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Biotech industry flirts with XBI milestone as it surpasses $100

As bankers and investors were getting their Monday afternoon pick-me-up coffee, they might have noticed a slight upswing in the biotech industry’s main stock index. For an approximately 70-minute...

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FDA again rejects Orexo's nasal spray for opioid overdose rescue

For a second time, the FDA has turned away Orexo’s nasal spray treatment for opioid overdoses. The company will need to complete another “human factor” study before resubmitting its application, Orexo...

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After a handful of stumbles, argenx doubles down on pipeline-in-a-product...

Five years ago, the Dutch biotech argenx outlined plans to test its drug Vyvgart in more than a dozen autoimmune conditions. By removing the self-sabotaging antibodies believed to be responsible for...

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Renalys raises $37.8M to take Travere's kidney disease drug into Phase 3...

Japanese biotech Renalys Pharma has raised $37.8 million (¥6 billion) in a Series A round to work on an approval in Japan for the drug Filspari in a rare kidney disease. Renalys took over the rights to...

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Caribou to slash preclinical allogeneic CAR-NK work, lay off 12% of staff

Caribou Biosciences is cutting its CAR-NK research and laying off 21 employees, or 12% of its staff, the company announced Tuesday. “We are undertaking this reduction to extend our cash runway by...

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#ASRS24: Adverum prepares pivotal study for wet AMD gene therapy, touts Phase...

Adverum Biotechnologies’ eye disease gene therapy has traversed a rocky road of safety troubles, but the company — presenting new Phase 2 data in wet AMD — now believes it has a clear shot to a pivotal...

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Genentech ends SHP2 deal with Relay Therapeutics after other pharma exits

Roche’s Genentech is scrapping a collaboration and license agreement with Relay Therapeutics surrounding the biotech’s clinical-stage oral SHP2 inhibitor. It’s the latest pharmaceutical company to...

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Manufacturing investment firm BioProcess360 launches with $100M for...

With its first round of $100 million in hand, a new investment firm has emerged to help fund and mentor up-and-coming businesses that are developing tools and tech that can help reduce manufacturing...

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#ASRS24: 4DMT builds out case for wet AMD gene therapy with new Phase 2 data

4D Molecular Therapeutics presented new Phase 2 data for its wet AMD gene therapy, showing a durable response in a broad patient population, as it prepares to enter Phase 3 testing early next year. The...

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Three months after delisting, NGM Bio is back with $122M for slimmed-down...

NGM Biopharmaceuticals is pushing ahead with two of its 10 clinical-stage programs after the drug developer was taken off the Nasdaq by one of its original investors, The Column Group, back in April....

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Roche declares early win for oral GLP-1 drug it bought from Carmot

Roche’s $2.7 billion acquisition of Carmot Therapeutics delivered another success this week. The Swiss pharma said Wednesday morning that its oral GLP-1 receptor agonist produced positive weight loss...

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AI drug development company gets $80M backing from Pfizer, Nvidia and Thermo...

Pfizer, Nvidia and Thermo Fisher have pitched in to help a machine learning firm amplify its AI approach, which could help biopharma companies better succeed in drug development. CytoReason will use...

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Cassava founder and CEO resigns as federal probes progress

Cassava Sciences founder and CEO Remi Barbier is resigning amid two federal probes into the company, which said it’s looking for a new leader. Remi Barbier The news, announced Wednesday, marks the end...

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Human challenge trial company hVIVO looks to buy small CROs

LONDON – Viral challenge study service provider hVIVO is in “search mode” to buy small contract research organizations (CROs) to help reach its goal of £100 million ($130 million) in revenue by 2028,...

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SK to pay up to $571M in new radiopharma deal; Aslan lets go of all employees

Plus, news about Aclaris, OMERS Life Sciences, Draupnir Bio, Pharnext and Actuate: SK Biopharmaceuticals licenses Full-Life’s radiopharma drug: The deal — which is worth $571.5 million in upfront and...

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Big three PBMs will testify before Congress next week, following FTC report

Pharmacy benefit manager executives from Cigna, CVS Health and UnitedHealth Group are scheduled to testify before Congress on July 23, giving lawmakers a chance to question the companies after a...

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Gilead chief medical officer Merdad Parsey to leave company early next year

Merdad Parsey, Gilead’s chief medical officer, will leave the company at a time when its pipeline has stalled and it’s faced several major stumbles in cancer drug development. He is staying on until...

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Thyme Care scores $480M valuation in new funding round

(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.)  Thyme Care’s latest funding round bumped its valuation to $480 million, more than double what it was a...

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FDA announces rare disease hub in bid to streamline treatment paths

The FDA will launch a rare disease center to unify its policies and find new ways to evaluate drugs that can pose a regulatory dilemma, it announced Wednesday. The new Rare Disease Innovation Hub comes...

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J&J has its final offer in hand from the government over IRA pricing

Johnson & Johnson said the final price offers it has received under the IRA won’t affect the long-term sales growth projection it gave last year, making it the latest drugmaker to suggest it can...

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