selected for Medicare drug price negotiations under guidance that seeks to align with and improve transparency in the...

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CRISPR patent spat revived by federal appeals court ruling

An order from a federal appeals court has kicked the battle wide open again over who holds the key patents for CRISPR-Cas9, a revolutionary gene editing technology. The US Court of Appeals for the...

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Omada Health joins the digital health IPO corral

On Friday afternoon, Ngai, Shelby and I dropped what we were doing when we saw Omada Health had filed to go public. Omada, the virtual chronic care provider, joins virtual ...

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Advocacy groups and experts call for decade-long ban on germline editing

Cell and gene therapy advocacy organizations are jointly calling for a 10-year international moratorium on gene editing of the human germline. They say such use of gene editing comes with questionable...

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Novo turns to Septerna for oral obesity medicines in deal worth up to $2.2B

Novo Nordisk continues to sling obesity drug partnerships. Its latest biotech of choice is Septerna, which will help the Danish pharma make oral small molecules. Novo will give over $200 million in...

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GSK to pay $1.2B upfront to snag Boston Pharma’s mid-stage MASH hope

GSK will hand over $1.2 billion in upfront cash to license a closely-watched candidate for fatty liver disease from Boston Pharmaceuticals. The drug in question is Boston Pharma’s lead asset,...

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AbbVie doubles down on siRNA with $335M upfront bet on ADARx

After getting into siRNA work with its $1.4 billion acquisition of Aliada Therapeutics late last year, AbbVie is beefing up its presence in the hot subfield of genetic medicines. On Wednesday, AbbVie ...

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SK, Carlyle bolster bluebird bio bid; Therini Bio raises $39M

Plus, news about Allogene, Kyverna, Sernova, ADC Therapeutics, Acelyrin, Alumis, Atara, Lava Therapeutics and Repare Therapeutics: SK, Carlyle offer more upfront cash to bluebird bio shareholders:...

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FDA gives AbbVie accelerated approval for antibody-drug conjugate in lung cancer

The FDA approved a new antibody-drug conjugate from AbbVie on Wednesday to treat patients with certain kinds of lung cancer. Regulators granted accelerated approval to telisotuzumab vedotin in...

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Sanofi touts $20B investment in US over five years

Sanofi announced plans to invest “at least” $20 billion in the US through 2030, following similar commitments made by several pharma companies. The company said Wednesday that the investment includes...

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Ex-FDA chief Robert Califf thinks RFK Jr.'s vaccine opinions are relevant

HHS Secretary Robert F. Kennedy Jr. told a House committee Wednesday morning that he believed his opinions on vaccines were “irrelevant,” prompting a rebuke from a former top US health official. The...

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RFK Jr. defends HHS staff cuts at two congressional hearings

HHS Secretary Robert F. Kennedy Jr. faced hours of congressional grilling on Wednesday over his proposed budget cuts and planned overhaul of the agency that’s expected to shrink the workforce by 20,000...

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Hengrui, one of China's leading biotechs, anticipates $1.2B in proposed Hong...

Jiangsu Hengrui, a 55-year-old drugmaker that has become one of China's leading forces in biotech, expects net proceeds of about 9.4 billion Hong Kong dollars ($1.2 billion) from its proposed float on...

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Biohaven stock sinks on three-month delay for neuro drug's FDA approval decision

Biohaven said late Wednesday that the FDA would be delaying the PDUFA date for its neurodegenerative disease therapy troriluzole and will also require an advisory committee meeting to review the drug....

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Merck KGaA Q1 earnings: Tariff surcharge for US customers will continue

Despite pausing a tariff surcharge for China-based clients, Merck KGaA will carry on with adding an extra charge for US customers to account for President Donald Trump’s levies. “What we're doing is we...

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Exclusive: Datavant will acquire Aetion, double life sciences team

The health tech company Datavant is acquiring Aetion, a rival in the real-world data space, Endpoints News exclusively reports. Datavant on Thursday plans to announce the deal, which will double the...

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Abundant Venture Partners teams up with 17 health systems to develop tech

Seventeen health systems have signed up for a venture firm to help them vet which health tech companies to adopt and invest in, as more hospitals look towards a more concierge-style approach to...

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