AstraZeneca criticizes CMS guidance in appeal over price negotiations
More than four months after losing a legal attempt to overturn parts of the Inflation Reduction Act’s drug price negotiations, AstraZeneca is firing back in a court appeal, arguing that CMS’ latest...
View ArticleFederal judge dismisses Hawaii’s lawsuit against top three PBMs
A federal judge has tossed a lawsuit against the three largest pharmacy benefit managers, pouring cold water on the state of Hawaii’s claim that the companies unlawfully inflate drug prices. Friday’s...
View ArticleLarge group of state attorneys general backs Oregon drug price transparency law
In the latest chapter of years of legal back-and-forth, attorneys general from 20 states and the District of Columbia have asked a federal appeals court to reverse a decision that an Oregon drug price...
View ArticleClik here to view.
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...
View ArticleFDA 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...
View ArticleAfter 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...
View ArticleRenalys 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...
View ArticleCaribou 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...
View Article#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...
View ArticleGenentech 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...
View ArticleManufacturing 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...
View Article#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...
View ArticleClik here to view.
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....
View ArticleRoche 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...
View ArticleAI 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...
View ArticleClik here to view.
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...
View ArticleHuman 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,...
View ArticleSK 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...
View ArticleBig 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...
View ArticleGilead 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...
View Article