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Deals:

Novartis has signed an up to $5.2 billion licensing and options deal with Argo Biopharmaceutical.

Arrowhead Pharmaceuticals and Novartis agreed to a deal worth up to $2 billion for a license to a neuromuscular therapy.

Remedy Meds is set to acquire Thirty Madison for just over $500 million.

OMass Therapeutics and Genentech agreed on a deal for a preclinical oral small molecule program for inflammatory bowel disease – the former company will receive $20 million upfront and up to $400 million in milestone payments.

John Maraganore and Clive Meanwell teamed up to support Corsera Health with $50 million to prevent cardiovascular disease.

Gilead Sciences unveiled a partnership with PEPFAR to deliver twice-yearly lenacapavir for HIV prevention for up to 2 million people in primarily low- and lower-middle-income countries.

Mytos agreed to cell therapy manufacturing deals with three European biotechs.

FreeWheel announced its FreeWheel Buyer Cloud is joining with IQVIA Digital’s purpose-built Media Operating System.

FDA:

The FDA approved Teva Pharmaceuticals’ cheaper generic version of Novo Nordisk’s weight-loss drug, Saxenda.

Agios Pharmaceuticals said the FDA extended the review of its drug Pyrukynd by three months in order to fully vet a drug-safety plan to mitigate the risk of liver toxicity.

The agency declined to approve Outlook Therapeutics’ bevacizumab product Lytenava (ONS-5010) for the treatment of wet age-related macular degeneration.

Replimune Group said a meeting with FDA officials has been scheduled to discuss the recent rejection of its treatment for advanced melanoma.

AstraZeneca will seek FDA approval for its blood pressure drug Baxdrostat by the end of the year.

The FDA delivered Ori Biotech’s IRO platform an Advanced Manufacturing Technology designation.

The FDA proposed a new process to accelerate the approval of drugs for rare diseases.

The agency approved Biogen-Eisai’s Leqembi Iqlik (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer’s disease.

Subsequently, Eisai initiated a rolling supplemental Biologics License Application to the agency for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer’s disease under Fast Track Status.

Sanofi’s Wayrilz was approved as the first BTK inhibitor for immune thrombocytopenia.

The agency called on manufacturers of nicotine pouches to use child-resistant packaging in order to better prevent accidental ingestion.

Amneal Pharmaceuticals relied on contaminated bags for a sterile injectable drug even after identifying the risk and then lowered its standards so that the bags could continue to be used, according to a warning letter issued by the FDA.

Eli Lilly’s olomorasib received an FDA Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers.

The FDA announced it will release future complete response letters promptly after they are issued to sponsors.

Funding rounds:

Atlas Venture raised a $400 million opportunity fund.

Treeline Biosciences raised another $200 million.

Propanc Biopharma announced a plan to acquire $100 million of Ethereum.

CHARM Therapeutics raised $80 million in Series B financing.

MRM Health raised a €55 million Series B financing round. 

New Haven-based Revalia Bio raised $14.5 million.

Artelo Biosciences priced a $3 million public offering. 

Layoffs:

Exelixis announced it will shutter its facility in Pennsylvania, laying off 130 employees.

Novartis will lay off 58 employees at its U.S. headquarters in East Hanover, New Jersey.

Alphabet’s health science company Verily has shut down its devices program and cut staff.

Industry news:

BeOne Medicines said its candidate for a rare but aggressive form of B cell lymphoma passed an early-stage test.

United Therapeutics reported positive results from a Phase 3 study of its inhaled medicine Tyvaso in patients with idiopathic pulmonary fibrosis.

Cytokinetics’ experimental drug aficamten beat the standard-of-care treatment in a head-to-head Phase 3 trial of newly diagnosed patients with obstructive hypertrophic cardiomyopathy.

Under a court settlement, the Trump administration agreed to restore scores of health agency webpages and datasets that went dark to comply with executive orders on diversity, equity and inclusion and gender identity.

Republicans on a House Appropriations panel advanced a bill that would cut the Department of Health and Human Services budget by six percent for the fiscal year.

Oregon, Washington and California formed a healthcare alliance to protect vaccine access.

Ionis Pharmaceuticals’ Tryngolza has succeeded in two crucial late-stage tests that could broaden the drug’s commercial reach.

Sanofi’s atopic dermatitis drug fell short of Wall Street’s expectations in a late-stage trial.

Amgen is set to invest $600 million in a new research and development facility in California. 

Additionally, Amgen and partner Zai Lab reported that their stomach cancer drug’s survival benefit dropped in a Phase 3 trial.

Signal Theory was named U.S. agency of record for global animal health firm Virbac.

Wave Life Sciences reported updated results from a mid-stage study of its RNA-editing treatment for the serious lung condition alpha-1 antitrypsin deficiency.

Immunovant reported longer-term outcomes of its autoimmune treatment batoclimab in Graves’ disease, but it’s unlikely the company will advance the experimental drug.

A bankruptcy judge rejected a chapter 11 filing by an affiliate of National Resilience.

Novartis’ Leqvio achieves early LDL-C goal with less muscle pain.

Merck said its investigational oral PCSK9 inhibitor Enlicitide Decanoate met all primary and key secondary endpoints in adults with hypercholesterolemia in pivotal CORALreef lipids study.

EpiCypher launched Cutana Fiber-seq.

AnalyticsIQ announced the launch of its healthcare provider datasets in the Snowflake Marketplace.

See last week’s edition of Rx Rundown.